Pharmaceutical & Cosmetic Review February 2021

February 2021 Volume 48 | Number 2

48

years www.pharmacos.co.za

sunscreen products

Innovative preservative systems for

FROM BACKSTREETS TO BOARDROOMS: CBD explodes on the healthcare market

LOVE THOSE LOCKS: Anti-hair loss, scalp care & fibre repair solutions

EFFECTIVE PROTECTION:

How to formulate new-age sunscreens

2020/21 P&C Review and Symrise

P&C Review and Symrise are unveiling a re-energised New Product Competition that is relevant to all players in the South African cosmetics industry.

The 2020/21 P&C Review/Symrise New Product Competition will now be judged according to the following market segments: • Mass/Masstige • Prestige • Privé Label The entries scoring the highest in each of the three segments will all be named winners of the 2020/21 P&C Review/Symrise New Product Competition.

Who is eligible to enter: • Local and international personal care, hair care, skin care, beauty and cosmetics brands, whose products are available in South Africa.

• Brand owners, private label or house brands, manufacturers, retailers or distributors who have launched new products between 1 January 2019 and May 2021.

review Pharmaceutical & & Cosmetic

All entries will receive confidential reports with extensive feedback from our panel of expert judges, who collectively hold over 100 years’ experience in their respective fields. Each product/range entered into the 2020/21 New Product Competition will be judged on the following criteria: • Formulation design • Regulatory compliance • Packaging • Marketing incorporating social media and digital campaigns.

Entries are now open and will close on 1 June 2021.

For more information or to enter, contact Abby Vorster, editor of P&C Review on 071 359 4519 or send an email to Abby.Vorster@newmedia.co.za. www.pharmacos.co.za

Volume 48 | Number 2 www.pharmacos.co.za

February 2021

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Contents

20

44 INSPECTION & DETECTION Realise the benefits of X-ray for quality assurance Using AI to validate a syringe inspection unit

36

6 NEWS

12 PRESERVATIVES

28 SUN CARE

47 STUDENT FOCUS

DHL invests R126mn in new SA facility

Solving the sunscreen preservation challenge

A convenient approach to sun protection

P&C Review/Coschem essay prize winner

Keep COVID-19 at bay with atomised cleansing

Ashland introduces Phyteq raspberry

Dispersions for new-age sun protection

UPM Raflatac scales up its linerless business

Sustainable broad-spectrum antimicrobials

Tips to optimise sprayable formulations

9 PRODUCT NEWS

19 PHARMA FOCUS: CANNABIS

32 HAIR CARE

What’s new on our radar

11 INDUSTRY TALK Plant-based trend moves into dietary supplements

Functional CBD-based topicals from Afriplex

Hair health activist explores summer trends Regulate grey naturally with Wisegrade

How to encapsulate and spray-dry CBD and THC

Advice on keeping your claims in check

Tracking cannabis from seed to manufacturing

360° solution for hair loss prevention

The future development of cannabinoid production New certification standard for CBD consumer products M2Bio Sciences clarifies common CBD misconceptions

New rich bio-oil promises healthier hair Hair health and wellness take centre stage A natural approach to managing sebum

12

On the cover Innovative preservative systems for sunscreen products

WWW.PHARMACOS.CO.ZA // FEBRUARY 2021

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FROM THE EDITOR

Enter the New Product Competition

2

020 was the year of the hand sanitiser – sales and innovations boomed as people sought to protect themselves from COVID-19.

According to Mintel, this unprecedented demand caused disruption to NPD while ongoing lockdowns resulted in a difficult year for beauty sales worldwide. Despite these challenges, it’s encouraging to see the South African cosmetics industry’s interest in the 2020/21 P&C Review / Symrise New Product Competition (NPC).

Last year, we put the competition on ice due to the coronavirus and took some muchneeded time to re-strategise the NPC. Working in conjunction with our sponsor Symrise, we revamped the NPC to ensure its relevance to all players in the South African beauty and cosmetics industry. We’ve introduced new categories – mass, masstige, prestige and privé label – and we’ve extended the deadline for entries to 1 June 2021. This was to ensure that the lockdown regulations of 2020 wouldn’t have a negative effect on the ability of brands to enter this year.

Entries are coming in fast and we’re highly encouraged by the support we have received so far. If you feel your brand has what it takes to be named the most innovative in its respective category, then you need to enter. Please send me an email (abby.vorster@newmedia.co.za) to request the info pack and entry form for this year’s competition.

In this edition of P&C Review, we take a closer look at the booming medical cannabis market. After decades of prohibition, marijuana has undergone a radical makeover.

Emerging from the streets to being embraced by the boardroom, cannabidiol – or CBD as it’s commonly known – has taken centre stage on the global health and wellness market. Turn to page 19 now to read about the new cannabis offerings from Afriplex, check out Buchi’s technical advice on how to encapsulate and spray-dry CBD and THC, and learn more about the benefits of cannabis seed-tomanufacturing tracking software from Mitas.

CJP Chemicals is featured on the cover this month in an effort to help our readers solve their sunscreen preservation challenges. You can read more about this on page 12, where the essence of successfully assembling and preserving a sunscreen formula in discussed in detail.

On page 32, the section on hair care explores top tips and summer hair trends.

We also share insightful technical content on LipoTrue’s Wisegrade – an active ingredient that helps to regulate the amount grey in a natural, non-damaging way, and AlgaPūr HSHO algae oil from Lubrizol Advanced Materials – which provides multiple benefits for hair and scalp care.

Stay safe and enjoy the read!

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Professor Emeritus, Faculty of Health Sciences, Nelson Mandela University

FEBRUARY 2021 // WWW.PHARMACOS.CO.ZA

SUB-EDITOR: Katrien Smit CONTRIBUTORS: Naama Eylon, Dershana Jackison, Reneé Potgieter, Eulalia Peri, Juliana Gomiero, Elena Cañadas, Carole Lepilleur, Jean Xavier, Raquel Delgado, Michelle Nott

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EDITOR: Abby Vorster +27 (0)71 359 4519 abby.vorster@newmedia.co.za

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Past-President, Society of Cosmetic Chemists SA

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Pharmaceutical & Cosmetic Review is published by New Media 11 times a year and circulates to manufacturers, packers and distributors of pharmaceuticals, health products, cosmetics, detergents, soaps, toiletries and allied products. The journal is an up-to-date source of reference for company directors, factory and production managers, marketing executives, engineers, import agents, buyers and research personnel.

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NEWS

New consumer study set to assess the

skin health benefits of a food supplement SkinBioTherapeutics, a life science company focused on skin health, has announced that AxisBiotix, a wholly owned subsidiary of the company, has commenced enrolment for its food supplement consumer study.

Further to research exploring the relationship between the gut and the skin and the scientific evidence pointing to a link between gut dysfunction, stress-induced alterations to the gut microbiome and skin inflammation, the company has been working with Winclove Probiotics for the development of a blend of bacterial strains as a food supplement.

A proprietary blend of bacterial strains has been specifically designed to balance the gut microbiome to address the over production of new skin cells often seen in aggressive skin conditions such as psoriasis. This is a debilitating skin condition caused by a malfunction of the immune system whereby raised plaques form on the skin, which can be flaky, scaly and itchy. There is currently no cure for psoriasis; therapies tend to be steroid based, which cannot be used long term and have side effects. The condition is common, with approximately 2% of the global population believed to suffer from psoriasis.

With Winclove having completed formulation and manufacture of the supplement, and unable to initiate its clinic based human study due to the COVID-19 restrictions, the company has established a protocol for a self-managed food supplement study.

The study, which will accept approximately 200 applicants, is now open for enrolment through the website www.axisbiotix.com. The

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participants will be asked to take a powdered food supplement dissolved in a glass of water on a daily basis and the study will run for a total of 56 days (two x 28-day blocks). Thereafter the data will be collated and analysed to assess the impact the supplement has had on the health of the skin. The study is monitored through a mobile phone application with frequent questions for participants and the submission of photographs of affected areas taken using their smart devices. As such the study is not impacted by current COVID restrictions.

The study will conclude before the end of April 2021 and the company expects to be able to report on the findings shortly thereafter. Subject to a positive outcome, the company will then target a commercial launch of the product during the course of 2021 and in parallel initiate a clinical study looking at specific markers.

Stuart Ashman, CEO of SkinBioTherapeutics, said: “2020 was a year of transition for SkinBioTherapeutics with a focus on flexibility. We managed a smooth evolution from research into development, and proactively managed our way around the everchanging obstacles that the global pandemic continues to present. The preparatory work carried out last year has ensured that we remain on track with all our strategic and commercial goals as we move into 2021, where we expect to see significant progress across several of our strategic channels. The launch of the AxisBiotix website and the recruitment of candidates for our AxisBiotix-Ps study, as well as the ongoing progress made

by Sederma with our skin care programme, heralds the start of our commercialisation drive.”

FEBRUARY 2021 // WWW.PHARMACOS.CO.ZA

Clement Blanc, managing director, DHL Global Forwarding, South Africa

DHL invests R126.5mn in new SA facility In a strategic move that reinforces its commitment to the country, DHL Global Forwarding is investing R126.5mn in a new facility in Johannesburg. Aimed at cementing its market-leading position in South Africa, the new 13 000m2 facility will be located within the bonded zone at Skyparks Business Estate – a hair’s breadth from OR Tambo International Airport.

Clement Blanc, managing director, DHL Global Forwarding, South Africa said: “While it’s too early to fully grasp the economic impact of the current pandemic, our confidence in investing ahead of the curve is abetted by our diverse service portfolio and long-established foothold in Africa. As the world’s largest free trade area moves toward economic integration, our five-year strategy to sharpen our core business offerings and accelerate digitalisation will further our growth in the region and specifically, in South Africa.”

Twice the size of its current set-up, this new facility will consist of a 10 000m2 warehouse that enables DHL to consolidate all its customers’ warehousing requirements. There will be an exclusive and specialised cold chain facility, which consists of three adjustable temperature-controlled refrigerators geared to handle the life science and healthcare products in and out of South Africa. The warehouse will also support other value-added services including cross-docking, storage for air, ocean and road freight services, and a platform for breakbulk cargo.

“Custom-built to our world-class specifications and located in proximity to the airport, arterial thoroughfares and upcoming industrial parks, this new facility will be the game-changer for DHL in the country. We are well-poised to focus on delivering excellence to our customers as we surround ourselves with the critical infrastructure that is needed to enhance our productivity and efficiency,” added Blanc.

NEWS

Keep COVID-19 at bay with atomised cleansing With the new highly contagious variant of COVID-19 spreading throughout South Africa, it is our responsibility to ensure the safety of our families, friends, co-workers and customers. You can put their health and safety first with the Ster-Safe no-touch room decontamination systems from Imasol which use atomised hydrogen peroxide in the sterilisation application.

Studies have shown that even with comprehensive manual cleaning, less than 50% of room surfaces are cleaned properly when using conventional wipedown methods. For this reason, new

no-touch methods have been developed for combating the spread of COVID-19.

The American Journal of Infection Control indicates that one of the most effective no-touch methods uses atomised cleansing which has been shown to inactivate most of the important viruses including coronavirus.

The Steri-Safe pure-peroxide system rapidly disinfects all surfaces and air in a room at the press of a button, maximising hygiene and safety for all people using the room.

Imasol is offering free demonstrations Atomised cleansing is one of the most effective no-touch methods to disinfect areas during the within the Gauteng region. Visit www.steriCOVID-19 pandemic safe.co.za for more information.

Jazz Pharmaceuticals agrees to acquire GW Pharma for $7.2bn

Sustainable cyclopentanone production

The medical cannabis and wellness UCITS ETF is

getting involved in the medical cannabis market.

Solvay has begun a process of decarbonising

Europe’s first ETF focused on cannabis. The fund

This could be a notable turning point as a more

the cyclopentanone unit of its Melle plant

trades in London under CBDX and in Germany as

traditional pharma company, Jazz pharma, has

in France. Through an agreement with an

CBSX and is passported for sale across Europe. It

agreed to purchase GW Pharma for over $7bn.

agricultural cooperative for the next 15 years,

has focused on the medical side of cannabis with

We don’t think this is the last deal we will see in

the entire cyclopentanone production will

pharmaceutical companies such as GW Pharma

the sector.”

indeed rely solely on biomethane gas, a green

at the core of its portfolio – it accounts for around 14% of the fund’s holdings.

Nawan Butt, portfolio manager of the

One of the sectors that benefited the most from the US election results is cannabis. The

source of energy.

The cooperative built a facility to convert

sector is still in the early phase of its growth to

waste biomass into 18GWh of renewable

medical cannabis and wellness UCITS ETF,

becoming a more mainstream consumer and

natural gas (RNG) per year, which Solvay has

said: “GW Pharmaceuticals is a UK-based

healthcare category and with the democrats in

committed to purchase for the Melle plant.

company which made history by getting the

power, the move towards legalisation in the US

first FDA-approved drug derived from cannabis.

is expected to gain momentum. With is reality

block for so many fragrance applications,

The drug, Epidiolex has changed the lives of

becoming more widely appreciated, many of the

such as jasmine, we are committed to

many living with epilepsy, and it is building out

US recreational focused cannabis names have

producing it in the most sustainable way,”

a platform looking at other areas. When GW

been seen to do extremely well over the past

said Guillaume Meunier, flavour and fragrance

Pharma started most global pharmaceutical

month. But now the focus of the sector could

global marketing director for Solvay Aroma

companies were hesitant to do work with this

switch to the medical side.

Performance. “Powering the Melle plant

plant, ignoring centuries of evidence of health

“This acquisition should draw attention to

“Since cyclopentanone is used as a building

with biomethane gas is a part of our Solvay

benefits. As times are changing and attitudes

other companies doing work in this sector and the

One Planet initiative, which aims to reduce

adjusting, more and more companies are

opportunities they are exploring,” says Butt.

greenhouse gas emissions by 26%, by 2030.”

Solvay commercialises two grades of cyclopentanone – one for the fragrance market and another ultra-high purity version for the electronics market – which are manufactured at the Melle plant.

In fragrance applications, cyclopentanone is used as a building block mainly in methyl dihydro jasmonate (MDJ), which provides a delicate floral bouquet of blooming jasmine flowers. Other aroma chemicals derived from cyclopentanone include an entire range of delta-lactones, which offer a variety of delicate creamy and fruity notes.

WWW.PHARMACOS.CO.ZA // FEBRUARY 2021

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NEWS

Pyrotec remains positioned for growth With Pyrotec’s 55th anniversary approaching in 2022, Rowan Beattie, the company’s managing director, reflects on the long history of this privately-owned and managed business.

Pyrotec has always been an innovative, forward-thinking and proudly South African organisation, which has built a strong reputation for its expertise in industryleading, on-pack product identification solutions and an extensive range of coding machinery and labelling equipment.

The company is also well known for its software that ensures product integrity, optimises coding activities, helps secure

to change, and have delivered on our promise of quality, trust, and innovation,” he adds.

With Pyrotec’s growth and focus on innovation, its brands have evolved to include Pyrotec PackMark, the company’s machinery division; Pyrotec PackMedia, which offers innovative on-pack, informational and promotional solutions; as well as Pyrotec PackLink and Pyrotec Finance.

Once again showing its appetite for growth and innovation, in March 2020

centralised data management systems and label tracking systems, and detects and combats counterfeit activities.

“We have come a long way since trading in the 60s and 70s,’ says Rowan. “Our business has seen the rise and fall of the economy, the turnaround of our country’s political position, the introduction and explosion of technology, massive shifts in consumer expectations, and most recently a global pandemic. Through it all, we believe that we have remained steady in our approach

Pyrotec PackMedia unveiled a first for the African continent with the groundbreaking purchase of an eight colour Durst Tau 330 RSC digital label press and an ABG Digicon Series 3 digital finishing machine. This investment in state-of-the-art equipment shows the company’s continuing ability to identify niche markets and to embrace technology as changing markets demand.

“Our digital press and finishing machine ensure we stay close to our customers, offering them the best possible service

P h o to machingraphed in t pictur e operator, he 70s , a P y ed alo r o te c ngside Neville Darie a hot f oil labes is l printe r

and turnaround times, as well as eyecatching, consistent print quality. This investment truly reflects our company’s mission statement of ‘Together, We Grow’,” says Timothy Beattie, Pyrotec PackMedia’s general manager.

“The sound relationships we’ve developed over the last 54 years between staff, suppliers and customers are based on our shared values. We’re proud of our achievements, experience and history, as well as our ability to remain focused on innovation and provide service and product excellence well into the future,” Rowan concludes.

UPM Raflatac scales up its linerless business By scaling up its production capacity and building a new production line in Nowa Wies, Poland, UPM Raflatac is strengthening its position in the fast-growing

DT linerless market has seen approximately 15% year-on-year growth in recent years.

“This investment in linerless is a natural continuation of our innovative product

linerless labelstock market. and technology development Direct thermal (DT) work and is a timely response linerless labelling is to current market needs. a cost-efficient and Sustainability and sustainable alternative efficiency benefits are to traditional label significant as linerless stock. Driven by brings up to a 40% sustainability trends reduction in material and the need for usage. This enables our increased efficiency, end-users to improve their linerless has quickly carbon footprint and reach gained ground alongside their sustainability targets,” says An interior view of UPM traditional labelling Antti Jääskeläinen, executive vice Raflatac’s Wroclaw label stock factory in Poland technologies. Boosted by the president, UPM Raflatac. growing demand in endThanks to its in-house user categories such as grocery labelling, developed proprietary technology, logistics and quick service restaurants, the world-leading product performance and

8

FEBRUARY 2021 // WWW.PHARMACOS.CO.ZA

existing global distribution network, UPM Raflatac is now ready to scale up its linerless production and take full advantage of the DT linerless opportunities available with converters, original equipment manufacturers (OEMs) and end users.

The €13mn investment in Nowa Wies, Poland includes a new linerless coating line and increased slitting and packing capacity, expanding the company’s DT linerless annual production capacity by 100mn m2.

The new production line is expected to be operational at the end of 2021.

Operations at UPM Raflatac’s Wroclaw label stock factory started in 2008 followed in 2012 by the nearby UPM Raflatac Nowa Wies factory. Located in Western Poland, today these two factories employ over 700 people and form a significant UPM Raflatac label stock production hub.

On the Street New products on our radar

1. Bare essentials for hair care

Founded by two young South Africans, be.bare was born out of a desire to empower consumers to make greener, more ethicallyminded choices in their daily personal care regimes.

The eco-conscious brand’s mission is simple – to create amazing, natural beauty products that are 100% plastic-free, formulated without water, vegan and cruelty-free, kind to people and the planet, a delight to use, safe and gentle and incredibly effective. The brand also sought to offer consumers products that are on par with, if not superior to, their conventional bottled counterparts.

Starting with the launch of its innovative shampoo and conditioner bars with many more products to come, be.bare has set its sights on ridding the modern bathroom of the scourge of single-use plastic to minimise the catastrophic impact this material is wreaking on our planet. Check out www.bebarelife.com for more information.

2. Food for beautiful skin

The nutritional health experts from Futurelife are excited about their supplementary meal range, Beauti Food. This scientificallyformulated product – available in delicious, on-the-go bar and shake

1

formats – enhances skin health through a unique mixture of collagen peptides, vitamins, minerals and protein.

This collagen supplement in a food format is low-GI, contains no added sugar and is high in protein, making it ideal for a mid-morning or mid-afternoon snack. The protein and fibre in Beauti Food help sustain energy levels while keeping hunger pangs at bay between meals.

With 18 vitamins and minerals, omega-3 fatty acids and prebiotics, the Futurelife Beauti Food nutritional shake is a delicious and convenient meal supplement. The high-protein, low-GI nutritional bar, with beauty-specific collagen peptides, is a great on-the-go snack. International research has shown that one serving daily (shake or bar) of Futurelife Beauti Food will reduce the appearance of wrinkles in 28 days*, when the product is consumed daily, as directed. Visit www.futurelifefood.com/BeautiFood/ for more info.

3. Revive tired feet

Give hard-working feet a refreshing dose of moisture with Burt’s Bees Peppermint Foot Lotion. The cool sensation will revive

2

tired feet while glycerine and coconut oil in the formulation will soften rough calluses, leaving feet smooth and ready for their next adventure.

The lotion is 99% natural. Burt’s Bees is a pioneer and leader in natural skin care and believes in healthy and beautiful skin through the power of nature. The brand strives for 100% natural origin with each product and formulates its products without parabens, phthalates, petrolatum, SLS and other chemicals of concern.

Burt’s Bees Peppermint Foot Lotion, priced from R 200, is available on Takealot and at Dischem stores.

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WWW.PHARMACOS.CO.ZA // FEBRUARY 2021

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What’s on in 2021

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April

Cleanroom Exhibition Istanbul

7 to 9 April Istanbul, Turkey www.bioexpo.com.tr/cleanroom

Natural & Organic Products Europe 18 to 19 April London, UK www.naturalproducts.co.uk

May Coschem Golf Day

18 May Zwartkops Golf Club, Pretoria www.coschem.co.za

Beauty Düsseldorf 2021 28 to 30 Düsseldorf, Germany www.beauty-duesseldorf.com

INDUSTRY TALK

Plant-based ingredients for dietary supplements The newly expanded supplement ingredients portfolio of DuPont Nutrition & Biosciences for plantbased solutions is set to help supplement manufacturers diversify their offerings and align to consumer trends.

C

onsumers are increasingly prioritising dietary supplements to support their immune health, weight management and sleep habits. In a recent industry survey, 95% of supplement manufacturers report that consumer interest in the power of nutrition to boost health and wellness and support immunity, has never been higher.¹ Manufacturers seeking to grow their business with this increased demand can turn to the expanded dietary supplement ingredient portfolio and newly launched website of DuPont Nutrition & Biosciences (DuPont), which are equipped to help brands develop high-quality, efficacious formulations.

ON-TREND INGREDIENTS Backed by decades of technical expertise, DuPont‘s sustainably-sourced and plantbased ingredient portfolio is tailored to tackle the toughest formulation challenges, from taste-masking bitter botanicals and delivering convenient new formats to keeping up with consumers’ evolving preferences and lifestyles. With a finger on the pulse of the industry, DuPont stands poised to help manufacturers grow their business. This promise is based on survey results that indicate: • 57% of survey respondents say they are focused on novel delivery formats and dosage forms to combat pill fatigue and make compliance easier.² From enabling delicious, vegan gummies and easy-toswallow capsules to chewable tablets with a creamy mouthfeel, DuPont can help turn natural sources into unique products, in a range of applications.

• 56% say their company is prioritising ‘nonGMO’ claims for their end-products while 48% say ‘plant-based’ claims are their company’s second priority.² Offering manufacturers a convenient way to meet both claims, DuPont has a large portfolio of plant-based ingredients and non-GMO ingredients.* • Nearly one-third report their toughest manufacturing problem is ensuring ingredients can also enable nutritional claims, such as ‘sugar free’.² Instead of attempting to mask the flavour of nutritional ingredients with excessive sweeteners, DuPont works with customers to complement the natural taste.

Manufacturers can discover these innovative offerings and more on DuPont’s new dietary supplement ingredients website. Serving as a robust, holistic hub, customers can refine their search based on their individualised needs – by product, solution or delivery formats – and explore how they can turn natural sources into shelf-ready products, in a variety of application forms.

supplement manufacturers with the innovations they need to stay one step ahead,” says Michael Baumann, global strategic marketing manager, DuPont Nutrition & Biosciences. “By partnering with a supplier that understands natural ingredients and the science behind complicated formulations, manufacturers can ensure they’re well equipped to meet any consumer trend – now and into the future.”

Dedicated to ongoing collaboration with supplements manufacturers, in a recent webinar DuPont demonstrated how formulators can create great-tasting, lowsugar gummy supplements while increasing speed to market. The webinar also shared survey insights and a technical overview of plant-based options for gummies to address sensory challenges, enable low sugar claims, increase stability and decrease development time. • REFERENCES: 1. NutraIngredients, USA State of the Industry Survey 2020 2. Ibid

INNOVATION-READY SOLUTIONS “As the dietary supplement industry expands at a dizzying rate, we’re leveraging our pharmaceutical expertise, as well as our market and industry insights, to equip

*Please note that regional differences in applicable laws and regulations may restrict the use of certain products in dietary supplements or different terminology definitions.

DuPont Nutrition & Biosciences – dietarysupplements.dupont.com

WWW.PHARMACOS.CO.ZA // FEBRUARY 2021

11

PRESERVATIVES

Solving the sunscreen preservation challenge Sunscreen products are known to be challenging to preserve. Yet, the reasons are diverse and not fully addressed. Naama Eylon, VP personal care at Sharon Laboratories, looks at the influence of the unique composition and features inherent to sunscreen formulations and how they affect preservation, as well as new alternatives that solve the antimicrobial challenges of this changing segment.

S

un care is considered one of the most important categories in personal care.

Formulating sunscreens requires specific knowledge, as many different aspects should be taken into account.

An optimum sunscreen formula should first provide broad-spectrum skin photoprotection. However, as a sunscreen is a cosmetics product, it should also hold sensorial appeal and good skin feel.

Over the years, the preservative challenge for sunscreens has remained a known fact, but it is one that is not fully explained. As a result, it has become common practice to concede a quantitative answer by raising the level of use of the preservatives, creating issues such as incompatibility with other ingredients, instability of the formula, odour and colour impact, potential skin irritation and more.

In discussions with sunscreen formulators, we hear the same struggle: a high SPF formula with common or popular preservatives fails a challenge test. At this point, the product development team will likely add another booster, and sometimes another system, to reinforce the antimicrobial protection. We also often see the use of traditional preservatives, which are no longer in favour, such as parabens and formaldehyde-donors like diazolidinyl urea, for the sole reason that they provide the protection needed, even if they go against the requirements of a clean INCI or the clean beauty marketing perception.

BACK TO THE BUILDING BLOCKS To uncover the reasons why sunscreen formulations require special preservation attention, we need to start with the core building blocks of SPF formulations – UV filters.

A sunscreen can be classified depending on its mode of action. UV filters absorb, reflect or scatter harmful UV rays, preventing them

12

FEBRUARY 2021 // WWW.PHARMACOS.CO.ZA

Did you know?

SharoSENSE Plus systems have the right polarity to ensure the preservation of sunscreen formulations while using a clean INCI. The maltol-based line is not pH-dependent and is also readily biodegradable, offering an additional benefit in terms of sustainability.

from penetrating the skin. A formula would contain either a physical UV filter such as zinc oxide or titanium dioxide, or an organic UV filter like benzophenone, octyl salicylate, or more commonly – a combination of organic and mineral. Blending of various UV filters at low percentages is sometimes preferred.

Processing oily-soluble UV filters into a stable fine emulsion dictates the use of a greater dosage of solubilisers and humectants, resulting in a significantly higher oily-phase formula.

Unlike other cosmetic emulsions, which are composed of both polar and non-polar phases evenly dispersed in one another, in sunscreen emulsions, the non-polar phase has a greater organic share.

THE SIGNIFICANCE OF POLARITY Defining polarity is important to understand the key to the solution. Each molecule has a polarity value that can be scaled in many ways.

One of the most popular polarity scales is Log

P (or the partition coefficient). Preservatives also have a Log P value that can anticipate their distribution in a cosmetic emulsion.

Non-polar preservatives, which can be defined by a Log P value that is greater than 1, will have a tendency to migrate into the organic phase. This characteristic will result in the preservative ‘deserting’ the water phase.

As antimicrobial activity originates in the water phase, a poorly protected water phase is surely going to pose a problem.

As we review the polarity index of various preservatives, we find that many popular and accepted preservatives such as phenoxyethanol-based systems are in fact non-polar, have a Log P value greater than 1 and are likely to demonstrate low performance in sunscreen formulas.

This assumption was taken to a comparative test. Several preservatives with different polarity indexes were chosen and challenged in an EP protocol test in the same representative formula (see Figure 1).

PRESERVATIVES

Figure 1: The representative formulation used in the EP protocol challenge test

The challenge test results show that a non-polar system based on phenoxyethanol, with a Log P of 1.12, is insufficient to protect such a non-polar high SPF formula. At the same time, polar preservatives such as methylisothiazolinone with a Log P value less than 1 (-0.83) demonstrated good results (see Figure 2).

This understanding initiated a search for a polar preservative system which is free from traditional and undesired ingredients, supports broad-spectrum protection and offers good compatibility with various UV filters. In addition, the non-pH-dependent characteristic is important, as sunscreen formulations are mostly at a neutral pH, which eliminates organic acids as an option.

The subsequent R&D process resulted in a line of preservative blends known as SharoSENSE Plus. Available in South Africa from CJP Chemicals, the SharoSENSE Plus line is based on the active ingredient maltol, which was identified as a key ingredient in this concept. It is a naturally occurring organic compound, found in several plants. Maltol is used as a flavour enhancer (food additive E636), as an intermediate in pharmaceuticals and sometimes in fragrances.

It has interesting antimicrobial activity, but not sufficient to be considered a preservative. In the quest to enhance the properties of maltol, the addition of a cationic surfactant component within a specific range was found to be the best solution. A series of cationic surfactants were tested and through an optimisation process, a specific ratio was determined as the optimal way to achieve high efficacy, presenting synergistic effects with maltol.

A ROBUST AND EFFECTIVE SOLUTION

Figure 2: Challenge test results

We can visualise the comparison of one gram-negative bacteria as a benchmark, to four alternative preservative systems. With the non-polar preservatives, from inoculation and as the test continues, the bacteria continue to grow, resulting in a failed challenge result.

However, the polar preservatives show excellent results as the challenge test continues.

A NEW LINE OF PRESERVATIVE BLENDS Once we understand that it is key to use the Log P of a preservative to determine its efficacy in sunscreen products, all we have to do then is select a polar preservative. Yet, there is another challenge: the list of polar preservatives with good consumer perception is in fact very short to non-existent.

The patented SharoSENSE Plus line demonstrates high solubility, with no need to use a solvent to carry it into the final product. This solventfree approach offers immense benefit to the formulator, answering clean beauty trends, which can be achieved through the use of a minimalistic approach and green ingredients.

It is also interesting to note the activity of maltol in a high pH-range. Many of the popular preservative solutions such as organic acids are suitable for pH of up to 5.5, leaving less preservation options for high pH-products.

Maltol, however, demonstrates increased activity at a pH of 7 to 8.

SharoSENSE Plus has the ideal polarity profile for sunscreens with a Log P of 0.09. This system was used as a single preservative system in the same formula shown earlier, as can be seen in the comparison noted in Figure 3. Being a polar preservative, SharoSENSE Plus performed well in the same high SPF formulation.

Figure 3: Comparison results

Figure 4: Full challenge test results

Looking at the full challenge results, Figure 4 shows that at a level of use of only 0.7%, full broad-spectrum protection is achieved.

SUSTAINABLE AND SUNSCREEN-FRIENDLY In conclusion, SharoSENSE Plus products have a proven ability to preserve sunscreen formulations at a level of use lower than 1% and as a sole preservation system in a formulation.

When we think about a sunscreen, we take into account the safety of the consumer, their skin, and most recently, environmental safety. Today we understand the safety of the product itself is being questioned, which can only be addressed through adequate protection.

With SharoSENSE Plus, formulators now have a solution that will not only address the technical challenges unique to formulations containing UV filters but also the regulatory changes pertaining both to UV filters and preservative systems, while meeting consumers’ needs for green, clean and transparent ingredient lists.

Ultimately, the essence of assembling a successful sunscreen formula lies in the sensitive balance of these complexities. •

CJP Chemicals – www.cjpchemicals.co.za Sharon Laboratories – www.sharon-labs.com

WWW.PHARMACOS.CO.ZA // FEBRUARY 2021

13

PRESERVATIVES

The end of the road for

free-from claims

Preservatives are essential to ensure an adequate shelf-life for cosmetic products as well as product and consumer safety during use. Yet these ingredients have in recent times faced scrutiny by consumer advocacy groups worldwide based on the belief of their potential safety risks that they pose to the consumer. Dershana Jackison explores compliance in the local context when it comes to formulating with preservatives.

S

cientific studies have been undertaken internationally to determine the safety and use levels of preservatives.

Based on these studies, regulators around the globe have devised annexes of permitted preservatives to cosmetic regulations

preservatives allowed for use in cosmetics, appearing in the regulation, is complied with to ensure product and consumer safety. This annex provides permitted preservatives as well as their specific maximum use levels for different product applications. Referencing

been proactively preparing the industry for the imminent changes to promote alignment with international best practice.

including the South African National Department of Health’s draft Regulations relating to labelling, advertising and composition of cosmetics, R. 1469, 22 December 2017.

For local product compliance, it is imperative that the Annex IV List of

and complying with this list will ensure compliance to the draft regulations and the development of safe cosmetic products from a preservative ingredient perspective.

by CTFA to include new and/or amended entries in the Journal of the European Union.

These updates are included in the CTFA Cosmetic Compendium and are accompanied by a transition period to allow industry a reasonable time period to comply to the imminent regulatory updates. It is important to note that these updates are also informed to the national regulator in an effort to keep the local draft regulations aligned to the EU regulations, which continue to form the premise for local regulations.

In addition to complying with Annex IV of the draft regulations, it is the responsibility of the brand owner or manufacturer to ensure that the preservative used is efficacious in protecting the product from contamination during use and throughout it’s shelf life. This is established through a preservative efficacy test or a challenge test, as it is better known. Only products that pass this test qualify to be placed on the market. These test results may be included in the product information file to support the safety assessment report requirement of the draft regulations.

083

14

AVOID NON-CONTENT CLAIMS

As a result of the scrutiny mentioned, advertising campaigns have jumped onto the ‘free-from’ Protect your movement. Such formulations claims are not with permitted in many cosmetic parts of the world, preservatives especially where from the safety and level of use of such ISCA UK, preservatives has proudly been scientifically distributed in substantiated. This South Africa type of advertising is

by Chempack also denigrating and Industries. is not permitted in South Africa by virtue of the Advertising Regulatory Board’s (ARB) Advertising Code of Practice. In 2021, the cosmetic industry can anticipate specific updates within the ARB’s Appendix B- Cosmetic code to address local Chempack Industries | Contact: Linda Thieme | guidelines on free600 0167 / 064 610 2736 | Email: linda@cpack.co.za | from claims. CTFA Website: www.cpack.co.za has for the last year,

FEBRUARY 2021 // WWW.PHARMACOS.CO.ZA

DO THE NECESSARY TESTING On an annual basis the Annexes are updated

GET THE INCI RIGHT In terms of the ingredient listing of preservatives, this is to follow the requirements as stipulated in the local regulations guided by the South African National Standard, SANS 98: 2012 Ingredient labelling of cosmetic products. This standard is available on the CTFA website for members or can be purchased from the South African Bureau of Standards (SABS). • CTFA – www.ctfa.co.za

crush preservative challenges with the power of raspberry — phyteq™ raspberry multifunctional

Discover more about our new natural and nature identical multifunctional preservative booster, powered by raspberry technology. This is the first product under our phyteq™ brand, which will be a range of antimicrobial technology and protection inspired by plants.

Phyteq™ raspberry is a multifunctional preservative booster, globally approved, readily biodegradable and with a wide pH applicability. It acts as preservative potentiator that helps protect the cosmetic against spoilage. Additional skin benefits make it an excellent choice for skin care products, as it is a strong antioxidant and free radical scavenger that helps to protect the elasticity of the skin. ashland.com/raspberry

® Registered trademark, Ashland or its subsidiaries, registered in various countries ™ Trademark, Ashland or its subsidiaries, registered in various countries ©2020, 2021, Ashland PHC21-023

PRESERVATIVES

Crush preservative challenges with the

power of raspberry Using artificial intelligence and machine learning techniques, Ashland discovered raspberry ketone, which led to the development of PhyteqTM raspberry multifunctional.

This natural antimicrobial has preservative-boosting and skin-mildness benefits, as well as a favourable biodegradability profile.

C

onsumers today associate natural and nature-identical ingredients with safety. They expect cosmetic products to be well-protected against contamination and to be mild to skin.

Phyteq raspberry multifunctional is based on raspberry ketone, a compound occurring in different plants and one that has been used for decades in traditional Chinese medicine and Ayurveda. As a globally-approved and readily-biodegradable multifunctional additive, it acts as preservative potentiator that protects a cosmetic product against spoilage. Its additional skin benefits make it an excellent choice for skin care products. It acts as strong antioxidant and free radical scavenger and helps to protect the elasticity of the skin. Phyteq raspberry is available in two variations, Phyteq raspberry N (natural) and Phyteq raspberry I (nature-identical). It can be sourced in South Africa from IMCD.

GREAT FOR SKIN CARE PRODUCTS “PhyteqTM raspberry multifunctional furthers Ashland’s innovations for plant-inspired clean beauty,” says Andrea Wingenfeld, global marketing manager, Ashland. “The product

KEY FEATURES AND BENEFITS 1. PhyteqTM raspberry addresses plant-inspired and clean beauty trends: • INCI: Raspberry Ketone, which is recognised by consumers as ‘natural’ • well-known and widely-cited benefits in health and nutrition • readily biodegradable and globally compliant (including China) • gentle on native skin flora.

2. Antimicrobial protection and formulation benefits: • low dosage – 0.5% to 1% provides a broad antimicrobial boosting effect • wide pH applicability (pH 4 to 8) • excellent temperature stability (up to 80°C) • good formulation compatibility (no impact on stability and colour).

3. Skin benefits: • strong antioxidant and free radical scavenger • helps to protect skin’s elasticity.

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PRESERVATIVES

Table 1: Micellar water (pH4.8) Phase

Ingredient

INCI

%w/w

A

Purified water

Water/Aqua

as. 100

B

Blanose 7H3SF CMC

Cellulose Gum

0.05

Phyteq raspberry I multifunctional

Raspberry Ketone

0.05

Optiphen HD preservative booster

1,2-Hexanediol

1.00

Lubrajel marine hydrogel

Water/Aqua (and) Glycerin (and) Sodium PCA (and) Erythritol (and) Chondrus Crispus (Carrageenan) (and) Xanthan Gum

5.00

Sepiclear G7

Heptyl Glucoside

0.90

Decyl Glucoside

0.10

C

Oramix NS10

Did you know?

You can solve your preservative challenges with Ashland’s preservatives selector tool. Click here to access the tool online: https://bit.ly/2LQvt9T.

Organism

48 hours

7 days

14 days

21 days

28 days

S.aureus

<10

<10

<10

<10

<10

Bacterial composite

<10

<10

<10

<10

<10

Mould composite

1.90E+02

<10

<10

<10

<10

Figure 1: The combination of 0.5% Phyteq raspberry I and 1% 1,2-Hexanediol provides excellent antimicrobial protection

"PhyteqTM raspberry multifunctional furthers Ashland’s innovations for plant-inspired clean beauty" will be popular in formulations because end consumers increasingly evaluate labels that include products inspired by nature. Being readily biodegradable and globally compliant, this ingredient builds on the already wellknown health benefits of raspberry.”

Phyteq raspberry is an excellent choice for skin care products, because it performs as a strong antioxidant and free radical scavenger, which helps to protect the elasticity of the skin.

Organism

48 hours

7 days

14 days

S.aureus

<10

<10

<10

Bacterial composite

<10

<10

<10

Mould composite

4.50E+04

8.60E+03

1.00E+03

Karine Deruddre, global skin care applications manager, Ashland, adds: “Phyteq Raspberry fits perfectly with global skin care formulations as it helps to reduce the levels of approved preservatives or antimicrobials, which can reduce unwanted side effects.

This technology combines antimicrobial boosting with skin care benefits, and it has a favourable biodegradability profile. It’s also a great solution for cosmetic formulators as it does not require acidic conditions.”

21 days

Discontinued

Figure 2: Data showing 1% hexanediol failed the challenge test

ANTIMICROBIAL BEHAVIOUR One of the most challenging applications in cosmetics is protecting high watercontaining systems like micellar water, against contamination without

changing the appearance of the formulation.

A combination of 0.5% Phyteq raspberry I multifunctional and 1% Optiphen HD (1,2-Hexanediol) provides excellent protection even after two inoculations cycles (day 0 and day 21). No impact on clarity or colour was observed, and the sample with 1% Optiphen HD failed the test.

See Figures 1 and 2. The formulation used in the challenge test is featured in Table 1.

PHYTOCHEMICAL TESTS Phyteq raspberry acts as multifunctional ingredient. Besides its antimicrobial boosting properties, it is gentle on skin’s native flora and provides skin benefits when used in cosmetic products. It is ideal for use in the following applications: skin and body care, w/o and o/w emulsions, tonics and shampoos or body wash, sun care formulations (both w/o and o/w) with organic and/or inorganic UV filters, hair styling products, treatments and conditioners. • Ashland – www.ashland.com/raspberry IMCD – www.imcdgroup.com

WWW.PHARMACOS.CO.ZA // FEBRUARY 2021

17

PRESERVATIVES

Sustainable anti-microbials to protect cosmetics & consumers Consumer exposure to a list of preservative substances, which is becoming increasingly shorter, can result in higher incidences of primary sensitisation since the same preservatives are being used in a wide range of cosmetic products. This creates a paradox for formulators. In response, Chemyunion has developed the Hebeatol range of broad-spectrum antimicrobials.

P

reservatives are frequently associated with contact allergies in cosmetic products or drugs.

Among the top ten allergens listed in 2018 by the North American Contact Dermatitis Group (NACDG), four preservatives are part of the list: methylisothiazolinone (MIT); methylchloroisothiazolinone (CMIT)/ methylisothiazolinone (MIT) and formaldehyde at 1 and 2%. Imidazolidinyl urea, quaternium-15 and methylbromeglutaronitril/ phenoxyethanol are also among the top 20 allergens listed by the NACDG. While there are safe alternative preservatives on the market which meet the needs of formulators, the list is short. Recent developments that offer excellent biological compatibility include sugar, fatty acid and amino acid-derived ingredients. These also contribute to a good sensory experience and the stability of cosmetic formulations by functioning as emollients, humectants, solubilisers and co-emulsifiers.

Hebeatol BA efficacy study results

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A SAFE ALTERNATIVE In response to the challenge of replacing traditional and controversial preservatives, Chemyunion developed the Hebeatol range, whose main structure is based on xylitol esters. Hebeatol Plus has a broad antimicrobial activity and may act alone or in synergy with other non-controversial preservatives, offering a safe and effective alternative for the development of cosmetic formulations.

Hebeatol BA, Hebeatol PS VG and Hebeatol CG were developed after exhaustive studies to determine the best synergistic combination between the xylitol esters and benzyl alcohol, potassium sorbate or caprylyl glycol, respectively.

NATURAL AND SUSTAINABLE Hebeatol Plus is obtained from xylitol and caprylic acid, which are both plant-based.

Xylitol is a pentiol sugar whose main source is a by-product of the industrial process of grains (corncob is an example).

APPLICATIONS: • Hebeatol Plus is ideal for skin and hair care products.

• Hebeatol BA works best in skin care products.

• Hebeatol PS VG is suited to shampoos and formulas for skin care, including sunscreens.

• Hebeatol CG is good for more challenging skin care applications, such as micellar water, mascara and wet wipes.

In addition, the caprylic acid is obtained from vegetal oils sustainably extracted and certified by the Roundtable on Sustainable Palm Oil. A synthetic route of Hebeatol Plus has been developed in order to meet the requirements of being an ecological process – generating a 100% biodegradable molecule.

The use of the Hebeatol range in cosmetic formulations allows for development of compositions free from controversial and traditional preservatives, because it acts as a broad-spectrum antimicrobial. These antimicrobials also offer protection of the cutaneous barrier by reducing transepidermal water loss by 21%.

The Hebeatol range is available locally from Chemgrit Cosmetics, the approved distributor of Chemyunion in South Africa. • Chemgrit Cosmetics – www.chemgritcosmetics.co.za Chemyunion – www.chemyunion.com/en

SPONSORED CONTENT

A budding industry –

Cannabis Functional Topicals AFRIPLEX strives to offer innovative product solutions to the complementary and alternative medicines (CAMs), pharmaceutical, botanicals and food and beverage industries. Due to its vast experience in unlocking the full potential of indigenous plants, it was a natural step for AFRIPLEX to venture into the cannabis industry.

T

o retain its competitive edge, AFRIPLEX continuously pursues new areas of research and innovation. This was proven yet again with the development of a range of cannabidiol (CBD) functional topical solutions.

AFRIPLEX understands the value of innovation and flexibility, offering products tailored to each customer’s specifications.

Amongst these offerings are full spectrum and broad spectrum cannabis distillates, CBD and cannabigerol (CBG) isolates, as well as hemp seed oil. Combining these cannabis-derived components with functional topicals bolsters the potential for significant growth within the already fastgrowing medicinal skin care industry.

Responsible pharmacist, Robert Longrigg notes: “AFRIPLEX has positioned itself at the forefront of topical solid dosage forms. Through its dedicated research and development department, AFRIPLEX keeps abreast of global trends meshed together with innovation and supported by the analytical services, quality and regulatory departments. This allows Afriplex to offer clients the ultimate service to assist them in bringing novel products to market.”

DISCOVER THE CANNABIS OFFERINGS Full spectrum distillates include cannabinoids and terpenes from the Cannabis sativa L. plant, whereas broad

CONTACT DETAILS Web: www.afriplex.co.za Email: info@afriplex.co.za Tel: +27 (0)21 872 4976

Hemp seed oil is another of AFRIPLEX’s cannabis offerings. The oil is anti-comedogenic and its high level of polyunsaturated fatty acids nourishes the skin.

WATER-SOLUBLE CBD Yet another innovative product offering by AFRIPLEX is the proprietary LIPOZOME® technology. This technology creates new opportunities in the functional topical as well AFRIPLEX’s GMP certified manufacturing facility

AFRIPLEX is home to stateof-the-art laboratories and stability chambers

spectrum distillates contain the same cannabinoids and terpenes with the exclusion of tetrahydrocannabinol (THC).

CBD and CBG isolates are individual cannabinoids extracted and purified from cannabis. These isolates neither contain terpenes nor THC, with CBD isolate being the most generally used in South Africa.

With broad spectrum distillates, the entourage effect of combining cannabinoids with terpenes creates a synergism, enhancing their respective medicinal values.

This is a very attractive combination to offer in the development of functional topicals.

Terpenes used by AFRIPLEX in formulating functional topicals include caryophyllene, limonene, linalool, myrcene and pinene.

Each terpene has its own sensorial effect and medicinal value, including antibacterial, anti-inflammatory, antifungal, antiseptic and antioxidant properties. These can address specific conditions or ailments, such as acne, eczema, psoriasis, skin rashes, muscle spasms and pain.

Also offered by AFRIPLEX, CBG is a lesserknown cannabinoid that is of growing interest in the cannabis industry. This therapeutically diverse cannabinoid has medicinal value supportive of CBD with the added benefit of having antibacterial properties.

as food and beverage industries.

CBD isolate is fat-soluble which poses limitations in product development. With AFRIPLEX’s LIPOZOME® technology, CBD can now be formulated in water-based products with the added benefit of enhanced bioavailability.

AFRIPLEX offers cannabis functional topicals in various formats including creams, gels, serums, ointments, oils, masks, transdermal patches and powders. These products are produced in AFRIPLEX’s GMP certified manufacturing facility, which operates under strict adherence to SAHPRA regulations.

QUALITY AND TRACEABILITY As a quality and solution-driven company, AFRIPLEX utilises high-quality cannabis from its Good Agricultural Practice-approved cultivation facilities. The track-and-trace system used by AFRIPLEX does not start or end at the primary manufacturing facility.

This system extends from the dedicated cultivators to the delivery of final products, ensuring the finest quality from seed to shelf. This guarantees a complete, traceable, sustainable and reliable source-to-shelf service, assuring customers that products produced by AFRIPLEX meet the most stringent regulatory requirements.

AFRIPLEX is home to the dedicated cannabis testing laboratory of the Cannabis Research Institute (CRI) of South Africa. As a member of the CRI, AFRIPLEX is paving the way in novel cannabis research projects in collaboration with various local and international research institutions. •

WWW.PHARMACOS.CO.ZA // FEBRUARY 2021

19

PHARMA FOCUS: CANNABIS

How to encapsulate and spray-dry CBD and THC Spray-drying and encapsulation are two approaches to improve the bioavailability of cannabinoids after oral ingestion. Buchi’s B-290 mini spray dryer offers efficient production of dried powders from cannabis oil. With its encapsulator B-390/B-395 Pro, it is possible to encapsulate different concentrations of cannabis oil into coreshell or matrix-type microparticles. In this formulation advisory article, Buchi presents studies showing the spray-drying and encapsulation of CBD hemp oil. All results were in accordance with expected values.

L

aboratory-scale spray-drying is used to convert liquid samples into solid powder.

The spray-drying process and sample characteristics affect the properties of the final powders or formulas. The technique is ideal for testing a series of different formulations, since small liquid volumes can be quickly transformed into a solid powder and analysed later.

Cannabinoids, such as cannabidiol (CBD) and tetrahydrocannabinol (THC), have been shown to have considerable therapeutic

effects. However, both CBD and THC suffer from low bioavailability of approximately 6% to 9% when administered orally. To enhance oral bioavailability, several formulation approaches can be applied. One of these is bioavailability enhancement by incorporating the CBD and THC into liquid nanoformulations or nano-emulsions.

Cannabinoids exhibit very low water solubility. For example, the water solubility of THC is 2.8mg/ℓ at 23°C. Yet cannabinoids exhibit good solubility in organic solvents, such as ethanol or oils.

Because of their solubility characteristics, it is necessary to formulate cannabinoid samples either as emulsions (O/W) or as organic solvent solutions.

Organic solvent-based samples must be spray-dried under inert atmospheric conditions to allow for safe processing conditions.

Depending on the oxygen sensitivity of the cannabinoid to be formulated, emulsion-type samples can be processed under nitrogen atmosphere to reduce the contact with ambient oxygen to a minimum. Buchi’s inert loop B-295 is an ideal accessory to establish inert conditions with minimal nitrogen consumption.

Buchi’s B-290 is a world-leading R&D solution for spray-drying

20

FEBRUARY 2021 // WWW.PHARMACOS.CO.ZA

Some cannabinoids are reported to be sensitive to the influence of light. To reduce the impact of light on these substances, Buchi offers amberised glassware that helps to reduce the influence of UV light to a minimum.

The option to process samples under a highly-reduced oxygen atmosphere and with minimal impact of UV light offers the greatest protection of formulated cannabinoids. Since Buchi instruments offer these options, they are well-suited to realising cannabinoid formulations on a small scale.

NANO-EMULSION FORMULATION AND SPRAY-DRYING Using a B-290 mini spray dryer typically results in powder particle sizes of 2μm to 25μm at a throughput of 1ℓ of sample per hour. The minimum sample quantity is 30mℓ.

Setup and cleaning times are short.

To formulate full-strength CBD oil, a set of 200mℓ to 250mℓ nano-emulsions and controls were prepared as summarised in Table 1. Emulsions were passed a few times through a microfluidiser processor equipped with a Y-type interaction chamber and under a desired pressure to obtain a nano-sized emulsion with narrow size distribution. Resulting formulations were about 25% to 27% (w/w) solids

With Buchi’s B-390 encapsulator, different concentrations of cannabis oil can be encapsulated

PHARMA FOCUS: CANNABIS

solutions at a ratio of 10:1 (encapsulant: CBD/MTC oil).

Spray-drying parameters for each formulation are provided in Table 2. Midrange processing parameters were selected to allow room for the potential optimisation of spray-drying outcomes (i.e. particle size and solubility) on a per-formulation basis.

To determine a baseline of solubility, 250mg samples of each spray-dried formulation was dissolved in 10mℓ of water at ambient temperature and observations recorded. The particle size of the oil droplets was measured in liquid nano-emulsion state and after dissolution of the spray-dried powder in water to compare the effect of spray-drying on the size distribution of the dispersed oil droplets.

Particle size is reported in terms of the mass median diameter (D50) of the oil droplets in the nano-emulsions and of spraydried particles, respectively, as summarised in Table 3.

Particle size of the spray-dried particles was approximately 10μm, with a range of 5μm to 12μm as noted in Table 3. The powder was free-flowing and the oil droplet size unaffected during encapsulation by spray-drying, as indicated by the equivalent D50 recordings before and after the spray-drying process.

A Buchi B-290 mini spray dryer was used to produce water-soluble powders from an insoluble oil. In this example, CBD hemp oil was made into a stable nano-emulsion in water and encapsulant material, then successfully spray-dried to obtain freeflowing powders with size ranges between 5μm and 12μm.

ENCAPSULATION Lipids like oils and fats are not only found in high-fat meals but also in lipid-based oral formulations of cannabinoids. Recent

Table 1: Controls and experimental formulations of CBD oil Formulation 1

2

3

4

MCT emulsion control

MCT/Hemp nano-emulsion

Maltodextrin control

MCT/Hemp nano-emulsion

0

3.12

0

3.12

MCT Oil (g)

3.12

3.12

0

3.12

Polysorbate 80 (g)

1.25

1.25

1.25

1.25

62.5

62.5

250

250

Sample Hemp Oil CBD (g)

Maltodextrin (g) (added pre-emulsion) Maltodextrin (g) (added post-emulsion) H2O (ml)

53

53

200

200

Table 2: Mini spray-dryer B-290 process parameters Formulation 1

2

3

4

Control MCT

MCT/Hemp

Control

MCT/Hemp

Tin °C

170

170

170

170

Tout °C

90

91 to 94

89 to 90

85

Aspirator (%)

90 = 35m3/hr

90

90

90

Feed (%)

30 = 9.5mℓ/hr

30

30

30

Gas (mm)

40 = 670ℓ/hr

40 = 670ℓ/hr

35 = 540ℓ/hr

45 = 830ℓ/hr

Experiment

Table 3: Experimentally-measured values of D50 for oil droplets in a nano-emulsion, particle size of the spray-dried particles as well as D50 for oil droplets after dissolution in water Formulation 1

2

3

4

Control MCT

MCT/Hemp

Control

MCT/Hemp

D50 of oil as nano-emulsion (nm)

130 to 140

130 to 140

N/A

90 to 130

D50 of spray-dried powder (μm)

11.59

5.15

7.88

5.37

130 to 140

130 to 140

N/A

90 to 130

Sample ID

D50 of oil after dissolution of SD powder (nm)

Did you know?

Cannabinoids exhibit very low water solubility but excellent solubility in oils. Dissolving cannabinoids in oil and subsequently entrapping the oil in solid round particles is one approach for enhancing cannabinoid bioavailability.

WWW.PHARMACOS.CO.ZA // FEBRUARY 2021

21

PHARMA FOCUS: CANNABIS

"Buchi instruments … are well-suited to realising cannabinoid formulations on a small scale" research has shown that they play an important role in cases where cannabinoids are ingested orally. Data shows that lipids can increase the systemic exposure to orallyadministered cannabinoids like CBD and THC. The encapsulator B-390/B-395 Pro is the perfect instrument to screen a series of formulations of precisely-formed oilcarrying particles. It can be used to achieve homogeneous droplets in combination with oils: matrix-type particles and core-shell capsules, which are detailed and compared in Table 4.

Core-shell as well as matrix-type particles can be produced from alginate; however, the technique is also applicable to other polymers like chitosan, pectin, gelatine and others. To obtain dry particles, suitable drying techniques such as fluid-bed drying or drying in a rotary evaporator or freeze-dryer must be applied in a subsequent step after use of the encapsulator B-390/B-395 Pro.

CORE-SHELL FORMULATION APPROACH To produce cannabis oil-core microcapsules with a Ca-alginate membrane, an encapsulator B-390/B-395 Pro was used with a shell nozzle of 400μm and core nozzle of 150μm in diameter.

Firstly, 4.0g of Na-alginate powder was added to 200mℓ of deionised water and dissolved. The solution was left undisturbed until all the air was released, and the solution became clear. Then, 1.47g of CaCl2 (dihydrate) and 0.1mℓ of Tween 80 were dissolved in 100mℓ of water. This helps prevent the capsules from bursting during their entry into the solution.

The alginate was first pumped through the shell nozzle. After obtaining a stable droplet chain, the cannabis oil was pumped through the core nozzle. Both flow rates were slightly adjusted to obtain a stable chain of monocentric droplets, which produce the liquid core microcapsules after landing in the gelling bath.

The final process parameters were: • shell nozzle size: 400μm • core nozzle size: 150μm • flow rate: 10 (shell) and 1.5mℓ/min (core) • frequency: 600hz • pressure: 0.5 bar • amplitude: 3 • charge: > 2 000 V

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The particles were left to harden in the CaCl2 bath for 20 minutes. Then the capsules were washed with water.

The percentage of loading (makeup) of the microcapsules with cannabis oil (liquid) can be calculated using the microcapsule volume, liquid core volume and volume of sphere equations.

The cannabis oil yield was > 95% in core microcapsules with spherical morphology.

The percentage of oil loaded was 15% with a standard deviation of ± 2.5%.

MATRIX PARTICLE FORMULATION APPROACH To produce Ca-alginate microbeads incorporating cannabis oil, encapsulator B-390/B-395 Pro were used with a 300μm nozzle.

Firstly, 4.0g of Na-alginate powder was added to 200mℓ of deionised water and dissolved using a blender. Cannabis oil was added (maximum 20%) to the Na-alginate solution and emulsified using a blender.

The solution was left to sit until all the air was released.

Then, 1.47g of CaCl2 (dihydrate) and 0.1mℓ of Tween 80 were dissolved in 100mℓ of water. A stable droplet chain was obtained on the encapsulator before starting with the production/hardening process. Electrostatic charge was used to disperse the droplets and prevent collision before entering the hardening/gelling bath. The droplets were allowed to harden for at least 30 minutes after the very last drop had landed in the gelling bath. The microbeads were washed with deionised water to remove any unreacted material.

The final process parameters were as follows: • nozzle size: 300μm • flow rate: 7.5mℓ/min to 8mℓ/min • frequency: 600hz • pressure: 0.5 bar • amplitude: 3 • charge: > 1 000 V Cannabis oil particles at different concentrations of the total capsule volume were successfully encapsulated. For example, cannabis oil at a concentration of 2% of the total capsule volume was obtained at a yield of 99% in spherical Ca-alginate microbeads of a size of 953μm. The standard deviation was ±1.8%.

Table 4: Comparison of core-shell and matrix-type particle production in the encapsulator B-390/B-395 Pro Core shell

Matrix type

400μm to 1 800μm

160μm to 2 000μm

Max. oil loadings

25%

20%

Extrusion method

Coextrusion by means of a concentric nozzle

Extrusion by means of a single nozzle

Sample feed

Feed 1: polymer solution Feed 2: oil

Pre-formed emulsion of polymer and oil

Max. productivity (largest nozzle)

25mℓ/min to 35mℓ/min

30mℓ/min to 40mℓ/min

Possible particle diameters

Table 5: Recommended frequency and flow-rate range according to nozzle size Nozzle (μm)

Flow-rate range (mℓ/min)

Frequency range (Hz)

80

1.1 to 1.2

1 300 to 3 000

120

1.5 to 1.8

1 000 to 2 500

150

2.3 to 2.8

800 to 1 800

200

3.5 to 4.5

600 to 1 200

300

6.0 to 8.0

400 to 800

450

11 to 15

200 to 500

750

19 to 25

40 to 300

1 000

30 to 40

40 to 220

Alternatively, cannabis oil at a concentration of 20% of the total capsule volume was encapsulated within Ca-alginate microbeads of 1 085μm in size. The standard deviation was ±4.5%.

The formation of core-shell capsules with Na-alginate and cannabis oil using the encapsulator B-390/B-395 Pro was demonstrated. The method of encapsulating cannabis oil into a Ca-alginate matrix was also demonstrated with various concentrations of cannabis oil (recommended ≤ 20% of oil) on the Buchi encapsulator B-390/B-395 Pro. With the different single nozzle sizes available, the particle size can be selected in the range of 150μm to 2 000μm.

The Buchi instruments and lab equipment highlighted in this article are available in South Africa from Labotec. • *References available on request

Buchi – www.buchi.com Labotec – www.labotec.co.za

PHARMA FOCUS: CANNABIS

Tracking cannabis from seed to manufacturing The legalisation of cannabis comes with great risk and responsibility. By implementing seed-to-sale tracking, regulators worldwide are working to secure the legal cannabis supply chain. Like serialisation of pharmaceuticals, it increases transparency on all levels, benefits consumers and ensures accountability from all industry players.

A

ssisting the state and regional governmental departments to enforce regulations, collect taxes, and prevent illegal cannabis diversion and inversion, seed-to-manufacturing software can track every gram of legal cannabis throughout the production life cycle. Effective seed-to-sale tracking also benefits consumers since it increases transparency across all supply chain levels, ensuring accountability from growers, processors and product producers.

Tracking cannabis is not the only solution Mitas Corporation can offer commercial medicinal cannabis growers. Its Internet of Things precision farming management solution can increase the quality and quantity of cannabis products, by monitoring the entire farm. In turn, this can provide data in terms of pH-levels, moisture content and humidity levels, helping to reduce the amount of wasted plants processed during harvesting.

ENSURING TRACEABILITY

The company’s continuous inkjet (CIJ) plant passport solution can print a barcode directly onto the individual seed trays. With its udaFormaxx offline solution, a plant passport can be printed offline, easily and quickly, on stock cards, plant labels or cardboard labels.

Printing the barcode onto seedling trays gives traceability to the seed planted in the

tray. This solution is easily integrated into the production line and shows the time and date when it was planted, the strain, how many seeds are in a tray, and the location of the tray.

Once the seedlings are ready to be transferred from the tray to the field, cannabis growers can use Mitas Corporation’s unique polypropylene RFID tags, which are specially designed for tree and plant inventory, maintenance and tracking.

These tags are available in UHF, HF and NFC or with several customisations such as QR codes, barcodes, logos or serial numbers. The tags are linked to the plants in the tray and refer back to the specific strain that connects the individual plant to a particular row in a specific field – so different strains can be planted in one field.

NEXT-LEVEL SOLUTIONS

During the harvesting process, traceability makes the cannabis easier to process without mixing strains. Strain information is also recorded by using a mobile handheld RFID reader to scan the RFID tags on the individual plants.

A RFID tag attached to a plant With the plant passport solution, a barcode can be printed directly onto individual seed trays

Mitas Corporation can also trace the produce and not the packaging by applying DNA barcodes during regular processing, providing the only on-food safety solution.

During the trimming and sorting of buds, size samples are taken for testing and anything under a specific weight becomes a retention sample.

Vacuum-sealed bags are weighed and coded by either labelling or using CIJ or thermal inkjet printers to print lot codes, ingredients etc. The products are then boxed.

Mitas Corporation can also assist with highlevel inventory and warehousing solutions.

If cannabis is processed into capsules, logos, a best-before date and any other alphanumerical codes can be engraved directly onto the capsules themselves. • Mitas Corporation – www.mitascorp.com

A typical example of the production life cycle of cannabis

WWW.PHARMACOS.CO.ZA // FEBRUARY 2021

23

PHARMA FOCUS: CANNABIS

The future development of

cannabinoid production There is huge market potential for CBD and other cannabinoids with cannabis removed from the UN prohibition schedule and CBD no longer considered as a narcotic drug. A new report is now available from nova-Institute which explores the full potential of one of the major and longest established medicinal plants.

C

annabis sativa, one of the oldest and most versatile cultivated plants, has been used by humans for over 5 000 years, ranging from fibre production from seeds for food and feed, as well as oils for food and technical applications to medicinal use of cannabinoids for the treatment of pain, depression and nausea among a variety of

secondary metabolites of C. sativa. For 40 years, ∆9-THC has been classified as a narcotic drug and authorised by the FDA as a medicinal product for medical issues and uses, such as side effects of cancer chemotherapy and loss of appetite with weight loss in HIV/AIDS patients. On the other hand, the non-psychotropic CBD accounts

Biotechnological production of cannabinoids can be achieved in many different ways, including: • in eukaryotes, such as plants, algae, eukaryotic cell cultures and yeast • in prokaryotes, such as bacteria, or in enzymatic cell-free systems.

Natural cannabinoid synthesis in C. sativa

other symptoms.

After 60 years of being listed as a Schedule IV controlled substance, also referred to as the prohibition schedule, the UN has removed cannabis and cannabis resin from this list. In addition, natural cannabidiol (CBD), first announced as to likely qualify as a narcotic under the UN Single Convention on Narcotic Drugs, has been declared “not to be considered as such” by the European Commission. These decisions will enable and drive further research to access the full medicinal potential of cannabis.

for around 50% of the global hemp industry’s revenue, with this CBD market expected to grow globally to $3.5bn by 2024.

Besides these two commonly known cannabinoids, about 120 different cannabinoids have been identified in C. sativa.

Targeted biotechnological synthesis of the currently known 120 cannabinoids, which are only represented in small amounts in the plant, may circumvent the current limits of unveiling the pharmacological profile and effects.

Biotechnological production routes and resulting synergistic effects with current state-of-the-art extraction and production processes will enable the elucidation of the possible further beneficial effects of these molecules, which are currently unknown.

is performed via a complex pathway system that combines enzymes, products and intermediates from three different pathways.

A CLOSER LOOK AT CANNABINOIDS Cannabinoids are one of the best-known and most extensively studied classes of

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FEBRUARY 2021 // WWW.PHARMACOS.CO.ZA

HIGHLIGHTS AND KEY THEMES What is the current status of plant extraction and chemical synthesis? What requirements are needed for biotechnological cannabinoid production?

What is the most promising production host? What are the advantages and disadvantages

PHARMA FOCUS: CANNABIS

of plant extraction, chemical synthesis and biotechnological cannabinoid production? Does biotechnology have the potential to provide rare cannabinoids in significant amounts?

Which synergies might emerge with these three production routes and how can they drive the future development of cannabinoid production?

The answers to these questions are detailed in a new report by nova-Institute entitled Production of Cannabinoids via Extraction, Chemical Synthesis and Especially Biotechnology – Current Technologies, Potential & Drawbacks and Future Development. The report also explores the current state of biotechnological cannabinoid production, as well as plant extraction and chemical synthesis. These concepts have been extensively reviewed and finally compared to show general technology-related claims and to elaborate on the potential of biotechnological cannabinoid production, possible synergistic effects of all three production routes and to outline the future development of cannabinoid production.

It also provides extensive information on production technologies, medical applications and political framework conditions.

The report will guide you through the complex synthesis of cannabinoids, state-of-the-art methods for extraction and production and extensively shows the major hidden potential and synergistic effects of biotechnological cannabinoid production. It is aimed at experts in the pharmaceutical and biotech industry and provides deep insights into (bio)chemical reactions, processes and producers.

New certification standard for CBD consumer products In line with SAHPRA’s requirements, the CRI has certified a total of 43 CBD consumer products to date, including capsules, oils, teas, shots and functional topicals, as well as a range of pet oils.

According to the Cannabis Research Institute (CRI), before certification can be awarded, a brand and its CBD-containing products undergo a rigorous auditing process, with the certification only being awarded to those candidates meeting all of the criteria set by the CRI. This is done to ensure all CBDcontaining products across the brand are of the highest quality and are compliant. The brand and products also have to adhere to the current requirements set by the South African Health Products Regulatory Authority (SAHPRA).

RECOGNISED STAMP OF APPROVAL

To enable consumers to easily identify products certified by the CRI, approved brands may place the CRI certification logo on packaging material, with the logo indicating a stamp of approval from the CRI. “With this certification, the CRI is setting a standard for the industry while providing consumers with a clear way of knowing which products are reliable and safe to use,” says Dr Leandi van der Westhuizen, senior researcher of the CRI.

"Non-psychotropic CBD accounts for around 50% of the global hemp industry’s revenue"

A FIRST FOR AFRICA

The CRI is the first centre of excellence in the field of cannabis and cannabinoid therapy management in Africa. It is primarily focused on developing the medicinal cannabis capability in South Africa through substantiated clinical research.

The CRI incorporates the use of multidisciplinary approaches to further advance cannabis medicinal, veterinary and complementary drug development. This involves clinical research and data analytical trials as well as developing cutting-edge methodology and utilising state-of-the-art equipment and technology. •

EXPERT AUTHORS The main authors of the report are biotechnology experts and physicians from the nova-Institute, Dr Pia Skoczinski and Dr Franjo Grotenhermen, as well as chemist Dr Bernhard Beitzke, who has for years been advising the European Industrial Hemp Association as an expert.

The 142-page technology report provides in-depth information on established and emerging biotechnological approaches on the production of cannabinoids, as well as an overview of the state-of-the-art production methods using plant extraction and chemical synthesis. An extensive description of pharmacological effects, therapeutic potential and medicinal applications for ∆9-tetrahydrocannabinol (∆9-THC) and CBD, together with a short excursus on the EU regulatory framework for cannabinoids, conclude this comprehensive study. Additionally, 59 companies active in cannabinoid production are listed, of which 20 specialising in biotechnological production and chemical synthesis are described in detail. •

CRI – www.cannabisresearchinstitute.co.za

nova-Institute – www.renewable-carbon.eu/publications

WWW.PHARMACOS.CO.ZA // FEBRUARY 2021

25

PHARMA FOCUS: CANNABIS

For the love of CBD and living a healthy lifestyle The acronym CBD is floating around everywhere. But before jumping on this global health and wellness trend, it is important to clarify the common questions – what is it, where does it come from and most importantly, is it good for you?

C

BD, short for the tough-topronounce word cannabidiol is only one of the 100+ compounds of the Cannabis sativa plant. The compound

chemical compounds that helps maintain the functioning of this system. This is why the health benefits of CBD range from stress and chronic pain relief to relief from

is generally extracted from hemp, which is a part of the same species as marijuana.

But it contains a much higher percentage of CBD than the latter. In fact, it only contains about 0.3% tetrahydrocannabinol (THC). THC or is the psychoactive component of these plants that causes a ‘high’, so to speak.

This infers that the common notion of ‘CBD can get you high’, is nothing more than a misinterpretation.

The health benefits of CBD are often referred to as magic, but there is hard science evidence backing its benefits. The miracle compound has been proven to have several therapeutic benefits for species with an endocannabinoid system or ‘ECS’. This system is what keeps our body in balance by smoothing out problems that develop when an imbalance occurs. CBD is one of the

psoriasis, insomnia and nicotine addiction, as well as PTSD relief.

Countries such as South Africa are still new to the world of CBD and often confuse the compound with the entire plant and its ‘high’ effect. However, the global acceptance of CBD is changing this belief and the initial perception of the cannabis plant, when it was first criminalised in the 1920s. As a result, the rise of CBD companies has been exponential and is expected to grow steadily in the coming years.

THE BUSINESS OF CANNABIS One of the companies progressing the science of hemp and CBD is M2Bio Sciences. Through its wholly-owned subsidiary MJ MedTech, M2Bio Sciences is a nutraceutical biotechnology company that

Did you know?

According to a global market report

by Market Research Future, the cannabidiol or CBD market is likely to grow at a 125.78% CAGR during the forecast period of 2019 to 2026.

"Our CBD definitely meets the legal standard for CBD in South Africa"

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FEBRUARY 2021 // WWW.PHARMACOS.CO.ZA

researches, develops and commercialises a range of CBD-based products. It is also researching and developing indications for psilocybin new therapies, which will help patients who suffer from mental illness such as depression, Alzheimer’s and Parkinson’s. M2Bio Sciences is headquartered in Canada, publicly listed on the OTC market in the USA and operating out of Cape Town, South Africa.

M2Bio CEO, Jeff Robinson says, “Currently, there is, unfortunately, a lot of ‘gene pollution’ in South African cannabis.

There is also a high degree of corruption prevalent in obtaining the third-party certifications to prove the quality of CBD to consumers – which is a key concern. We want to serve the best to our customers and ensure they can trust us. At the moment, we import pharmaceutical-grade CBD from Colorado, USA for all of our products. Our CBD definitely meets the legal standard for CBD in South Africa. It may very well make us one of the safest CBD companies in South Africa.”

The recent acquisition of Tsime Pharmaceuticals by M2Bio Sciences earned it the license to cultivate, extract and process medicinal cannabis and sell the commodity for medicinal, scientific and other legal purposes. This project will be undertaken in the Kingdom of Lesotho. Tsime Pharmaceuticals plans to cultivate up to 3ha of medicinal-grade cannabis on a farm with a land area covering 23ha (57 acres).

PHARMA FOCUS: CANNABIS HEMP AND ITS IMMENSE BENEFITS Hemp is not only starting up a worldwide health transformation, but also has great potential to put the amazing sustainability revolution into overdrive. This notion led the company to launch the M2BIO Hemp product research and development division in Cape Town. This division consists of a team of remarkable engineers spanning multiple engineering disciplines and is led by the M2Bio Sciences COO, Willem Jonker. One of the aims of this initiative is to create plastic packaging alternatives that are sustainable and true to their social responsibility values.

M2Bio Sciences is currently in the process of launching its second brand, Dr. AnnaRx. The company chief medical officer, Doctor Anna Morera Leralta and her team of molecular research scientists are creating a CBD-infused beauty and health product line that will kick off with a CBD-infused pet care range. Dr. AnnaRx products are formulated using only natural ingredients and are all gender neutral.

Taking a seed-to-store approach, the company has a new and efficient way to operate. It is involved in everything from the cultivation, processing, manufacturing and labelling to the distribution of CBD in store. This comprehensive chain of

operation enables M2Bio Sciences to maximise profit, remain competitive and guarantee an excellent product and service to consumers.

CBD, COFFEE AND COMMUNITIES Africa is the home to the Tanzanian peaberry coffee, a truly unique and awardwinning coffee. Usually, coffee cherries contain two coffee beans that are flat on one side and rounded on the other. In the case of peaberries, only one seed is fertilised. This results in a single round seed with a ridge down the middle. Peaberries are considered to be superior in quality and taste from regular flat beans. Tanzanian Peaberry coffee is known for its rich, chocolate flavour. It also has hints of dark fruits like blackcurrant and a soft sweet finish. Drinkers can also expect to taste floral notes and hints of citrus fruit, coconut and pineapple.

When CEO Jeff Robinson found the Tanzanian Peaberry coffee, he understood it had the power of building a very strong community which would include farmers and producers from the African region and coffee lovers from all around the world, who care about their health.

“The idea is to bring the often-overlooked but amazing taste of Africa to the world

and ensure that rural communities can reap the benefits. Look, almost everyone has a similar morning routine. They wake up with their favourite cup of coffee or tea. That’s when I asked what if we could incorporate the health benefits of CBD in our favourite morning beverage? This was the exact thought that led to the creation of our first brand, Medspresso.”

Medspresso is an eco-conscious brand that encompasses a range of high-quality premium CBD-infused beverages including two blends of coffee, Rooibos tea and a hot chocolate drink which come in Nespresso compatible pods. Behind Medspresso is a team of experienced and passionate coffeelovers with a drive to showcase, educate and inspire people about specialty coffee. It is a community-minded coffee brand that is dedicated to providing their community with an excellent quality product.

“Through ongoing collaborations with these exceptional farmers and producers who have become like family, we hope to continually build sustainable long-term relationships. We will also continue to showcase the passion, hard work and dedication of the farmers, families and communities behind each cup that we serve to our customers daily,” concludes Robinson. •

Medspresso is an eco-conscious brand offering high-quality premium CBDinfused beverages

M2Bio Sciences – www.m2bio.co

WWW.PHARMACOS.CO.ZA // FEBRUARY 2021

27

SUN CARE

A convenient approach to

sun protection

Sunscreens have evolved from basic creams and emulsions, to gels, sprays and more recently stick formats which allow for quick, easy application. The latest sunscreen sticks are even more sophisticated and incorporate innovative technology for enhanced efficacy and greater skin care benefits.

S

tick-based skin care is one of the most popular trends emerging from the K Beauty movement. This trend has driven leading manufacturers like Sunjin Beauty Science to improve its formulations.

The first generation of stick formulations were made using only oils. This is according to Botanichem, the South African agent of the Korean ingredient manufacturer, Sunjin Beauty Science. These solid-format skin care products left a sticky residue on skin making them uncomfortable to use.

The next generation was also mainly oil-based but contained water-soluble ingredients in the form of microbeads, which were added to the formulation to give it extra properties such as a mattifying effect.

The third generation of sticks saw the development of the first two-phase waterin-oil emulsion stick. This formulation incorporated sodium stearate – an aqueous gelling agent traditionally used in solid deodorants and fragrance sticks. Although this generation was an improvement on

Formulation guide: Moisturising sun stick SPF50 Phase

A

B

C

Ingredients

INCI Name

MLB

Polyglyceryl-4 Isostearate & Coco-Caprylate/Caprate & Disteardimonium Hectorite & Polyglyceryl-3 Polyricinoleate & Sorbitan Isostearate

Parsol MCX

Ethylhexyl Methoxycinnamate

Parsol EHS

Ethylhexyl Salicylate

5

Parsol 340

Octocrylene

3

Saboderm AB

C12-15 Alkyl Benzoate

7

Neossance CleanScreen Z80nano

Zinc Oxide & C13-16 Isoparaffin & Polyglyceryl-3 Polyricinoleate & Sorbitan Isostearate & Triethoxycaprylylsilane

Sunsil-Oleo130

Silica & Cetyl Alcohol

5

SunbeMT-S

Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine

3

Ozokerite Wax SP1020P

Ozokerite

Phytowax Olive 12L 44

Hydrogenated Lauryl Olive Esters

EDTA-2Na

Disodium EDTA

0.05

2,3-BG

2,3-Butanediol

2

1,2-Hexanediol

1,2-Hexanediol

1

Sensiva SC50

Ethylhexylglycerin

Aqua Phytoplex

Glycerin, Limnanthes alba (Meadowfoam) Seed Oil, Canola Oil, Vitis Vinifera (Grape) Seed Oil, Helianthus Annuus Seed Oil, Calendula Oil, Cannabis sativa Seed Oil, Rosa Canina Fruit Oil, Argania Spinosa Kernel Oil, Polyglyceryl-10 Stearate

Water

Aqua

A transparent w/o waterdrop sun stick by Sunjin Beauty Science

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FEBRUARY 2021 // WWW.PHARMACOS.CO.ZA

% w/o 5 7.5

7.5

12 5

0.05

1

35.9

previous stick products, there were foaming and hardening issues, mainly due to the softness of the sodium stearate. The pH for hardening should be in the range of 8 to 10 which is too high for a facial product.

HECTORITE TECHNOLOGY The latest generation of sunscreen sticks developed by Sunjin Beauty Science are true emulsion sticks formulated with MLB. This ingredient is a special blend of an extremely stable water/oil emulsifier containing plolyglyceryl-4 isostearate, coco-/caprylate/ caprate, disteadimonium hectorite, polyglyceryl -3 polyrincinoleate and sorbitan isostearate.

According to Robyn Brown of Botanichem, emulsion sticks which use water are more economical. They are also offer increased hydration as opposed to sticks which only use oils and waxes. They are considerably less tacky and water resistant.

“To impart even more hydration and moisturisation in a stick formulation, Sunjin has developed a hectorite blend containing ceramides. Ceramides are the ‘glue’ that hold together the skin’s cells and help reduce TEWL. They also help maintain good barrier function and skin’s moisture content,” explains Brown. “Ceraplex contains squalene, ceramides and phytosterols to help repair very dry and damaged skin. As the ceramides are part of the hectorite technology, they are fully stabilised. Hectorites also help stabilise formulations as well as impart a beautiful skin feel.”

These fourth-generation skin care sticks are incredibly versatile and can be used in various applications, including lipsticks, moisture sticks, BB sticks as well as sunscreen sticks. • Botanichem – www.botanichem.co.za Sunjin Beauty Science – www.sunjinbs.com

SUN CARE

Dispersions for

new-age sun protection The sun has been identified as the main contributor to premature skin ageing. It radiates various frequencies of rays, but there are three particularly concerning types – UVA, UVB and UVC – which fall in the ultraviolet spectrum and are mainly responsible for certain types of skin cancers and premature skin ageing. AECI Specialty Chemicals offers a variety of UV filter dispersions for sun care products that protect against these harmful rays.

A

lthough the earth’s ozone layer blocks UVC rays, which reduces the risk of skin cancer, UVA and UVB rays need to be managed through adequate sun protection. When the UV rays penetrate the skin’s layers, melanin in the epidermal layer is triggered to protect the skin and gives the skin a tan colour. Too much sun exposure will allow the UV rays to penetrate into the dermal layer, leaving the skin burned.

Sunburn causes redness, blisters,

peeling and itching – which damages skin cells and could potentially develop into skin cancer.

The sun care market has grown in recent years, with a huge demand for skin protection against harmful UV rays.

Climate change, due to global warming, requires us to be more vigilant of the sun’s damaging rays. There is also a heavy focus on sustainability, resulting in regulatory changes for sun care products.

The challenges the industry is currently facing are due to the newfound demand for products featuring claims such as reef-safe, mineral sunscreens, prebiotic, probiotic, plastic free, vitamin D-promoters, blue light protection, infrared light protection, nonwhitening and less tackiness.

EFFICIENT SUN FILTERS AECI Specialty Chemicals, in partnership with Jeen International, offers a wide variety of sun care filters – octocrylene, octyl methoxicinnamate and avobenzone, to name a few. Its dispersions are known as the Jeesperse® NDA filter range. These are efficient, high-volume load dispersions of physical sun filters in naturally-derived alkanes and hydrocarbons. They are infused with 70% sun-protecting actives and are easy to formulate.

Jeesperse NDA sun dispersions are stable despite their high content of zinc oxide and titanium dioxide. The pure, non-polar alkane used as the solvent also functions as an emollient that adds slip and cushion to finished formulations, significantly reducing the draggy and dull-like feel of inorganic UV filters. These sun dispersions have 95% natural content and can be used as standalone UVA/UVB protective systems, or in combination with other sunblock/sunscreens.

In addition to sun care applications, Jeesperse T70-CC is ideal for use in colour cosmetics such as lipsticks and foundations, while Jeesperse Z70-CC is suitable for use in wound or rash-healing skin care formulations.

Jeechem® NDA alkanes are the choice carriers for mineral sunscreens leveraging the need for mineral sunblocks with naturallyderived biodegradable alkanes that are ideal dispersants without compromising SPF. The clear, bright ultra-pure and highly antioxidantresistant properties make Jeechem NDA alkanes ideal mineral sunblocks, solubilisers, dispersants and solvents. • AECI Specialty Chemicals – Charmaine.dupreez@aeciworld.com Jeen International – www.jeen.com

WWW.PHARMACOS.CO.ZA // FEBRUARY 2021

29

SUN CARE

How to optimise sprayable sun care formulations The sprayable format within the sun care category has grown considerably in popularity, mainly due to consumer preference for a convenient product format that can be sprayed directly onto skin and the desire for a non-greasy application.

In this article, Alchemy Ingredients explores the optimisation of sprayable oil-inwater emulsions formulated with organic sun filters.

T

he formulation of sprayable sun care products can take different forms, including water-in-oil and oil-in-water emulsions, oil-based products and volatile solvent-based formulas (aerosol or non-aerosol).

To reach a high SPF, a relatively high level of organic or inorganic (mineral) sun filters must be used. Certain sun filters are more effective at absorbing in the UVB range, while others perform better in the UVA range. Ultimately, the formulator needs to select a suitable blend of filters to obtain the correct UVB/UVA protection ratio to prevent ageing and skin cancer. However, this fine balance is beyond the scope of this article.

The maximum permitted levels of some organic sun filters are outlined in Table 1. Approvals for sun filters vary greatly throughout the world and are constantly changing. There are some online tools available for calculating the predicted SPF of a product by entering the level of different sun filters used. For example, by adding 5% of Homosalate, 10% of Octylmethoxycinnamate and 5% of Octyl Salicylate to a formulation, you can achieve an SPF of 15. If you add a further 10% of Octocrylene, you can reach an even higher SPF of 26.

However, these tools are only an indication and further testing is required to determine the actual in vitro or in vivo SPF. The aim of the formulator is to develop formulas that not only have the required SPF, but also feel good on skin and are light and non-greasy. It is helpful for a sun care formulation to have additional characteristics such as waterproofing, anti-ageing properties and favourable rheology. This means other formulation additives should be selected with care. Some of the commonly used sun care additives and their functions are detailed in Table 2.

KNOWLEDGE ON EMULSIFIERS One of the most desirable characteristics of an oil-in-water emulsion is the fine,

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smooth texture. This can be achieved by obtaining a small oil droplet size. A smaller, more uniform droplet size will also lead to greater stability as Ostwald ripening and flocculation will be minimised.

Certain emulsifiers are better at producing a small particle size than others, so different emulsifiers need to be investigated to see what works well. Another factor to consider is that the emulsifier should not add a lot of viscosity to the sprayable formula, or it will become too thick to spray.

The rheology of the product should be carefully considered – formulations that are Newtonian or shear thickening may have issues when packaged in a sprayable format.

The ideal type of rheology for this formulation is thixotropic, as the force applied when the material is sprayed causes it to temporarily thin down. The structure reforms once it has been applied on skin, preventing run-off. This also helps with stability, as the thixotropic thickening system prevents phase separation.

RECOMMENDED EMULSIFIER SYSTEM An emulsifier system that works well in sprayable oil-in-water products is Sucragel AP V2 (INCI: Glycerine, Aqua, Sucrose Laurate) from Alchemy Ingredients, represented locally by Carst & Walker. This emulsifier effectively emulsifies high levels of oil while remaining at a low viscosity. It also produces a small droplet size due to the unique shape of the sucrose laurate molecule, which allows tightly-packed micelles.

A special method is recommended when using Sucragel as an emulsifier to obtain optimum texture and stability.

Firstly, the oil phase must be incorporated into Sucragel to make a gel. This forms a concentrated emulsion where the oil phase

Table 1: A selection of permitted organic sun filters EU

US

Rest of world incl. Japan and Australia

4-Aminobenzoic Acid

Banned

15%

15%

Padimate O

Banned

8%

8%

8%

4%

Varies between 3% and 8%

Banned

3%

6%

Dioxybenzone

3%

3%

3%

Oxybenzone

10%

6%

5% to 10%

Homosalate

10%

15%

10% to 15%

Banned

5%

5%

Octocrylene

10%

10%

10%

Octyl Methoxycinnamate

10%

7.5%

10% to 20%

Octyl Salicylate

5%

5%

5% to 10%

Sulisobenzone

5%

10%

10%

Banned

12%

12%

5%

3%

5% to 10%

Ingredient

Phenylbenzimidazole Sulfonic Acid Cinoxate

Menthyl Anthranilate

Trolamine Salicylate Avobenzone

SUN CARE

Table 2: Sun care additives Ingredient

Function

Usual % added

VP/Eicosene Copolymer; VP/ Acrylates/Lauryl Methacrylate Copolymer; Triacontanyl PVP; VP/ Hexadecene Copolymer (Antaron)

Waterproofing

1% to 5%

C12-15 Alkyl Benzoate

Solvent for sun filters, emollient

Silicones e.g. Dimethicone

Waterproofing and emollient

Pigments

Adding colour or interest to product

1% to 5%

Plant extracts

Soothing properties, adding interest to product

1% to 5%

Diisopropyl Adipate

Low-viscosity emollient, solvent for filters

1% to 10%

Vitamins, Tocopherol Acetate, Sodium Ascorbyl Phosphate

Antioxidants for formulation and skin

Carbomer, Cellulose, Xanthan Gum

Thickener / rheology modifier / stability enhancer

5% to 20%

0.2% to 0.5% 0.5% to 3%

Table 3: Medium SPF spray Phase A

B

C

D

Ingredient

INCI

% w/w

Sucragel AP V2

Glycerine (and) Aqua (and) Sucrose Laurate

5.0

Escalol 517

Butyl Methoxydibenzoylmethane

3.0

Escalol 597

Octocrylene

4.0

Neo Heliopan HMS

Homosalate

8.0

Neo Heliopan HMS

Ethylhexyl Salicylate

5.0

Cosmacol EBL

C12-15 Alkyl Benzoate

5.0

Caprylic/Capric Triglyceride

Caprylic/Capric Triglyceride

2.0

Water

Aqua

Sucrathix VX

Microcrystalline Cellulose, Cellulose Gum, Xanthan Gum

1.0

Euxyl PE9010

Phenoxyethanol (and) Ethylhexylglycerin

1.0

66.0

Predicted SPF using online calculator: 16.3 Stability: three months at RT, 40°C and 4°C Measured SPF: 29.0

A

B

C

D

SUCRAGEL CONCEPT IN SUN CARE A study was carried out to establish whether a Sucragel emulsifier system would be suitable for a sprayable sun care product and whether it gives an enhanced SPF compared to the online calculator. It was predicted that using Sucragel / Sucrathix VX would result in a better than predicted SPF due to a small particle and even dispersion of sun filter.

In these two formulations, featured in tables 3 and 4, Sucragel AP V2 was used in conjunction with various sun filters and other ingredients to create a low-viscosity, thixotropic, stable sun lotion with an elegant skin feel. The sprays were also tested to determine SPF. Testing was carried out independently at Helioscreen SAS, France, using a Labsphere UV2000c in vitro method.

The use of another additive from Alchemy Ingredients, Sucrathix VX (INCI: Microcrystalline Cellulose, Cellulose Gum, Xanthan Gum), proves useful in optimising stability in these formulations. Sprayable formulas are very susceptible to separating due to their low viscosity – Sucrathix VX allows the structure to remain fully sprayable while providing thixotropy.

It also gives a light, non-sticky skin feel.

CONCLUSION

Table 4: High SPF spray Phase

is approximately 85% and droplets are around 300nm in size.

The second step involves dilution of the gel or concentrated emulsion with water to make the emulsion and increase the size of the external phase. The degree of dilution can be varied depending on the level of oil required. Viscosity will remain low regardless of the amount of oil; however, it can be manipulated using rheology modifiers in the diluting external phase.

Ingredient

INCI

% w/w

Sucragel AP V2

Glycerine (and) Aqua (and) Sucrose Laurate

5.0

Escalol 517

Butyl Methoxydibenzoylmethane

3.0

Escalol 597

Octocrylene

10.0

Neo Heliopan HMS

Homosalate

8.0

Neo Heliopan HMS

Ethylhexyl Salicylate

5.0

Cosmacol EBL

C12-15 Alkyl Benzoate

7.0

Water

Aqua

Sucrathix VX

Microcrystalline Cellulose, Cellulose Gum, Xanthan Gum

1.0

Euxyl PE9010

Phenoxyethanol (and) Ethylhexylglycerin

1.0

55.0

Sucragel, in conjunction with Sucrathix VX, provides a stable, sprayable system for sun care products. It fulfils the brief for a light, non-greasy product, with thixotropic rheology, ensuring the product remains on the skin until rubbed in.

Due to the small droplet size, the SPF is maximised and minimal skin whitening occurs. Sucragel AP V2 and Sucrathix VX are classified as natural according to the COSMOS standard, meaning that the natural index of formulations can be increased when using these ingredients. In addition, a major benefit is the enhanced SPF benefit of this system as a result of the small particle size and excellent dispersion of sun filters in the formulation. • Alchemy Ingredients – www.alchemy-ingredients.com Carst & Walker – www.carst.co.za

Predicted SPF using online calculator: 24.4 Stability: three months at RT, 40°C and 4°C Measured SPF: 70.7

WWW.PHARMACOS.CO.ZA // FEBRUARY 2021

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HAIR CARE

Top tips and

summer hair trends

Reneé Potgieter, hair health activist and colour alchemist, is on a mission to change the way beauty is perceived. She knows, as an expert with over 25 years’ experience, that a less-is-more approach to hair is what leads to healthy, beautiful locks. She also knows that the summer season gives consumers the perfect opportunity to bring out their hair’s natural beauty.

I

t is summer, and many consumers are enjoying an easier laid-back approach to their beauty regimes – especially those working from home, who get to enjoy less stress when getting ready in the morning.

NO-HEAT STYLING For anybody that wants to restore health, vitality, and strength to their hair, the absence of artificial direct heat on the hair is an absolute must. The no-heat method works

because hair consists in part of hydrogen bonds and artificial heat manipulates the hair, thereby controlling its shape.

The temporary hydrogen bonds are radically responsive to moisture. So, while hair may look fabulous just after styling, the moment steam, water or sweat hits, the killer styling is lost within seconds. The bonds are also responsible for controlling the temporary texture of the hair. However, if they are consistently manipulated with styling, long-term damage occurs to the bonds and hair suffers a sort of ‘memory loss’.

Constantly manipulating hair texture, like straightening curls with frequent blowdrying and flat-ironing, result in the bonds eventually forgetting their true natural form and, essentially, hair goes into crisis mode.

The only way to prevent this is to work with the hair structure instead of against it.

Enhancement and nourishment, in place of relentless manipulation, will bring out the best in the hair structure.

Leave-in nourishing treatments are also great. Of course, you won’t wake up with perfect hair, but they do help to nourish hair, leaving it healthier and more cooperative.

NATURAL STYLING PRODUCTS Caucasian consumers often experience great hair after a day at the beach. There are two reasons for this. One is that there are no mirrors for them to consistently critique themselves, so they’re forced to embrace their hair and its reaction to the elements.

Did you know?

Scalp care was big in 2020 and will continue into 2021. With more people experiencing hair loss and hair maintenance being put into our own hands, it’s becoming ever more important for consumers to care for their scalps at home with multitasking products.

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HAIR CARE

MORE NATURAL COLOUR

Two, the salt in seawater acts as a filler to help smooth out the microscopic ridges on the cuticle layer of the hair shaft which creates hair irritation, thereby acting as a styling aid.

Broadly, a styling aid is a product that helps control irritation by smoothing the cuticle layer when the hair is left to dry naturally.

Despite popular belief, damage is the main contributor when it comes to creating unmanageable hair structure. Any hair that is in bad condition will suffer from frizziness and in an attempt to help it, consumers often use styling aids that do more damage than good. When it comes to the gazillion styling products on the market, less is more and many of them will become redundant once hair is in a healthy condition.

Quality styling aids are important in the beginning as they are formulated to not coat the hair with silicones or other chemical ingredients that do more damage than good.

With any natural products, such as salt sprays, it is important to read the ingredients list to ensure that they are of high quality and truly cleaner.

Some of the worst build-ups on hair come from brands developed by traditional cosmetic companies that have ventured into hair care. To avoid this, ensure products are free from parabens, alcohol, and any other nasty chemicals that consumers struggle to pronounce.

in all sorts of forms such as masks and conditioners. This process doesn’t need to be another laborious step in the hair care regime and can be applied overnight.

Thankfully, natural oils are making a comeback, taking inspiration from numerous ancient traditions. It’s better to use top-grade pure oils such as jojoba for moisture and almond for a strengthening protein boost. These natural oils are so pure they become solid when placed in the fridge, which is a great indicator of quality.

During summer, we often become more mindful of our blessings in life; it’s a time for consumers to sit back, relax and let their natural beauty shine through.

We all have the hair of our dreams – we just need to let it down. •

Every time we colour our hair, we expose it to harsh pigments and chemicals no matter how gentle the product. The more chemical exposure to the entire length of the hair shaft, the more compromised the entire cuticle layer will become and the worse the state of the hair will be.

A less-is-more approach to colouring means being open to blending techniques such as balayage. This is a technique for highlighting hair which creates a graduated effect for asymmetrical, natural-looking results. The regrowth from this technique is far less stark and for an extended period ABOUT THE AUTHOR Reneé Potgieter is a natural between colouring sessions. hair health activist, colour Being smart about colour choices also alchemist and owner of the blog Naturally Reneé. Send an email to goes a long way. The variance between one’s renee@gentleapproach.co.za for more info. natural colour and a chosen colour should be as minimal as possible. For the softest regrowth, the gap between one’s natural colour and the altered colour shouldn’t Organic Raw and Refined Shea Butter be more than Avocado Butter two shades. The Organic Grape Seed Oil bigger the gap, the Organic Castor oil more obvious the Hydrolysed Wheat Protein regrowth will be, Olivem 1000, 900 & 300 ultimately requiring Rhassoul & Bentonite clays colouring more BTMS often and therefore compromising hair’s condition.

Natural Hair Care Ingredients

HAIR FOOD

www.nauticaorganics.com 083 266 2657

Elasticity and porosity are the building blocks of naturally good hair structure. It is important to care for these building blocks by nourishing the hair.

Natural beneficial treatments formulated with botanical oils come

WWW.PHARMACOS.CO.ZA // FEBRUARY 2021

33

HAIR CARE

Embracing the wise and pro-ageing gradient In the recent years, the use of silver and grey hair dyes has revealed an increasing trend among women of all ages – going grey gracefully. In line with this trend, LipoTrue has developed Wisegrade, an active ingredient that helps to regulate the amount of desired grey in a natural, non-damaging way.

W

omen are either embracing their natural salt and pepper tones (grombre) or going totally silver, in pursuit of the pro-ageing trend. With the extended lockdown, many women have embraced their greying hair, resulting in rising numbers of pro-ageing consumers.

pool, reactivating the melanogenesis cycle and reinforcing melanosome integrity.

Wisegrade provides antioxidant protection, enhances gloss and allows for the amount of grey hair to be regulated.

Besides, men who are blessed with grey ‘wisdom’ highlights are known as silver foxes and considered attractive and sexy. However, in an ageist society, they prefer more pepper than salt in their hair. So, for them dying is not an option.

The loss of pigmentation in hair is due to an unbalanced redox homeostasis, reduced melanogenesis and less melanocyte stem cells migrating into the bulb. Oxidative stress is mainly caused by melanogenesis and emotional stress, though heavy metals from tap water and other external factors can play a role. In grey hair shafts, oxidative stress can oxidise keratin proteins and remaining melanin leading to an undesired yellowing.

LipoTrue’s Wisegrade helps to regulate the amount of desired grey, in a natural non-damaging way. It improves endogenous antioxidant rebalancing redox homeostasis, protecting the stem cell

LipoTrue tested Wisegrade against various parameters, including gene expression modulation, antioxidant boosting, repigmentation, efficacy in human scalp hair follicles and the ability to embrace the wise gradient.

Neonatal (HEMn), moderately (MP) and darkly (DP) pigmented human epidermal melanocytes were treated with Wisegrade.

The RNA was extracted, purified and quantified, and retro-transcripted to cDNA. It was then measured by real time quantitative polymerase chain reaction (RT-qPCR).

HEMn-MP were treated with Wisegrade for 24 hours and superoxide dismutase (SOD-1) activity was evaluated by absorbance. HEMn-MP were treated with Wisegrade for 72 hours and basal cells were used as a control. Melanin quantification was performed by spectrophotometry.

Human scalp hair follicles in anagen phase of a 50-year-old donor were treated with Wisegrade and its efficacy determined by immunofluorescence.

Lastly, 20 men (aged 40 to 55) with salt and pepper hair applied a tonic with 3% Wisegrade on the scalp, once a day for four months.

The ratio of grey to natural hair colour was evaluated with a dermatoscope, hair radiance with a colorimeter and the total antioxidant capacity by the Ferric Reducing Antioxidant Parameter (FRAP).

Figure 1: An untreated hair follicle (left) and another treated with Wisegrade (right). MITF shown in green

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MATERIALS AND METHODS

Figure 2: Evolution of grey to natural colour ratio with Wisegrade

RESULTS AND DISCUSSION The gene expression modulation test showed Wisegrade to improve the recovery of redox homeostasis by up-regulating the genes encoding the antioxidant catalase and MSRB1, which repairs proteins damaged by oxidative stress.

It also up-regulated genes encoding BCL2 (an antiapoptotic factor), LEF1 (melanocyte survival) and PAX3 (prevents terminal differentiation), which are involved in the protection of the stem cells pool.

Moreover, it up-regulated genes related to the reactivation of the pigmentation like c-KIT and MITF, which is a master regulator of genes in melanocyte proliferation, survival, differentiation, apoptosis, redox homeostasis and melanogenesis. Wisegrade was also able to up-regulate TYR, TYRP1, TYRP2 (DCT), which are key in melanin biosynthesis.

Wisegrade was able to boost SOD-1 activity in a dose-dependent manner in the antioxidant booster test.

Cells treated with Wisegrade in the repigmentation study showed a melanin increase efficacy in a dose-dependent manner.

Wisegrade increased PGC1α in the dermal papilla and the hair matrix by 15% and 16%, confirming its efficacy in human scalp hair follicles. PGC1α is activated by MITF and induces the expression of ROS detoxifying enzymes like SOD. It also increased MITF protein in the outer root sheath (ORS) and in the hair matrix and enhanced by 40% cells containing MITF in hair

HAIR CARE

Figure 4: Antioxidant protection with Wisegrade

Figure 3: Photos of a volunteer at the beginning of the study (left) and after four months of using Wisegrade (right)

matrix and the ORS (see Figure 1). Moreover, it was observed that 180% more cells contained activated MITF in the hair bulb.

The study showed very good results for Wisegrade in graduating grey hair to its natural colour and for radiance and antioxidant capacity, in only two months. Its efficacy increased during the study achieving excellent results at the end of the study (see Figures 2, 3, 4 and 5). Moreover, the number of responders to the treatment also increased with notable average values.

CONCLUSION Wisegrade has shown, both in vitro and in hair human follicles, to be able to protect the stem cells pool, provide antioxidant balance and reactivate pigmentation of hair follicles.

In vivo, Wisegrade was able to regulate the ratio between grey and natural hair colour and to provide antioxidant protection and gloss.

These results highlight Wisegrade as an excellent candidate for formulations looking to delay the appearance of grey hairs or even regress them a little. It is also suitable

Figure 5: Radiance efficacy during the study

in products aimed to provide a good health and shine in a new pro-ageing approach in hair care. • LipoTrue – www.lipotrue.com

For more information visit www.lipotrue.com | info@lipotrue.com

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HAIR CARE

Keep your claims in check As hair care trends expand locally and internationally, the South African regulatory landscape consistently considers the specific local nuances in order to provide guidance to brand owners and manufacturers. The end goal is to ensure they provide innovative and efficacious products with consumer safety in mind. By Dershana Jackison

H

air care is one of the cosmetic product

categories identified by the National Department of Health (NDoH) in the draft Regulations relating to labelling, advertising and composition of cosmetics, R.1469, 22 December 2017.

But what does this category constitute?

Historically, CTFA together with industry experts have initiated the writing of the South African National Standard, SANS 10393 Hair care products – General requirements under the auspices of the South African Bureau of Standards (SABS) as well as the Advertising Regulatory Board’s (ARB’s) Advertising code of practice – Cosmetic code as a reference for industry to remain compliant in terms of product labelling, product claims, claim substantiation, product composition and advertising material. The draft regulations echo these requirements and further include requirements for good manufacturing practices; a product information file and postmarketing surveillance.

Hair shampoo and conditioner are the traditional hair care products, but further subcategories as defined by SANS 10393 include flammable hair products, hair colour modifiers, colour removers and bleachers, and hair structure modifiers and neutralisers.

These have been included specifically to provide guidance on labelling and advertising

Did you know?

Copies of the standards mentioned in this article can be accessed on the CTFA website or purchased from SABS. The advertising code of conduct can be accessed via the CTFA website or the ARB website. CTFA also hosts training sessions on all aspects of the draft regulations.

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FEBRUARY 2021 // WWW.PHARMACOS.CO.ZA

to ensure the provision of useful information to consumers. The labelling requirements as per the draft regulations are aligned with that of SANS 289 Labelling requirements for prepackaged products.

BE CAUTIOUS WITH CLAIMS According to the draft regulations, as well as the ARB’s advertising code of practice – cosmetic code, it is imperative that no medicinal or medical claims or medical conditions are mentioned on the labelling of hair care products, as with all cosmetic products. The inclusion of such claims will mean that such products are to be registered with the South African Health Products Regulatory Authority (SAHPRA) and are not considered as cosmetics.

Although cosmetic products can claim that regular use can alleviate symptoms of a hair or scalp condition, the claim cannot include benefits such as a preventative or curative function. Such functions are the effect of medicinal products only which can have permanent benefits.

Furthermore, product claims that are permissible must be supported by scientific substantiation. Both the ARB and NDoH require this in the event of an advertising challenge or audit. It is the responsibility of the brand owner or distributor to ensure that the claims are appropriately substantiated.

Ensuring that the claims made on the product are truthful will support a positive brand image and promote customer loyalty.

INGREDIENT SAFETY AND TRANSPARENCY Within the NDoH’s draft regulations are annexes that provide a list of prohibited

REGULATORY STANCE ON MICROBIOME TECHNOLOGY One of the latest trends in the cosmetics industry is the use of microbiome technology. This trend is also filtering through to the hair care market. It is important to note that currently, there are no clear local regulations and guidelines on the use of microbiota in cosmetic products; CTFA is in conversation with regulators locally and internationally to provide clarity in this regard. cosmetic ingredients, restricted cosmetic ingredients, permitted preservatives, permitted colourants and permitted UV filters. These annexes should be consulted when designing a hair care product to ensure full compliance in terms of the product composition.

Furthermore, ingredient listing requirements as per the draft regulations and SANS 98 Ingredient listing should be complied with.

SANS 22716 – Cosmetic good manufacturing practice – is also recommended by the NDoH to ensure product safety.

Lastly, the draft regulations call for post-marketing surveillance whereby the product safety surveillance is required during consumer use.

If you require more information on cosmetic regulatory aspects, please reach out to the CTFA by sending an email to info@ctfa.co.za. • CTFA – www.ctfa.co.za

HAIR CARE

360° solution for hair loss prevention SymHair Force 1631 is a natural, highly-potent active ingredient for hair loss prevention. It addresses thinning hair and hair loss concerns, which are among the top hair care solutions that consumers are willing to pay a high price for.

A

part from greying hair, for both men and women hair loss and thinning are among the main signs of ageing. They can be accelerated by a wide variety of factors such as stress or seasonal climatic changes.

These factors cause a premature transition of the hair fibres from the anagen phase (growth) to the catagen (regression) phase.

INSPIRED BY BIOTECHNOLOGY

Looking for an efficient and sustainable solution to a global problem, Symrise carefully screened an extensive series of molecules and developed an original extract from microalgae found in Mataiva, Tahiti, which is acknowledged for its high nutritional value and active potential.

SymHair Force 1631 (INCI: Pentylene Glycol, Isochrysis Galbana Extract)

is produced using a sustainable blue biotechnology process, offering hair care brands a complete solution for hair loss claims.

The natural ingredient is developed using a renewable source while the biomass production is highly controlled.

Because SymHair Force 1631 is cultivated with selected additives, it is possible to ensure an extremely valued ingredient with compounds that are potentially active on human skin and hair.

VISIBLE RESULTS

As a 360° solution, SymHair Force 1631 decreases dying cells in the hair bulb and stimulates the proliferation cells, decreases the regression phase and stimulates hair growth, as well as

Did you know?

82% of global consumers want

scalp solutions that target problems at their origin. strengthens hair fibres preventing breakage and enhancing hair volume.

A clinical study has attested to its effectiveness while users were also convinced by its hair-strengthening properties. According to their evaluation, the ingredient fortifies hair and improves hair density. In an ex vivo assay on human hair follicles, SymHair Force 1631 proved to be effective after eight days of treatment and provided thicker and more voluminous hair. • Symrise – www.symrise.com

Hair Actives

AMAZING HAIR INSIDE OUT

Experience our creativity in the latest evaluation technologies and highly efficient solutions dedicated to the areas of hair repair & conditioning, color protection, anti-pollution, anti-hair loss, scalp care and eyelash enhancement.

Addressing and investigating all key aspects of hair complexity.

COSMETIC INGREDIENTS BY SYMRISE always inspiring more ...

www.symselect.com I www.symrise.com Follow us on Instagram @symrise.ci

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HAIR CARE

A holistic hair and scalp oil derived from biotech fermentation

AlgaPūr HSHO algae oil from Lubrizol Advanced Materials provides multiple benefits for hair and scalp care.

Containing over 90% of beneficial omega-9, it helps protect and strengthen the fibres while hydrating and rejuvenating the scalp. By Eulalia Peri, Juliana Gomiero, Elena Cañadas, Carole Lepilleur, Jean Xavier and Raquel Delgado

T

hroughout history, women have invested time and effort into treating their hair. Greek women were known to use olive oil to condition their hair. Even today, this tradition of applying oils to provide nourishment and shine to both hair and scalp is still present in women’s beauty routines. For example, in India, women use coconut oil to nourish their hair and scalp.

Although cold-process methods are the most common way of obtaining natural oils, they can also be obtained through biotechnology thanks to fermentation with algae. Algae can be found in environments other than water, such as plants.

AlgaPūr high-stability high-oleic (HSHO) algae oil (INCI: Triolein) is an oil derived from microalgae that was originally sourced from the sap of a chestnut tree. Under favourable

Did you know?

AlgaPūr HSHO algae oil also provides shine, frizz control, smoothness and a conditioning feel to the hair fibre. These added benefits were determined during several additional tests performed on different types of hair, in which the algae oil showed excellent results that are comparable to argan oil.

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FEBRUARY 2021 // WWW.PHARMACOS.CO.ZA

conditions, these microalgae will convert sugars into triglyceride oils, resulting in a highly stable bio-based oil with a low environmental footprint.

SCALP CARE A fibroblast cell culture model was used to assess the ability of 0.05% AlgaPūr HSHO algae oil to exert an effect on collagen and elastin synthesis by means of an ELISA. Untreated cells were used as a control.

In vitro, AlgaPūr HSHO algae oil increases type I collagen (superior to argan oil, which is well-known for its anti-ageing benefits), as well as elastin synthesis (see Figures 1 and 2).

To determine the ability of the oil to repair photodamage, EpiDerm tissue – a skin model consisting of normal human-derived epidermal keratinocytes cultured to form a multilayered, highly-differentiated model of the human epidermis – was exposed to UVB and treated with 0.05% AlgaPūr HSHO algae oil for 24 hours. Tissue viability (MTT assay) and thyamine dimer formation (TT dimer assay) were measured. Untreated cells were used as a control.

Results showed AlgaPūr HSHO algae oil can increase cell viability after UVB exposure, and it could have reparative properties as it decreases the signs of UV-induced cell damage in vitro (see Figures 3 and 4).

The algae oil was also tested in vivo on 14 volunteers who applied 18μL (2μl/cm²) of AlgaPūr HSHO algae oil on the volar forearm. Skin hydration and transepidermal water loss (TEWL) were measured using a corneometer and a vapometer, respectively. Test data confirmed that the oil confers immediate (four-hour) and long-lasting (24-hour) moisturisation to the skin. This is better than olive oil, which is well-known for its

Figure 1: Type I collagen synthesis (*p<0.05)

Figure 2: Elastin synthesis (*p<0.05). #: 1% DMSO

Figure 3: Cell viability hydration properties. AlgaPūr HSHO algae oil also improves skin barrier function in the short and long term.

FIBRE CARE To determine the protective benefit against hair breakage, bleached Caucasian type I hair tresses were treated with 0.5mℓ AlgaPūr HSHO algae oil or 0.5ml argan oil and repeatedly brushed 10 000 times. The broken fibres were evaluated every 1 000 strokes, and untreated hair tresses were used as control.

An 83% reduction in broken fibres was recorded, confirming that AlgaPūr HSHO algae oil provides excellent breakage protection

HAIR CARE Figure 4: UVinduced cell damage

similar to that of argan oil (see Figure 5).

Thereafter, 50 double-bleached Caucasian type 1 hair fibres with split ends were randomly selected and each of the split end fibres was photographed. AlgaPūr HSHO algae oil (0.17mℓ/g hair) or argan oil (0.17mℓ/g hair) was applied on the tresses, which were left overnight and photographed the following day. The before/after images were graded and judged according to a visual evaluation scale, from one (no repair) to five (complete repair), showing AlgaPūr HSHO algae oil can mend split ends (see Figure 6).

Figure 5: Number of broken fibres after repeated combing tests

CONCLUSION AlgaPūr HSHO algae oil helps to naturally deliver a healthy fibre and scalp. The natural ingredient is produced through fermentation and is readily biodegradable. It also has a low environmental footprint in water, carbon and land use.

In vitro, the ingredient has been proven to increase type I collagen and elastin synthesis while decreasing the signs of UV-induced cell damage. In vivo, it provided immediate and long-lasting moisturisation and improved skin barrier function.

AlgaPūr HSHO algae oil is available in South Africa from Carst & Walker – an approved local distributor of Lubrizol. •

CARST & WALKER (Pty) Ltd Tel: +27 (11) 489 3600 - E-mail: info@carst.co.za I www.carst.co.za

Sin título-1 1

Figure 6: Visual evaluation of the split end

Carst & Walker – www.carst.co.za Lubrizol Advanced Materials – www.lubrizol.com

© 2020, 2021 The Lubrizol Corporation. All Rights Reserved.

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HAIR CARE

Hair health & wellness take centre stage

The ‘skinification’ trend in hair care is driven by the need to address scalp health over the long term.

Greentech’s new natural ingredients target exposome-induced hair ageing, which includes both environmental and behavioural factors known to have deleterious health effects. These ingredients address three main issues of hair loss, greying and daily damage.

R

epresented locally by Natchem, Greentech’s vision and values have remained constant since the group was established in 1992. Its business model is based on innovation for human well-being and health while preserving biodiversity in a sustainable and balanced manner.

Greentech’s team is made up of explorers, scientists and biotech pioneers.

“We source the best that nature has to offer for everyone’s benefit: in cosmetics; healthcare; human and animal nutrition; agronomy and the environment. We operate worldwide to build sustainable subsidiaries that are founded on the principles of protecting biodiversity and human relationships,” says a representative of Greentech, for which nature is a source of inspiration, information and the company’s technologies.

HAIRILINE Environmental and behavioural factors can have an impact on skin and hair, leading to dry, sensitive and reactive skin, premature ageing, dull and brittle hair and hair loss.

With Hairiline®, Greentech focused on addressing hair loss – more specifically, alopecia – using a systemic approach, combining the study of the Wnt/β-catenin cell-signalling pathway (which is essential to the hair cycle) and the study of the scalp microbiota.1 Hairiline is a natural active ingredient derived from the roots of Lindera strychnifolia, a plant used in traditional Chinese medicine.

Using an integrative approach, supported by an innovative metagenomic study, Hairiline rebalances the scalp bacteriobiota and mycobiota to restore a healthy microbiota-scalp cross-talk. Hairiline also outperforms the benchmark, Minoxidil, in the stimulation of dermal papilla cell proliferation. With Greentech’s active ingredient, the number of hair fibres is both significantly and visibly increased.

The recommended use level of Hairiline is 1%. This active ingredient is both Chinacompliant and Cosmos-approved.

ARCOLYS Targeting the mechanisms that lead to grey hair, Arcolys® is a Cosmos-approved natural

Did you know?

The Greentech Group creates high-tech active ingredients sourced from plant, marine and microbial resources. Assigned to major markets, including cosmetics, pharmaceuticals, nutraceuticals, agronomy and environment, the group’s innovations represent proven, healthy and sustainable alternatives.

active ingredient, consisting of picroside II and terponoids derived from the plant Picrorhiza scrophulariiflora. It significantly restores the natural hair colour and visibly decreases white hair density by 16% after 2.5 months.

For many consumers, grey hair can result in a loss of self-esteem and an increase in anxiety and other emotional issues. According to Greentech, 23% of individuals over the age of 50 have at least 50% grey hair. The most common causes are psycho-emotional stress, nutrition, genetic factors, pathologies, topical agents and environmental factors – in other words, the exposome.

Arcolys has been proven to significantly boost self-esteem by 8%, according to the Rosenberg Self-Esteem Scale (Rosenberg, 1965); and reduces an unpleasant mood by 22%, according to the Brief Mood Introspection Scale (Mayer and Gaschle, 1988), which emphasises the unconscious connection between hair health and an individual’s self-representation. Inspired by ayurvedic medicine, Arcolys offers a holistic approach to hair care.

This ingredient is both China-compliant and Cosmos-approved; the recommended use level is 1%.

ZORYALYS Designed to pollution-proof hair, Zoryalys® is an oil-based natural active ingredient produced using a biomimetic approach. It combines the powerful antioxidant and

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HAIR CARE term exposure equivalent to one day, to long-term exposure equivalent to 67 days), but also that it protects against air pollution. Test results showed Zoryalys reduces oxidative damage like hair protein carbonylation and protects keratin structural integrity as well as tryptophan and cystine, which are key amino acids of hair colour and structure respectively.

Zoryalys has also been evaluated on Caucasian and Asian hair for its ability to maintain hair strength and to improve hair gloss. The result is shiny, completely healthy hair that is full of vitality. It has been shown that the active ingredient limits colour degradation caused by full spectrum sunlight exposure in dyed hair, maintaining hair’s beauty.

The recommended use level of Zoryalys is 1%. It is also China-compliant and Cosmos-approved. •

THE

Buyer’sguide

photo-protective molecules of ginger and magnolia, with the long chain fatty acids of pracaxi oil.

Shine is one of the most important criteria of healthy hair. When hair lacks shine, it could be due to the cuticle layer being damaged

by UV radiation, chlorine or air pollution. As a result, hardly any light is reflected off the hair’s surface, so it appears dull and lifeless.

The technology of Zoryalys is based on natural lipids from pracaxi which are similar to those of

hair (biomimetic lipids), filling the damaged hair surface structure. However, Greentech’s active ingredient is more than a simple lipidic filler as the active molecules of Zoryalys have been proven to penetrate up to the heart of hair and to work within the whole hair shaft, repairing structural and chemical damages.

Indeed, numerous studies led on Caucasian and Asian hair have proven that this active ingredient not only offers effective protection against full spectrum sunlight (from short-

REFERENCE:

1. Filaire et al., Characteristics of healthy and androgenetic alopecia scalp microbiome: Effect of Lindera strychnifolia roots extract as a natural solution for its modulation. International Journal of Cosmetic Science, 2020

2017/2018

Greentech – www.greentech.fr Natchem – www.natchem.co.za

THE

Buyer’sguide

2020/2021

The directory for manufacturers of food, beverages, pharmaceuticals, cosmetics, toiletries, packaging and the printing industry

Available online: www.thebuyersguide.co.za Buyers Guide 2018.indd 1

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HAIR CARE

A natural approach to managing sebum

An oily scalp is caused by over-reactive sebaceous glands. To address this concern, Mibelle Biochemistry has developed AstraForce, which is proven to rebalance excessive sebum production on the scalp.

S

ebum is one of the scalp’s most important weapons to protect it from dehydration and to keep the lipid barrier intact. The production of sebum is primarily governed by sebocytes. These specialised cells in the sebaceous glands are associated with the hair follicles. As soon as sebum is excreted from the pilo-sebaceous duct, it naturally spreads over the scalp of the surface and later migrates onto the surface of the hair shaft by capillary forces.

While sebum is generally beneficial to hair and influences various processes ranging from epidermal differentiation to skin-specific hormonal signalling, excessive sebum production is the cause of oily scalp and hair. It makes hairs become greasy at the roots and as they stick together, they trap dust and pollution particles. Mibelle Biochemistry’s active ingredient AstraForce (INCI: Astragalus Membranaceus Root Extract (and) Dipropylene Glycol (and) Glycerin (and) Lecithin (and) Phenoxyethanol (and) Aqua/ Water), is ideally suited to rebalance sebum production on oily scalp and hair. AstraForce is a liposomal preparation of the traditional Chinese herb Astragalus membranaceus.

VALIDATED SEBUM REDUCTION In vitro studies show that AstraForce decreases the lipid droplet formation in sebocytes, efficiently reducing sebum production. Additionally, AstraForce prevents hair follicle inflammation by reducing the activity of the enzyme lipase, which breaks down sebum into free fatty

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acids. These foster the growth of the skin bacterium Cutibacterium acnes and act as inflammatory mediators.

In a clinical study involving 60 volunteers with oily scalp and hair, AstraForce reduced the amount of sebum observed on the scalp by up to 38.4% after only 28 days. The volunteers confirmed the sebum-reducing efficacy of the active ingredient on the scalp, by self-evaluation. The score given by the volunteers was significantly higher compared to initial conditions and to the treatment with a placebo product.

Trans-epidermal water loss was significantly reduced upon treatment with AstraForce, further proving the barrierenhancing activity of the active, despite reduced sebum content.

A WIDE RANGE OF APPLICATIONS AstraForce is ideally suited for incorporation into the whole hair care regimen. It can be formulated in traditional shampoos and is suitable for trending formulations such as scalp serums and scrubs or dry shampoos.

With its positive effect on scalp biology, the active ingredient is also ideal for use in hair conditioning products and provides added benefits in products for oily and grease-prone

Visible reduction of scalp sebum after four weeks of treatment with AstraForce hair. AstraForce can support the feeling of cleanness of the hair while reducing the production of excess sebum without impairing the barrier-function of the scalp.

AstraForce and other active ingredients from Mibelle Biochemistry are available in South Africa from Carst & Walker. • Carst & Walker – www.carst.co.za Mibelle Biochemistry – www.mibellebiochemistry.com

A MAJOR MEDICINAL HERB Astragalus membranaceus is capable of growing in extreme habitats.

Its roots strengthen the immune system and stimulate metabolism.

This sweet tonic herb is known to be an adaptogen because it helps the body cope with stress and to maintain optimal homeostasis. It also has anti-bacterial, anti-inflammatory and antiviral effects – these properties make it one of the most frequently used medicinal herbs in nutritional supplements and remedies.

Astragalus membranaceus

INSPECTION & DETECTION

X-ray quality assurance for healthcare products Although X-ray based quality assurance is largely best practice in food manufacturing, the healthcare industry can definitely learn from the benefits this technology brings to the food industry. We speak to Wipotec-OCS about X-ray and other technologies for medicine, medical devices and cosmetics.

T

he typical reason for using X-ray technology is the detection of foreign bodies. In comparison to metal detectors, the sensitivity is not much affected by metal film and in most cases less effected by metal packaging in general. Besides different types of metal, they are used to find glass, ceramics and sometimes certain kind of plastics. This ensures the health of consumers and avoids costly and often brand-destroying recalls.

Another typical field of application is the use of X-ray inspection technology to check fill levels. Besides these typical jobs, there are many more applications where the benefits of an X-ray inspection unit are useful and can create added value, depending on the product and the packaging.

ADDED VALUE FOR PHARMA Blister packs are widely used in the pharmaceutical industry for tablet and

Did you know?

Wipotec-OCS is a German manufacturer of world-class weighing technology, X-ray and vision inspection, as well as track-and-trace solutions. It produces sophisticated specialised solutions for demanding applications as well as high-quality entry-level solutions at a competitive price. In South Africa, Wipotec-OCS is represented by USS Pactech, which is well-known locally for its high-quality service and support level.

Setup of an SC-4000 X-ray Scanner from Wipotec-OCS

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INSPECTION & DETECTION

capsule packaging. In a single layer blister pack, X-ray technology can be used to find missing elements (e.g. counting the tablets), as well as to detect broken tablets. Packaging leaflets can also be checked to ensure they are not missing.

In bottles, the fill level can be detected to confirm that the consumer will receive the amount of product they are paying for and that the producer does not overfill the packaging. The same applies for tablets packed in cylindrical tubes.

The correct position of the cup can be checked as well as the potential presence of an additional dosage cup – even when the product is packed into secondary packaging.

Besides this, X-ray technology helps to ensure that certain other parts, like dosing spoons, are part of the package.

the product, like counting shaving blades.

This technology is a good method to verify that nothing is broken. For example, X-ray technology can inspect the integrity of mascara brushes and that a compact face powder is not crumbled.

Ultimately, it can help ensure better customer satisfaction.

COMBINED SYSTEM FOR ONE QUALITY CENTRE

Assembling of HMI in the facilities of Wipotec-OCS in Germany

OFFICIAL APPROVAL CONCERNS Despite the big advantages, there are many reservations against using X-ray technology in the production of pharmaceuticals. But producers of pharma products should also think this: If the medicine or its ingredients travel by airplane the products absorb a large amount of natural radiation. Besides this, cargo quite often is also scanned using X-ray technology during transportation, for example at the harbour.

To prevent any issues with authorities, pharmaceutical producers should declare in the approval process of new products that they might use X-ray technology. Then, depending on the rules, they may have better possibilities to use this modern quality assurance technology in the future, even they don’t plan it today.

QUALITY ASSURANCE FOR MEDICAL DEVICES X-ray technology is also a good method to guarantee the quality of medical devices. It is very useful to detect missing components or to check the correct number of products in packaging. For example, producers of contact lenses can ensure that the correct amount of product is contained in the packaging. With first aid kits can, producers could survey whether scissors are included

"X-ray technology can inspect the integrity of mascara brushes" in each pack. Depending on the product, the presence of certain screws and springs can also be detected. Respirator masks can be sorted, whether they contain a valve or a piece of wire.

Besides that, X-ray inspection units can analyse the correct shape of certain components. For example, syringes can be investigated to see whether the needles are straight, bent or broken.

BENEFITS FOR COSMETICS Producers of cosmetics also benefit from the advantages of modern X-ray inspection technology. Besides looking for foreign objects and checking the fill level, X-ray can be used to inspect if all parts of the packaging are present. This includes parts of the packaging itself as well as elements of

X-ray technology is a good technology but it’s not the only one that helps to ensure product quality and safety.

Modern vision systems check the presence of labels and the correct printing of expiry dates for example. Precise checkweighers ensure that there is no underfilling or product wastage due to overfilling. There are many advantages in combining all these systems into one unit. The most obvious is the reduced space consumption.

Besides this, real combination systems only have one HMI. With this HMI, the entire system is controlled. This reduces the training effort as well as the effort of a product changeover in daily operations.

It also eases the burden of the quality assurance team and operational staff by clearly showing the quality and performance of the production process through a single user-friendly interface. In combination with an advanced data management software, it leads to increased transparency for the management team.

PREVENT COUNTERFEITING WITH SERIALISATION Healthcare products are highly susceptible to counterfeiting. Modern track-and-trace systems are heavily related to quality assurance by X-ray, weighing and vision.

Healthcare producers are well advised to select a supplier that is familiar with all these fields. Sophisticated manufacturers use the same structure of the HMI for all of these quality tools. Once again, this reduces the training effort, effort in daily operations as well as the likelihood of mistakes during production. •

USS Pactech – www.usspactech.co.za Wipotec-OCS – www.wipotec-ocs.com/en/

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INSPECTION & DETECTION

World-first syringe inspection machine successfully validated using AI Using AI, Syntegon Technology recently installed the first fully-validated visual inspection system on an automated inspection machine. The installation constitutes a major step in the company’s sustained effort to introduce AI to pharmaceutical visual inspection.

D

r José Zanardi, responsible for vision inspection development and applications at Syntegon, comments: “We are proud to announce this important move, which is as a result of our long-standing visual inspection expertise, solid software and pharmaceutical validation competence, courage to cross boundaries, and an excellent partnership with our customer.”

As one of the most challenging stages in the pharmaceutical manufacturing process, inspection requires ever more sophisticated visual systems to process increasingly complex products.

“Especially for high-cost pharmaceuticals, every false reject is one too many,” he adds.

BENEFITS OF DEEP LEARNING

Using AI, Syntegon recently installed the first fully-validated visual inspection system on an automated inspection machine

"Syntegon’s AIbased vision system increased the particle detection rate by 70%, while reducing the false detection rate by 60%” 46

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Artificial intelligence (AI) applications have the potential to increase detection rates while decreasing the number of false rejects in difficult products. These include highly viscous parenteral solutions with air bubbles, which are sometimes hard to differentiate from harmful particles. AI utilises deep learning algorithms, which are capable of accurately identifying recurring patterns and deviations.

“A growing number of deep learning vision applications are already on the market. Our task was to adapt those applications for pharmaceutical purposes, which essentially also includes validation,” Dr Zanardi explains.

Thanks to its thorough in-house software and visual inspection expertise, Syntegon was able to develop a solution that only requires moderate modifications to the already existing vision systems. The company leads the field with over 40 years’ experience in the development and manufacture of visual inspection machines, covering a wide array of manual, semi-automated and fully automated solutions for all liquid pharmaceuticals and container types.

FIRST SUCCESSFUL INSTALLATION After starting with AI development in 2017 and performing a large number of tests, Syntegon recently installed its first AIequipped visual inspection system on a fully automated and validated machine, on a customer’s production line.

Amgen, one of the world’s leading biotechnology companies, uses the system to reliably distinguish air bubbles at the syringe’s rubber stopper from foreign particles, where conventional vision technology often mistakenly identifies safe products containing bubbles as defective.

“This challenging project required a lot of dedication and expertise. In cooperation with Syntegon, we have implemented the worldfirst syringe inspection machine with AI and have underlined our market position, both in biotechnology production and in technology,” says Manuel Soto, principal process development engineer at Amgen.

In this customer project, Syntegon’s AIbased vision system increased the particle detection rate by 70%, while reducing the false detection rate by 60% (average values in a particular inspection station).

“We are very happy that our new technology is able to contribute to the increased safety and production efficiency of injectable drugs,” says Dr Zanardi.

Backed by this success, Syntegon is set to implement AI in further inspection machines for different products and container types, contributing to the production of safe and reliable pharmaceutical products worldwide. • Syntegon – www.syntegon.com

Syntegon has more than 40 years’ experience in the development and manufacture of automated visual inspection machines for all liquid pharmaceuticals and container types

STUDENT FOCUS

Do natural ingredients pose a threat to sustainability?

The winner of this year’s Coschem training in cosmetic science/P&C Review essay prize is Michelle Nott of Botanica Natural Products. To acknowledge Nott’s achievement, a shortened version of her essay is published in this student focus and she has received a prize sponsored by P&C Review.

T

he term ‘sustainability’ has become a buzz word in the cosmetics industry and more recently, it has become conflated with the term ‘sustainable development’.

According to a report entitled Our Common Future, sustainable development is defined as development that is able to meet the current needs of the population without compromising future generations to meet their own needs.¹ The key principles of sustainable development include the integration of environmental, social and economic concerns in all decision making for it to be truly sustainable.² As a result, the commercialisation of natural resources, also known as non-timber forest products, has gained increased popularity to meet environmental, social and economic challenges.³ Examples of natural resources commonly used in the cosmetics industry include: • plant-based extracts (Ceratonia siliiqua leaf extract is used as a skin brightening agent) • vegetable oils (marula oil is commonly used for its skin moisturising benefits) • essential oils (neroli oil is a popular cosmetic ingredient for its floral scent) • butters (shea butter is used for its antiinflammatory properties) • clays (kaolin clay is used as a natural exfoliator) • gums (xanthan gum is often used as a thickening agent).

The core idea surrounding the concept of biodiversity-based commercialisation is that the resources are renewable and can be utilised to enhance rural livelihoods – economically, socially and physically – while fostering environmental conservation. The recognition and admiration around natural

The growing commercialisation of natural resources has resulted in the increased harvest of wild populations of fauna which has raised concerns of overexploitation.11, 12 Palm oil, a vegetable oil collected from the seeds of oil palm trees, is a natural cosmetic ingredient which has not met the goals of environmental conservation intended by the trade of natural resources. The commercialisation of palm oil was initially seen as a poverty reduction scheme, but it has grown exponentially over the past five decades.13

62.6mn tonnes.

It is expected that by 2050, annual production will quadruple again, Palm oil is popular is reaching 240mn cosmetics because it blends well with other oils and acts tonnes. Although as a good foaming agent palm oil is not only used in cosmetics, it gained popularity in the industry because it blends well with other oils and acts as a good foaming agent in shampoo, liquid soap and detergents.

Cosmetic manufacturers prefer it to animal tallow because of its natural origin, ease of application and low price, and it has been preached as a natural and ‘sustainable’ alternative to synthetic ingredients.13, 14 However, as the palm oil industry expanded, conservationists and environmentalists started to raise concerns about its devastating effects on carbon emissions and wildlife habitat.

Hectares of tropical rainforests were cleared for the plantation of oil palm trees, threatening endangered animal species such as orangutans. As the value of natural ingredients increases, the competition for resources increases which can lead to damaging environmental consequences.15 Beeswax, an animal derived product, is another natural cosmetic ingredient where sustainability issues have become a concern based on how the bees are kept and treated.

Beeswax is often used as an emollient and humectant in body creams and a thickener in lipsticks and lip balms. In this instance, a natural ingredient can only be deemed sustainable if it has been grown, harvested and treated in the appropriate manner.14 Today, sustainability has gone from being a trend to an integral part of the cosmetic industry. As a result, cosmetic brands

resource commercialisation are derived from the numerous plant and animal products

From 1995 to 2015, palm oil production quadrupled annually from 15.2mn tonnes to

and manufacturers are requesting more information about their raw material supply

NATURAL RESOURCE COMMERCIALISATION

incorporated into the livelihoods of many underprivileged rural people, which allows these individuals to be better off than they were before.4 Thus, it is believed that because natural resource commercialisation allows communities to gain economically, this incentive would encourage them to preserve the resource base.6, 7, 8, 9, 10 Most developing countries are poor with a large portion of the population living in poverty, making biodiversitybased commercialisation a viable income opportunity. It is seen as poverty-alleviation tool, which can aid in development that is both sustainable and achieves economic growth, social responsibility and environmental protection.

Given the increasing demand for natural cosmetic ingredients, natural resource commercialisation has played an important role in the cosmetic industry. According to ISO 1612 (guidelines on technical definitions and criteria for natural and organic cosmetic ingredients and products), natural ingredients are those obtained from plants (including fungi and algae), animals, microorganisms or minerals.

INCREASED DEMAND AND OVEREXPLOITATION

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STUDENT FOCUS

chains and demanding transparency in terms of how the ingredients are made and what processes and people are involved.16

Under Ecocert standards, in order for a cosmetic product to be classified as organic, a minimum of 95% of the ingredients must be derived from natural sources and 95% of vegetable ingredients should be produced from organic farming practices.14 At least 10% of the entire product’s contents should be sourced from organic production.

A POSITIVE PUSH FROM CONSUMERS Consumers are also more informed about climate change, the use of pesticides and chemicals, child labour and fair working conditions, ethical sourcing, and corporate social and environmental responsibility.

Thus, consumers are the main role players in pushing the cosmetics industry to become more sustainable. Some of the expectations from consumers is that packaging should be recyclable, reusable or biodegradable; raw materials should not be derived from endangered flora or fauna; manufacturing processes should produce minimal waste; and the use of synthetics should be avoided.

There is a strong public perception that natural ingredients are safer for human health and the environment and therefore suitable substitutes to synthetic products. A synthetic substance is a compound made artificially through chemical reactions. Synthetic products have largely been portrayed as bad amongst consumers, while nature-based ingredients are good. This is clearly not true as synthetics are used when concerns around sustainability are raised with regard to the supply of natural ingredients. For example, in Asia, the roots of the sassafras tree were highly valued for their hay-like aroma. This resulted in the mass removal of sassafras trees to extract the pleasant aroma from the roots for use in soaps and perfumes. To save the sassafras tree population, International Flavors & Fragrances developed a molecule that mimicked the fragrance derived from the roots, saving 110 000 trees from being destroyed per year.14 Therefore, the part of the plant or tree which is harvested to produce natural ingredients largely determines whether continuous offtake can be economically, socially and environmentally viable. It has been found that harvesting fruits, seeds and short-lived leaves has a higher potential for sustainable harvest compared to harvesting an entire plant, its roots, bark and bulbs.10, 31 This shows that synthetic ingredients can play a vital role in the conservation of natural raw materials. Consumers should be educated on the use of alternatives when natural options pose a threat to wild populations.

REGULATIONS AND CERTIFICATION The word ‘natural’ is unregulated in the beauty industry and therefore companies are free to define ‘natural’ as they wish and

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A CLOSER LOOK AT THE MARKET

Bulbine frutescens plants cultivated by Botanica

to market products as natural if they fit their definition of the term.17 Due to the fact that the term is unregulated, there is now an increasing demand for natural ingredients that are certified organic.18 ‘Organic’ refers to how an ingredient is grown – it must be prepared and grown without pesticides, chemical fertilisers, growth hormones or antibiotics. According to ISO 1612 (guidelines on technical definitions and criteria for natural and organic cosmetic ingredients and products), organic ingredients are natural ingredients originating from organic farming methods or from wild harvesting in compliance with national legislation or equivalent international standards. For a product to claim that it is ‘certified organic’, it must meet a number of strict specifications that go beyond organic requirements. The formulation ingredients must still be grown and prepared under the same rigid conditions, but the concentration percentage of organic ingredients in the final product must be higher. Therefore, the term ‘organically certified’ should only be used if the product has been certified by an accredited certification body.

There are a number of certification bodies established internationally which have developed regulatory standards for natural and organic cosmetics. Ecocert, for example, supports and guides over 1 000 companies internationally through its certification processes for natural and organic cosmetics.20 There are three main principles which underpin Ecocert’s standards: 1. the use of ingredients derived from renewable resources that have been manufactured using environmentally friendly processes 2. a minimum threshold of natural ingredients from organic farming needs to be reached in order to obtain certification 3. an on-site audit is performed annually by an Ecocert auditor.20

Given that there are regulatory standards which govern organic products, the market for natural and organic cosmetic ingredients is on the rise. Market research predicts that the global market for organic cosmetics will grow by 8% to 10% annually from 2016 to 2022.21 By the end of 2024 and 2028, the global market value for natural and organic personal care products is expected to be valued at approximately $22bn and $30bn respectively. Particularly in Europe and North America, the interest for organic and natural products has increased exponentially.22 As the market for natural and organic cosmetics grows, particularly in developed countries, companies look to source natural ingredients from regions where they are grown abundantly and in a sustainable manner. The abundance of natural resources, however, is not evenly distributed across the globe, with developing countries taking the lead in terms of plant species diversity and supply. South Africa in particular is the third most biodiverse country worldwide, making it an attractive region to source natural ingredients to meet increasing consumer demand.23 The South African cosmetics industry is growing at a retail level of 6% annually.24 It is one of the biggest personal care markets on the African continent, employing 50 000 people and contributing R25bn at retail level and R5.2mn at a manufacturing level.

Currently there is a fundamental shift towards natural and organic cosmetic ingredients that support economic, social and environmental sustainability goals.24 The total revenue produced from value-added bioproducts in the domestic retail market was approximately R1.5bn in 2013. A total of 70% of these products were personal care products and cosmetics. The natural ingredients sector contributed R101mn to the GDP in 2014.24 This amount has increased significantly as companies from all over the world look to South Africa for unique natural cosmetic ingredients in order to compete in the growing market.

Market requirements play a vital role in determining the sustainability of natural resources.9 It was found, as with palm oil, that natural resource harvesting can be

STUDENT FOCUS

sustainable until the demand for a product increases, leading to long-term ecological consequences if not managed properly.7 Researchers advise that in order to meet increasing demands, the following conditions need to be met: • harvesting of wild products must be sustainable, ensuring that the population of the species harvested is maintained • harvesting must not interact with secondary threats • commercialisation of the product must be economically feasible • the harvesters must reap the benefits from the commercialisation of the wild products • income from natural resource commercialisation must be an incentive to conserve the resource being harvested.9, 25 Many of these conditions have been enforced through an international agreement known as the Convention on Biological Diversity (CBD) and the Nagoya Protocol. The CBD was implemented in 1993 with the aim of achieving these three objectives: 1. the conservation of biological diversity 2. the sustainable use of its components 3. the fair and equitable sharing of benefits arising from its utilisation.26, 27 The Nagoya Protocol was adopted in 2010 to further advance the third objective of the CBD. The Nagoya Protocol is the latest international environmental agreement that provides a solid legal platform for consolidating and developing modern biodiversity-based business.29 The protocol does this by regulating the way in which natural resources are accessed and how the benefits of their use are shared, contributing to a fairer and more equitable economy that supports rural livelihoods and sustainable development.26 To achieve this, countries and communities that provide natural resources must be included in the financial profits from product commercialisation.

They must also be involved in receiving nonmonetary benefits such as knowledge and skills transfer regarding the products derived from their natural resources.30 Therefore, the Nagoya Protocol has become one of the main regulations and standards concerning ethical sourcing where economic, environmental and social sustainability are prescribed in order for natural resource commercialisation to commence. As a result, companies across the globe are increasingly sourcing natural cosmetic ingredients that are Nagoya compliant.

A TRULY SOCIAL ENTERPRISE Botanica Natural Products is an example of a cosmetic ingredient producer that offers a plant-based extract, which is Nagoya compliant.

This extract is derived from the organic cultivation of the indigenous South Africa plant, Bulbine frutescens. The gel found in the leaves of the plant is used widely in the cosmetics industry due to its soothing, moisturising and natural anti-bacterial properties.

Botanica is based in a remote, rural part of Limpopo Province and, as a social enterprise, the company focuses equally on social development, environmental sustainability and financial viability. This is supported by academics in the field who have highlighted that organic farms are considered one of the most environmentally, socially and economically sustainable methods of production.32 To achieve this, Botanica offers sustainable employment to 25 employees who live within the surrounding villages and are the sole providers for their families.

These employees ensure that cultivation is sustainable and that all waste plant material is recycled into organic compost used for agricultural production. Botanica also aims to offer this cosmetic ingredient as a carbonneutral product. To achieve this, the company has established a plantation of 250 000 spekboom (Portulacaria afra) trees to offset its carbon emissions and reduce soil erosion.

The selection of natural raw materials for cosmetic applications is now being chosen on the basis that the environment is respected, energy and water consumption is reduced and emissions to water and air are minimised.14 Botanica is an example of one of the many producers of natural ingredients which have incorporated the social, environmental and economic aspects of sustainability into its business model. This is becoming more apparent as new cosmetic ingredients derived from agricultural-based raw materials enter the market.14 Therefore, to ensure sustainable practices are maintained, natural cosmetic producers are moving away from wild harvesting and investing in organic cultivation to meet increasing demands.

CONCLUSION With the international demand for natural ingredients reaching an all-time high, natural resource commercialisation has become an integral part of the cosmetics industry.

As consumers become more conscious of sustainable environmental, social and economic development, ethical natural ingredient sourcing is paramount.

Global regulatory frameworks and certification standards have been introduced to ensure sustainability is achieved.

Previously, the environmental impact of natural ingredient commercialisation was

the key focus of sustainability, but today, the social and economic components have been incorporated into the definition. Therefore, companies across the globe have adopted a holistic view that embodies the multiple dimensions of sustainable development.

Even though there are examples of natural ingredient commercialisation being unsustainable in the past, today consumers are demanding transparency throughout the value chain which ultimately helps to ensure environmental, social and economic responsibility in the cosmetics industry.

The cultivation of biodiversity-based ingredients is proving to be a viable approach to ensuring the long-term conservation and sustainability of the species harvested. In this way, environmental integrity is maintained, and economic and social upliftment can be achieved as the supply of raw material is guaranteed through agricultural production.

This is increasingly adopted within the cosmetics industry to ensure that natural ingredient supply is sustainable.

Wild harvesting can also be sustainable given that the population of the species harvested is monitored and maintained.

In such cases, caution should be exercised regarding the seasonal timing of harvest, timing of harvest in the plant life cycle, frequency of harvest, size of individuals harvested, intensity of harvest, method or tools used when harvesting and part of the plant harvested.

The use of natural ingredients does not pose a threat to sustainability if the requirements and regulations described are followed. With consumers demanding verification of economic, social and environmental sustainability, natural ingredient producers are required to follow the necessary protocols to meet these conditions. Thus, safeguarding the sustainability and transparency of natural ingredients supplied to the cosmetics industry. • References available on request

ABOUT THE AUTHOR

Michelle Nott graduated in 2018 with a master’s degree (cum laude) in environmental science from the University of Cape Town. She is passionate about ethnomedicine and the use of African medicinal plants in cosmetics and pharmaceuticals. Nott has been employed by Botanica Natural Products as a relationship manager since 2019 and is based in Johannesburg.

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contact

To advertise in Anita Raath

Carla Melless

Sales executive

Sales executive

+27 (0)82 976 6541

+27 (0)83 260 6060

www.pharmacos.co.za

Càndida Giambò-Kruger Sales executive

+27 (0)71 438 1918

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ONLINE

INDUSTRY WEB REVIEW ESSENTIAL SPECIALISED PRODUCTS

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Supplier of cosmetic and personal care ingredients.

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From one

brave team to another…

Thank Thankyo you u to everyone in everyone in manufacturing and manufacturing and essential ices essential serv services for keeping keeping tthe for he machines machines run running ning and shelves shelves sto stocked, and cked, during the COVID-19 COV ID-19 the shutdown.

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