HealthcareNews 1/20

HealthcareNews

Content 1 New: Microencapsulated

Polysaccharide Iron Complex

3 DavosLife E3 DVP 30-WD:

Solving product development challenges

5

Nu-SORBTM blends oils into powder

6 Innovative calcium product

solutions to maintain better health

7 Ultra pure zinc bisglycinate 9 ENOTprost® for male wellness 10 Sharp PS - a partner for the growing nootropic market

12 Alsiano Food & Healthcare Team

01/20

New: Microencapsulated Polysaccharide Iron Complex Innovative breakthrough product enables use of Polysaccharide Iron Complex in chewable and other oral dosage formulations addressing market needs Particle Dynamics is a pioneer in the innovation of products to address Iron Deficiency and Anemia. One such product, Polysaccharide Iron Complex (PIC), has attracted significant attention for its superior performance in terms of absorption and tolerability versus other active iron products.

Until now, PIC had not been available in a form conducive for chewable tablets, rapid dissolve applications or to enable PIC to be placed into matrices with other active ingredients possessing acidic or other properties that could negatively impact PIC’s stability.

Now, however, Particle Dynamics has microencapsulated PIC ready for your next application!

Particle Dynamics has launched a breakthrough innovation to accommodate patients’ specific needs for the PIC product. Specifically, Particle Dynamics has developed a microencapsulated PIC product to enhance stability and enable PIC’s use in chewable and other oral dosage formulations.

This innovation opens up for PIC to be used in applications previously >> unavailable!

HealthcareNews 1/20

>>

Case Study: Microencapsulated Polysaccharide Iron Complex Innovative iron deficiency technology to enhance patient compliance Successful treatments are encouraged by continual use of the medicinal product. Overcoming tablet swallowing challenges has been addressed through chewable tablets; however, the active ingredients must be stable within a chewable tablet and have good taste and mouthfeel.

Particle Dynamics has unlocked an innovative solution to address stability of iron products in chewable tablets while addressing product organoleptic experiences.

Technology advancements in polysaccharide iron complex (PIC) microencapsulation influence a stable iron product while incorporating vitamin C in a chewable tablet. The novelty of the microencapsulated iron product innovation is that the iron is protected from other ingredients in the tablet preventing premature interactions and provides organoleptic advantages to promote ongoing iron treatments.

The integration of organoleptic properties in chewable microencapsulated iron tablets is advantageous for the following reasons:

• Palatable • No discoloration in the oral cavity from iron • Increased disintegration Descote® PIC 50% is a turn-key innovative microencapsulated polysaccharide iron complex that delivers the novelty in providing consumers with an iron in chewable tablets. The technology is a big step forward to enable solutions for global health problems that make a positive impact on the human condition.

Particle Dynamics provides a breadth of integrated technologies to streamline a fully integrated approach aligned with the trending needs of the customer. Particle Dynamics is a full-service contract manufacturer, backward integrated into functional materials that enable superior dosage forms. Coupled with an industry leading process innovation team, Particle Dynamics delivers a seamless solution from concept to commercialisation.

Contact us to learn more about the benefits of PIC and microencapsulated PIC from Particle Dynamics.

The industry’s widest and deepest blend of enabling technologies for pharma, OTC and nutritional products companies.

Why microencapsulated ingredients • Improved organoleptic properties • Flavour enhancements • Masking unpleasant tastes • Enabling product benefits • Chewable tablets convenience • Products that afford smooth mouthfeel • Better options to swallowing large tablets • Products with improved compliance • Increased product stability

Descote® Ferrous Sulfate

• Flavoured naturally for improved consumer acceptance (especially for children)

Descote® Ferrous Fumerate Descote® PIC 50%

• Pleasant smooth texture, not gritty or chalky

Polysaccharide Iron Complex

• Ingest without water • Easy, convenient – chew-on-the-go 2

HealthcareNews 1/20

DavosLife E3 DVP 30-WD: Solving product development challenges Davos Life Science has developed a stable water-dispersible powder of natural Tocotrienols for easy incorporation and dispersion of powder into liquid A growing functional future Worldwide, populations are ageing.

An ageing population has led to an increased awareness about the crucial importance of a healthy diet and lifestyle to enhance health and minimise the risk of chronic diseases. Modernday consumers are seeking a wider range of food and beverage choices in the market to help them fulfil some of their health and wellness needs.

This interest in healthy ageing is driven also by growing healthcare costs as people live longer. Altogether, this has driven interest in functional food and beverages, which are able to provide benefits beyond energy and basic nutrition. Food and beverages are good delivery vehicles for nutraceuticals. The addition of nutraceutical ingredients to food and beverages in sufficient amounts may help to reduce the risk of chronic di-seases such as heart disease, cancer, hypertension, and obesity (Augustin and Sanguansri, 2015).

Consumer awareness of these benefits is high. European consumer market reports state that 8 in 10 consumers believe that functional foods can

help prevent or delay the onset of heart disease, hypertension, osteoporosis, and type-2 diabetes. The functional food ingredient market in Europe is projected to reach USD 108.7 billion by 2025, with a CAGR of 6.6 % over the forecast period of 20182025 (Market Watch, 2020).

Bioactive healthy ageing ingredient for functional food and beverages DavosLife E3 Tocotrienols (Super Vitamin E) are bioactive ingredients that fit perfectly into these consumer needs. It is a Super Vitamin E derived from nature, with many properties that can help to support healthy ageing. Tocotrienols are potent antioxidants with strong anti-inflammatory properties and numerous research studies have proven its efficacy in promoting cardiovascular health, cognitive function, bone and joint health, skin health and liver health.

As a lipid-soluble vitamin, however, the process of incorporation of Tocotrienols into food and beverages, which are typically aqueous-based, is complex. The non-polar character of 3

Tocotrienols means that it cannot simply be dispersed directly into an aqueous phase as it would rapidly coalesce and separate through gravitational forces, leading to a layer of oil on top of the product (Piorkowski and McClements, 2013). Additionally, if it were to be used directly, it would be susceptible to degradation, and may interact with other components in the food, resulting in loss of bioactivity of the Tocotrienols.

Tocotrienols powder specially formulated to have advanced dispersion properties, organoleptic excellence and stability

To ensure that Tocotrienols can be easily incorporated into functional food and beverages, Davos Life Science has developed DavosLife E3 DVP 30-WD, a stable and bland-tasting waterdispersible powder format of natural Tocotrienols. >>

HealthcareNews 1/20

After stirring

Figure 2: Uniform suspension of DVP 30-WD in water

Standing after stirring

Figure 3: DVP 30-WD in suspension over 48 hours

>> DavosLife E3 DVP 30-WD:

Advanced dispersion technology a) Superior Dispersibility DavosLife E3 DVP 30-WD has superior dispersibility in aqueous systems.

It will begin to self-disperse upon addition to aqueous medium (Figure 1), and minimal agitation is required to fully disperse this in an aqueous medium. This has a number of advantages for manufacturers. Firstly, it means that a specialised production facility with a high shear mixer is not needed for successful incorporation of Tocotrienols into the finished product.

Secondly, because it disperses easily into the aqueous medium without the need for very vigorous mixing, this in turn means that there is minimal incorporation of air into the final product. This would reduce foaming, oxidation and other stability issues. b) Forms a uniform and stable dispersion DVP 30-WD will form a uniform dispersion in aqueous medium upon mixing (Figure 2). A uniform dispersion means that there will be no localised high concentrations of Tocotrinols powder, which will then separate out of solution. Heating is also not required in order to achieve this fine dispersion, and this means that fresh taste, fresh aroma and appearance of the product are preserved.

Once DVP 30-WD has been fully dispersed throughout the aqueous medium, it will remain stably dispersed for up to 48 hours (Figure 3). Under manufacturing conditions, this means that DVP 30-WD will remain stably

Figure 1: Timelapse photography over 8 minutes of DVP 30-WD in aqueous medium

dispersed in pre-blended compound mixtures throughout the production process. c) Organoleptic excellence The organoleptic properties of DVP 30-WD were tested using a Triangle Taste Test (ASTM Standard Test Method for Sensory Analysis — Triangle Test (ASTM E1885) on every day consumer products (e.g. milk, yoghurt, orange juice, carbonated drinks and cultured milk drinks).

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Figure 4: Triangle taste test results after the incorporation of DVP 30-WD into various beverages and yoghurt. The minimum significant number of correct judgements is above 6. DVP 30-WD is organoleptically acceptable.

Organoleptic test

*

* Results statistically not significant, therefore taste profile is unaffected.

>>

HealthcareNews 1/20

Nu-SORBTM blends oils into powder Ribus Inc. launches alternative to silicon dioxide in high oil systems Nu-SORB™ offer producers of high oil ingredients an alternative to synthetic carriers such as silicon dioxide.

This blend of ingredients provides the oil holding capacity necessary for the production of capsules, tablets, powders and food products.

Nu-SORB™ Oil, which is made from rice fibre, oat fibre and sunflower lecithin, can be declared on a label as a “fibre blend”.

>> The triangle taste test results showed

that the number of correct judgements for each food or beverage category was below the minimum significant number required (α = 0.05) to conclude that a perceptible difference exists between the samples (Figure 4). Therefore, the addition of DVP 30-WD at GRAS-recommended levels is organoleptically acceptable. d) Excellent stability Other manufacturing challenges include the need to (1) limit the degradation of Tocotrienols when it is incorporated under conditions used for food processing, and (2) stabilise Tocotrienols during the shelf life of the finished product. Stability studies of DVP 30-WD conducted at elevated

Nu-SORB™ Oil • Label as “fibre blend” • Ingredients: rice fibre, oat fibre, sunflower lecithin • Usage rate: 1-3 %

New alternative to synthetic carriers

Nu-SORB™ Water (coming soon) • Label as “fibre blend” • Ingredients: rice fibre, psyllium fibre, banana flour • Usage rate: 2-5 %

The final powder mix can be directly compressed to solid dosage forms after homogenisation (mixing).

storage (40˚C) over 24 months (Figure 5) show that the total Tocotrienols content is very stable. This translates to stability during thermal processing at this temperature, storage, and food preparation.

References:

Available in conventional and organic grade.

1. Augustin, M.A. and Sanguansri, L. (2015).

Challenges and Solutions to Incorporation of Nutraceuticals in Foods. Annual Review of Food Science and Technology, 6(1): 463-477.

2. Piorkowski, D.T., and McClements, D.J. (2014).

Beverage emulsions: Recent developments in formulation, production, and applications. Food Hydrocolloids, 42: 5e41

DVP 30-WD elevated storage Minimum amount of Total Tocotrienols and Tocopherols declared

Figure 5: DVP 30-WD accelerated time stability data over 24 months at 40° C ± 2° C / 75% RH ± 5% RH

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HealthcareNews 1/20

Innovative calcium product solutions to maintain better health DestabTM directly compressible calcium carbonate supports the development of sachets, tablet compression, and capsules with high palatability and exceptional bioavailability Calcium is the most common mineral found in the body and is an essential key mineral supporting overall bodily health and functionalities. Particle Dynamics supports emerging calcium product needs that helps manage calcium deficiencies. According to Medical News Today (Newman, 2020), calcium plays an integral role in the human body as calcium helps: • Build bone health by boosting bone density • Support strong teeth • Regulate muscle contractions: calcium works synergistically with the proteins in the muscle to aid in muscular contractions and relaxation • Maintain cardiovascular health: calcium helps maintain the heart muscle functionality • Lowering blood pressure - linked to high calcium consumption • Improve cholesterol levels • Lower the risk in colorectal adenomas • Manage acid reflux • Prevent calcium deficiency health problems

Calcium product offerings by Particle Dynamics Particle Dynamics explores new approaches to great tasting tablets and capsules using flavoured ingredients and Destab™ direct compressed ingredients. Particle Dynamics’ Destab™ direct compressed Calcium Carbonate supports the development of sachets, tablet compression, and capsules.

Complete packaging, stability and regulated documents support the efficacy of Particle Dynamics’ calcium product lines coupled with Drug Master Files for various product lines.

Destab™ is an innovative direct compressible excipient from precipitated calcium carbonate offering exceptional bioavailability with improved swallowability comprising grades that provide superior mouth feel for an ultimate organoleptic experience and more.

Utilising the full benefits of Destab™ Calcium Carbonate 95/90 HD Destab™ Calcium Carbonate 95/90 HD offers an advantage as its high density (HD) affords high loading elemental calcium ions into capsules.

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Particle Dynamics Destab™ direct compression advantages • Superior compaction properties at low compression forces • Decreased friability concerns • Improved flowability • Uniform particles • Low dust • Improves content uniformity of tablets • Ensures accurate dose delivery • Bulk density increased • Improved surface tension • Improved porosity • Reduced wear of tooling dies - Increased tooling life - Increased compression ease (fluid & cohesive powder flow properties) - High speed tablet compression - increased throughput • Eliminates powder segregation • Improves tableting: strength + compressibility = compactability • Minimises lot to lot variances • Reduces quality control concerns

• Uniform tablet weights

>>

HealthcareNews 1/20

Ultra pure zinc bisglycinate Zinc is an essential mineral supporting many areas of your health.

Jost Zinc glycinate is 100% pure and fully reacted and with ultra low levels of Pb/Cd/As/Hg Jost Zinc Bisglycinate is 100% pure chelate, which can be readily verified for identity, purity, and potency. Chelated minerals are often a preferred choice by nutritionists because their complex structures better survive passage through the stomach and small intestine where absorption into the bloodstream occurs. Jost Zinc Bisglycinate has a zinc content of minimum 27% and 5% solubility at 25°C.

unreacted compounds can lead to formulation stability problems and inaccurate ingredient declarations on the finished product. The process for manufacturing fully reacted pure salts involves the reaction of an acid and a base in an aqueous solution and the precipitation of a salt compound. Dissolving the reactants provides the opportunity for a complete reaction to occur.

Fully reacted Jost mineral salts are fully reacted.

The use of mineral salts containing

For instance, non-fully reacted zinc bisglycinate may result in remaining zinc oxide and glycinic acid. Other zinc

>> The SmoothMask™ Calcium

Citrate advantage Extraordinary advantages exist for the direct compressible excipient called SmoothMask™ Calcium Citrate which enables smooth chewable tablets and can be used in sachets.

• Delivers fortified and functional ingredients • Increases palatability • Organoleptic smooth tasting delivery system for vitamins in chewable form

• Supports trends: elevated convenience – what consumers want - Chew ‘On-the-Go’ - Chew & Swallow (alternative to swallowing tablets/capsules) • Chewable vitamins break down easier before reaching the stomach creating easier faster bioavailability • Highly bioavailable calcium form - Supports calcium delivery for bodily health

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Zinc applications    

Dietary supplement Clinical applications Cold remedies Animal nutrition

bisglycinate products with less than 27% zinc content may contain other ingredients such as unreacted glycine, citric acid and silica in their product which cuts >> down the weight percentage of zinc.

Guiding you to the optimum DestabTM solution Particle Dynamics ensures success by providing use guide to lead product development with ease. Scan the code to download the guide.

Destab™ Calcium Guide

HealthcareNews 1/20

>> High purity

The European Regulation No. 629/2008 (amending 1881/2006) has established limits for heavy metals in food supplements of a maximum of 3 ppm for Pb, a maximum of 1 ppm for Cd, and a maximum of 0.1 ppm for Hg. By offering an ultra pure zinc bisglycinate from Jost, we allow our customers to easily meet the requirements of the EC regulation for their finished products.

Arsenic (as As) Cadmium (Cd) Lead (as Pb) Mercury (Hg)

1 ppm maximum 1 ppm maximum 1 ppm maximum 0.1 ppm maximum

Free of silica Jost mineral salts do not contain silica. The European Food Safety Authority (EFSA) have expressed concerns about using silica nanoparticles in food, as there are no long-term safety studies.

Health benefits of zinc The trace mineral zinc is essential for body growth, maturation and development, as well as tissue repair and resistance to disease. Zinc is an important mineral for children and the elderly. Zinc is involved in numerous aspects of cellular metabolism. It is required for the catalytic activity of approximately 100 enzymes, and it plays a role in immune function, protein synthesis, wound healing, DNA synthesis, and cell division. Zinc also supports normal growth and development during pregnancy, childhood, and adolescence and is required for proper sense of taste and smell.

Zinc supplementation has been used to help with: • Immune function

Jost: committed to quality for more than 35 years • Manufacturing in the United States and Europe

• Wound healing • Tissue growth

• In-house tested

• Diarrhea • The common cold

• USP/EP/FCC mineral salts

• Fertility and reproduction

• cGMP compliant, FDAregistered facilities

• Age-related macular degeneration Zinc RDA Zinc is an essential mineral that must be absorbed in small amounts to keep humans healthy. A daily intake of zinc is required to maintain a steady state because the body has no specialised zinc storage system.

Groups at risk of zinc inadequacy - People with gastrointestinal and other diseases - Vegetarians - Pregnant and lactating women - Older infants who are exclusively breastfed - People with sickle cell disease - Alcoholics

• Consistent from lot-to-lot and meet all customer requirements • Provide particle size options • Custom product development and technical support • Traceability from raw material to end product

More Jost zinc products • Zinc Ascorbate • Zinc Sulfate Monohydrate • Zinc Sulfate Heptahydrate • Zinc Gluconate Hydrate • Zinc Lactate Dihydrate • Zinc Citrate Dihydrate • Zinc Phosphate • Zinc Oxide

Age

Male

0-6 months

2 mg*

2 mg*

7-12 months

3 mg

3 mg

1-3 years

3 mg

3 mg

4-8 years

5 mg

5 mg

9-13 years

8 mg

8 mg

14-18 years

11 mg

9 mg

12 mg

13 mg

19+ years

11 mg

8 mg

11 mg

12 mg

* Adequate Intake (AI)

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Female Pregnancy Lactation

HealthcareNews 1/20

ENOTprost® for male wellness Let prostate problems fly away with the right ingredient. ENOTprost® has proven strong antioxidant and anti-inflammatory activities Prostatic ailments are among the most common urologic problems in adult males. BPH (benign prostatic hyperplasia) is the third most frequent urologic diagnosis in men over 50, although prostatitis can also affect young people, especially sportsmen and cyclists. Prostatic ailments share inflammation and oxidative stress as risk factors and cause of chronicity.

phytocomplex variety and chemical profile was very similar to the native extract. The digested extract still contained 20 compounds, among which there were organic acids, hydroxycinnamic acids and many flavonols.

Moreover, miquelianin, the major flavonoid glycoside that only characterises the E. angustifolium species, was identified in the digested extract.

Epilobium

Strong anti-inflammatory activity In vitro tests demonstrated that pretreatment of prostatic cells with ENOTprost® followed by lipopolysaccharide induced inflammation, strongly reduces TNF-α production.

TNF-α is one of the most important pro-inflammatory cytokines.

Epilobium angustifolium L. (Onagraceae) is a well-known European plant traditionally used for prostatic ailments such as prostatitis and BPH. ENOTprost® from EPO Srl is a dry ex tract with a very rich phytocomplexcontaining more than 15 % of Oenothein B. It is a strong anti-inflammatory and antioxidant ingredient for innovative food supplements. The metabolic profile of ENOTprost® was studied simulating the oro-gastroduodenal digestion and the gastroresistant oral administration (duodenal digestion). In this latter case, the RT=0.00-149.98

Oenothein B

Enotprost® enhances cellular antioxidant defence In vitro tests demonstrated that treatment of prostatic cells with ENOTprost® enhances cellular antioxidant defences by increasing the level of SOD1. This enzyme is one of the most important endogenous antioxidant defence mechanisms.

References

uAU

1. Granica S et al. Phytochemistry, pharmacology and traditional uses of different Epilobium species (Onagraceae): A review. Journal of Ethnopharmacology, 156, 316–346, 2014

Time

2. Schepetkin IA et al. Therapeutic Potential of Polyphenols from Epilobium Angustifolium (Fireweed).

Phytother Res, 30, 1287-1297, 2016

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EPO extracts • Manufacturing process entirely made in Italy.

• Full traceability from the field to the final packaging • Botanical species certified by DNA barcoding analysis • No harmful solvents used in the manufacturing process

Ctrl-: not inflamed and not treated cells Ctrl+: inflamed but not treated cells with ENOTprost Ctrl ENOTprost: not inflamed and not treated cells ENOTprost: pre-treated with ENOTprost and inflamed cells

Ctrl: not treated cells Enotprost: pre-treated with ENOTprost and inflamed cells

3. Vv.Aa. Anti-inflammatory and anti-oxidant activities of a new E. angustifolium dry extract - unpublished data 4. Paulis G. Inflammatory mechanisms and oxidative stress in prostatitis: the possible role of antioxidant therapy. Res Rep Urol, 10, 75-87, 2018

HealthcareNews 1/20

Sharp PS - a partner for the growing nootropic market Looking to add a cognitive position to your product?

Phosphatidylserine is clinically proven to support cognition As we reach the third decade of the 21st century, it is increasingly evident that the population is aging1. For people and societies alike, healthy, successful aging becomes an increasingly important issue. After the age of 50, many start to suffer from agerelated cognitive decline also known as age-related memory impairment (AAMI).

Phosphatidylserine, PS for short, is a building block of cell membranes, found in all living cells. PS is also a natural component of our food. A human first consumes PS when it suckles from its mother, because human milk contains PS among other phospholipids. Every food from biological origin (fruits, vegetables, meat and fish) contains some PS, though levels are relatively low. The average consumption of PS through regular diet is estimated to be around 130 mg per day. Nonetheless, for specific populations, such as vegan or vegetarians and children, the estimation is much lower2. Thus, for many, supplementation with PS is the only way to ingest 100-300 mg per day, the amount, on top of regular diet, that is shown to be clinically effective.

Supplementation with PS can have benefits for human cognition An interesting fact about PS is that it is especially enriched within the brain, up to 6 times more so than in any other tissue.3 This fact intrigued researchers to examine the role of PS within the brain, leading to years of research which in turn led to a clear understanding that supplementation with PS can have certain benefits for human cognition. Benefits of PS consumption are not immediate, it is not a cognitive booster, but improvement

can be seen over time. Unlike cognitive boosters, working quickly but for a short period of time, the effect of PS builds up and is sustained over time, so people may benefit from its consumption over the long run. This fact about PS ingestion was shown in Japanese elderly, who consumed PS or a placebo, for a period of 6 months. After 6 months, the participants stopped taking the supplement but returned to be tested three months later. The results, shown in the figure below, demonstrate that even three month after supplementation... >>

Test for cognitive function n = 48 Age 50-69 100 mg PS per day

*p<0.01 (relative to baseline) **p<0.01 (relative to placebo)

3 months of treatment 6 months of treatment follow-up (3 months post treatment)

Figure 1: Effects of PS supplementation on memory of elderly participants with memory complaints was tested over 6 months with 3 months follow-up. Ingestion of 100 mg/day PS was shown to be effective even 3 months after termination of the study (grey bars)4.

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HealthcareNews 1/20

>> of PS stopped, the study participants

still benefited from its earlier consumption, while results of those in the placebo group returned to baseline4: Cognitive health is not just for the elderly The usage of ingredients with cognitive effect is not limited to the adult population. From young children whose parents are looking to support their physical and mental development, through students who need to be focused in their learning, adults in a demanding work environment and, of course, elderly who may worry about age-related cognitive decline - many are looking for cognitive support. Some even look for cognitive support to their aging pets. Benefits of PS to various populations, including the pet population, have all been demonstrated in clinical studies.

Nootropics – moving to new delivery formats Today, many people prefer to take their nootropics not through classic supplements such as capsules or soft gels, but rather through “regular” food consumption. Take, for example, the rise of the gummy delivery system. While these solutions do not fall under “standard food” category, but rather a different segment of supplements, the number of solutions available in gummy format, and the shelf space accommodating these products, is sharply increasing, as people move away from traditional supplements delivery formats. Moreover, traditional food companies are also increasingly looking to add functionality to their products, including the

addition of nootropics. Thus, the trend of foods with cognitive functionality is becoming ever more significant.

Add a cognitive position to your food product Sharp●PS is a high-quality phosphatidylserine that is clinically proven to have a cognitive effect. It is regulated, for food and for supplement use, throughout the world. For example, Sharp●PS is generally recognised as safe, or GRAS5,6, making it a perfect partner for global companies seeking to add a cognitive position to their food products.

The ingredient is available from various sources including soy, sunflower (Sharp●PS Green, a soy-free alternative) and fish (Sharp●PS Gold, a version conjugated to DHA) and different grades (powder, fine powder and patented dispersion for soft gels) to fulfil any need.

Sharp●PS is particularly suitable for use in food, including dairy products and breakfast cereals. One characteristic of PS making it suitable for foods is the lack of organoleptic issues (taste, smell or mouthfeel). Another interesting characteristic of PS is that it is an amphipathic molecule, meaning it has both water soluble and oil soluble parts. This makes PS especially useful in foods which are water and oil emulsions such as dairy products or chocolates.

Approved cognition claim in the US The body of scientific evidence has led the US FDA to accept in 2003 two qualified health claims for the ingredient: • “Consumption of Phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly”; and • “Consumption of Phosphatidylserine may reduce the risk of dementia in the elderly” These claims come with a disclaimer that “very limited and preliminary scientific research suggests that phosphatidylserine may reduce the risk of cognitive dysfunction/dementia in the elderly. FDA concludes that there is little scientific evidence supporting this claim”.7 To this day, phosphatidylserine is the only ingredient with approved cognitive claims in the US.

3. Svennerholm, L. Distribution and fatty acid composition of phosphoglycerides in normal human brain. J Lipid Res 9, 570-579 (1968).

4. Kato-Kataoka, A. et al. Soybean-derived phosphatidylserine improves memory function of the elderly Japanese subjects with memory complaints. J Clin Biochem Nutr 47, 246-255, doi:10.3164/jcbn.10-62 (2010).

5. FDA. GRN No. 223: GRAS notice for phosphatidylserine, http://www.accessdata.fda.gov/ scripts/fcn/ fcnDetailNavigation.cfm?rpt=grasListing&id=223 (2007).

References

6. FDA. (2015).

1. UN. (ed United Nations Department of Economic and Social Affairs) (2002).

7. FDA. Phosphatidylserine and Cognitive Dysfunction and Dementia (Qualified Health Claim: Final Decision Letter http://www.fda.gov/Food/ IngredientsPackagingLabeling/LabelingNutrition/ ucm072999.htm (2003).

2. Hamm, M. Nutritional-scientific statement on the change of nutritive provision with phosphatidylserine. (2002).

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Alsiano Food & Healthcare Team

Anders Hager

Anna Carin Djerf

Bente Mørkøv Ølgaard

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Hedvig Åkesson

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Managing Director E: ahg@alsiano.com T: +45 8230 0026 M:+45 2618 8545

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Publisher: Alsiano A/S Circulation: 400 copies Editor-in-chief: Lene Aarøe Nissen Coordinator, text, layout: Dorthe Andersson