BASF Company Overview by Business Review Brasil

150 years

BASF:

INNOVATIONS AND NEW SOL

BASF’s pharma business unit invests in new technology to offer solutions to the pharmaceutical and nutritional supplement mark Written by: Flávia Brancato | Produced by: Karla Sohn

LUTIONS

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ocused on innovation, BASF is recognized in the industry for the excellence of its products and expertise throughout the value chain, from drug development in the laboratory to market release. To further stimulate product performance and expand its activities for customer needs, the company has launched a new way to interact with the market, based on four platforms of the line of excipients. Each of these platforms has unique characteristics aimed at serving its clients in a customized way: • Immediate and Modified Release: functional excipients for use with multiple doses and various release profiles • Solubility: products and technologies that help solve the most complex challenges for drugs with lower solubility • Skin Care: ingredients for use in pharmaceutical topical dosage forms • Soft Gelatin Capsules: active pharmaceutical ingredients and a wide variety of excipients for the development of modern drugs 4

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presented in this pharmaceutical form These platforms offer added value solutions by combining BASF’s experience, manufacturing excellence, applied technology, and strength in R&D in the chemical industry. “ The platforms are presented as solutions to circumvent the challenges of the industry and create an easy link between

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customer requirements and functional BASF solutions based on our chemical expertise,” said Fernanda Furlan, Business Manager of BASF’s Pharma business unit for South America. PVP chain In terms of growth, Furlan confirmed the investment plans in the market for Polyvinylpyrrolidone (PVP), where the company is responsible

for creating the product and considered to be the market leader. “BASF plans to invest up to 56 million euros in expanding its PVP value chain over the next four years,” said Furlan. PVP is a polymer used in various industries such as pharmaceutical, personal care, home and construction, primarily due to its flexibility in applications and various chemical properties. “With w w w. b a s f . c o m . b r

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this investment, we are actively participating in the strong growth of the PVP market, especially within the pharmaceutical industry,â&#x20AC;? she added. Through the renewing of existing plants in Ludwigshafen, Germany and Geismar, Louisiana and the introduction of PVP technology in the BASF site in Shanghai, China, the company will increase its global capacity of PVP production by up to 6,000 tons. Most of BASF PVP production is earmarked for the pharmaceutical industry.

Kollicoat IR Brilliant Blue

Laboratories Expanding the global innovation network of BASF for the food and pharmaceutical industries in South America, the company began its first Nutrition and Health Applications Centre in the continent in May 2014, providing more opportunities and expanding BASF Pharma capacity. â&#x20AC;&#x153;Through this structure, we do not depend on the German lab as much and now we can offer local support a lot faster and more solid. In the past some projects had to

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be abandoned due to the lack of a regional center,” said Furlan. The investment of over 1 million euros in Jacareí, São Paulo state, includes specialized technology, providing the pharmaceutical industry active ingredients such as ibuprofen and Omega-3, as well as excipients for a wide variety of pharmaceutical applications. According to Furlan, “Today more than 80 percent of BASF’s pharmaceutical development projects involve direct cooperation with our customers, adapted to specific characteristics and needs of their formulations. The laboratory will strengthen our customer service the South American market.” In addition to accelerating the launch of new products to the market, the new center also has

the function of helping to find innovative and effective solutions for the customers’ challenges in the region, such as solubility, coating, optimizing and reduction of variability productivity. With cutting-edge equipment for pill manufacturing, as well as quick and easy transfer to industrial scale, the laboratory uses extrusion technology by fusion (Hot-MeltExtrusion), recognized for its potential to increase bioavailability of pharmaceutical actives with lower solubility. “The laboratory is designed to stimulate innovation, as an open area with latest technology equipment at hand that allows the use of different simultaneous technologies. This elevates the productivity of our industries, as

“Today more than 80 percent of BASF’s pharmaceutical development projects involve direct cooperation with our customers, adapted to specific characteristics and needs of their formulations.” – Fernanda Furlan, Business Manager of BASF’s Pharma business unit for South America

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Hot Melt Extrusion technology

well as increasing convenience and patient compliance to treatment. With the use of new excipients and new technologies such as HotMelt-Extrusion, we can reconsider pharmaceutical assets that were discarded in the past due to the low solubility and then reformulate our products, hence increase the drug life cycle,” said Fernanda. “What we at BASF believe is that we can do this together with our customers. The new laboratory helps us find innovative and

effective solutions to meet the challenges of the pharmaceutical industry in South America. We believe that we can challenge our reality and do better,” explained the manager. Portfolio Seeking to find solutions to improve people’s quality of life and well being, the Pharma business unit of BASF offers a broad portfolio of excipients and active pharmaceuticals. w w w. b a s f . c o m . b r

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Immediate release platform and Modified Featured products of this platform are: Kollicoat®: a highly flexible polymer line and productivity for pill coating, it is the best solution for the pharmaceutical active protection, taste masking, immediate release, enteric and controlled active ingredient. Kollicoat® IR: In addition to its outstanding performance as a coating polymer for immediate

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release, it is also an excellent binder, specially developed for formulations sensitive to oxidation, since it is a peroxide free excipient. Kollidon®: PVP polymer can be used in a number of applications due to its versatile features. It is water soluble, but can also absorb large quantities of liquid. It does not irritate the skin and it is not a health hazard. It is temperature resistant, has stable pH, it is non-ionic and is colorless. Solubility Platform The low solubility of active ingredients is one of the biggest challenges that pharmaceutical companies face in the development new drugs. BASF offers several solutions to address these problems. The main products of this platform are: Soluplus®: Specifically developed to solubilize pharmaceutical active APIs and low in solubility, it has high flow and excellent extruding in forming solid solutions, especially in hot extrusion processes. Kollidon VA 64®: Initially

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developed as a binder for wet granulation, direct compression and coating, this polymer has hydro and lipophilic characteristics and adequate physical properties. It has been widely used in extrusion processes by hot melt extrusion. Kolliphor®: BASF’s solubilizing line, it consists of Kolliphor RH40, EL, ELP, HS, P 188, P 338, P407 and PS. It is an excellent alternative for active ingredients solubilizing in several different ways such as oral pills and injectable liquids.

Skin Care Platform Excipients and solutions for topical drugs allow customers to create ideal applications for the skin. The solubilizing excipients and skin penetration enhancers help in the effectiveness of the active ingredients to reach the location of action. The main products are: Kollicream OD®: displays excellent and important properties for semi-solid formulations, such as improved application of the drug, solubility of lipophilic w w w. b a s f . c o m . b r

BASF active ingredients and increased cutaneous permeation of the active principles, regardless of the formulation pH. Kolliphor P407®: extremely efficient solubilizing, it was initially developed for use in solid drugs but it also has an excellent performance in topical medications as solubilizing and active-tense. Platform Soft Gelatin Capsules Easily ingested and attractive and

translucent appearance, the soft gelatin capsules have become popular. BASF’s portfolio helps customers achieve the best possible outcome in all technical information necessary to formulate a soft capsule, is in its filling or coating. Kollicoat Protect®: the highly flexible polymer Kollicoat IR® is mixed with polyvinyl alcohol in the manufacture of this product. Its flexibility properties, protection from moisture and high solubility is ideal for coating soft gelatin capsules. Kollisolv PEG 300®: this solubilizing traditionally employed in soft gelatin capsules formulations of excipients is marketed by BASF for all challenges encountered in the development of gel capsules. Active ingredients With a strong international presence, BASF is tailored to meet local needs reliably. Thanks to the manufacturing sites located in various parts of the world, the company can deliver highquality products when and where customers need. The main active ingredients of BASF’s portfolio are:

Fernanda Furlan

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Manufacture of pills - immediate and modified release

“That’s exactly our focus. The platforms are presented as solutions to circumvent the challenges of the industry” – Fernanda Furlan, Business Manager of BASF’s Pharma business unit for South America

Omega-3: BASF is the world leader in pharmaceutical grade omega-3 and a pioneer in innovative methods for purification of fatty acids. The broad portfolio covers high to super high concentrations of omega-3 fatty acids for use in medicines, nutritional supplements and clinical nutrition.

Ibuprofen: for over 20 years, BASF has been an ibuprofen manufacturer in a plant audited by the FDA and cGMP certified in Bishop, Texas, USA. It belongs to the class of non-steroidal anti-inflammatory (NSAID) with analgesic activity, anti-inflammatory and antipyretic (antipyretic). w w w. b a s f . c o m . b r

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Quality Standards and Employees Operating with the highest existing quality standards, BASFâ&#x20AC;&#x2122;s manufacturing facilities are ISO 9001 certified and meet the standards of Good Manufacturing Practices (GMP) and are regularly inspected by national and international authorities, including the FDA. The new European chemicals legislation, Registration, Evaluation, 14

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Authorization and Restriction of Chemicals (REACH), brings even greater demands for companies to provide information regarding product management and safety of the substance. To help customers comply with REACH certification, BASF has grouped its capabilities in EU chemicals legislation, offering tailored packages. â&#x20AC;&#x153;Our success and that of our customers is based on research and innovation. At BASF that

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