Sizing Up the Global Market for Excipients - Pharmaceutical Technology

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PharmTech Europe

Sizing Up the Global Market for Excipients
The global excipients market shows moderate growth, increased consolidation, and expansion activity in emerging markets and select product areas.

Pharmaceutical Technology
Volume 35, Issue 10, pp. 62-68

In a smaller, separate deal, in February 2011, BASF and Sigma-Aldrich signed a global distribution agreement for several of BASF's pharmaceutical excipients. Under the deal, Sigma-Aldrich will repackage the products into small pack sizes to make them available for academic-oriented R&D activities for use by universities and laboratories. The excipients portfolio offered comprises various grades of binders (i.e., Kollidons), coatings (i.e., Kollicoats), and solubilizers (i.e., Cremophors, Lutrols, and Solutol).

On the new product front, BASF introduced Kollicoat Smartseal 30 D, a water-based dispersion for taste-masking and moisture-barrier applications, in 2010. The product is highly impermeable to water vapor, which facilitates preserving the potency of sensitive active ingredients, according to a Nov. 15, 2010, BASF press release. The polymer is stable in saliva and soluble in gastric juice. These properties ensure effective protection from unpleasant taste in the patient's mouth and rapid release and onset of active ingredient action in the stomach, according to the BASF press release. Kollicoat Smartseal 30 D complements BASF's existing tablet coatings portfolio, which includes polymers and copolymers used to coat tablets, capsules, and pellets, and to control the release of drugs from solid dosage forms.

Evonik. The specialty- and fine-chemicals company Evonik reorganized, effective Sept. 1, 2011, and combined its businesses for custom API manufacturing (i.e., exclusive synthesis), pharmaceutical amino acids (i.e., its Rexim product line), and pharmaceutical polymers in a new healthcare business line. The pharmaceutical polymers business includes the company's Eudragit and Resomer product lines. The Eudragit line consists of acrylic copolymers for oral solid dosage forms, and the Resomer line includes bioresorbable poly(lactic-co-glycolic acid) copolymers, which are used in depot formulations. Evonik acquired the Resomer business from Boehringer Ingelheim in March 2011.

Avantor Performance Chemicals. Avantor Performance Chemicals is proceeding with an expansion in India, following a key acquisition in 2010. Avantor Performance Chemicals was the new name given to the company after the acquisition of Mallinckrodt Baker from Avantor's former parent company, Covidien, to the private equity group, New Mountain Capital. Avantor is a producer of products and materials for the pharmaceutical industry, including excipients.

In May 2011, Avantor opened a new pharmaceutical formulation application laboratory in Sinnar Nashik, Maharashtra, India, with its partner RanQ Remedies. The new laboratory will be used to characterize excipients, perform functional testing, develop and characterize drug formulations, and support customer applications and product implementation. In terms of excipients, RanQ has a position in microcrystalline cellulose and sodium starch glycolate and also has expertise in developing premixed and other application-focused pharmaceutical excipients that result in a homogenous mix and coprocessed excipients.

In addition to the applications laboratory, Avantor completed construction of a pilot plant onsite at the RanQ facility. The pilot plant will be used to develop and scale up additional performance excipients to extend Avantor's J.T. Baker PanExcea product line. The PanExcea line includes performance excipients that combine fillers, binders, and disintegrants for increased functionality for immediate-release formulations and orally disintegrating tablet applications.

Other companies. Several other excipient companies are expanding. In 2011, DMV–Fonterra agreed to acquire the business and assets of Brahmar Cellulose Private Ltd. an Indian-based producer of pharmaceutical microcrystalline cellulose and sodium carboxylmethylcellulose. The acquisition, subject to customary closing conditions and regulatory approval, is scheduled to close in the fourth quarter of 2011.

In April 2011, FMC completed an expansion of its microcrystalline cellulose plant in Cork, Ireland. Production from the final phase of the expansion began in March 2011 and increased FMC's global capacity by 25% for pharmaceutical- and food-grade microcrystalline cellulose. FMC operates another microcrystalline cellulose plant in Newark, Delaware.

In March 2011, Grace Davison Discovery Sciences, part of W.R. Grace & Co., opened a new technical service knowledge center in Southern India for customers in the pharmaceutical and biotechnology industries. The new facility is located in the Genome Valley near Hyderabad. The knowledge center supports Grace's customers in the areas of excipients, pharmaceutical intermediates, laboratory separations, and bulk purification. The center also will provide product development and applications support and include such services as customer training, validation, testing for various products, and product demonstrations. The new center complements existing application laboratories in the United States, Europe, and China.

In October 2010, ABITEC and Mutchler Pharmaceutical Ingredients, announced a comarketing and distribution partnership for ABITEC's Captex, Capmul, Acconon, Sterotex, BBS-C, and Hydro-Kote lipid-based pharmaceutical-grade excipients. The partnership provides for expanded customer service, sales, technical formulation-development support, and supply capability.


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