Expanding Opportunities for Specialty Excipients - Pharmaceutical Technology

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Expanding Opportunities for Specialty Excipients
China creates a potential outlet for specialty excipients as its pharmaceutical market grows.

Pharmaceutical Technology

Diversified supplier base

The supplier base for specialty excipients in China consists of both multinational excipient manufacturers and domestic suppliers. Multinational excipient suppliers tend to focus on multinational pharmaceutical companies and select large, domestic pharmaceutical companies, and local excipient suppliers focus on the local pharmaceutical companies in China, according to the recent Kline analysis (1).

Among the multinational excipient providers, Dow Chemical Company (Midland, MI) is a leading player on a value basis in the supply of cellulosics to China's market. International Specialty Products (ISP, Wayne, NJ) and BASF (Ludwigshafen, Germany) dominate the supply of crosprovidone in China. Croscarmellose sodium supply is dominated by such multinational companies as FMC (Philadelphia, PA), JRSPharma (West Paterson, NY), and DMVInternational (Vegel, Netherlands). Coloron (West Point, PA) is a global supplier of formulated coatings and has a strong presence in China (1).

The growing importance of China in the global exicpient market was underscored by a scheduled conference on excipient control strategies in Beijing in mid-March. The conference was organized by the China Center for Pharmaceutical International Exchange (CCPIE, Beijing), the International Pharmaceutical Excipients Council (IPEC), and China's research and development-based group, the Pharmaceutical Association Committee.

Formulation strategies of CMOs
CCPIE is an affiliated organization of China's State Food and Drug Administration (SFDA, Beijing) and promotes nongovernmental international cooperation and exchange. IPEC is the federation of three independent regional industry associations of pharmaceutical excipient manufacturers, headquartered in the United States (IPEC-Americas, Arlington, VA), Europe (IPEC Europe, Leidschendam, Netherlands), and Japan (Japan Pharmaceutical Excipients Council, Tokyo).

The meeting was designed to provide China-based pharmaceutical manufacturers, excipient producers, SFDA, and pharmacopeial personnel an opportunity to interact with the global counterparts on excipient-control topics. On the agenda was how pharmaceutical excipients are evaluated for safety and controlled for quality in the United States, Europe, and Japan and a sharing of information about how various pharmacopeial systems work when developing monographs and general chapters for excipients among the pharmacopeial systems in the United States, Europe, Japan, and China. Compliance with current good manufacturing practices, third-party auditing, and the possibility of forming an industry-based excipient working group in China also were scheduled topics of discussion.

Product development at work

While local and multinational companies adjust to China's changing position in the global market, excipient manufacturers also must respond to the pharmaceutical industry's ongoing demand for innovation and improved performance.

Improving the bioavailability of poorly soluble drugs is an example, and excipient producers are responding. ISP, for example, expanded production capacity for "Polyplasdone," a polyvinyl-pyrrolidone polymer used as a tablet disintegrant, at its facilities in Texas City, Texas. This second manufacturing site was validated early this year. The capacity increase is driven by increased demand for fast-dissolving oral tablets as well as a need to enhance the solubility of poorly water-soluble actives, says Tim Bee, ISP's senior director of pharmaceuticals and oral care.

Company Web sites
The dissolution rate is an important determinant of the bioavailability of a drug, and the interaction of a disintegrant with the active ingredient may promote or slow dissolution. ISP recently conducted a study of the drug- dissolution capability of Polyplasdone, a nonionic superdisintegrant, compared with anionic disintegrants, when formulated in tablets containing cationic active ingredients of varying solubilities. Nonionic disintegrants will not complex with ionic drug actives to retard drug dissolution. Anionic disintegrants such as croscarmellose sodium and sodium starch glycolate can complex with cationic drug actives and slow dissolution.


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