| By Alex Shaw, Pharmaceutical Manufacturing News |
| Wednesday, 04 March 2009 |
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While the worldwide pharmaceutical excipient market has experienced dramatic growth in recent years, China still lags behind developed countries in terms of the research, the development and the application of pharmaceutical excipients. Statistics show that around 1,000 types of
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pharmaceutical excipients are commonly used in the development and manufacturing of preparations inside and outside of China, demonstrating the importance of pharmaceutical excipients in promoting the development of the pharmaceutical sector.
Appropriately using pharmaceutical excipients helps in developing a variety of new preparations in compliance with international standards.
Significant progress seen in developed countries
The rapid growth of the pharmaceutical preparation markets in developed countries, for the most part, relies on the appropriate application of pharmaceutical excipients. Currently, pharmaceutical excipients used in these countries mainly consist of high molecular polymers, biosynthetic and semi-synthetic excipients, as well as those extracted from plants and animals. Developed countries pay particular attention to R&D and application of pharmaceutical
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excipients for the purpose of developing new preparations and improving the quality of pharmaceutical products, and for this reason, a large number of specialized companies have been established to make the excipients.
Current development in China
In 1980, China began to use pharmaceutical excipients such as starch, powdered sugar, lactose, dextrine and magnesium stearate to produce oral solid preparations. However, the finished preparations were proved to be of poor quality due to the lack of diversity. This led the scientific research institutions, universities and colleges as well as pharmaceutical companies in the country to work closely with each other to develop and promote new pharmaceutical excipients.
Shanghai Institute of Pharmaceutical Industry took the lead in developing a variety of pharmaceutical excipients for oral solid preparations, including microcrystalline cellulose, calcium sulphate and Pluronic F-68. Shenyang Pharmaceutical University then successfully developed pregelatinized starch and poloxamer, while Jinhua Pharmaceutical Factory introduced dozens of new pharmaceutical excipients such as sucrose fatty acid ester, low-substituted cellulose and ethyl cellulose. In addition to the strong market demand, the entry of foreign companies is also vital to the |
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accelerated growth of China’s pharmaceutical excipient market. Dozens of foreign pharmaceutical excipient producers have to date set up branches in China, providing more choices for the country’s preparation makers.
Nevertheless, China still lags behind developed countries in the research and development of pharmaceutical excipients, as certain issues continue to dog the sector: most pharmaceutical excipients are manufactured by chemical or food companies instead of specialized excipient makers, while homegrown products remain inferior to those produced by developed countries in terms of quality, stability and diversity.
China has a ways to go before it catches up with developed countries in terms of the development of pharmaceutical excipients. Industry analysts encourage the entire sector to develop innovative excipients and improve the quality of existing products.
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