Ashland Inc. (Covington, Ky.; www.ashland.com) started up a new production line in Nanjing, China to manufacture polymer excipients for China’s pharmaceutical industry.
Demand for polymer excipients, the substances formulated alongside the active ingredients of medications, is rising in China as the country’s pharmaceutical industry moves to modernize oral drug manufacturing and comply with new quality standards set forth in the 2015 edition of the Chinese Pharmacopoeia.
Among the cellulose-based excipients, Ashland will make available to China’s markets include those sold under the Klucel HPC, BenecelHPMC, Blanose CMC and Aqualon EMC trade names. The company also will make available a series of PVP-based polymer excipients, including Plasdone PVP and Polyplasdone PVPP polymers. All of these products are sold with a Registered Pharmaceutical Excipient Certificate, as required by the China Food & Drug Administration.
Alongside Ashland’s first-ever pharmaceutical excipient production facility in China is an advanced quality control laboratory that contains equipment to measure and analyse products throughout the production process, including Thermal Fourier transform infrared spectrometers, Agilent liquid chromatography systems, and PE ICP optical emission spectrometers. The quality control system design and advanced analytical equipment allow Ashland to test all excipient products in accordance with Chinese Pharmacopoeia quality standards.
Experts in the structure-function relationships of excipients and their impact on the end-use functionality of oral pharmaceutical dosage forms, Ashland is able to support formulators of pharmaceuticals with formulation studies that solve complex formulation problems.