IPEC e-newsletter - Excipients Insight September 2017 - 19-09-17


Inside this issue


Recommended reading

Salvagers of solubility

High throughput excipient discovery looks set to boost oral bioavailability. A collaboration between the Dow Chemical Company and University of Minnesota has yielded a new method allowing the production of excipients that triple the oral bioavailability of drugs, when compared with commercial excipients.

The Medicine Maker

Pharmaceuticals, printers and paintballs: when variability in excipient quality is and isn’t acceptable

Regardless of whether it’s prescription or over-the-counter, the ingredients on a drug product label typically include one, maybe two, active pharmaceutical ingredients (APIs). The rest of the list is comprised of “inactive” ingredients (excipients) which in reality are far from inactive. Their functions range from helping to guarantee the stability and bioavailability of the API to the drug product’s manufacturability to its texture and taste. Because of the multiple roles they play in drug product formulations, excipient quality is as important as that of the API, so standards are needed to ensure their purity and reliability.

USP Quality Matters (video)

Recent developments regarding a Novel Excipient Qualification process

The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) and the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) are working toward accelerating excipient innovation and ways to bring forth novel excipients with enhanced functionality that improve drug delivery and manufacturability (e.g., continuous manufacture) and that focus more on the needs of special populations (e.g., pediatrics). This collaboration led to a Critical Path Initiative Meeting (CPIM) with the FDA on March 10 to discuss developing an independent Novel Excipient Qualification process that encourages the development of innovative novel excipients and their use.

Tablets & Capsules

Indian Gov outlines plan to favour drugs containing locally made APIs

Price controls and procurement programmes would favour drugs containing locally-made APIs under a Government proposal designed to reduce India's reliance on imported ingredients and intermediates.





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