Journal of Pharmaceutical Sciences 2015-10-01

Continuous Processing of Active Pharmaceutical Ingredients Suspensions via Dynamic Cross-Flow Filtration.

Johannes Gursch, Roland Hohl, Gregor Toschkoff, Diana Dujmovic, Jörg Brozio, Markus Krumme, Norbert Rasenack, Johannes Khinast

Index: J. Pharm. Sci. 104 , 3481-9, (2015)

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Abstract

Over the last years, continuous manufacturing has created significant interest in the pharmaceutical industry. Continuous filtration at low flow rates and high solid loadings poses, however, a significant challenge. A commercially available, continuously operating, dynamic cross-flow filtration device (CFF) is tested and characterized. It is shown that the CFF is a highly suitable technology for continuous filtration. For all tested model active pharmaceutical ingredients, a material-specific strictly linear relationship between feed and permeate rate is identified. Moreover, for each tested substance, a constant concentration factor is reached. A one-parameter model based on a linear equation is suitable to fully describe the CFF filtration performance. This rather unexpected finding and the concentration polarization layer buildup is analyzed and a basic model to describe the observed filtration behavior is developed.© 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.