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

Journal of pharmaceutical sciences (2015-07-07)
Johannes Gursch, Roland Hohl, Gregor Toschkoff, Diana Dujmovic, Jörg Brozio, Markus Krumme, Norbert Rasenack, Johannes Khinast
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.

MATERIALS
Product Number
Brand
Product Description

Supelco
Ibuprofen
Sigma-Aldrich
α-Lactose monohydrate, BioXtra, ≥99% total lactose basis (GC)
Sigma-Aldrich
α-Lactose monohydrate, ≥99% total lactose basis (GC)
Sigma-Aldrich
Ibuprofen, meets USP testing specifications
Sigma-Aldrich
Ibuprofen, ≥98% (GC)
Sigma-Aldrich
Sodium pyrophosphate tetrabasic, ≥95%
Sigma-Aldrich
α-Lactose monohydrate, suitable for cell culture, BioReagent