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J Pharm Sci. 2019 Mar;108(3):1090-1100. doi: 10.1016/j.xphs.2018.10.044. Epub 2018 Oct 30.

Application of a Refined Developability Classification System.

Author information

1
Institute of Pharmaceutical Technology, Goethe University Frankfurt, Frankfurt am Main, Germany.
2
Product Development and Supply, GlaxoSmithKline R&D, Ware, UK.
3
Chemical and Pharmaceutical Development, Research & Development, Pharmaceuticals, Bayer AG, Wuppertal, Germany.
4
Institute of Pharmaceutical Technology, Goethe University Frankfurt, Frankfurt am Main, Germany. Electronic address: Dressman@em.uni-frankfurt.de.

Abstract

In 2010, the Developability Classification System was proposed as an extension of the Biopharmaceutics Classification System to align the classification system with the need for early evaluation of drug candidates according to their developability as oral formulations. Recent work on the Developability Classification System has resulted in the refined developability classification system (rDCS), consisting of standard investigations to estimate drug candidate solubility and permeability and offering customized investigations that are triggered when there is a potential for supersaturation/precipitation (e.g., salts of acids, weak bases) or to investigate permeation versus dissolution-limited absorption. In the present study, the rDCS concept was successfully applied to 6 marketed compounds (aciclovir, albendazole, danazol, dantrolene, dipyridamole, and piroxicam), for which there is a rich database of information. Furthermore, the rDCS was applied to 20 pipeline compounds from past and current research projects at Bayer AG. The rDCS was able to predict the results in humans correctly in 80% of cases. Overall, the results suggest that the rDCS is a highly useful tool for estimating the in vivo behavior of new drug candidates.

KEYWORDS:

Biopharmaceutics Classification System (BCS); dissolution; formulation; high throughput technologies; in vitro models; oral absorption; permeation enhancers; solubility; supersaturation

PMID:
30389565
DOI:
10.1016/j.xphs.2018.10.044

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