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J Pharm Sci. 2018 Oct 30. pii: S0022-3549(18)30676-2. doi: 10.1016/j.xphs.2018.10.044. [Epub ahead of print]

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, Bayer AG, 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 (DCS) was proposed as an extension of BCS to align the classification system with the need for early evaluation of drug candidates according their developability as oral formulations. Recent work on the DCS has resulted in the refined developability classification system (rDCS), consisting of standard investigations (SI) to estimate drug candidate solubility and permeability and offering customized investigations (CI) that are triggered when there is a potential for supersaturation/precipitation (e.g. salts of acids; weak bases) and/or to investigate permeation vs. dissolution-limited absorption. In the current work, the rDCS concept was successfully applied to six marketed compounds (acyclovir, albendazole, danazol, dantrolene, dipyridamole, piroxicam), for which there is a rich database of information. Further, 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 behaviour of new drug candidates.

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

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