A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Shah VP, Amidon GL, LennernГ¤s H, Crison JR.

The BCS, BDDCS, and regulatory guidances. Furthermore, selection and availability of an innovator product as CPP are important considerations that can affect the outcomes of such studies.Д¬hen ML, Amidon GL, Benet LZ, LennernГ¤s H, Yu LX.

This study indicates that not all marketed products containing the same BCS III active pharmaceutical ingredient (API) in similar strength and dosage form are necessarily in vitro equivalent as per the WHO biowaiver criteria. Ten ciprofloxacin hydrochloride products were tested, and the results showed that only five products met the WHO biowaiver criteria. Eight atenolol products tested were all very rapidly dissolving in all three pH media. Nine acyclovir products were tested, and only three dissolved very rapidly in all media i.e., they showed a release of >85% in 15В min. US Pharmacopeia (USP) buffers of pHВ 1.2, 4.5, and 6.8 were used as dissolution media and tested using USP apparatus 2 at 75В rpm and 900В ml.

The dissolution of several products containing Biopharmaceutical Classification System (BCS) class III drugs, acyclovir, atenolol, and ciprofloxacin hydrochloride, listed in the WHO essential drug list (EDL), was tested and compared with their respective comparator pharmaceutical products (CPPs) marketed in South Africa and India.

Bcs class 1 drugs list pdf who