The in vivo predictive dissolution for immediate release dosage of donepezil and danazol, BCS class IIc drugs, with the GIS and the USP II with biphasic dissolution apparatus

The formulation developments and the in vivo assessment of Biopharmaceutical Classification System (BCS) class II drugs are challenging due to their low solubility and high permeability in the human gastrointestinal (GI) tract. Since the pH change in the GI environment influences the drug dissolution of BCS class IIa and IIb drugs but not for IIc drugs, the incorporation of the human GI characteristics into the in vitro dissolution system may not be crucial for BCS class IIc drugs to predict their bioperformance. An absorptive compartment in dissolution apparatus would be important to predict bioperformance of BCS class IIc drugs due to their physicochemical characteristics, low solubility and high permeability.