Exploring a Bioequivalence Failure for Silodosin Products Due to Disintegrant Excipients.

ABSTRACT: Some years ago, excipients were considered inert substances irrelevant in the absorption process. However, years of study have demonstrated that this belief is not always true. In this study, the reasons for a bioequivalence failure between two formulations of silodosin are investigated. Silodosin is a class III drug according to the Biopharmaceutics Classification System, which has been experimentally proven by means of solubility and permeability experiments. Dissolution tests have been performed to identify conditions concordant with the non-bioequivalent result obtained from the human bioequivalence study and it has been observed that paddles at 50 rpm are able to detect inconsistent differences between formulations at pH 4.5 and pH 6.8 (which baskets at 100 rpm are not able to do), wh

SUBMITTER: Gonzalez-Alvarez I 

PROVIDER: S-EPMC9783061 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature