Method Development For Equilibrium And Kinetic Binding In Vitro Bioequivalence Of Colesevelam Hydrochloride In Simulated Intestinal Fluid (sif)

Adam C. Myers, Ph.D., Josef K. Ludwig, Jennifer L. Sassman, Jonathan W. Henry, Yinyan Zhao, Ph.D.

Abstract

Bioequivalence (BE) is defined as “the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study”. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. Bioequivalence is usually established by in vivo studies, e.g. pharmacokinetic, pharmacodynamic, and clinical studies. Under certain circumstances, product bioequivalence can be documented using in vitro approaches. For example, those orally administered drugs intended for local action.

The objective of the study reported in this poster is to develop and validate an HPLC method for a bioequivalence study to quantitate free bile acid salts in aqueous solutions containing colesevelam hydrochloride and the excipients of Welchol® at various concentration levels.