Gulcin Tok
Research and Development Center, Sanovel Pharmaceuticals,
Istanbul
Turkey
Research Article
In vitro Bioequivalence Studies in Tablet Formulation Containing 625 mg
of Colesevelam Hydrochlorides
Author(s): Gulcin Tok, Ediz Yildirim and Ali TurkyilmazGulcin Tok, Ediz Yildirim and Ali Turkyilmaz
Colesevelam hydrochloride is a second generation bile acid sequestrant that is used principally for treatment of elevated LDL cholesterol. Additionally, it is indicated to improve glycemic control in adults with type 2 diabetes mellitus. Colesevelam hydrochloride is an insoluble, non-absorbed polymer that binds bile acids in the intestine, impeding their reabsorption. Because the drug is not absorbed into the systemic circulation, pharmacokinetic information is not available. The present abstract focuses on the study of in vitro BE in tablet formulation containing 625 mg of Colesevelam hydrochloride. Bile acid salts of Glycocholic Acid (GC), Glycochenodeoxycholic Acid (GCDC) and Taurodeoxycholic Acid (TDC) were used in vitro BE studies. The binding capacity HPLC method was developed and validated for these bile acid salts. The equilibrium binding study tha.. View More»
DOI:
10.4172/jbb.1000323