Determination of the binding parameter constants of.pdfVIP

Journal of Pharmaceutical and Biomedical Analysis 29 (2002) 195–201 /locate/jpba Determination of the binding parameter constants of Renagel® capsules and tablets utilizing the Langmuir approximation at various pH by ion chromatography Ronald A. Swearingen *, Xi Chen, John S. Petersen, Kristine S. Riley, Donghui Wang, Eugene Zhorov GelTex Pharmaceuticals, 153 Second Aenue, Waltham, MA 02451, USA Received 30 July 2001; received in revised form 11 January 2002; accepted 29 January 2002 Abstract Sevelamer hydrochloride is a cross-linked polymeric amine; it is the active ingredient in Renagel® capsules and tablets. Sevelamer hydrochloride is indicated for the control of hyperphosphatemia in patients with end-stage renal disease. The binding parameter constants of sevelamer hydrochloride were determined using the Langmuir approxi- mation for three different dosage forms at pH 4.0, 5.5 and 7.0. The three dosage forms were Renagel® 403 mg capsules, Renagel® 400 mg tablets and Renagel® 800 mg tablets. The results demonstrate the equivalency of all three dosage forms at each pH. The results also demonstrate a shift in the binding mechanism from pH 4.0 to 7.0. © 2002 Elsevier Science B.V. All rights reserved. Keywords: Sevelamer hydrochloride; Ion chromatography; Langmuir; Quaternary amines; Hydrogel; Renagel® 1. Introduction minum supplementation, is that it is non-ab-