Comparative dissolution of commercuially available hydroxyzine hydrochloride tablets

Carol Noory Center for Drug Evaluation and research, Food and Drug administration, Rockville, Maryland, 20857

Cecilia Wolyniak Baltimore district Laboratory, Food and Drug Administration, Baltimore Maryland

Kathryn E. Ogger Detroit District Laboratory, Food and Drug Administration, Detroit, Michigan

Vinod P. Shah Center for Drug Evaluation and research, Food and Drug administration, Rockville, Maryland, 20857

Abstract

A comparative dissolution study was conducted on commercially available hydroxyzine hydrochloride tablets using USP Apparatus 2 (Paddle Method) at 50 rpm and two dissolution media: Water and Simulated Intestinal Fluid (SIF) and the USP recommended method employing the disintegration apparatus. The dissolution characteristics of 22 samples of hydroxyzine hydrochloride tablets representing four dosage levels and seven manufacturers were profiled.

The study illustrated that the Modified Disintegration apparatus is not able to distinguish slow dissolving formulations from fast dissolving formulation and, consequently, does not provide assurance of bioequivalence and does not perform as an adequate manufacturing control to insure lot to lot uniformity.

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Comparative dissolution of commercuially available hydroxyzine hydrochloride tablets

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Comparative dissolution of commercuially available hydroxyzine hydrochloride tablets

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