Evaluation of Pharmaceutical Quality of Phenytoin Sodium Capsules and Tablets from Multinational Markets

Abstract

This report presents the results obtained in the above-titled study for the quality of phenytoin sodium tablets and capsules (100 mg) available in the markets of various countries worldwide, especially members of the Official Laboratories and Medicines Control Services (OLMCS) section of FIP. The products were analyzed following a common protocol based on the methodologies described in the European (Ph.Eur.), British (BP), and/or United States Pharmacopeia (USP). Pharmacotechnic tests (uniformity of weight, disintegration), identification, assay, and dissolution of active ingredient were preformed by 23 laboratories from 20 countries that submitted data from 52 samples representing 37 products available in the local markets. Innovator products from 17 countries were analyzed in LEF. Most products tested &Wed the pharmacopeial requirements concerning uniformity of weight, disintegration, identity, and content. Marked differences were recorded in respect of in vitro dissolution behavior. This applies not only to the products of different brands but also among lots of the same brand name produced in difei-ent countries