MS 09157 ABSTRACT The sale and use of substandard drugs is a major health problem in many developing countries where strict drug control legislation does not exist. The study investigates pharmaceutical quality of different brands of cefixime 400mg capsules marketed in Karachi (Pakistan). Compendial standards and government regulations require that all drug products, whether prescription or OTC products, meet strict standards of identity, potency, and purity. Each type of dosage form requires careful study of the physical and chemical properties of drug substances to achieve a stable and effective product. The different brands were subjected to various tests like uniformity of weight, diameter, length, disintegration, dissolution and chemical assays. The susceptibility test of drug was also carried out using agar dilution method along different isolates obtained from health care set ups. All the 6 brands had satisfactory drug content, antimicrobial activity and all passed the USP drug release test. The six brands are physically and chemically equivalent and could be interchanged. The study reinforces the need for constant monitoring of proprietary products of the same generic drugs to ensure quality and consequent efficacy with pharmacoeconomy, which would help in the selection of the most appropriate brand in terms of Pharmacoeconomy and quality. Keywords: Cefixime; Comparative evaluation; Physiochemical property; Pharmacoeconomy; Antibiotics; Study of Pharmaceutical quality; Cephalosporin. Journal of Pharmaceutical Research Vol. 8, No. 2, April 2009 : 98-104. PHARMACEUTICAL EVALUATION OF COMMERCIAL BRANDS OF CEFIXIME 400MG CAPSULES MARKETED IN KARACHI (PAKISTAN) * Gauhar Shahnaz, Hafiz Muhammad Arshad, * Naqvi Syed Baqir Shyum, Raheela Bano, Mahmood Shoukat and * Muhammad Iyad Naeem * Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Baqai Institute of Pharmaceutical Sciences, Baqai Medical University, Karachi, Postal code: 75270, Pakistan. Cell # 0300-8962840 Fax: 92-021-9261367 Received on : 29.01.09 Revised : 31.03.09 Accepted : 30.04.09 *Correspondence : shahnaz_gauhar@yahoo.com INTRODUCTION Marketing of poor quality drugs is of concern in developing countries and has been widely reported 1-4 . In some cases, expired drugs have been intentionally given to patients due to economic reasons or lack of adequate drug information and education 4 . In a recent study in Sudan, a number of drugs used in the country such as ergometrine, lignocaine, adrenaline, suxamethonium and ampicillin were shown to degrade rapidly under tropical conditions 1 . The Caribbean Regional Drug Testing Laboratory found that between 10 and 50% of the samples from different countries in the region did not comply with test requirements during 1988-91. Similarly, the Drug Quality Control Laboratory in Daru, Kenya, found that about 45% of the locally manufactured drugs and 31% of those imported during 1983-86 did not meet test requirements 3 . The increase in the number of generic drug products from multiple sources has placed people involved in the delivery of health care in a position of having to select one from among several seemingly equivalent products. For instance, in 1975 approximately 9% of all prescription drugs dispensed in the United States were generic versions 5 . This figure 5 rose to 20% in 1984 and 40% in 1991. Over 80% of the approximately 10,000 prescription drugs available, in 1990, were Review Article Journal of Pharmaceutical Research Vol. 8, No. 2, April 2009 : 98 obtained from more than one source and variable clinical responses were documented due to two or more drug manufacturers who supplied these dosage forms 6 . These variable responses may be due to formulation ingredients employed, methods of handling, packaging and storage and even the rigors of in-process quality control. Thus, there is need to determine their pharmaceutical and therapeutic equivalence in order to ensure interchangeability 7 . However, many developing countries do not have an effective means of monitoring the quality of generic drug products in the market. This results in widespread distribution of substandard and/or counterfeit drug products. It was in view of this fact that the World Health Organization issued guidelines for global standard and requirements for the registration, assessment, marketing, authorization and quality control of generic pharmaceutical products 8 . Preliminary physicochemical assessment of the products is very important and in vitro dissolution testing can be a valuable predictor of the in vivo bioavailability and bioequivalence of oral solid dosage forms 9 . Cefixime, a broad spectrum, bactericidal, -lactamase stable, third generation cephalosporin, is a semi synthetic first orally active and effective antibiotic 10-11 . Years of extensive investigations on cefixime have