Quality assessment of ciprofloxacin tablets obtained from community pharmacies in Lagos, Nigeria

Abstract

Ciprofloxacin is increasingly being used in the management of various cases of infectious diseases including gonorrhoea and acute exacerbation of chronic bronchitis. As bioavailability and bioequivalence of drug products (especially multi-sourced products) and product selection have emerged as critical issues in healthcare, it is essential that products used in patient management are of acceptable quality. Using a sampling frame of community pharmacists in Lagos obtained from the Association of Community Pharmacists of Nigeria (ACPN) Lagos State Branch, sixteen brands of ciprofloxacin (500 mg) tablets were purchased from selected pharmacies for the study. Physicochemical tests were carried out according to BP (2007) specifications. The results showed that the products had acceptable physical quality thus satisfactory in appearance, size and ability to abrade or be crushed. All but one of the brands tested passed the dissolution tests. A quarter of the brands tested (25%) did not pass the chemical assay test i.e. percentage content of active ingredient. The study concluded that not all the products tested are of sufficiently good quality with up to four brands failing the chemical assay test. This may be due to deliberate counterfeiting, failure of current good manufacturing practices (cGMP) by manufacturers or poor handling by wholesalers/retailers. This has serious impact on healthcare delivery and public health. The study recommends effective post marketing surveillance and enforcement of cGMP. Future analytical studies on ciprofloxacin should consider dissolution testing in solutions of different pH.

Key words: Ciprofloxacin, Quality, GMP, Drug Faking, Pharmacy and Infectious Diseases