Pharmaceutical Quality Analysis of Ceftriaxone Sodium Brands Marketed in Southern Nigeria
Ogbonna Okorie
Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, University of Port Harcourt, Rivers State, Nigeria.
E. Omotoso Abayomi *
Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmaceutical Sciences, University of Port Harcourt, Rivers State, Nigeria.
Ebinyansi Onyinyechi
Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, University of Port Harcourt, Rivers State, Nigeria.
*Author to whom correspondence should be addressed.
Abstract
One of the paramount controversies between Physicians and Pharmacists is the issue of generic substitution. Prescribers are compelled to choose from such a large range of brands. The objective of this study was to compare the Pharmaceutical quality of innovator brand of injectable Ceftriaxone sodium with its generic brands that are marketed in Southern Nigeria. Seven brands of injectable Ceftriaxone sodium marketed in some pharmacies in Southern Nigeria were analysed. Standard physical and chemical tests for quality control of parenterals approved by the British Pharmacopoeia were performed on the branded sampled. The tested brands complied with the BP specifications for quality of Parenterals. Although one of the generic brands has content weight of Ceftriaxone greater than the upper limit specified (127.906%). The brands of Ceftriaxone sodium tested have been proven to be pharmaceutically and therapeutically equivalent. Though, there are variations among these brands due to the different manufacturing processes and formulation factors.
Keywords: Ceftriaxone sodium, pharmaceutical quality, quality control, generic substitution, pharmaceutical equivalence.