Abstract

Omotoso E. A., Ucheokoro Adaeze S.* and Nwanochi C. Joyce

ABSTRACT

The use of branded products and their cost implications are source of concerns in the developing countries. The study was done to evaluate nine different brands of Olanzapine 10 mg tablets which are commercially available in the Nigerian Market. The study aimed to compare the cost to benefit ratio of generic brands using both Pharmacopeia and non-pharmacopeia test methods and infer on their interchange ability with the innovator brand. The tablets were subjected to thickness, diameter, weight uniformity, drug content, friability and disintegration tests, which all the samples passed. Only samples AAO, BTO and CTO passed the hardness test with each having a hardness of 4kg/m2 .The in-vitro release studies were quantitatively determined using UV spectroscopy method and their release pattern evaluated using Model-independent methods (Fit factors and dissolution efficiency).The release patterns of the evaluated samples showed only brands BTO, DEO, FCO and GNO had similarity of above 50% when compared to the innovator brand (IZO), the values for difference factor were within the range 0 and 15 except for brand EAO, indicating slight differences from the innovator brand. The dissolution efficiencies when compared to the innovator brand showed that only brands BTO, DEO and FCO were within the acceptable limits of ±10%. This study concluded that the brands of olanzapine studied passed most of the conducted tests, including the content of active ingredient tests. However, based on their dissolution efficiencies and other tests, only brands BTO (Teva-Olanzapine™) and FCO (Excelpin™) showed enough similarity with the innovator product (ZyprexaTM) and can therefore be interchanged with minimal cost-implications in clinical settings.