EVALUATION OF THE PHYSICOCHEMICAL PROPERTIES AND QUALITY INDICES OF MULTISOURCE FLUOXETINE CAPSULES MARKETED IN NIGERIA

Ukwueze S.E.*, Andrew-Kekii L.P., Nwoke E.A. and Odigie J.

ABSTRACT

The need to constantly evaluate the quality of multisource drugs to ascertain their pharmaceutical equivalence and interchangeability cannot be overemphasized. Fluoxetine, a selective serotonin re-uptake inhibitor antidepressant, is one of the commonly utilized multisource psychotropic agents in many parts of the globe, with an equally great potential for abuse. This study examined the extent to which commonly available brands of fluoxetine hydrochloride in Nigeria comply with quality and safety standards. Different brands of fluoxetine hydrochloride capsules obtained from retail pharmacies located in some parts of Nigeria were assessed using official BP and USP and unofficial methods. Tests for uniformity of weight, disintegration, dissolution, content of active ingredients and similarity factor determination for capsules were employed. The content of active ingredient test was carried out using UV-spectrophotometer at a wavelength of 241 nm for fluoxetine. The innovator brand (Prozac®) was used as primary standard. The results showed that all the brands passed the uniformity of weight (< 5 mg), disintegration (< 10 min), and dissolution tests (> 85% after 30 min). However, one sample failed the assay for active ingredient (75%), while only one brand had a similarity factor greater than 50. Thus, only one brand was found to be interchangeable with the innovator brand. Therefore, the random therapeutic use of multisource fluoxetine in Nigeria can potentially affect therapeutic outcome.

Keywords: Substandard, Counterfeit, Fluoxetine, Interchangeability, Multisource medicines.