Abstract Pregabalin, a neuropsychotropic agent, is a drug of choice for the treatment of epilepsy and neuropathic pain. Several brands are available in the Nigerian drug market which raises the challenge of determining the products that could be interchanged with the innovator brand or with other generics. Therefore, the current study was carried out to evaluate and compare the quality and physicochemical characteristics of five different pharmaceutical brands of Pregabalin (75 mg) capsules available in the pharmacies of some southern states in Nigeria. For the brands studied, physical examination, drug content, weight variation, disintegration, dissolution, amongst other quality control tests were carried out. Results showed that most of the samples complied with the standards specified for capsules. Drug contents were not exactly the same with the reference sampleas two brands (P3 and P5) had their drug contents to be less than 80%. There was a consistency in drug release carried out within 30min at intervals of 5, 10, 15, and 30min. Thus, the results of the study indicated that all brands of pregabalin tested conformed with the pharmacopeial standards for disintegration, weight uniformity and dissolution tests, while two brands (P3 and P5) failed the content uniformity test. Also, the samples were found to be interchangeable with the innovator brand (P1) as their dissolution profiles showed that they all released more than 85% of their active content within 30 min. The study therefore underscored the need for constant post-market surveillance and quality assurance of multisource essential drug agents, especially in developing countries such as Nigeria.
Keywords Quality Assurance, Pregabalin, Quality Control, Comparative Studies, Bioequivalence.