ABSTRACT
The increasing number of reports of sub-therapeutic responses elicited by many essential medicines, even at their therapeutic doses, including those which are considered as first-choice medications in the treatment and management of various disease conditions, have raised questions about the quality of these medicines available to both healthcare professionals and patients.
In this study, eight brands of gabapentin, which is one of the most widely used drugin treatment of spasticity and neuropathic pain in the populace, was subjected to quality assessment using quality parameters for capsules, such as weight variation, active content/drug assay, and disintegration time. The result showed that all the brands satisfactorily passed all the quality assessment tests, as the weight variability of the individual capsule weight of each gabapentin brand fell within the IP specified weight range, and the percentage active content fell within the USP specification for gabapentin (90.0 % - 110.0 % of the labelled content) using the USP non-aqueous titration method. All the samples met with the BP specification for the disintegration time of hard capsule.
Although some patient-specific factors may also contribute to this health issue, however, conducting post-marketing assessment of the quality of these medicines to ascertain whether they meet pharmacopoeia standards or not, represents a huge step in determining the extent to which the quality of essential medicines is implicated in contributing to health challenges in the country, and in the world at large.
