Physicochemical equivalence of some brands of Nifedipine retard tablets available in Nigeria

Abstract

This research evaluated the physicochemical equivalence of some samples of Nifedipine 20 mg Retard Tablets available in Nigeria. Seven samples were randomly procured from various zones of the country and standard protocols applied to evaluate their tablet weight uniformity, dimensions, hardness, disintegration time, content of active Ingredient and in vitro drug release profile. Results showed that all the samples tested were chemically, but not physically equivalent. Although within each sample,
compendial requirement for tablet weight uniformity was met, there were significant differences in the mean tablet weights, diameters and thickness of the samples studied (p < 0.05). Furthermore, tablet hardness and disintegration time varied much among the samples, but not within each sample. All the samples met the compendial requirement for content of active ingredient and released more than 80% of the drug within 4 h. It is therefore pertinent that manufacturers of this product be advised to
formulate tablets that are equivalent in size, as different tablet sizes may impart negative psychological effects on clinicians and their patients when the need arises for switch over from one product to another, since the availability of particular products is never guaranteed at all times in Nigeria, a largely import dependent nation.