Comparative In Vitro Quality Evaluation of Different Brands of Ibuprofen Tablets Marketed in Mekelle, Ethiopia
Keywords:
Ibuprofen tablets, quality evaluation, comparative study, dissolutionAbstract
Introduction: Circulation of poor-quality drug products in the international market mainly in developing countries like Ethiopia has been increased as a result of ineffective regulation. Therefore, post marketing quality evaluation of medicines has paramount importance to guarantee their safety and efficacy.
Objective: The main purpose of this study was to evaluate the quality of different brands of ibuprofen tablets marketed in Mekelle, Ethiopia.
Methods: The methods stated in the British Pharmacopeia (BP) were adopted for weight uniformity, hardness, friability, disintegration test and assay of drug content of ibuprofen tablets. Whereas, dissolution test was carried using the procedures stipulated in the United States Pharmacopeia (USP). To compare dissolution profiles of the investigated brands, statistical analysis of drug releases at different time points was performed using ORIGIN® and ANOVA was particularly used to compare the mean differences among the different brands.
Results: The identification tests confirmed that there was ibuprofen active ingredient in all of the investigated brands of ibuprofen tablets. The weight uniformity, friability, hardness, assay of drug content and dissolution test results were found within the acceptable pharmacopoeial specifications. Six brands fulfilled quality requirements for disintegration test while one brand failed to disintegrate as per the BP specification. However, there was a significant difference in mean weight, hardness, disintegration, dissolution and amount of drug content among the tested samples.
Conclusion: All of the investigated ibuprofen products fulfilled the required quality evaluation parameters as stipulated in the official pharmacopeias except one brand which failed the disintegration test. However, the in vitro dissolution profiles indicated that there could be a potential bio-in equivalence among the pharmaceutical products.
