Comparision of the quality of Iranian and imported brands of sertraline HCl tablets in the Iranian market

Abstract

Introduction: In this post-marketing surveillance study, the physicochemical properties of Iranian and imported brands of SER was investigated according to the tests recommended by USP 37 pharmacopeia for tablet dosage forms. Aims: In this study, we aimed to assess the quality of Iranian and innovator Sertraline tablets (SER) in the market based on in-vitro characterization by the United States Pharmacopeia (USP) 37 to answer the question asking that if we could decrease therapy costs via providing adequate evidences confirming the similar physicochemical quality of Iranian and imported SER products. Method and materials: Seven SER products including one imported and 6 Iranian brands of SER tablets were purchased from local pharmacy stores in Tabriz. Quantification of the amount of active ingredient in assay, uniformity of dosage units and dissolution tests was performed using a HPLC method recommended by Pharmacopoeia monograph and other physicochemical properties were assessed in accordance with the recommendations of USP 37. Results and Discussion: The average weight of all products was acceptable and below 5% variance. All products hardness (≤ 10 Kg) and friability (1% ≥) were acceptable except one products friability (15.8%). All products disintegration time was acceptable. The amount of active ingredient in all products was in the acceptable range (%90 - %110). All products content uniformity test results were acceptable (AV ˂ 15) and all products dissolution results were acceptable at first stage. Due to coating issues of the formulation of product F1, assay and content uniformity test was not performed for this product. Conclusion: The results of this study showed the acceptable quality of most Iranian brands of SER compared to the imported brand. However, it is necessary to improve the quality of some pharmaceuticals in Iran.