In vitro Comparative Study of Branded and Generic Marketed Pantoprazole Sodium Tablets
Abstract
Various doses are available in the market, including generic and branded formulations, with costs varying based on type and product quality.Quality assessment follows Indian Pharmacopeia (IP) criteria.Both generic and branded pantoprazole variants undergo bioequivalence studies, involving tests for weight variation, size, hardness, and friability, disintegration, and dissolution parameters.The study revealed that the branded formulation adheres to rigorous validation standards, while the generic dosage conforms to minimum criteria.In 0.1N HCl, none of the products exhibited disintegration, cracks, or swelling after one hour.However, all products disintegrated in phosphate buffer as per IP specifications.Most medications achieved 85% solubility within 60 minutes, meeting pharmacopeial requirements.Nevertheless, the dissolution rates of certain generic medications varied significantly at 60 and 120 minutes.In conclusion, both branded and generic pantoprazole sodium tablets met the in vitro quality control testing requirements outlined in the official monograph.
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