Equivalencia farmacéutica in vitro de Carvedilol (12,5 mg) frente a Carvedilol® de Sandoz

Abstract

The study aimed to determine the in vitro pharmaceutical equivalence of carvedilol (12,5 mg) against Sandoz carvedilol, the methodology applied was experimental, quantitative, analytical design, comparative, and quality control in solid dosage forms. As a result, it was obtained that the tablets were subjected to organoleptic, mechanical, geometric, dosage, and biopharmaceutical tests based on the United States Pharmacopoeia USP 42-NF37, however, the independent model to compare the dissolution profiles through the factors of difference (fi) and similarity (fz) 3 of the 4 pharmaceutical houses meet the two parameters against the SZO laboratory, on the other hand, in the pharmaceutical house M the difference factor (fi) is > 1 5 and similarity (f:) < 50. According to USP 42, all tablets meet the reference values in the tests: a) geometric characteristics, b) disintegration time not exceeding 30 minutes, c) Uniformity of dosage No pharmaceutical house exceeds 15%, d) friability values are less than 1%. Within the kinetic method, the model that best fits is Korsmeyer Peppas, the study presents significant statistical assessments where they do not present a deviation greater than 5% according to USP 42, finally, it was concluded that the release of the active ingredient ranges from 90 to 110% so the study allows knowing whether or not a generic drug is similar to the brand based on different tests that guarantee the quality of the drugs, so it is recommended to perform pharmaceutical equivalence studies to minimize therapeutic failures, evaluate the safety and efficacy of drugs.