Abstract

Introduction: Clonazepam belongs to a group of medications called benzodiazepines. It is known that these drugs act in the brain through GABA. It is an anticonvulsant used for various types of attacks, including myotonic or atonic attacks, photosensitive epilepsy, and absence attacks, although tolerance may develop. It is rarely effective in generalized or partial tonic-clonic attacks. Method: the present study was carried out to analyze the comparative parameters of in vitro quality control by evaluating the variation in weight, friability; hardness, disintegration time and dissolution profile between the innovative drug (Rivotril (R)) and multi-source drugs that are marketed in the Peruvian market. To carry out the comparative study; Clonazepam 0.5 mg multi-source tablets were selected from different laboratories comparing them with the innovative medicine and the physicochemical and biopharmaceutical characteristics were evaluated. Pharmacopoeial trials were evaluated as established in USP 42. Results: the results made it possible to establish that all the brands analyzed met the acceptance criteria established in the pharmacopoeia for each active ingredient and that their biopharmaceutical behavior was very similar for both types of molecule. Conclusions: it was established that all Clonazepam 0.5 mg multisource tablets included in this research are bioequivalent with the chosen innovative brand and, therefore, allow the determination of biopharmaceutical equivalence as a support element in decision-making to be proposed to the scientific community purchase in the pharmaceutical service