Estudio comparativo de la calidad biofarmacéutica de Clonazepam 0,5 mg comercializados en el mercado peruano

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®) 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 multi-source 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 serviceIntroduction: 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®) 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 multi-source 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 serviceIntroducción: el Clonazepam pertenece a un grupo de medicamentos llamados benzodiazepinas. Se sabe que estos medicamentos actúan en el cerebro a través del GABA. Es un anticonvulsivante utilizado para varios tipos de ataques, incluyendo ataques miotónicos o atónicos, epilepsia fotosensible, y crisis de ausencia, aunque puede desarrollarse tolerancia. Raras veces es eficaz en ataques tónico-clónicos generalizados o parciales. Método: el presente estudio se realizó para analizar los parámetros comparativos de control de calidad in vitro mediante la evaluación de la variación de peso, friabilidad, dureza, tiempo de desintegración y perfil de disolución entre el medicamento innovador (Rivotril®) y medicamentos multifuente que son comercializados en el mercado peruano. Para realizar el estudio comparativo, se seleccionaron tabletas de Clonazepam 0,5 mg multifuente de diferentes laboratorios comparándolos con el medicamento innovador y se evaluaron las características fisicoquímicas y biofarmacéuticas. Los ensayos farmacopeicos se evaluaron según lo establecido en la USP 42. Resultados: los resultados permitieron establecer que todas las marcas analizadas cumplieron los criterios de aceptación establecidos en la farmacopea para cada principio activo y que el comportamiento biofarmacéutico de ellas era muy similar para ambos tipos de molécula. Conclusiones: se estableció que todas las tabletas multifuente de Clonazepam 0,5 mg incluidos en esta investigación son bioequivalentes con la marca innovadora elegida y, por lo que permite proponer a la comunidad científica la determinación de la equivalencia biofarmacéutica como elemento de apoyo en la toma de decisiones de compra en el servicio farmacéutico.