Perfiles de disolución de tabletas de carbamazepina 200 mg multifuente y referente comercializados en Perú

• Autores: Paredes Llico, Lesdy Brhiggite, Polo Gomez, Ayde Marisol
• Formato: tesis de grado
• Fecha de Publicación: 2018
• Institución: Universidad Nacional de Trujillo
• Repositorio: UNITRU-Tesis
• Lenguaje: español
• OAI Identifier: oai:dspace.unitru.edu.pe:20.500.14414/10700
• Enlace del recurso: https://hdl.handle.net/20.500.14414/10700
• Nivel de acceso: acceso abierto
• Materia: perfil de disolución, tegretol, carbamazepina

The objective of the present investigation was to compare the dissolution profiles between the formulations of carbamazepine multifuente of 200mg and TEGRETOL 200 mg as a reference. In the dissolution test, 12 tablets of each formulation were used for the media: 0.1 N HCl pH 1.2; Buffer acetate pH 4.5 and Buffer phosphate pH 6.8; using the dissolution equipment (pallets), 75 rpm, volume 900 mL, temperature 37 ºC +/- 0.5 ºC. The concentrations were determined from standard curves previously elaborated. The percentage dissolution data were analyzed using the independent model method to compare the dissolution profiles of the products by calculating the similarity factor (ƒ2). It was observed that ƒ2 is between the 50-100 range, a specification established by the Food and Drug Administration (FDA), to indicate similarity between two profiles. The values of ƒ2 found for multifuente A were: 82,3880; 71,3141 and 93,6519 likewise for multifuente B were: 83,4759; 77,8066 and 87,7343 worked at pH 1,2; 4,5 and 6,8 respectively. To evaluate the kinetics of drug release, 5 mathematical models were applied (zero order equation, order one, cubic root, Higuchi and Weibull). It was identified that the best dissolution kinetics of carbamazepine, in 200mg multi-source and reference tablets, was of order one at pH 1,2 and the Weibull function at pH 4,5 and at pH 6,8. The results showed that there is no significant difference between the products, determining the similarity between the dissolution profiles of carbamazepine of 200mg, between the multi-source A, multi-source B and the reference