Calidad fisicoquímica de las tabletas de glibenclamida 5 mg, comercializadas en el Perú
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Date
2017
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Universidad Nacional de Trujillo
Abstract
El objetivo del estudio fue determinar la calidad fisicoquímica de las tabletas de glibenclamida 5 mg, comercializadas en el Perú. Se evaluó la solubilidad de glibenclamida en diferentes soluciones. Posteriormente se realizó el perfil de disolución de las tabletas de glibenclamida con el medio de disolución fosfato pH 7,5 a la par se les determinó: dimensiones, peso promedio, dureza y características organolépticas. En cuanto al perfil de disolución, al comparar los productos multifuente vs el producto de referencia, el % de disolución a los 45 min aún no se encontraba al 85%, posteriormente se calculó el factor de similitud (f2) obteniéndose para M1 (44%), M2 (46%), M3(54%), M4 (79%) y M5 (37%). La prueba calorimetría diferencia de barrido (DSC) nos mostró claramente tres picos endotérmicos para las muestras analizadas correspondientes al principio activo glibenclamida y los excipientes (estearato de magnesio y lactosa).
Conclusiones: Las muestras analizadas cumplieron con las pruebas de calidad: dimensiones, peso promedio, dureza y características organolépticas pero para el perfil de disolución sólo M3 y M4 presentaron similar solubilidad.
The objective of the study was to determine the physicochemical quality of glibenclamide 5 mg tablets, marketed in Peru. The solubility of glibenclamide was evaluated in different solutions. Subsequently, the dissolution profile of the glibenclamide tablets with the pH 7.5 phosphate dissolution medium was determined at the same time: dimensions, average weight, hardness and organoleptic characteristics were determined. As for the dissolution profile, when comparing the multi-source products vs. the reference product, the% solution at 45 min was not yet at 85%, then the similarity factor (f2) was calculated for M1 (44% ), M2 (46%), M3 (54%), M4 (79%) and M5 (37%). The differential scanning calorimetry test (DSC) clearly showed us three endothermic peaks for the analyzed samples corresponding to the active principle glibenclamide and the excipients (magnesium stearate and lactose). Conclusions: The analyzed samples met the quality tests: dimensions, average weight, hardness and organoleptic characteristics but for the dissolution profile only M3 and M4 presented similar solubility.
The objective of the study was to determine the physicochemical quality of glibenclamide 5 mg tablets, marketed in Peru. The solubility of glibenclamide was evaluated in different solutions. Subsequently, the dissolution profile of the glibenclamide tablets with the pH 7.5 phosphate dissolution medium was determined at the same time: dimensions, average weight, hardness and organoleptic characteristics were determined. As for the dissolution profile, when comparing the multi-source products vs. the reference product, the% solution at 45 min was not yet at 85%, then the similarity factor (f2) was calculated for M1 (44% ), M2 (46%), M3 (54%), M4 (79%) and M5 (37%). The differential scanning calorimetry test (DSC) clearly showed us three endothermic peaks for the analyzed samples corresponding to the active principle glibenclamide and the excipients (magnesium stearate and lactose). Conclusions: The analyzed samples met the quality tests: dimensions, average weight, hardness and organoleptic characteristics but for the dissolution profile only M3 and M4 presented similar solubility.
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Keywords
Glibenclamida, Pruebas de calidad, Disolución, Factor de similitud calorimetría diferencial de barrido