Estudio comparativo de los parámetros fisicoquímicos de cefalexina 500 mg cápsulas genéricas de dos laboratorios farmacéuticos ecuatorianos frente al medicamento innovador
Fecha
2020
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Universidad de Guayaquil. Facultad de Ciencias Químicas
Resumen
Actualmente el mercado farmacéutico produce una gran variedad de medicamentos, tanto genéricos como innovadores, los medicamentos genéricos son comercializados una vez que la patente del innovador se expira y gracias a ello son los más solicitados por la ciudadanía ecuatoriana. Debido a factores como el bajo costo y fácil disponibilidad, el medicamento genérico se ha incrementado con el paso del tiempo, a pesar de contener el mismo principio activo en igual concentración que el innovador es fundamental verificar el cumplimiento de los parámetros de calidad según la normativa oficial para así garantizar su eficacia y seguridad. La presente investigación se realiza con el objetivo de evaluar los parámetros de calidad en cápsulas Cefalexina de 500 mg de dos laboratorios farmacéuticos ecuatorianos frente al innovador. La metodología usada corresponde a la USP 41; el método fue descriptivo, experimental y comparativo basado a los análisis de los laboratorios y los ensayos respectivos para control de calidad se realizaron por HPLC, espectrofotometría UV/VIS, Desintegrador. Los resultados obtenidos para Laboratorios G-002, G-003, frente innovador I-001 respectivamente, son los siguientes: Tiempo de desintegración: 2´ 38”; 2´ 36”; 2´ 39”. Valoración por HPLC: 100,22%; 98,33%, 95,66%. Ensayo de disolución 105,90%; 105,91%; 105,21%.
Uniformidad de Dosis por Variación de peso: L1= 9,55%; L1= 8,93%; L1= 8,93%. Se concluye que los medicamentos genéricos estudiados cumplen los parámetros de control de calidad frente al innovador, según las especificaciones técnicas de la USP correspondiente y presentan mínimas variaciones entre sus análisis.
Actually, the pharmaceutical market produces a great variety of medicines, both generic and innovative, the generic medicines are commercialized once the innovator's patent expires and thanks to this, they are the most requested by the Ecuadorian population. Due to factors such as low cost and easy availability, the generic medicine has increased over time, despite containing the same active principle in the same concentration as the innovator, it is essential to verify compliance with quality parameters according to official regulations in order to guarantee its effectiveness and safety. The present investigation is carried out with the aim of evaluating the quality parameters in 500 mg Cephalexin capsules from two Ecuadorian pharmaceutical laboratories against the innovator. The methodology used corresponds to the USP 41; the method was descriptive, experimental, and comparative based on the analyses of the laboratory and its determinations were made by HPLC and UV/VIS spectrophotometry. The results obtained for Laboratories G-002, G-003, innovative front I-001 respectively, are as follows: Disintegration time: 2' 38"; 2' 36"; 2' 39". Valuation by HPLC: 100.22%; 98.33%, 95.66%. Dissolution test 105,90%; 105,91%; 105,21%. Uniformity of Dose by Weight Variation: L1= 9,55%; L1= 8,93%; L1= 8,93%. It is concluded that the studied generic medicines meet the quality control para meters against the innovator, according to the technical specifications of the corresponding USP and present minimum variations among their analyses.
Actually, the pharmaceutical market produces a great variety of medicines, both generic and innovative, the generic medicines are commercialized once the innovator's patent expires and thanks to this, they are the most requested by the Ecuadorian population. Due to factors such as low cost and easy availability, the generic medicine has increased over time, despite containing the same active principle in the same concentration as the innovator, it is essential to verify compliance with quality parameters according to official regulations in order to guarantee its effectiveness and safety. The present investigation is carried out with the aim of evaluating the quality parameters in 500 mg Cephalexin capsules from two Ecuadorian pharmaceutical laboratories against the innovator. The methodology used corresponds to the USP 41; the method was descriptive, experimental, and comparative based on the analyses of the laboratory and its determinations were made by HPLC and UV/VIS spectrophotometry. The results obtained for Laboratories G-002, G-003, innovative front I-001 respectively, are as follows: Disintegration time: 2' 38"; 2' 36"; 2' 39". Valuation by HPLC: 100.22%; 98.33%, 95.66%. Dissolution test 105,90%; 105,91%; 105,21%. Uniformity of Dose by Weight Variation: L1= 9,55%; L1= 8,93%; L1= 8,93%. It is concluded that the studied generic medicines meet the quality control para meters against the innovator, according to the technical specifications of the corresponding USP and present minimum variations among their analyses.
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CONTROL DE CALIDAD, CEFALEXINA, USP 41, MEDICAMENTO INNOVADOR, MEDICAMENTO GENÉRICO