Estudio comparativo de control de calidad de Cetirizina 10mg tableta genérica frente al medicamento de marca por un laboratorio farmacéutico de Ecuador
Fecha
2023
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Universidad de Guayaquil. Facultad de Ciencias Químicas
Resumen
Hoy en día los síntomas asociados a las alergias han aumentado, haciendo común el uso de los antihistamínicos, siendo parte de este tipo de medicamentos las tabletas de Cetirizina, por lo que se ha incrementado su fabricación en diversas casas farmacéuticas. El objetivo del estudio es comparar los parámetros de calidad de 3 lotes diferentes de Cetirizina 10 mg genéricas frente al medicamento de marca por un laboratorio farmacéutico de Ecuador. En la metodología se utiliza una investigación descriptiva, comparativa y de campo, con un enfoque cuantitativo dando como referencia los análisis del laboratorio. En el cual se, analizaron los parámetros físicos, como son: el aspecto, diámetro, espesor, peso promedio, dureza, desintegración, friabilidad, y los parámetros químicos: valoración del principio activo, ensayos de disolución y uniformidad de contenido. En los resultados obtenidos se muestran pocas variaciones entre los valores, como lo es el peso promedio (149.8 mg), dureza (6,39 KgF), desintegración (1´52´´) de las tabletas innovador con las genéricas y entre los lotes de tabletas de Cetirizina de 10 mg donde todos los valores demostraron estar dentro de los parámetros de calidad. En conclusión, el estudio realizado muestra que tanto el medicamento genérico como el comercial se encuentra dentro de los límites establecidos por la USP 42-NF37 demostrando seguridad para los consumidores.
Today the symptoms associated with allergies have increased, making the use of antihistamines common, with Cetirizine tablets being part of this type of medication, which is why their manufacture has increased in various pharmaceutical houses. The objective is to comparatively study the quality parameters of 3 different batches of generic Cetirizine 10 mg compared to the brand drug by a pharmaceutical laboratory in Ecuador. As a methodology, a descriptive, experimental and comparative research is used, with a quantitative approach using laboratory analyzes as a reference. For the study, the physical parameters were analyzed, such as: appearance, diameter, thickness, average weight, hardness, disintegration, friability, and chemical parameters: valuation of the active principle, dissolution tests and content uniformity. The results obtained show few variations between the values, such as the average weight (149.8 mg), hardness (6.39 KgF), disintegration (1'52'') of the innovative tablets with the generic ones and between the batches. of 10 mg cetirizine tablets where all values were found to be within quality parameters. In conclusion, the study carried out shows that both the generic and the commercial medicine are within the limits established by USP 42-NF37, demonstrating safety for consumers.
Today the symptoms associated with allergies have increased, making the use of antihistamines common, with Cetirizine tablets being part of this type of medication, which is why their manufacture has increased in various pharmaceutical houses. The objective is to comparatively study the quality parameters of 3 different batches of generic Cetirizine 10 mg compared to the brand drug by a pharmaceutical laboratory in Ecuador. As a methodology, a descriptive, experimental and comparative research is used, with a quantitative approach using laboratory analyzes as a reference. For the study, the physical parameters were analyzed, such as: appearance, diameter, thickness, average weight, hardness, disintegration, friability, and chemical parameters: valuation of the active principle, dissolution tests and content uniformity. The results obtained show few variations between the values, such as the average weight (149.8 mg), hardness (6.39 KgF), disintegration (1'52'') of the innovative tablets with the generic ones and between the batches. of 10 mg cetirizine tablets where all values were found to be within quality parameters. In conclusion, the study carried out shows that both the generic and the commercial medicine are within the limits established by USP 42-NF37, demonstrating safety for consumers.
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CETIRIZINA, MEDICAMENTO GENÉRICO, MEDICAMENTO INNOVADOR, CONTROL DE CALIDAD, ANTIHISTAMÍNICO