Reformulación y estudio de estabilidad acelerada de Acetilcisteína 100 mg/5 mL x 120 mL Jarabe, en un Laboratorio Farmacéutico Nacional. Lima, 2019
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Date
2021
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Publisher
Universidad Nacional de Trujillo
Abstract
El presente informe de prácticas pre-profesionales tuvo como finalidad determinar la estabilidad acelerada de tres lotes de Acetilcisteína 100 mg/5 mL x 120 mL Jarabe, ingresados por reformulación a las cabinas de estabilidad con las condiciones ambientales que corresponden a la zona climática IV a, dónde se ubica nuestro país (Perú; temperatura de 40 °C ± 2 °C y una Humedad Relativa de 75% ± 5% para este tipo de estudio). El estudio se ejecutó en un laboratorio farmacéutico nacional, realizándose los ensayos especificados en la Técnica analítica, propia del laboratorio a los 0, 3 y 6 meses del estudio, con la finalidad de obtener el Registro Sanitario para su comercialización. Concluyendo que al finalizar el tiempo (6 meses) los tres lotes reformulados, siendo la cantidad mínima de lotes para realizar un estudio de estabilidad a un medicamento, cumplían con los ensayos de descripción organoléptica, volumen de entrega, pH y dosaje (% de Acetilcisteina entre 90% - 110%).
ABSTRACT The purpose of this pre-professional practice report was to determine the accelerated stability of three batches of Acetylcysteine 100 mg / 5 mL x 120 mL Syrup, entered by reformulation to the stability cabinets with the environmental conditions that correspond to climatic zone IV a, where Our country is located (Peru; temperature of 40 ° C ± 2 ° C and a Relative Humidity of 75% ± 5% for this type of study). The study was carried out in a national pharmaceutical laboratory, carrying out the tests specified in the analytical technique, typical of the laboratory at 0, 3 and 6 months of the study, in order to obtain the Sanitary Registry for its commercialization. Concluding that at the end of the time (6 months) the three reformulated batches, being the minimum quantity of batches to carry out a study of stability to a drug, complied with the tests of organoleptic description, delivery volume, pH and dosage (% of Acetylcysteine between 90 % - 110%).
ABSTRACT The purpose of this pre-professional practice report was to determine the accelerated stability of three batches of Acetylcysteine 100 mg / 5 mL x 120 mL Syrup, entered by reformulation to the stability cabinets with the environmental conditions that correspond to climatic zone IV a, where Our country is located (Peru; temperature of 40 ° C ± 2 ° C and a Relative Humidity of 75% ± 5% for this type of study). The study was carried out in a national pharmaceutical laboratory, carrying out the tests specified in the analytical technique, typical of the laboratory at 0, 3 and 6 months of the study, in order to obtain the Sanitary Registry for its commercialization. Concluding that at the end of the time (6 months) the three reformulated batches, being the minimum quantity of batches to carry out a study of stability to a drug, complied with the tests of organoleptic description, delivery volume, pH and dosage (% of Acetylcysteine between 90 % - 110%).
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Keywords
Acetilcisteína, estabilidad acelerada, cabina de estabilidad