Diferencia entre la estabilidad a largo plazo de la solución oftálmica de Timolol y Dorzolamida, Marzo 2019 a Abril 2022
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Date
2024
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Universidad Nacional de Trujillo
Abstract
El Glaucoma es una enfermedad que afecta a gran parte de la población y representa a su vez la principal razón de pérdida total de la visión. Como parte del tratamiento de primera línea de esta patología se emplean dos fármacos de rápida acción, Dorzolamida y Timolol. Este informe tiene por objetivo comparar los resultados del estudio de estabilidad de una solución oftálmica de Timolol y de una solución oftálmica de Dorzolamida cuya duración fue de 36 meses con un almacenamiento a 30°C ± 2°C y una humedad relativa de 35% ± 5%. Las soluciones fueron analizadas en las etapas de 6, 12, 24 y 36 meses. Se analizó aspecto, volumen, pH y valoración la cual se realizó mediante un análisis de cromatografía líquida de alta eficiencia (HPLC). La solución oftálmica de Dorzolamida empezó el estudio con una descripción de solución incolora, transparente, ligeramente viscosa. Libre de partículas visibles; pH de 5,62; volumen 5,2 mL y valoración 100,5%. Al finalizar el estudio solo hubo variación de pH (0,06); volumen (0,1 mL) y la valoración finalizó con un valor de 99,5% teniendo una reducción de 1%. La solución oftálmica de Timolol empezó el estudio con una descripción de solución incolora, transparente. Libre de partículas visibles; pH de 6,63; volumen 5,2 mL y valoración de 102,2%. Al finalizar el estudio hubo variación de pH (0,1); volumen (0,2 mL) y la valoración finalizó con un valor de 98,2% teniendo una reducción de 4%
ABSTRACT Glaucoma is a disease that affects a large part of the population and represents the main reason for total vision loss. As part of the first-line treatment of this pathology, two fast-acting drugs are used, Dorzolamide and Timolol. This report aims to compare the results of the stability study of a Timolol ophthalmic solution and a Dorzolamide ophthalmic solution whose duration was 36 months with storage at 30°C ± 2°C and a relative humidity of 35% ± 5%. The solutions were analyzed in the stages of 6, 12, 24 and 36 months. Appearance, volume, pH and titration were analyzed, which was carried out using high- efficiency liquid chromatography (HPLC) analysis. Dorzolamide ophthalmic solution began the study with a description of a colorless, transparent, slightly viscous solution. Free of visible particles; pH of 5.62; volume 5.2 mL and titration 100.5%. At the end of the study there was only a variation in pH (0.06); volume (0.1 mL) and the assessment ended with a value of 99.5%, having a reduction of 1%. Timolol ophthalmic solution began the study with a description of a colorless, clear solution. Free of visible particles; pH 6.63; volume 5.2 mL and titration of 102.2%. At the end of the study there was a variation in pH (0.1); volume (0.2 mL) and the assessment ended with a value of 98.2%, having a reduction of 4%.
ABSTRACT Glaucoma is a disease that affects a large part of the population and represents the main reason for total vision loss. As part of the first-line treatment of this pathology, two fast-acting drugs are used, Dorzolamide and Timolol. This report aims to compare the results of the stability study of a Timolol ophthalmic solution and a Dorzolamide ophthalmic solution whose duration was 36 months with storage at 30°C ± 2°C and a relative humidity of 35% ± 5%. The solutions were analyzed in the stages of 6, 12, 24 and 36 months. Appearance, volume, pH and titration were analyzed, which was carried out using high- efficiency liquid chromatography (HPLC) analysis. Dorzolamide ophthalmic solution began the study with a description of a colorless, transparent, slightly viscous solution. Free of visible particles; pH of 5.62; volume 5.2 mL and titration 100.5%. At the end of the study there was only a variation in pH (0.06); volume (0.1 mL) and the assessment ended with a value of 99.5%, having a reduction of 1%. Timolol ophthalmic solution began the study with a description of a colorless, clear solution. Free of visible particles; pH 6.63; volume 5.2 mL and titration of 102.2%. At the end of the study there was a variation in pH (0.1); volume (0.2 mL) and the assessment ended with a value of 98.2%, having a reduction of 4%.
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Soluciónes oftálmicas