Diseño y Formulación de Vitamina C Intravenosa de 25g/50mL
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Date
2022
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Publisher
Universidad Nacional de Trujillo
Abstract
El presente trabajo tuvo como objetivo presentar el desarrollo y formulación de vitamina C inyectable – intravenosa de alta concentración como tratamiento adjunto para Covid-19 para pacientes que se encuentran en UCI, realizándose en un laboratorio – recetario magistral de categoría 3D en Santiago de Chile, año 2021. Se partió con la revisión bibliográfica de posibles formulaciones de vitamina C inyectable – intravenosa teniendo como criterios de selección la accesibilidad de las materias primas y dificultad de la formulación propiamente dicha. Finalmente se optó por la referencia del IJPC (International Journal of Pharmaceutical Compounding), se procedió a realizar un pequeño piloto para tener en cuenta posibles ajustes en la formulación debido a las características propias de las materias primas a utilizar. Posteriormente, se procedió a elaborar la planilla de producción de la solución y POE (Procedimiento Operativo Estandarizado) correspondiente ajustando a volúmenes mayores de producción. Por último, se enviaron muestras a controles de calidad a un laboratorio externo por motivos de aseguramiento de calidad para su posterior comercialización. Se concluye que la calidad de los productos cumple con lo estipulado y podría ser fabricado para su uso respectivo.
ABSTRACT The objective of this report was to show the formulation and development of injectable- intravenous of high dose Vitamin C as adjunct treatment for Covid-19 for patients in ICU, which was done at a compounding pharmacy, categorized in 3D in Santiago of Chile, year 2021. It began with the bibliographic review of the possible formulations of injectable- intravenous vitamin C having as selection criteria the accessibility of the excipients and difficulty of the formulation. Finally we took the reference from IJPC (International Journal of Pharmaceutical Compounding), a pilot was done for adjustments of the formulation in reason of the excipients properties. Subsequently, production sheet and SOP (Standard Operating Procedure) were made for bigger volume. At last, samples were sent to an external laboratorie for reasons of quality assurance for subsequent marketing. It is concluded that the quality of the products meets the corresponding quality and could be manufactured for their respective use.
ABSTRACT The objective of this report was to show the formulation and development of injectable- intravenous of high dose Vitamin C as adjunct treatment for Covid-19 for patients in ICU, which was done at a compounding pharmacy, categorized in 3D in Santiago of Chile, year 2021. It began with the bibliographic review of the possible formulations of injectable- intravenous vitamin C having as selection criteria the accessibility of the excipients and difficulty of the formulation. Finally we took the reference from IJPC (International Journal of Pharmaceutical Compounding), a pilot was done for adjustments of the formulation in reason of the excipients properties. Subsequently, production sheet and SOP (Standard Operating Procedure) were made for bigger volume. At last, samples were sent to an external laboratorie for reasons of quality assurance for subsequent marketing. It is concluded that the quality of the products meets the corresponding quality and could be manufactured for their respective use.
Description
Keywords
SARS-CoV-2, Tratamiento, Vitamina C, Inmuno-modulador, Antioxidante.