Estudios de estabilidad predictiva acelerada y caracterización farmacotécnica de fórmulas magistrales y preparados oficinales
Loading...
Download
Official URL
Full text at PDC
Publication date
2024
Defense date
19/01/2024
Authors
Editors
Journal Title
Journal ISSN
Volume Title
Publisher
Universidad Complutense de Madrid
Citations
Exportar
Citation
Abstract
Los elevados tiempos de análisis de estabilidad de medicamentos y la estrecha ventana de caducidad de preparados oficinales y fórmulas magistrales, han supuesto un reto para la industria farmacéutica y la farmacia comunitaria a lo largo de los años. Según el Consejo Internacional para la Armonización de los Requisitos Técnicos para Productos Farmacéuticos de Uso Humano (ICH) junto con la Organización Mundial de la Salud (OMS), se han proporcionado un conjunto de directrices (ICH Q1A-F, Q3A-B, Q5C, Q6A-B) con la intención de unificar los estándares para la Unión Europea, Japón y los Estados Unidos. Los estudios de estabilidad de una sustancia farmacológica deben incluir condiciones de almacenamiento que evalúen diferentes aspectos de temperatura y humedad durante un mínimo de 12 meses. Por este motivo, han surgido como un enfoque novedoso para predecir la estabilidad a largo plazo de forma más eficiente, los estudios de Estabilidad Predictiva Acelerada (APS) que son llevados a cabo durante un período de 3-4 semanas combinando temperaturas extremas (> 40 °C) y condiciones de humedad relativa (HR > 50 %)...
The long drug stability analysis times and the narrow expiry date of official preparations and compounding formulations have been a challenge for the pharmaceutical industry and community pharmacies over the years.According to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) together with the World Health Organization (WHO), a set of guidelines have been provided (ICH Q1A-F, Q3A-B, Q5C, Q6A-B) with the intention of unifying standards for the European Union, Japan and the United States.Stability studies of a drug substance must include storage conditions that evaluate different aspects of temperature and humidity for a minimum of 12 months. For this reason, Accelerated Predictive Stability (APS) studies have emerged as a novel approach to predict long-term stability more efficiently, which are carried out over a period of 3-4 weeks combining extreme temperatures (> 40 °C) and relative humidity conditions (RH > 50%).Currently, industrially fabricated medicines have a well-defined expiry date supported by rigorous studies before they are approved to be commercialised. However, the expiry date of topical, oral and parenteral formulations prepared in both hospital and community pharmacies of compounding formulations and tends to be shorter, especially when data demonstrating a longer stability period are not available...
The long drug stability analysis times and the narrow expiry date of official preparations and compounding formulations have been a challenge for the pharmaceutical industry and community pharmacies over the years.According to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) together with the World Health Organization (WHO), a set of guidelines have been provided (ICH Q1A-F, Q3A-B, Q5C, Q6A-B) with the intention of unifying standards for the European Union, Japan and the United States.Stability studies of a drug substance must include storage conditions that evaluate different aspects of temperature and humidity for a minimum of 12 months. For this reason, Accelerated Predictive Stability (APS) studies have emerged as a novel approach to predict long-term stability more efficiently, which are carried out over a period of 3-4 weeks combining extreme temperatures (> 40 °C) and relative humidity conditions (RH > 50%).Currently, industrially fabricated medicines have a well-defined expiry date supported by rigorous studies before they are approved to be commercialised. However, the expiry date of topical, oral and parenteral formulations prepared in both hospital and community pharmacies of compounding formulations and tends to be shorter, especially when data demonstrating a longer stability period are not available...
Description
Tesis inédita de la Universidad Complutense de Madrid, Facultad de Farmacia, leída el 19/01/2024