Publication: Estudio comparativo de estabilidad fisicoquímica y disponibilidad in vitro de ketoprofeno en formas tópicas desarrolladas con nuevos excipientes
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2002
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Universidad Complutense de Madrid, Servicio de Publicaciones
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Abstract
Uno de los problemas críticos que nos presenta la formulación de antiinflamatorios no esteroideos en uso tópico, es el efecto perjudicial del almacenamiento por la interacción antiinflamatoria no esteroideo-excipiente y demás adyuvantes en medio acuoso, lo cual influye negativamente sobre la estabilidad. Basándose en un criterio riguroso de elección de la formulación capaz de conseguir el efecto terapéutico deseado, se prepararon diversas formas tópicas donde se incorporó ketoprofeno y estas fueron sometidas a un protocolo de estabilidad que monitorizaba la evolución de parámetros de calidad e incluía la evaluación de la disponibilidad del principio activo incorporado en función del tiempo y de la temperatura de almacenamiento. Asimismo, se realizó el desarrollo de métodos analíticos validados y apropiados para la evaluación de nuevas formulaciones tópicas y para el control de calidad de las ya existentes comercializadas. Estos métodos cumplieron con las condiciones de fiabilidad y practicabilidad, proporcionando además una información fundamental sobre las variables fisicoquímicas y la disponibilidad del principio activo formulado. El objeto práctico de este trabajo, consistió en estudiar comparativamente formulaciones comerciales acreditadas frente a formulaciones elaboradas con excipientes modernos, que bien como gel, pomada-gel o pomada propiamente dicha nos reporten unos efectos de disponibilidad similares, extrayendo consecuencias tecnológicas que favorezcan el balance material del proceso y que sean fácilmente reproducibles desde el punto de vista industrial
One of the critical problems presented by the formulation of non-steroidal anti-inflammatory drugs in topical use is the detrimental effect of storage due to the non-steroidal anti-inflammatory drug-excipient and other adjuvants in aqueous medium, which negatively influences stability. Based on a rigorous selection criteria of the formulation capable of achieving the desired therapeutic effect, various topical forms were prepared where ketoprofen was incorporated and these were subjected to a stability protocol that monitored the evolution of quality parameters and included the evaluation of the Availability of the active ingredient incorporated as a function of time and storage temperature. Likewise, the development of validated and appropriate analytical methods for the evaluation of new topical formulations and for the quality control of the already commercialized ones was carried out. These methods met the conditions of reliability and practicability, also providing fundamental information on the physicochemical variables and the availability of the formulated active ingredient. The practical objective of this work consisted of comparatively studying accredited commercial formulations compared to formulations made with modern excipients, which, as a gel, ointment-gel or ointment itself, report similar availability effects, extracting technological consequences that favor material balance. of the process and that are easily reproducible from the industrial point of view
One of the critical problems presented by the formulation of non-steroidal anti-inflammatory drugs in topical use is the detrimental effect of storage due to the non-steroidal anti-inflammatory drug-excipient and other adjuvants in aqueous medium, which negatively influences stability. Based on a rigorous selection criteria of the formulation capable of achieving the desired therapeutic effect, various topical forms were prepared where ketoprofen was incorporated and these were subjected to a stability protocol that monitored the evolution of quality parameters and included the evaluation of the Availability of the active ingredient incorporated as a function of time and storage temperature. Likewise, the development of validated and appropriate analytical methods for the evaluation of new topical formulations and for the quality control of the already commercialized ones was carried out. These methods met the conditions of reliability and practicability, also providing fundamental information on the physicochemical variables and the availability of the formulated active ingredient. The practical objective of this work consisted of comparatively studying accredited commercial formulations compared to formulations made with modern excipients, which, as a gel, ointment-gel or ointment itself, report similar availability effects, extracting technological consequences that favor material balance. of the process and that are easily reproducible from the industrial point of view
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Tesis de la Universidad Complutense de Madrid, Facultad de Farmacia, Departamento de Farmacia y Tecnología Farmacéutica I, leída el 07-03-1995