Elaboración y control de calidad de una crema para el tratamiento de escabiosis

Abstract

The aim of this study was the elaboration and quality control of the magistral formulation, this is a cream for the treatment of scabies, to this purpose a Standard Operating Procedure (SOP) was first implemented and then the cream was elaborated. Four formulations were established and then the most appropriate formula was selected based on quality and safety criteria. In order to elaborate the standardized operating procedure, SOPs previously carried out in the Sciences College of the ESPOCH were taken as a reference, by implementing this SOP, the reproducibility of the magistral formulation for the treatment of scabies can be guaranteed. The four creams were formulated with different concentrations of active ingredients: Permethrin 5% in amounts of 0.5g 2g, 5g, 5g respectively and together with Hydrocortisone 1%, Gentamicin 0.1%, Allantoin and Vitamin E, it was analyzed whether the concentration of active ingredients and their excipients influenced the stability of the formulation in the short term. At the end, microbiological analysis was carried out, as well as physical-chemical tests such as extensibility, viscosity, pH, emulsion sign, and organoleptic properties such as color, odor, appearance. To conclude, a preliminary stability analysis was performed to the formulations for 30 days, the formulations were exposed to extreme conditions of temperature 25, 5, -10 degrees Celsius respectively; then, its organoleptic, physical and microbiological properties were studied, obtaining as a result a semisolid cream of easy application, which complies with the quality and safety standards and can be distributed by the pharmacy department, it is important that in the future long-term stability studies of the formulation are performed for better results.