Elaboración y control de calidad de una formula oficinal semisólida de urea usada para el tratamiento de xerosis

Abstract

The aim of the present study was to elaborate and carry out the quality control of a semi-solid official formula of urea used for the treatment of skin xerosis, the proposed research has a descriptive, explanatory and experimental design. The Standardized Operating Procedure (SOP) was carried out for the raw materials and the semi-solid official formula of urea, in this process, the formulations were compared with a commercial formula and the optimal formulation was chosen in which the quality controls were carried out, such as: organoleptic characteristics, experimental performance calculation of the formula, homogeneity, extensibility, microbiological and statistical analysis, for this, Excel and Minitab softwares were used. Three formulations with different concentrations of Urea were obtained, at 12%, 16% and 20%, guided by the SOP which was taken as the model of the laboratory of magisterial and officinal formulas of the science college at the Escuela Superior Politécnica de Chimborazo (ESPOCH). In the evaluation, a comparative study with a commercialized formula at 5% concentration was carried out, where the activity determination of the optimal urea formula was based on a hypothetical-deductive inference, its results were expressed quantitatively for statistical analysis, which resulted in a concentration of 20% as the optimal formulation, finally the quality control was carried out. It was concluded that it is necessary to elaborate the SOP because it is a guide, in which, errors can be avoided at the time of formulation preparation, after that the analyzes for quality control determined by the Formulario National (FN) for semi-solid preparations showed that the 20g urea formulation has better acceptability. It is recommended to duplicate formulations at the moment they are being developed and the concentrations are in accordance with the pathologies that the patients may present.