Elaboración, control de calidad y estudio de estabilidad de una fórmula oficinal semisólida en forma farmacéutica de gel de urea usada para tratamiento hidratante

Abstract

El The objective of this work was to elaborate a semi-solid officinal formulation of urea for topical moisturizing purposes. Most of the products in pharmaceutical form of gel made from Urea are imported from abroad, increasing their cost and making their accessibility difficult for the population, which is accompanied by the scarce knowledge of their application for skin dryness and cutaneous affections, therefore the need arises to obtain a product with keratolytic and moisturizing properties, in such a way that three formulations were made with concentrations of 5%, 8% and 10%, respectively, for their formulation Carbopol, Glycerin and Triethylamine were used as excipients. The methodology implemented had a quantitative approach to remediation, an experimental design of longitudinal type was used since described variables were handled and several formulations were treated to obtain the different results for this work; the population under study were the formulations that were made in different concentrations, accompanied by the use of different containers. Thus, quality control and stability studies were essential to comply with the guidelines and parameters that a gel must meet. By means of this methodology, it was possible to formulate and elaborate the urea gel, complying with the quality guidelines and by means of a Taguchi orthogonal polygonal design, the best conditions of optimal formulation developed for this research were reflected, which is based on the experimental adjustment made from the master formula of Urea Gel, adapting the variations in three fields of critical factors to establish those that can generate great changes in the stability and quality of the product, such was the result for the combination of Urea with 5% concentration, it was the best combination regardless of the factors of addition of TEA or type of packaging.