Elaboración y control de calidad de una fórmula oficinal semisólida con efecto antiinflamatorio

Abstract

The aim of this work was to collect information that allowed to establish the preparation method and quality control of the semi-solid officinal formulation with anti-inflammatory effect called: Ointment based on Menthol and Methyl Salicylate. To this purpose, the information was obtained from: Pharmacopoeias, National Forms and updated scientific papers. With the information obtained, the Standardized Operating Procedures (SOPs) were drawn up, which were executed in the analysis of raw material, preparation of the semi-solid officinal formulation and quality control of the final product. Experimentally, three formulations were made at different concentrations of active ingredients, which were subjected to comparative organoleptic quality control with a commercial formulation in order to define the optimal formulation. With the results obtained from the parameters evaluated, the data treatment was carried out with the statistical models Chi Square and Analysis of Variances, which evidenced the influence of the concentrations on the formulation consistency and the stability of the dosage in the conditioning. In compliance with the objectives proposed in this work; the development of quality control and preparation of the formulation was documented in three SOPs, the experimental results determined the suitability of the raw materials according to the quality criteria of the revised pharmacopoeias and allowed to define the optimal formulation with the best organoleptic characteristics and microbiological safety, which corresponds to concentrations of 12.5% methyl salicylate and 9.5% menthol. Finally, the experimental work established the general formula for obtaining the optimal officinal formula with the best organoleptic characteristics and microbiological quality. In addition, it is recommended that the generated procedures must be constantly updated to guarantee the reproducibility of the formulation.