Elaboración y control de calidad de la fórmula oficinal semisólida pasta Lassar usada para el tratamiento de dermatitis del pañal y úlceras por presión.

Abstract

The objective of this research was the elaboration and quality control of the semi-solid officinal formula Lassar paste used for the treatment of diaper dermatitis and pressure ulcers, for which a standardized operative procedure for the elaboration of Lassar paste was first elaborated, then the optimal and adequate formula of Lassar paste was chosen, and finally quality controls of microbiological, net weight, extensibility and organoleptic characteristics were carried out. For the standardized operating procedure (SOP), we began with a bibliographic review and followed as a model the previously established SOP of SOPs belonging to the Laboratory of magistral and officinal formulas of the Facultad de Ciencias, Escuela Superior Politécnica de Chimborazo ESPOCH. The purpose of this procedure was to establish uniformity, reproducibility and quality in the formula. Three formulations were made with different concentrations of Zinc oxide: 10%, 15% and 25%, and a comparative study was made with two commercial formulas with concentrations of 6.25% and 18.75%. The Mc Nemar statistical model was used in which two hypotheses were formulated: Null and alternative, in order to determine if the variation in the concentration of the excipients influenced the organoleptic characteristics of the Lassar paste. Finally, quality analysis was carried out on the formulation obtained as the optimum one, starting with the 30-day stability of the formula to know if it maintained its organoleptic characteristics, microbiological analysis to determine its microbiological stability over time, and analysis for bacteria, fungi and yeasts. Finally, an unctuous, homogeneous and quality paste was obtained, which also complies with all its requirements to be sold in the market. If the analysis time is longer, it is recommended to submit the paste to several external factors and check if it maintains its characteristics.