Procedimientos para la determinación de microorganismos en el análisis y control de calidad de formas farmacéuticas semisólidas no estériles (cremas)

Abstract

Contamination by microorganisms alters the chemical physical characteristics of pharmaceutical products and puts the health of patients at risk. Microbial contaminants can cause infections due to the toxic metabolites that are generated, the main contaminants being bacteria, molds and yeasts that affect the raw materials and the final product. To solve this problem, quality control plays a key role in obtaining products with the required quality and efficiency. Therefore, this research aims to describe the procedures in the analysis and quality control, for the determination of microorganisms that contaminate semi-solid pharmaceutical forms (creams), through the bibliographic review of scientific documents. A descriptive study was carried out for the resolution of the practical case through the review of scientific articles and Pharmacopoeias, obtaining as a result that contamination by microorganisms can be avoided by following Good Manufacturing Practices, which allows control of the raw material, the process manufacturing, storage and distribution of the final product. Finally, to ensure microbial quality, procedures such as the microbial limit test should be applied, which is based on the total mesophilic aerobic count (TAMC) and total yeast and mold count (TYMC), complying with the specifications recommended by the USP or Pharmacopoeias. Without forgetting the tests for the identification of specific microorganisms, the most interesting being Escherichia coli (E. coli), Pseudomonas aeruginosa (P. aeruginosa), Staphylococcus aureus (S. aureus), and Candida albicans (C. albicans).