Elaboración y control de calidad de una fórmula oficinal líquida agua conservante

Abstract

The main objective of this research study was to elaborate and perform the quality control of a liquid medicine compound, amount a bibliographic compilation of information described in the official monographs for the integration of Standard Operating Procedures (SOP) for the formulation and quality control of liquid compounds. The development of the method for the elaboration of the medicine compound of water conservative indicated as vehicle effect, the SOPs of the raw materials and liquid pharmaceutical preparations were used, followed by the selection of the best formulation and final quality control such as organoleptic properties, calculations of experimental performance of the formulation, homogeneity, and microbiology. The official monographs used in the study were the national formularies of the Agencia Española de Medicamentos y Productos Sanitarios-AEMPS (3rd edition), the Real Farmacopea Española (2nd edition), the Farmacopea Europea (Ph. Eur 11th edition). The SOP prepared helped us to obtain the optimum formulation corresponding to different concentrations of methylparaben and propylparaben from the standardized formulation (TF-NF). The optimal formulation (OF) has better homogeneity, consistency, development, and quality control specification documented in three standard operating procedures, the quality control tests determine the suitability of the raw materials and allow the identification of the optimal formulation. It is recommended for future studies that the SOPs should be constantly updated and revised in order to meet future needs, and the professional who created and uses them should be updated periodically.