Abstract

BIOASSAY FOR ANTIFUNGAL DRUGS QUALITY CONTROL. A CRITICAL REVIEW.

Josilene Chaves Ruela Corrêa*, Flávia Carnavalli, Hérida Regina Nunes Salgado

ABSTRACT

The quality control has a goal of evaluate the quality attributes of pharmaceutical products, as an effort to guarantee the efficacy, safety and stability required for these products. The use of appropriate analytical methodologies is crucial. Physicochemical methods are widely used for drug quality control. Although traditional microbiological assays have some limitations as a late result, low selectivity of culture medium and variability of biological response of microorganisms, these bioassays are efficient, simple and low cost. In addition, the microbiological assays give the possibility to evaluate the potency of drugs. At this work, the bioassay for antifungal drugs is approached focusing on the bioassay for systemic antifungal drugs analyzes. Here, we compile and discuss the microbiological assay recommended by official compendia and that available from several recently published papers. Most consulted monographs recommend chemical or physical chemical techniques to perform drug assay, as titration, spectrophotometry and liquid chromatography, for either raw material or dosage form. Moreover, there is not much paper addressing microbiological assays as a first choice analytical method for dosing these drugs. For antimicrobial agents such as antifungal drugs, microbiological evaluation of their activity may be so or more important than their physicochemical assay. The development and validation of microbiological assay methods for antifungal raw material or dosage forms drugs seems to be needed. In the same way, applying these methods to drug stability studies is very important to improve knowledge about the drugs potency and lead to their correct and safe use and handling.

Keywords: Antifungal drugs; quality control; microbiological assay; bioassay, review.