Microbiological Quality of Semi-Solid Pharmacy compounded Topical Preparations

Abstract

Pharmacy compounded topical preparations can be a favorable environment for microbial growth because of variable manufacturing condition and absence of antimicrobial agents in their formulations. In the present study evaluation of microbiological quality of three semi-solid pharmacy compounded topical preparations was performed according to United States Pharmacopeia (USP) acceptance criteria for non-sterile topical pharmaceuticals. Preparations were purchased from five different pharmacies in Hamedan, Iran and studied for total aerobic microbial count (TAMC), total yeast and mold count (TYMC) and presence of objectionable specified microorganisms. TAMC and TYMC were investigated using pour plate counting method and selective differential culture media combined with biochemical tests were used for detection of specified microorganisms in the preparations. Sixty percent of preparations were unacceptable due to at least one of the investigated items; TAMC, TYMC and presence of objectionable specified microorganisms. Half of the preparations had unacceptable TAMC, in 10 TYMC was above the acceptable range and four preparations were contaminated with Staphylococcus aurous (S. aurous) and Escherichia coli (E. coli). Other specified microorganisms were not detected. Results of this study showed unacceptable microbiological quality of pharmacy compounded topical preparations that can put consumers, especially those with compromised immunity, at serious risk. A direct relationship was observed between the pharmacies and microbiological quality of their preparations, indicating the importance of implementing hygiene and good compounding practice in the preparation process. © RJPT All right reserved.