Research Journal of Pharmacy and Technology

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Microbiological Quality of Semi-Solid Pharmacy compounded Topical Preparations


Affiliations
1 Department of Pharmacology and Toxicology, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran, Islamic Republic of
2 Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran, Islamic Republic of
3 Department of Clinical Biochemistry, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran, Islamic Republic of
4 Department of Dermatology, Hamadan University of Medical Sciences, Hamadan, Iran, Islamic Republic of
5 Hamadan University of medical sciences, Hamadan, Iran, Islamic Republic of
6 Department of Community Medicine, Hamadan Medical School, Hamadan University of Medical Sciences, Hamadan, Iran, Islamic Republic of
7 Departments of Pharmaceutics, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran, Islamic Republic of
     

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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.

Keywords

Microbiological, Pharmacy Compounded, Pour Plate, Quality, Topical.
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  • Microbiological Quality of Semi-Solid Pharmacy compounded Topical Preparations

Abstract Views: 262  |  PDF Views: 0

Authors

Sana Soheilian
Department of Pharmacology and Toxicology, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran, Islamic Republic of
Fatemeh Zeraati
Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran, Islamic Republic of
Iraj Khodadadi
Department of Clinical Biochemistry, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran, Islamic Republic of
Mahmoud Farshchian
Department of Dermatology, Hamadan University of Medical Sciences, Hamadan, Iran, Islamic Republic of
Marzieh Mosaed
Hamadan University of medical sciences, Hamadan, Iran, Islamic Republic of
Mohamad Ali Seif Rabiei
Department of Community Medicine, Hamadan Medical School, Hamadan University of Medical Sciences, Hamadan, Iran, Islamic Republic of
Shabnam Pourmoslemi
Departments of Pharmaceutics, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran, Islamic Republic of

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.

Keywords


Microbiological, Pharmacy Compounded, Pour Plate, Quality, Topical.

References