Research Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

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
     

   Subscribe/Renew Journal


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.
Subscription Login to verify subscription
User
Notifications
Font Size


  • D'souza J. I., More H. N., Topical anti-inflammatory gels of fluocinolone acetonide entrapped in eudragit based microsponge delivery system. Research Journal of Pharmacy and Technology 2008, 1 (4), 502-506.

  • Eileen Kairuz T., Gargiulo D., Bunt C., Garg S. Quality, safety and efficacy in the ‘off-label’ use of medicines. Current Drug Safety 2007; 2(1): 89-95.

  • Kaur L. P., Garg R., Gupta G., Topical gels: a review. Research Journal of Pharmacy and Technology 2010, 3 (1), 17-24.

  • Sharma, H.; Dapurkar, V. K.; Rai, G.; Sahu, G. K., Microemulsions for the Topical Administration of 5-Fluorouracil: Preparation and Evaluation. Research Journal of Pharmacy and Technology 2012, 5 (8), 1045-1049.

  • Shewale B. D., Patil P. O., Kosalge, S. B., Fursule, R. A., Sapkal, N. P. Quality Education in Pharmacy: Need of 21st Century. Research Journal of Pharmacy and Technology 2009, 2 (4), 648-652.

  • Lundov M.D., Moesby L., Zachariae C., Johansen J.D. Contamination versus preservation of cosmetics: a review on legislation, usage, infections, and contact allergy. Contact Dermatitis 2009; 60(2): 70-8.

  • United States Pharmacopeial Convention. U.S. Pharmacopoeia-National Formulary [USP 39 NF 34]. Volume 1. Rockville, Inc; 2015. [1111] Microbiological examination of nonsterile products: acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use; p. 605 .

  • Ratajczak M., Kubicka M., Kamińska D., Sawicka P., Długaszewska J. Microbiological quality of non-sterile pharmaceutical products. Saudi Pharmaceutical Journal 2015; 23(3): 303-7.

  • Shah, S., Pasha, T., Desai, D., Bhandari, A., Formulation development and evaluation of semisolid preparation of antifungal drug: Itraconazole. Research Journal of Pharmacy and Technology 2013, 6 (2), 152-157.

  • Charnock C. The microbial content of non-sterile pharmaceuticals distributed in Norway. Journal Hospital Infection. 2004; 57(3): 233-40.

  • Spooner D. Hazards associated with the microbiological contamination of non-sterile pharmaceuticals, cosmetics, and toiletries. Microbial quality assurance in pharmaceuticals, cosmetics, and toiletries. Chichester: Ellis Horwood.1988. p. 15-34.

  • Okeke I.N., Lamikanra A. Bacteriological quality of skin‐moisturizing creams and lotions distributed in a tropical developing country. Journal of Applied Microbiology 2001; 91(5): 922-8.

  • Behravan J., Bazzaz F., Malaekeh P. Survey of bacteriological contamination of cosmetic creams in Iran (2000). International Journal of Dermatology 2005; 44(6): 482-5.

  • Abdolahi Z.F., Zandi S., Jafarian A.H., Bahrampour A. Investigation of microbial contamination of semisolid galen's drug in Kerman pharmacies. Journal of Kerman University of Medical Sciences 2002; 9(3): 153-8.

  • Nitalikar M.M.; Sakarkar D.M., Formulation and evaluation of topical gel of Meloxicam with β-Cyclodextrin complex. Research Journal of Pharmacy and Technology 2013, 6 (7), 790-793.

  • Karudumpala S., Sangeeetha G., Praksh K.G., Harikrishna G., Balaji G., Anudeep K. Formulation and evaluation of carisoprodol topical gel. Research Journal of Pharmacy and Technology 2014, 7 (1), 34-38.

  • Mahmoudi H., Arabestani M. R., Mousavi S. F. and Alikhani M. Y. Molecular analysis of the coagulase gene in clinical and nasal carrier isolates of methicillin-resistant Staphylococcus aureus by restriction fragment length polymorphism. Journal of global antimicrobial resistance 2017, 8, 41-5.

  • Safari M., Alikhani M.Y., Arabestani M.R., Kamali Kakhki R., Jafari R. et al. Prevalence of Metallo-β-lactamases Encoding Genes Among Pseudomonas aeruginosa Strains Isolated From the Bedridden Patients in the Intensive Care Units, Avicenna Journal of Clinical Microbiology and Infection 2014 ,1(1):e19216. doi: 10.17795/ajcmi-19216.

  • Patel, D.V.; Patel, B.D.; Patel, N. K.; Sheth, N.R.; Dabhi, M.R.; Dudhrejiya, A.V. Quality Improvement Methodologies in Pharmaceutical Manufacturing. Asian Journal of Management 2010, 1 (1), 1-3.

  • Vishvnath, G.; Jain, U., Development of Quality Control Parameters for Herbal Formulation, Pippali churna. Asian Journal of Research in Chemistry 2010, 3 (4), 932-934.

  • Bollag U. Studies into the incidence of carriers of enteropathogenic E. coli. Transactions of The Royal Society of Tropical Medicine and Hygiene 1978; 72(6): 588-91.

  • Daharwal S., Naidu R.A. Review: Quality Management and Their Concepts. Asian Journal of Management 2013, 4 (4), 249-253.

  • Jimenez L. Molecular diagnosis of microbial contamination in cosmetic and pharmaceutical products: a review. Journal of AOAC international 2001; 84(3): 671-5.

  • Patel K.M.; Sen D.J. Synthesis and Microbiological Evaluation of Novel Azetidin-2–Ones Encompassing Benzimidazole. Asian Journal of Research in Chemistry 2012, 5 (7), 848-853.

  • Kantouch A., El-Sayed A.A., Salama M., El-Kheir A.A., Mowafi S. Salicylic acid and some of its derivatives as antibacterial agents for viscose fabric. International journal of food microbiology 2013; 62: 603-7.

  • da Rocha Neto A.C., Maraschin M., Di Piero R.M. Antifungal activity of salicylic acid against Penicillium expansum and its possible mechanisms of action. International journal of biological macromolecules 2015; 215: 64-70.


Abstract Views: 261

PDF Views: 0




  • Microbiological Quality of Semi-Solid Pharmacy compounded Topical Preparations

Abstract Views: 261  |  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