Effect of primary packaging on microbiological status of oral solid dosage form
Keywords:Microbiological quality, Alu-Alu, Blister, Total aerobic microbial counts (TAMC)Total yeast and mold counts (TYMC)
The emergence of microbial contaminants in non-sterile drugs caused not only the degradation of many products, but also proved to be a potential risk to consumer health. The aim of this study was to test microbial load of non sterile solid pharmaceutical product and investigate the effects of different packaging system on microbial status of pharmaceutical product. A total of 18 sample of solid dosage form packaged in different packaging were procured from market. All samples have been tested for the presence of specific microorganisms, Total aerobic microbial counts (TAMC) and Total yeast and mold counts (TYMC) using compendial procedures. Out of 18 sample 72.22 % (n=13) had shown microbial growth and only 16 % (n=3) of samples were non-compliant. Sample containing herbal ingredients, were the most heavily contaminated, showing a bacterial load > 104 CFU/g. The result showed that all the tested samples were free from E. coli. There was no significant difference (p>0.05) in microbial load of product packaged in different primary packaging
Eissa M E. Distribution of bacterial contamination in non-sterile pharmaceutical materials and assessment of its risk to the health of the final consumers quantitatively. Beni-Suef University Journal of Basic and Applied Sciences, 5, 217-230 (2016).
Sutton S, Jimenez L. A review of reported recalls involving microbiological control 2004-2011 with emphasis on FDA considerations of “objectionable organisms”. Americal Pharmaceutical Review, January, 1-6 (2012)
Dabbah R, Knapp J, Sutton S. The role of USP in the assessment of microbiological quality of pharmaceuticals. Pharmaceutical Technology, July, 54-60 (2011)
Rehman M S U, Rashid N, Ashfaq M, Saif A, Ahmad N, Han J I. Global risk of pharmaceutical contamination from highly populated developing countries. Chemosphere, 138, 1045-1055 (2015).
Ratajczak M, Kubicka M M, Kamińska D, Sawicka P, Długaszewska J.Microbiological quality of non-sterile pharmaceutical products. Saudi Pharmaceutical Journal, 23, 303-307 (2015).
Indian Pharmaceutical Industry:
Zadbuke N, Shahi S, Gulecha B, Padalkar A, Thube M. Recent trends and future of pharmaceutical packaging technology. Journal of Pharmacy & Bioallied Sciences, 5, 98-110 (2013).
Adetunji M, Kilani, Olaifa K W.Microbiological Quality of Selected Non-Sterile Pharmaceutical Products Sold in Retail Outlets in Dutsinma Metropolis, Katsina State, Nigeria. Journal of Public Health in Developing Countries,3,339-346(2017).
Kabir M S, Hossain M D. Microbiological Quality Assessment of Vitamin B Syrups and Antibiotic Susceptibility Profile of the Isolated Escherichia coli. Journal of Pharmacy and Biological Sciences,8,1-5 (2013).
Yasir Mehmood, Saleem N, Hammad Y, Saeed-ul-Hassan S, Iqbal J. Microbial Count of Non-sterile Pharmaceutical Products Sold in Pakistan. Microbiology Research Journal International . 18, 1-8 (2017).
Abu S, Qasem M, Shawaqfah M T, Al Momani W. Microbiological Quality of Blister Pack Tablets in Community Pharmacies in Jordan.Tropical Journal of Pharmaceutical Research, 13, 261-266 (2014).
Gamal F M, Reham A, Ibrahem A, Ashour M S E D, Microbial Evaluation of Some Non-sterile Pharmaceutical Preparations Commonly Used in the Egyptian Market. Tropical Journal of Pharmaceutical Research,10, 437-445 (2011).
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