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Microbiological Quality of Blister Pack Tablets in Community Pharmacies in Jordan

机译:约旦社区药房的泡罩包装片剂的微生物学质量

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Purpose: To investigate the microbiological quality of blister-packed tablets manufactured and marketed in Jordan in order to assess Good Manufacturing Practice by pharmaceutical industries in the country. Methods: A total of 66 items of 22 registered blister-packed tablet brands were purchased from community pharmacies in Amman. All the items were investigated for total bacterial count and the presence of specified microorganisms using compendial procedures. Results: Out of 66 items purchased, forty eight (72.7 %) products were free from microbial contamination, while 11 (16.7 %) harbored bacteria in counts Bacillus species but specified objectionable bacteria such as Escherichia coli and Staphylococcus aereus were not detected. Aspergillus and Penicillium species were isolated in low numbers from few products. Six of the products with the highest stratified bacterial count were manufactured by one company and were also found to be contaminated with Aeromonas species. Conclusion: This study demonstrates that blister-packed tablets produced by Jordanian pharmaceutical companies are within acceptable microbiological quality but the detection of microbial load in some brands close to the maximum allowable limit suggests the need for better adherence to GMP in the country.
机译:目的:调查在约旦生产和销售的泡罩包装片剂的微生物质量,以评估该国制药行业的良好生产规范。方法:从安曼社区药店购买了22个注册的泡罩包装片剂品牌中的66个项目。使用纲要程序调查所有物品的细菌总数和特定微生物的存在。结果:在购买的66件产品中,有48种(72.7%)产品没有受到微生物污染,而在芽孢杆菌属物种中有11种(16.7%)带有细菌,但未检出特定的有害细菌,如大肠杆菌和金黄色葡萄球菌。从少量产品中少量分离出曲霉和青霉菌。分层细菌数最高的产品中有六种是由一家公司生产的,也被发现被气单胞菌污染。结论:这项研究表明,约旦制药公司生产的泡罩包装片剂的微生物质量在可接受的范围内,但某些品牌中微生物载量的检测接近最大允许限值,表明该国需要更好地遵守GMP。

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