Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Microbial Evaluation of Some Non-sterile Pharmaceutical Preparations Commonly Used in the Egyptian Market

Gamal Fadl M Gad¹, Reham A Ibrahem Aly¹ , Mohamed S El-din Ashour²

¹Microbiology Department, Faculty of Pharmacy, Minia University, Minia; ²Microbiology Department, Faculty of Pharmacy, Modern Science and Arts University, Cairo, Egypt.

For correspondence:- Reham Ibrahem Aly Email: Rehameemicro@yahoo.com Tel:+020106804684

Received: 5 October 2010 Accepted: 14 May 2011 Published: 20 August 2011

Citation: Gad GF, Ibrahem Aly RA, El-din Ashour MS. Microbial Evaluation of Some Non-sterile Pharmaceutical Preparations Commonly Used in the Egyptian Market. Trop J Pharm Res 2011; 10(4):437-445 doi: 10.4314/tjpr.v10i4.9

© 2011 The authors.
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Abstract

Purpose: To determine the type and incidence of predominant microorganisms in certain non-sterile pharmaceuticals immediately after collection and one year later.

Methods: All pharmaceutical samples were subjected to the following examinations: total bacterial count and presence of microbial pathogens, using conventional techniques. Attempts were also made to identify the isolates. The bioburden rate of some of the syrups and oral drops after storage for 0, 6 and 12 months were evaluated in order to assess the effect of storage on microbial contamination level.

Results: Microbial load varied among the pharmaceutical preparations with the highest microbial load in suspensions and the lowest in tablets. Bacterial counts ranged from 10 to more than 10³ CFU per ml or g. The bacterial count at 6 and 12 months were significantly different from that at 0 month (p < 0.05). The isolated organisms were either of human flora types, essentially Gram-positive bacteria, or air-borne fungi.

Conclusion: The isolated organisms were either of human flora types, principally, Gram-positive bacteria, or air-borne fungi and the stored preparations lack an effective preservation. Several measures, including equipment automation, monitoring programs and post-marketing surveillanceare required to reduce the level of microbial contamination of non-sterile pharmaceutical products.

Keywords: Microbial contamination, Bacteria, Fungi, Non-sterile pharmaceuticals