Abstract
ESTABLISHMENT OF METHODS FOR MICROBIAL RECOVERY: MISCELLANEOUS NON-STERILE PHARMACEUTICAL DOSAGE FORMS (STUDY I)

Mostafa Essam Eissa* and Ahmed Mohamed Mahmoud

ABSTRACT

Microbial contamination of pharmaceutical products is of critical concern in drug manufacturing industry that impacts both the consumers and the manufacturers. Development and verification of the sensitivity for bioburden detection and enumeration in the dosage forms is crucial in minimizing the risk of delivering unsafe products with masked contamination to the market. In the present study, selected group of 14 non-sterile pharmaceutical products – including drugs with known antimicrobial properties - were tested for the ability to recover low level inoculums of pharmacopeial standard strains after applying specific neutralization and manipulation processes. The neutralization techniques included dilution, filtration, chemical neutralizers or combination of two or more of them together in a single procedure. Preliminary test was conducted to ensure non toxicity of the neutralization media or processes. The average combined microbial recovery of Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, Candida albicans (20–25°C), C. albicans (30–35°C) and Aspergillus niger (20–25°C) and A. niger (30–35°C) from all tested pharmaceutical dosage forms was 1.02±0.20, 0.95±0.17, 0.91±0.24, 0.99±0.29, 0.89±0.26, 0.96±0.24 and 0.79±0.19 respectively. The tested items passed the criteria of microbial enumeration and detection of specified pathogens as specified by USP 38–NF 33 and . Interestingly, a tablet formula of Tinidazole and Norfloxacin combination and Fluconazole capsule showed high total microbial recovery (1.09±0.30 and 1.09±0.19 respectively) among other products after applying combined modified neutralization process.

Keywords: Microbial contamination, bioburden detection and enumeration, pharmaceutical products, standard strains, neutralization process, microbial recovery.


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