Microbiological quality of non-sterile pharmaceuticals in Egypt

Abstract

Abstract Background The context and purpose of the study are as follows: Drug-borne infections may arise from non-adherence to strict microbiological quality of pharmaceuticals products. Moreover, presence of exceeding levels of microorganisms in non-sterile pharmaceuticals may lead to change of their organoleptic characteristics and loss of effectiveness. The aim of the study is to evaluate the microbiological quality of commonly used non-sterile pharmaceuticals in Alexandria, Egypt. Results Average microbiological quality of the studied products, where 17.03% and 19.23 % of samples had exceeded the maximum acceptable limit of TAMC and TYMC, respectively. No E. coli was isolated from oral products. None of S. aureus nor P. aeruginosa were isolated from topical products. Bacterial growth was recovered from 19 (10.44%) of the studied 182 samples, four Bacillus spp. had been recovered from topical products, two P. aeruginosa isolates were recovered from tablets and other two were isolated from syrups dosage forms. Other isolates were Pseudomonas stutzeri, Stenotrophomonas maltophilia, Acinetobacter Achromobacter denitrificans, Ochrobactrum anthropic and Aeromonas salmonicida. Conclusion Average microbiological quality of the tested pharmaceuticals used in Alexandria.

Keywords

• Acceptable limits
• Indictor organisms
• Microbial burden
• Pharmaceuticals
• US pharmacopeia