Microbiological quality of non-sterile pharmaceuticals in Egypt

Nourhan Mahrous Ahmed Salem,Mohamed Abbas Elbarrawy,Nashwa Fawzy Abd El Moez Azzam

doi:10.1186/s43088-021-00127-6

Abstract

BackgroundThe 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.ResultsAverage 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.ConclusionAverage microbiological quality of the tested pharmaceuticals used in Alexandria.

Highlights

The context and purpose of the study are as follows: Drug-borne infections may arise from nonadherence to strict microbiological quality of pharmaceuticals products
None of the specified organisms by US Pharmacopeia (USP) had been isolated from the studied pharmaceuticals
Differences of microbiological quality of herbal and non-herbal products were assessed; 2 (9.52 %) and 3 (14.29 %) out of 21 herbal pharmaceuticals had passed the permissible limits of TAMC and total yeast and mold count (TYMC), respectively

Summary

Introduction

The context and purpose of the study are as follows: Drug-borne infections may arise from nonadherence to strict microbiological quality of pharmaceuticals products. Presence of exceeding levels of microorganisms in non-sterile pharmaceuticals may lead to change of their organoleptic characteristics and loss of effectiveness. In Egypt, with an average-low socio-economic standard, serious effects may be superadded on debilitated patients by drug-borne infections [3]. Outcomes of these infections depend on the product types, route of administration, and patient immune status [4]. The presence of exceeding levels of microorganisms in nonsterile pharmaceuticals may lead to loss of effectiveness and change of organoleptic characteristics including breaking of emulsions, syrups fermentation, and odors changes [5]

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Conclusion