Microbiological quality of non-sterile pharmaceuticals in Egypt

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.

Microbial evaluation of some syrups in Syrian pharmacies

“…passed the European Pharmacopoeia “2010” specifications, a result that matches that of previous studies by Salem et al. (2021) [ 2 ] and Al−Kaf et al. (2015) [ 3 ].…”

“…(2021) of non-sterile pharmaceuticals in Egypt. The later study showed that 17.03% and 19.23% of samples exceeded the maximum acceptable limit of TAMC and TYMC, respectively [ 2 ]. Similarly, to the results in our study, the Egyptian study also confirmed oral products were free from E. coli [ 2 ].…”

“…Sterile production demands manufacturing drugs in an area free from microorganisms, such as production of intravenous injections and eye drops, while the production of non-sterile pharmaceuticals (NSP) demands a clean area which is not completely free from microorganisms and permits the presence of microorganisms within permissible limits. NSP include oral dosage forms (syrups, suspensions, and emulsions) and topical dosage forms (creams, gels, and ointments [ 2 ] (. Non-sterile pharmaceutical products are not required to be completely sterile, but are subject to some boundaries in terms of the number and types of acceptable microorganisms to ensure their effectiveness and safety for the consumer [ 3 ].…”

“…Microbiological quality of non-sterile pharmaceutical products should be evaluated as an important quality control step particularly in developing countries where the climatic conditions may encourage the proliferation of microorganisms in medical products. Moreover, many products may be stored or dispensed under uncontrolled conditions [ 2 ].…”

Microbial contamination of selected nonsterile pharmaceuticals in OPD pharmacy of a teaching hospital in Sri Lanka

“…Non-sterile pharmaceuticals are the products that may contain microorganisms within the limits of the type and concentration [2]. Usually, the oral medicines and topical medicines are non-sterile [7]. The acidity of the stomach may act as a barrier to ingested microorganisms in the oral route and inactivation of the biological activities of the microorganism occurs [8].…”