Microbiological Quality of Selected Local and Imported Non-Sterile Pharmaceutical Products in Dar es Salaam, Tanzania

Abstract

Background Pathogenic and non-pathogenic microbial contaminants can cause physical–chemical alterations of pharmaceuticals and medicine-related infections. This study aimed to examine the microbiological quality of selected local and imported non-sterile pharmaceutical products in the Dar es Salaam market and the antibiogram of the isolated microorganisms. Methods Samples were collected between April and June 2021 and analysed for microbial content as per the harmonised methods of the European Pharmacopoeia (EP). Antibiotic susceptibility of the microbial isolates was studied using Kirby-Bauer disc diffusion method. Results Fifty percent (50%) of the samples failed both bacterial and fungal enumeration tests. In this study, local products recorded lower microbial counts than imported products. Major bacterial contaminants isolated were P. aeruginosa (45.5%), S. epidermidis , (45.5%) and K. pneumoniae , while major fungal contaminants were A. flavus (58.3%) , followed by A. fumigatus (25%) and Penicillium spp (16.7%). The isolated bacterial contaminants recorded high resistance levels to commonly used antibiotics. Conclusion The tested products were contaminated with microorganisms at different levels, most of them exceeding the maximum acceptable colony counts. Syrups or suspensions were more contaminated than tablets and capsules. The isolated bacterial contaminants were highly resistant to commonly used antibiotics. Recommendations We recommend that pharmaceutical manufacturers abide by good manufacturing, distribution and storage practices to limit contamination and cross-contamination of products. Responsible drug regulatory authorities should heighten the frequency of inspection of manufacturing facilities and regularly conduct post-marketing surveillance (PMS) of registered products to assess continued conformity to GMP guidelines. Future studies should involve samples collected directly from manufacturing sites.

Detection and characterization of micro-organisms linked to unsealed drugs sold in Ihiagwa community, Owerri, Imo State, Nigeria

“…Unsealed drug containers, in particular, are susceptible to microbial contamination during storage and transportation [ 6 ]. This high prevalence of contamination is consistent with previous findings that highlight the vulnerability of unsealed drugs to microbial intrusion [ 1 ].…”

“…Fungal contaminants, such as C. albicans and A. niger , can also lead to adverse reactions and other health complications. Accurate identification of these bacterial isolates is crucial in assessing the potential risks associated with drug contamination [ 1 ]. This study utilized morphological and biochemical tests to identify S. aureus , E. coli and P.s aeruginosa .…”

“…Pharmaceutical products, including both prescription and over-the-counter drugs, are expected to meet stringent quality standards to ensure their safety and efficacy. The presence of micro-organisms, such as bacteria, fungi and viruses, in pharmaceutical products can compromise their quality and pose health risks to consumers [ 1 ]. Microbial contamination can occur at any stage of the drug manufacturing, distribution, or dispensing process [ 2 ].…”

"Prevalence of Microbial Contaminants in Non-sterile Pharmaceutical Antacids"

“…The acceptance criteria for microbiological quality of nonsterile dosage form of aqueous and non-aqueous preparation for oral use is mentioned in (Table 1). Non sterile oral drugs show the presence of various types of microbes which may result in the physicochemical deterioration of both active and inactive ingredients of the pharmaceutical product [10]. Further, possibility of presence of microbes in the final products may have hazardous health effects to the end users.…”

“…Several studies have been conducted on the microbial evaluation in antacids from different countries viz. Sudan, Nigeria, Tanzania etc [10][11][12][13]. Unfortunately, there is scarcity in such studies on antacids from India.…”