Detection of Fungal Contamination in Some Valid and Expired Gastrointestinal Drugs Produced by Some Pharmaceutical Companies City in Libya North Africa
Abstract:
Purpose: To determine the type and incidence of predominant microorganisms in certain non-sterile phar maceuticals immediately after collection and one year later. Objective: To determine the type and prevalence of microorganisms present in pharmaceutical preparations immediately upon collection.
Methods: The following tests were performed on all pharmaceutical samples: Detection of fungi associat ed with expired and valid medicines using conventional techniques. This study, conducted at Al-Mawakeb Institute during the academic year2024/2025, investigated fungal contamination associated with selected gastrointestinal medications. The drugs examined included Omeprazole 40 mg, manufactured by the Indian company Shifa_Ron, and Cystone, produced by the Indian company Himalaya. Samples were collected from private pharmacies in the Yefren region, Libya.The results revealed the presence of Candida parapsilosisin 75% of expired Omeprazole samples when diluted at ratios of 1:10 and 1:1000 on Potato Sucrose Agar (PSA) medium. In the case of Cystone, isolated on Sabouraud Dextrose Agar (SDA), the following fungi were detected in the expired product: Stemphylium (50%), Alternaria (40%), Aspergillus niger (5%), and Asper gillus candidus (5%). Additionally, Aspergillus niger was found on PSA medium in 25% of Cystone expired samples.For the non-expired Omeprazole samples, direct fungal isolation on PSA showed the presence of Penicillium in 25% of samples, while on SDA, both Alternaria spp. and Aspergillus spp. were found in 50% of samples each. In non-expired Cystone samples, Alternariawas detected on PSA in 25% of cases.This is the f irst study conducted in the Yefren region to investigate fungal contamination in gastrointestinal medications.
