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Microbiological quality control of some non-sterile preparations commonly used in Pakistan
Aisha Rauf1, Alia Erum1, Shumaila Noreen1
1Faculty of Pharmacy, University of Sargodha, Sargodha, Pakistan.
Abstract:
The quality of medicines in some developing countries including Pakistan is not very satisfactory regarding safety and efficacy. In addition to sterile preparations, the microbial contamination of non sterile preparations should also be monitored according to USP microbial limits for these preparations. This study was designed to check the microbial quality of some commonly used non-sterile preparations available in Pakistan. Total 133 samples containing national and multinational brands of different dosage forms were collected from retail setups of Sargodha, Khushab and Chakwal cities. The total aerobic bacterial count and fungal contamination was tested by pour plate method. The absence of objectionable microorganisms was confirmed by using selective media, biochemical testing and microscopy. Bioburden of these preparations was also tested after a storage period of six months. The bio burden varied among all the selected non-sterile preparations whether of local or multinational brands. The highest load was observed in syrups, among which syrup number 1 showed maximum aerobic count (8.4×106). Lowest count was observed in tablets, among which tablet preparation number 1 contained 1.5×103aerobic bacteria. Creams and capsules produced no recovered bacteria. The fungal contaminants were also observed in all dosage forms except tablets. The isolated organisms included Gramnegative bacteria which contained objectionable ones such as Salmonella, Shigella, Pseudomonas and E.coli and some airborne moulds including Aspergillus spp., Penicillium spp., Fusarium spp. and Acremonium spp. Several measures such as GMPs, monitoring programs and SOPs should be followed by the pharmaceutical companies to reduce the microbial contamination level in the non sterile preparations. The regulatory agencies have to implement strict analysis strategy to check the microbial quality of the medicines before their release for sale in the market.
Insights
Microbial contamination is a significant concern in Pakistani non-sterile medicines. This study found high levels of bacteria and fungi in various dosage forms, necessitating stricter quality control.
Area of Science:
- Pharmaceutical Microbiology
- Drug Quality Control
Background:
- Medicinal product quality in developing nations like Pakistan often falls short of safety and efficacy standards.
- Monitoring microbial contamination in non-sterile pharmaceutical preparations is crucial, aligning with United States Pharmacopeia (USP) microbial limits.
Purpose of the Study:
- To assess the microbial quality of commonly used non-sterile pharmaceutical preparations in Pakistan.
- To identify microbial contaminants and evaluate bioburden levels in these products.
Main Methods:
- Collected 133 samples of non-sterile preparations (national and multinational brands) from retail pharmacies.
- Assessed total aerobic bacterial count and fungal contamination using the pour plate method.
- Confirmed absence of objectionable microorganisms via selective media, biochemical tests, and microscopy; tested bioburden post-six-month storage.
Main Results:
- Microbial contamination varied across preparations; syrups exhibited the highest aerobic bacterial counts (e.g., 8.4×10^6 in syrup #1).
- Tablets showed the lowest bacterial counts (e.g., 1.5×10^3 in tablet #1), with no bacteria recovered from creams or capsules.
- Fungal contaminants were present in all dosage forms except tablets; isolated pathogens included Salmonella, Shigella, Pseudomonas, E. coli, and molds like Aspergillus and Penicillium.
Conclusions:
- Pharmaceutical companies must adhere to Good Manufacturing Practices (GMPs), monitoring programs, and Standard Operating Procedures (SOPs) to minimize microbial contamination.
- Regulatory agencies need to implement stringent analytical strategies to ensure the microbial quality of medicines before market release.
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