Microbiological quality control of some non-sterile preparations commonly used in Pakistan.
Pak J Pharm Sci. 2018 Jul;31(4):1237-1242
Authors: Rauf A, Erum A, Noreen S, Shujaat J, Ashraf MU, Afreen S
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.
PMID: 30033406 [PubMed – in process]