Effect of storage on microbial quality of non-sterile liquid dosage form

Abstract

This study attempted to evaluate effect of packaging system and storage on the microbiological quality of non sterile oral liquid dosage form. A total 14 sample, representing seven category of drug packed in different packaging system were subjected to microbial evaluation using: total aerobic bacterial count and identification of microbial pathogens. The samples were kept at 250C ± 2/60 % ± 5 for one year and microorganism growth rate of samples were evaluated at 0, 6 and 12months. Bio burden altered among the samples 42.85 % were free from microbial contaminants whereas the remaining held bacteria in levels below 102 cfu/mL and highest microbial load in liver tonic. The isolated organisms were gram positive bacteria including Staphylococcus spp. and Bacillus spp., and gram negative bacteria including Proteus spp, Klebesilla spp and Pseudomonas spp, there was no growth of fungi. The bacterial count of the products and the number of isolated contaminants increased after storage for 6 and 12 months, none of sample exceeded the acceptance criteria. The microbial quality of plastic pack were not significantly different from glass pack (p >0.05).