Vol. 5, Issue 9 (2016)

Author(s):
Rawaa E Biraima, Sabreen E Mohamed, Mona A Hajo, Anas M Elnazeer and Mohamed A Hussain

Abstract:
Pharmaceutical products manufactured today must meet high microbiological specifications that the microbial content if not sterile should not exceed a minimum limit. Antacid suspensions are basic pharmaceutical multi-dose products that are used to neutralize gastric acid. They are highly susceptible to microbial contamination due to the neutral pH. In this study we attempted to assess the microbial quality of commercially available antacid suspensions in Sudan. Twelve batches belonging to four different companies were collected from different community pharmacies in Khartoum state; each company represented by three different batches which were represented by three products to compute the mean of the bioburden. The guideline of USP has been followed in all procedures and identification of the objectionable microorganisms. The testing conditions were examined by means of negative control. The enumeration of total viable count was done using pour plate method. We found that nine out of twelve of the tested batches exceed the USP limit for total microbial content (10² CFU/ml), and five of which were found to be contaminated with objectionable microorganisms. This study is expected to benefit the manufacturers of these products to pay more attention for the microbial quality of their products.