"Prevalence of Microbial Contaminants in Non-sterile Pharmaceutical Antacids"

Abstract

In India the prevalence of acidity due to poor eating habit is high in Indian population. Unfortunately, the use of antacids is common which is widely available over the counter (OTC) drug in all pharmaceutical outlets. The primary healing advantage of antacids is the rapid onset of action, which provides immediate ease of gastric discomfort. Most antacids are water-based preparations, and the microbial bioburden of pharmaceuticals has long been a source of concern for pharmaceutical manufacturers around the world among varied pharmaceutical preparations. The presence of contaminants can cause physicochemical alterations in pharmaceutical drugs. The existence of microbial burden is analytically permissible in nonsterile pharmaceuticals regardless of dosage form; though, they should meet the suitable microbiological quality benchmark and meet the acceptance limit mentioned in recent edition of Indian pharmacopoeia (IP) 2022. The objective of this study was to enumerate the total aerobic microbial count (TAMC) and total yeast and mold count (TYMC) in antacids and check the presence and absence of specified pathogens. A total of twenty antacids samples in aqueous and non-aqueous form of preparation were tested. Our study's findings showed that microbial contamination varied among the pharmaceutical preparations, with the highest microbial contamination in aqueous preparations and the lowest in non-aqueous preparations. The isolated microbial contaminations were of human flora types, i.e., gram positive or air borne fungi. This study leads us to the conclusion that microbiological quality control is crucial for both the quality of the product and risk reduction for the end user.