Studies of Heavy Metal Contents and Microbial Profile in Selected Pediatric Oral Liquid Preparations Available in Bangladesh

Abstract

Thirty different Pharmaceutical, Complementary and Alternative Medicine (CAM) products were tested for heavy metal contents and microbiological profile using standard methods. Among the investigated eleven heavy metals, seven (Cr, Co, Cu, Mn, Fe, Ni and Zn) were in detectable level. However, according to the manufacturers’ recommended dose, 27.78% of pharmaceutical products (A-02, A-05, A-07, A-08, A-09) have crossed the oral Permissible Daily Exposure limit of ICH (International Conference on Harmonization) guideline for cobalt. However, in all CAM products, level of all tested heavy metals was within the permissible limit of United States Pharmacopoeia (USP), ICH and European Medical Agency (EMEA) guidelines. Most pharmaceutical and CAM products crossed the USP, British Pharmacopoeia (BP) and World Health Organization (WHO) acceptable limit for the total aerobic microbial count (TAMC). Pathogenic Escherichia coli was found in one Pharmaceutical (A-07) and two CAM products (D-06, D-08). Salmonella and Shigella spp. were absent in all tested products. In total combined yeast and mould count (TYMC) few pharmaceutical (A-03, A-07, A-14), as well as CAM products (D-02, D-06, D-08), were beyond USP, BP and WHO acceptable limits. Both pharmaceutical and CAM manufacturers should strictly follow the Current Good Manufacturing Practice to ensure the quality and safety of pediatric preparations.