Studies of Heavy Metal Contents and Microbial Profile in Selected Pediatric Oral Liquid Preparations Available in Bangladesh
Md. Monir Hossain *
Department of Pharmacy, Mawlana Bhashani Science and Technology University, Santosh, Tangail-1902, Bangladesh and Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh.
Shamsun Nahar
Department of Microbiology, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh.
Tasrina Rabia Choudhury
Analytical Chemistry Laboratory, Chemistry Division, Atomic Energy Centre, Dhaka, Bangladesh.
Masum Shahriar
Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh.
Nizam Uddin
Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh.
A. F. M. Mahmudul Islam
Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh and Department of Pharmacy, Gono Bishwabidyalay, Savar, Dhaka, Bangladesh.
Arjyabrata Sarker
Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh.
Pijus Saha
Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh.
*Author to whom correspondence should be addressed.
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.
Keywords: Heavy metals, microbial profile, pediatric preparations, complementary and alternative medicine.