Quality control study on conventional metronidazole tablets available in the Iraqi market
Majeed Saad M., Mohammed Al-Shaheen K., Al-Zidan Radhwan N.*
Department of Pharmaceutics, College of Pharmacy, University of Mosul, Iraq
*Corresponding Author E-mail: email@example.com
Online published on 30 April, 2021.
In the developing countries, particularly in Iraq, importing drugs from substandard manufacturers and smuggling of counterfeit medicines has become a major challenge to the healthcare services. Therefore, continuous post-marketing quality testing is necessary to verify the quality and determine which product could safely replace the innovator product in case of unavailability or the high cost of the innovator brand one. In the Iraqi market, Metronidazole tablets are available from different pharmaceutical companies. Metronidazole has been chosen for this comparative study because it is the most commonly prescribed antiprotozoal drug in Iraq and many other countries around the world. In this study, various quality control tests have been executed to determine the Pharmaceutical Equivalence of the various generic brands of Metronidazole film-coated tablets (500 mg) marketed in Iraq. The results of our study indicated that each of the tested brands has a unique pattern of in-vitro release profile concerning the (C10 min. and Tmax.), however, all the tested brands were in compliance with the USP specifications for the immediate release dosage forms. Also, there were considerable variations regarding the tablet weight, hardness, and disintegration time in comparison to the innovator brand, (Flagyl) ®. Moreover, there was a slight variance in content uniformity between the different brands. To conclude, brands MT-E and MT-C showed highest drug release at the required time interval with good quality as reflected by high values of the similarity factor (F2) and the physicochemical evaluation of the pharmaceutical parameters. Accordingly, brands MT-E and MT-C are pharmaceutically equivalent and can be used as an effective alternative to the innovator drug (Flagyl) ®.
Metronidazole, Quality Control, Bioequivalence, C10 min., Tmax..