Author(s): Saad M. Majeed, Mohammed K. Al-Shaheen, Radhwan N. Al-Zidan

Email(s): radhwan.alzidan@uomosul.edu.iq

DOI: 10.5958/0974-360X.2021.00141.4   

Address: Saad M. Majeed, Mohammed K. Al-Shaheen, Radhwan N. Al-Zidan*
Department of Pharmaceutics, College of Pharmacy, University of Mosul, Iraq.
*Corresponding Author

Published In:   Volume - 14,      Issue - 2,     Year - 2021


ABSTRACT:
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) ®.


Cite this article:
Saad M. Majeed, Mohammed K. Al-Shaheen, Radhwan N. Al-Zidan. Quality control study on Conventional Metronidazole tablets available in the Iraqi market. Research J. Pharm. and Tech. 2021; 14(2):803-808. doi: 10.5958/0974-360X.2021.00141.4


REFERENCES:
1.    Radhwan NA. Drugs in Pregnancy. 1st ed. AAP; 2020.
2.    Brog deu R. N., Hed R. C., Speight T. M. and Avery G. S.; Metronidazole in Anaerobic infections: are view of its activity, Pharmacokinetics and Therapeutic use. Drug 1978; 16 (5): 387-417.
3.    U.S. National Library of Medicine, National Center for Biotechnology information. Compound Summary; Metronidazole.
4.    Anthony C. Moffat, M. David Osselton, Brian Widdop. Clarkes Analysis of Drugs and Poisons. 3rd Edition, The Pharmaceutical Press; 2005.
5.    Food and Drug Administration, Center for Drug Evaluation and Research; 2004.
6.    Meredith P., Bioequivalence and other unresolved issues in generic drug substitution. Clin. Ther. 2003; 25: 2875-2890.
7.    Ngwuluk NC, Lawal K., Olorunfemi PO., Ochekpe NA. Post-market in vitro bioequivalence study of six brand of ciprofloxacin tablet/capsules. Sci. Res. Essay 2009; 4: 298-305.
8.    Chow S., Pharmaceutical validation and process contols in drug development. J. Drug Information 1997; 31: 1195-1201.
9.    Musab MK., Imad AT., AL-Jammas EA., Bioequivalence study of four carbamazepine generic tablets. Irq. J. Pharm. 2003; 3: 15-23
10.    Adegbolagun OA, Jegede OJ. Olaniyi AA. Chemical equivalence studies on four brands of Metronidazole tablets. Nig. J. Pharm. Res. 2002; (April – Sept.): 71-74.
11.    Barone JA., Lordi NG., Byerly WG., Colaizzi JL. Comparative dissolution performance of internationally availabile piroxicam product. Drug Intell. Clin. Pharm. 1988; 22(1): 35-40.
12.    Adegbolagun OA., Olalade OA., Osumah SE. Comparative evaluation of the biopharmaceutical and chemical equivalence of some commercially available brands of ciprofloxacine hydrochloride tablets. Trop. J. Pharm. Res. 2007; 6:737-745.
13.    Olaniyi AA., Babalita CP., Olandeinde FO., Adegoke AO. Towards better quality assurance of drugs. Proceeding sof. 4th National work shop, department of pharmaceutical chemistry, University of Ibadan, Ibadan 2001; 70-73.
14.    The United State Pharmaceutical Convention, USP. 35, 2011
15.    Asmaa Abdelaziz Bayoumi, Hawraa Fattah, Shams Abd-alRasoul, Mohammed Abd-AlRrasoul, Estabraq Jawad. Comparative In-vitro pharmaceutical evaluation of some selected brand of Metronidazole tablets marketed in Iraq. International Journal of Pharmaceutical Science and Research. 2019; 4(2): 13-15.
16.    Allen LV, Popovich NG., Ansel HC. Ansels pharmaceutical dosage forms and drug delivery system. In: Lippin Cott Williams and Wilkins, Philadelphia. 9th edition; 2004: 234-236.
17.    Induri M., Raju MB., Prasad YR., Reddy KP. Development and validation of a spectrophotometric method for quantification and dissolution studies of Metronidazole tablet. Eur. Journal of Chemistry 2012; 9(2): 993-998.
18.    Kishore L., Kaur N., Estimation of pioglitazin and Metronidazole in its pharmaceutical dosage form by spectrophotometric methods. Der. Pharmacia. Letter 2011; 3(4): 276-284.
19.    British Pharmacopoeia (BP); 2009.
20.    Marina Levina, Charles R. Cunningham. The effect of core design and Formulation on the Quality of Film Coated Tablets. Article at www.ptemagazine.com
21.    Reem Kh. Al Naimi, Shah A. Khan. Comparative in-vitro Pharmaceutical Evaluation of Four Brands of Metronidazole Tablets Marketed in Gulf Region. Jordon Journal of Pharmaceutical Sciences, Volume, No. 2, 2014.
22.    Ngwuluk NC, Lawal K, Olorunfemi PO, Ochekpe NA. Post-market in vitro bioequivalence study of six brands of ciprofloxacin tablets/caplets. Sci. Res. Essay; 2009; 4: 298-305.
23.    Du J., Hoag SW. Characterization of excipient and friability and breaking strength of oil – and water soluble multivitamin with mineral tablets. Drug Development and Industrial Pharmacy 2003; 29: 1134-1147.
24.    Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system; guidance for industry; U.S. Department of health and human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2000.
25.    John Z. Duan & Kareen Riviere and Patrick Marroum. In Vivo Bioequivalence and In Vitro Similarity Factor (f2) for Dissolution Profile Comparisons of Extended-Release Formulations: How and When Do They Match? Pharm Res (2011) 28:1144–1156.

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