jsmc-10100

IN VITRO EQUIVALENCE EVALUATION OF FIVE DIFFERENT METFORMIN TABLET PRODUCTS USING UV SPECTROMETER

Baraa Ramzi Abdulhameed*, Hazhar Ibrahim Karim*, Gulala Ibrahim Qader* and Mohammed Omer Mohammed*

* Department of Pharmacology, College of Medicine, University of Sulaimani.

Submitted: 18/5/2016; Accepted: 18/10/2016/; Published: 1/12/2016

DOI Link: https://doi.org/10.17656/jsmc.10100

ABSTRACT

Backgrond

Equivalence studies are needed to assess and confirm the safety and efficacy of generic formulations and are essential for the protection of patients from being treated by counterfeit medicines or from unwanted effects of medications. Two pharmaceutical products are considered to be bioequivalent when their bioavailability factors are similar and they show clinically comparable therapeutic effects.

Objectives

To compare the in vitro equivalence of five products of metformin tablets available in the markets of Kurdistan Region of Iraq.

Materials and Methods

This work involved studying of five products of metformin tablets available in the markets of Kurdistan Region of Iraq. The products were compared to investigate their contents, dissolution and friability profiles.

Results

Results of content assay indicated that all five products stayed within the standard value ranges, which should not be less than 95% and not more than 105% of labeled amount. The dissolution profile study showed that all five brands of metformin released at least 80% of their contents in 30 minutes and passed the acceptance criteria for US Pharmacopeia 2015. The friability test demonstrated that the tablets manufactured by Bristol had maximum loss while tablets manufactured by Merck showed minimum friability, as compared to other brands in the study.

Conclusion

The study indicates that the five tested products of metformin tablets, which are available in Iraqi markets, Comply with the standards set by US Pharmacopeia and are considered to be equivalent to each other.

KEYWORDS

Metformin, In vitro equivalence, UV-Spectrometry.

References

Bailey CJ, Day C (1989) Traditional plant medicines as treatments for diabetes. Diabetes Care 12:553–564.
Budavari S, editor. The Merck Index. 13th ed. Whitehouse Station: Merck & Co Inc; 2001. p. 998.
Davidsen M B and Peters A L, Am J Med.,1997, 102, 99-110.
Inzucchi SI, Bergenstal RM, Buse JB et al (2015) Management of hyperglycaemia in type 2 diabetes, 2015: a patient-centered approach. Update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 58:429–442
Kirpichnikov D, McFarlane S I and Sowers J R, Ann Intern Med.,2002, 137(1), 25-33.
DPP Research Group, N Engl J Med., 2002, 346, 393-403.
Pillay V. and Fassihi R. Evaluation and comparison of dissolution data derived from different modified release dosage forms: an alternative method. J Control Release. 1998; 55(1): 45-55.
Polli J. E. In vitro studies are sometimes better than conventional human pharmacokinetic in vivo studies in assessing bioequivalence of immediate-release solid oral dosage forms. AAPS J. 2008; 10(2): 289-299.
Anderson N. H., Bauer M., et al. An evaluation of fit factors and dissolution efficiency for the comparison of in vitro dissolution profiles. J Pharm Biomed Anal. 1998; 17(4-5): 811-822.
Arayne, M. et al. (2006). Development and validation of RP-HPLC method for analysis of metformin. Pak J Pharm Sci. 19 (1), p232.
Gadpe, H.H. and ParkishK.S.. (2011). Quantitative Determination and Validation of Metformin Hydrochloride in Pharmaceutical Using Quantitative Nuclear Magnetic Resonance Spectroscopy. E-Journal of Chemistry. 8 (2), 767.
Umapathi, P. et al. (2012). Quantitative Determination of Metformin Hydrochloride in Tablet Formulation Containing Croscarmellose Sodium as Disintegrant by HPLC and UV Spectrophotometry. TROP J PHARM RES. 11 (1), 107.
The United States Pharmacopeia 30: The National Formulary 25.2015 Rockville, the United States Pharmacopeial Convention, Inc,p433

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