Physicochemical and Pharmaceutical Equivalence of Different Metformin Brands Marketed in Davao City, Philippines

Authors

  • Marah Marie D. Areja University of the Immaculate Conception image/svg+xml Author
  • Annika Camille M. Bueno University of the Immaculate Conception image/svg+xml Author
  • Subiha T. Haiden University of the Immaculate Conception image/svg+xml Author
  • Cherrie G. Muaña University of the Immaculate Conception image/svg+xml Author
  • Annalee M. Montaño University of the Immaculate Conception image/svg+xml Author

Keywords:

Physicochemical, Pharmaceutical Equivalence, Generic Equivalence, Branded Formula

Abstract

Background: In recent years, the perception of generic medicines as inferior to branded counterparts has generated significant concern among healthcare providers and consumers alike.

Objectives: This experiment was conducted in Davao City, Philippines, to determine whether there were any differences in terms of physicochemical and pharmaceutical equivalence among different brands of Metformin Hydrochloride tablets marketed in the region.

Methods: These brands were named using letters A through J. The test involved assessing weight uniformity, hardness, friability, disintegration, assay, and dissolution according to both official and non-official pharmacopeial standards for metformin tablets.

Results: It has been determined that all ten different metformin brands conformed to the official requirements concerning weight variation, friability, disintegration time, as well as assay and dissolution. The hardness test complied with the unofficial USP limit.

Conclusion: This research work emphasizes the importance of continuous monitoring of generic drugs for their equivalence profile, as well as adherence to the principles prescribed in pharmacopeias, especially when prescribing decisions or generic dispensing guidelines are involved.

References

Flatie Alemu, A., Tegegne, A. A., & Getaw, N. S. (2024). Evaluation of Seven Different Brands of Metformin Hydrochloride Tablets Available in the Market in Gondar City, Ethiopia. Drug, healthcare and patient safety, 16, 19–28. https://doi.org/10.2147/DHPS.S419522

Sean Cayco, Cherrie Muaña. Physicochemical and In-Vitro Equivalence of 15 Generic Amlodipine Besylate Tablets Marketed in Davao City, Philippines. Research Journal of Pharmacy and Technology 2022; 15(12):5714-0. https://doi.org/10.52711/0974-360X.2022.00963

Chow, S. C. (2014). Bioavailability and bioequivalence in drug development. Wiley Interdisciplinary Reviews: Computational Statistics, 6(5), 304–312. https://doi.org/10.1002/wics.1310

Metry, M., Shu, Y., Abrahamsson, B., Cristofoletti, R., Dressman, J. B., Groot, D. W., Parr, A., Langguth, P., Shah, V. P., Tajiri, T., Mehta, M. U., & Polli, J. E. (2021). Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Metformin Hydrochloride. Journal of pharmaceutical sciences, 110(4), 1513–1526. https://doi.org/10.1016/j.xphs.2021.01.011

Abozaid DM, Saleh WM (2022) Evaluation of some metformin hydrochloride brands available in the Libyan market. Mediterr J Pharm Pharm Sci. 2 (4): 6-12. [Article number: 84]. https://doi.org/10.5281/zenodo.7479690

Olusola, A. M., Adekoya, A. I., & Olanrewaju, O. J. (2012). Comparative Evaluation of Physicochemical Properties of Some Commercially Available Brands of Metformin Hcl Tablets in Lagos, Nigeria. Journal of Applied Pharmaceutical Science, 2(2), 41–44. https://japsonline.com/abstract.php?article_id=377&sts=2

Osei, Y. A., Oppong Boakye, E., Bayor, M. T., & Akuffo Owusu, F. W. (2022). Physicochemical Equivalence and Quality Assessment of Various Brands of Gastro-Resistant Omeprazole Capsules in the Kumasi Metropolis. TheScientificWorldJournal, 2022, 7924600. https://doi.org/10.1155/2022/7924600

Osman, Z., Osman, A. E., & Abedelghayoum, A. (2017). Comparative evaluation of physicochemical properties of some commercially available brands of metformin HCl tablets marketed in Sudan. Indo American Journal of Pharmaceutical Research, 7(1), 7471–7477. https://doi.org/10.5281/zenodo.1007055

Prithi, I. J., Chowdhury, S. F., & Chowdhury, S. T. (2018). Comparative in vitro dissolution test and other physicochemical parameters of some commercially available metformin HCl brands in Bangladesh. The Pharma Innovation Journal, 7(6), 05–08. https://www.thepharmajournal.com/archives/2018/vol7issue6/PartA/7-5-83-364.pdf

Shekunov, B., & Montgomery, E. R. (2016). Theoretical Analysis of Drug Dissolution: I. Solubility and Intrinsic Dissolution Rate. Journal of pharmaceutical sciences, 105(9), 2685–2697. https://doi.org/10.1016/j.xphs.2015.12.006

Sougi, A., Ofori-Kwakye, K., Kuntworbe, N., Kipo, S. L., & Boakye-Gyasi, M. E. (2015). Evaluation of the physicochemical and in vitro dissolution properties of metformin hydrochloride tablet brands marketed in five cities in Ghana. Journal of Pharmaceutical Research International, 9(1), 1–14. https://doi.org/10.9734/BJPR/2016/21862

United States Pharmacopeial Convention. (2006). The United States pharmacopeia: The national formulary (USP 29–NF 24). United States Pharmacopeial Convention

United States Pharmacopeial Convention. (2018). United States pharmacopeia and national formulary (USP 41–NF 36). United States Pharmacopeial Convention.

Wong, J. Q., Baclay, R. M., Duque, R. G., Roque, P. M. S., Serrano, G. K. T., Tumlos, J. O. A., & Ronsing, A. A. (2014). The Prevalence of Philippine Prescribing, Dispensing, and Use Behavior in Relation to Generic Drugs and their Risk Factors. Philippine Institute for Development Studies. Discussion Paper Series No. 2014-17.

Published

27-04-2023

Issue

Section

Original Research Articles

How to Cite

Areja, M. M. D., Bueno, A. C. M., Haiden, S. T., Muaña, C. G., & Montaño, A. M. (2023). Physicochemical and Pharmaceutical Equivalence of Different Metformin Brands Marketed in Davao City, Philippines. Root Gatherers, 14(1). https://ojs.uic.edu.ph/index.php/rootgatherers/article/view/87