BIOEQUIVALENCE OF METFORMIN AS AN ORAL ANTIDIABETIC: A SYSTEMATIC REVIEW

Authors

  • FITRIANTI DARUSMAN Department of Pharmacy, Faculty of Mathematics and Natural Sciences, Universitas Islam Bandung, Bandung, West Java, Indonesia. Department of Pharmaceutical and Technology of Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia https://orcid.org/0000-0003-2351-9924
  • TAOFIK RUSDIANA Department of Pharmaceutical and Technology of Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia https://orcid.org/0000-0002-3321-2179
  • IYAN SOPYAN Department of Pharmaceutical and Technology of Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia https://orcid.org/0000-0001-7616-5176
  • NIKEN FITRIA YULIAR Department of Pharmacy, Faculty of Mathematics and Natural Sciences, Universitas Islam Bandung, Bandung, West Java, Indonesia https://orcid.org/0009-0000-1350-3887
  • RATIH ARYANI Department of Pharmacy, Faculty of Mathematics and Natural Sciences, Universitas Islam Bandung, Bandung, West Java, Indonesia

DOI:

https://doi.org/10.22159/ijap.2023v15i6.49142

Keywords:

Bioequivalence, Bioavailability, Pharmacokinetics, Glucophage®, Metformin

Abstract

Metformin is the first line in type 2 Diabetes Mellitus (DM). Metformin is available as an innovator drug and copy drug. The high price of innovator drugs makes it difficult for patients to obtain the required drugs. Therefore, many pharmaceutical industries have developed a copy of the innovator drug. To obtain .a distribution license, the pharmaceutical industry must conduct a bioequivalence test on metformin copy tablets to ensure that the copy drug has the same efficacy, safety, and quality as the innovator drug. However, several surveys show that most patients believe that the effectiveness of copy drugs is not equivalent to the innovator drug. This study aims to determine the bioavailability profile and bioequivalence profile of Metformin copy tablets to Glucophage® (Merck) innovator tablets so that it can provide an overview of the effectiveness of copy drugs with innovator drugs and the public no longer hesitate to use copy drugs. Metformin copy tablets are declared bioequivalent to the innovator drug if they provide a Confidence Interval (CI) value of 90% in the 80-125% range. All 500 mg, 850 mg, and 1000 mg doses of metformin copy tablets, both fasting and eating conditions, gave bioequivalent results to the innovator Glucophage® based on 90% CI.

Downloads

Download data is not yet available.

References

Kementerian Kesehatan RI. Infodatin tetap produktif, cegah, dan atasi Diabetes Melitus 2020. Pusat Data dan Informasi Kementerian Kesehatan RI; 2020. p. 1-10.

Dipiro JT, Talbert GC, Yee GR, Matzke BG, Wells LMP. Pharmacotherapy: a pathophysiology approach. 10th ed. McGraw-Hill Medical; 2017. p. 6007-48.

Rena G, Hardie DG, Pearson ER. The mechanisms of action of metformin. Diabetologia. 2017;60(9):1577-85. doi: 10.1007/s00125-017-4342-z, PMID 28776086.

AT SV, MGS, SB, MSU, AV, SV. Impact of diabetes mellitus on clinical profile and outcome of COVID-19 patients in a Tertiary Care Hospital. Int J Pharm Pharm Sci. 2023;15(2):31-4.

Peraturan Badan Pengawas BPOM. Obat dan Makanan Nomor 1 Tahun 2022. Menteri Kesehatan Republ Indones Peraturan Menteri Kesehatan Republ Indones; 2022. p. 1-53.

Colgan S, Faasse K, Martin LR, Stephens MH, Grey A, Petrie KJ. Perceptions of generic medication in the general population, doctors and pharmacists: a systematic review. BMJ Open. 2015;5(12):e008915. doi: 10.1136/bmjopen-2015-008915, PMID 26671954.

Meyers EC, Solorzan BR, James J, Ganzer PD, SE, Rennaker RL. Modernizing clinical trial eligibility criteria: recommendations of the ASCO-friends of cancer research washout period and concomitant medication work group. Physiol Behav. 2018;176(1):100-6.

Mussttaf GS, Habib A, Mahtook M. Drug prescribing pattern and cost-effectiveness analysis of oral antidiabetic drugs in patients with type-2 diabetes mellitus: real-world data from Indian population. Asian J Pharm Clin Res. 2021;14(7):45-9. doi: 10.22159/ajpcr.2021.v14i7.41677.

Sun ML, Liu C, Bai HH, Wei YL, Zhang W, Liu HJ. Bioequivalence and safety evaluation of two preparations of metformin hydrochloride sustained-release tablets (Boke® and Glucophage®-XR) in healthy Chinese volunteers: a randomized phase I clinical trial. Ann Med. 2022;54(1):2617-26. doi: 10.1080/07853890.2022.2125574, PMID 36135935.

Hu C, Gao D, Li D, Zhou D, Zhang L. Chinese and French-manufactured immediate-release glucophage® bioequivalence: a randomized, open-label, crossover study. Drugs RD. 2022;22(4):301-9. doi: 10.1007/s40268-022-00405-3, PMID 36264446.

Jin X, Kim E, Huh KY, Hwang I, Cho JY, Yu KS. Pharmacokinetics and pharmacodynamics of a fixed-dose combination of gemigliptin/metformin sustained release 25/500 mg compared to the loose combination in healthy male subjects. Transl Clin Pharmacol. 2020;28(1):43-54. doi: 10.12793/tcp.2020.28.e2, PMID 32274380.

Upreti VV, Keung CF, Boulton DW, Chang M, Li L, Tang A. Bioequivalence of saxagliptin/metformin immediate release (IR) fixed-dose combination tablets and single-component saxagliptin and metformin IR tablets in healthy adult subjects. Clin Drug Investig. 2013;33(5):365-74. doi: 10.1007/s40261-013-0075-z, PMID 23549864.

Dawra VK, Pelletier K, Matschke K, Shi H, Hickman A, Zhou S. Bioequivalence of metformin in ertugliflozin/metformin fixed-dose combination tablets to Canadian-sourced metformin coadministered with ertugliflozin under fasted and fed states. Clin Pharmacol Drug Dev. 2021;10(5):510-20. doi: 10.1002/cpdd.884, PMID 33135865.

McKenney EA, Hale AR, Anderson J, Larsen R, Grant C, Dunn RR. Hidden diversity: comparative functional morphology of humans and other species. Peer J. 2023;11:e15148. doi: 10.7717/peerj.15148, PMID 37123005.

Soelistijo S. Pedoman pengelolaan dan pencegahan diabetes melitus tipe 2 dewasa di Indonesia 2021. Glob Initiat Asthma. 2021;46. Available from: www.ginasthma.org.

Zhou Z, Wang C, Li M, Lan Q, Yu C, Yu G. In vitro dissolution and in vivo bioequivalence evaluation of two metformin extended-release tablets. Clin Pharmacol Drug Dev. 2021;10(4):414-9. doi: 10.1002/cpdd.857, PMID 32706921.

Sun ML, Liu HJ, Luo XD, Wang Y, Zhang W, Liu C. Bioequivalence and safety assessment of two formulations of metformin hydrochloride sustained-release tablets (Yuantang® SR and Glucophage® XR) under fed conditions in healthy Chinese adult subjects: an open-label, two-way crossover, sequence randomized Phase I Clinical Trial. Drugs RD. 2022;22(1):51-60. doi: 10.1007/s40268-021-00377-w, PMID 35061235.

Kim S, Jang IJ, Shin D, Shin DS, Yoon S, Lim KS. Investigation of bioequivalence of a new fixed-dose combination of acarbose and metformin with the corresponding loose combination as well as the drug-drug interaction potential between both drugs in healthy adult male subjects. J Clin Pharm Ther. 2014;39(4):424-31. doi: 10.1111/jcpt.12166, PMID 24806030.

Valizadeh H, Nayyeri Maleki P, Ghanbarzadeh S, Sheikhloo A, Servat H, Nemati M. Pharmacokinetics and bioequivalence of two brands of metformin 500 mg tablets in Iranian healthy volunteers. J Pharm Investig. 2014;44(1):61-8. doi: 10.1007/s40005-013-0102-3.

Khomitskaya Y, Tikhonova N, Gudkov K, Erofeeva S, Holmes V, Dayton B. Bioequivalence of dapagliflozin/metformin extended-release fixed-combination drug product and single-component dapagliflozin and metformin extended-release tablets in healthy Russian subjects. Clin Ther. 2018;40(4):550-561.e3. doi: 10.1016/j.clinthera.2018.02.006, PMID 29548719.

Ghori SS, Kapoor A. A clinical study on adverse drug reactions of combination therapy of dapagliflozin and metformin in the treatment of type 2 diabetes mellitus. Asian J Pharm Clin Res. 2017;10(3):406-8. doi: 10.22159/ajpcr.2017.v10i3.16380.

Published

07-11-2023

How to Cite

DARUSMAN, F., RUSDIANA, T., SOPYAN, I., YULIAR, N. F., & ARYANI, R. (2023). BIOEQUIVALENCE OF METFORMIN AS AN ORAL ANTIDIABETIC: A SYSTEMATIC REVIEW. International Journal of Applied Pharmaceutics, 15(6), 76–81. https://doi.org/10.22159/ijap.2023v15i6.49142

Issue

Section

Review Article(s)

Most read articles by the same author(s)

<< < 1 2 3 4 > >>