Quality of Metformin Tablets in Thailand

Main Article Content

Thanaporn Teppitak
Panida Ueasirikornkun

Abstract

Background: Metformin is a drug for the treatment of patients with type 2 diabetes mellitus (T2DM). The Department of Medical Sciences reported analytical data on metformin tablets in 2006 and 2018 showing that metformin tablet samples did not meet the standard requirement of 2.33 and 0.64%, respectively. The quality of the drug is crucial for effectively controlling blood sugar levels in diabetic patient.


Objective: To examine the quality of metformin tablets from public hospitals, domestic manufacturers, and importers.


Methods: It was an experimental research during October 2021 to September 2022. We used samples of instant-acting forms of metformin tablets from government hospitals and manufacturers and importers who volunteer by surveying drugs available in public hospitals nationwide through a Google form, then selecting samples according to the Pharmacopoeia registration number and lot release number notified by the hospital and selecting the Pharmacopoeia registration number of 3-5 lot release number per lot. Then, the samples of 500 mg and 850 mg metformin tablets were collected and analyzed the quality of drugs complied with the United States Pharmacopeia (USP 2020) in identification, assay, weight variation, dissolution test, and organic impurities.


Results: A total of 46 samples were collected from 15 local manufacturers (20 registration numbers and 45 lot numbers) and 1 foreign manufacturer (one registration numbers and one lot release number). The results of identification, assay, weight variation, dissolution test, and organic impurities, all samples met the requirements.


Conclusions: All samples of metformin tablets available in public hospitals, manufacturers and an importer complied with the USP standards and has pharmaceutical equivalence. Thus, the surveillance of the quality of metformin tablets should be further continued to ensure the consumer protection.

Article Details

How to Cite
1.
Teppitak T, Ueasirikornkun P. Quality of Metformin Tablets in Thailand. TFDJ [Internet]. 2023 Nov. 9 [cited 2024 Apr. 21];30(3):70-8. Available from: https://he01.tci-thaijo.org/index.php/fdajournal/article/view/266874
Section
Research Article
Author Biography

Thanaporn Teppitak, Regional Medical Sciences Center 10, Ubon Ratchathani, Thailand

Regional Medical Sciences Center 10, Ubon Ratchathani, Khlang Awut Road, Mueang District, Ubon Ratchathani, 34000, Thailand

References

ประกาศคณะกรรมการพัฒนาระบบยาแห่งชาติ. เรื่อง บัญชียาหลักแห่งชาติ พ.ศ. 2565. ราชกิจจานุเบกษา เล่มที่ 139, ตอนพิเศษ 182ง (ลงวันที่ 5 สิงหาคม 2565).

American Diabetes Association. Pharmacologic approaches to glycemic treatment: Standards of medical care in diabetes - 2021. Diabetes Care [Internet]. 2021 [cited 2022 Nov 9];44(Suppl1): S111-S124. Available from: https://pubmed.ncbi.nlm.nih.gov/33298420/

Zhu S, Yoshida N, Tsuboi H, Matsushita R, Kimura K. Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites. Therapeutic Innovation & Regulatory Science [Internet]. 2021 [cited 2022 Nov 9];55(4):656–66. Available from: https://pubmed.ncbi.nlm.nih.gov/33595786/

Odeniran O, Olayemi O, Galadima I, Kirim R, Isimi C, Mustapha K. Quality assessment of nine brands of metformin hydrochloride tablets marketed in Abuja, Nigeria. Journal of Pharmacy and Bioresources [Internet]. 2021 [cited 2022 Nov 9];18(3):215–22. Available from: https://www.ajol.info/index.php/jpb/article/view/218307

United States Pharmacopeia National Formulary (USP-NF/PF). 43rd ed. Metformin Hydrochloride Tablets. Rockville, MD: The United States Pharmacopeia Convention; 2020. p.2822.

United States Pharmacopeia National Formulary (USP-NF/PF). 43rd ed. Validation of compendial procedures <1225>. Rockville, MD: The United States Pharmacopeia Convention; 2020. p.8166.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Validation of analytical procedures: text and methodology Q2(R1). ICH Steering Committee; Nov 2005.

สำนักงานคณะกรรมการอาหารและยา. กองยา. แนวทางการดำเนินการจัดการปัญหาคุณภาพยา. กรุงเทพฯ: อักษรกราฟฟิคแอนด์ดีไซน์; 2563.

สำนักงานคณะกรรมการอาหารและยา. ระบบค้นหาข้อมูลผลิตภัณฑ์ยา [อินเทอร์เน็ต]. [เข้าถึงเมื่อ 27 มี.ค. 2566]. เข้าถึงได้จาก: https://pertento.fda.moph.go.th/FDA_SEARCH_DRUG/SEARCH_DRUG/FRM_SEARCH_DRUG.aspx