Evaluation of some metformin hydrochloride brands available in the Libyan market
Darine M. Abozaid, Wedad M. Saleh
Abstract
Various quality control tests are employed for solid dosage forms such as uniformity, dissolution and drug contents to assess their pharmaceutical equivalence. The objective of the current study was to assess and contrast five distinct metformin hydrochloride brands that are offered for sale in the Libyan market. The physicochemical equivalence of the five brands of metformin hydrochloride tablets (500 mg) was determined through the evaluation of official and non-official standards according to the USP including uniformity of weight, friability, hardness, dissolution rate and drug content. All the examined brands available in the Libyan market passed the official weight variation, friability, dissolution and disintegration tests and were equivalent. The friability test was found within the specified limit. All the formulations were disintegrated within 09-15 min. The tested brands were non-equivalent to the innovator Glucophage® according to their dissolution evaluation. The percentage content of the active ingredient of five brands of metformin tablets showed values within the monograph specifications (95%-105%). In conclusion, all the five brands available in the Libyan market that were evaluated in this study cannot be substituted with the innovator product in clinical practice.
Keywords
References
- Holman R (2007) Metformin as first choice in oral diabetes treatment: the UKPDS experience. Journees Annuelles de Diabetologie de I'Hotel-Dieu. 13-20. PMID: 18613325.
- Rojas LBA, Gomes MB (2013) Metformin: an old but still the best treatment for type 2 diabetes. Diabetology and Metabolic Syndrome. 5 (6): 1-15. doi: 10.1186/1758-5996-5-6
- IDF Clinical Guidelines Task Force (2006) Global Guideline for type 2 diabetes: recommendations for standard, comprehensive, and minimal care. Diabetic Medicine. 23 (6): 579-593. doi: 10.1111/j.1464-5491.2006.01918.x
- Wu T, Xie C, Wu H, Jones KL, Horowitz M, Rayner CK (2017) Metformin reduces the rate of small intestinal glucose absorption in type 2 diabetes. Diabetes, Obesity and Metabolism. 19 (2): 290-293. doi: 10.1111/ dom.12812
- Werner EA, Bell JM (1922) CCXIV - the preparation of methylguanidine, and of ββ-dimethylguanidine by the interaction of dicyanodiamide, and methylammonium and dimethylammonium chlorides respectively. Journal of the Chemical Society. (121): 1790-1794. doi: 10.1039/ct9222101790.
- Bailey CJ, Day C (2004) Metformin: its botanical background. Practical Diabetes International. 21 (3): 115-117. doi.org/10.1002/pdi.606
- Hemmingsen B, Schroll JB, Wetterslev J, Gluud C, Vaag A, Sonne DP, Lundstrom LH, Almdal T (2014) Sulfonylurea versus metformin monotherapy in patients with type 2 diabetes: a Cochrane systematic review and meta-analysis of randomized clinical trials and trial sequential analysis. Candian Medical Association Journal Open. 2 (3): E162-75. doi: 10.9778/cmajo.20130073
- Johnson JA, Majumdar SR, Simpson, Toth EL (2002) Decreased mortality associated with the use of metformin compared with sulfonylurea monotherapy in type 2 diabetes. Diabetes Care. 25 (12): 2244-2248. doi: 10.2337 /diacare.25.12.2244
- Azimova K, Juan ZS, Mukherjee D (2014) Cardiovascular safety profile of currently available diabetic drugs. The Ochsner Journal. 14 (4): 616-632. PMID: 25598727.
- Schernthaner G, Currie CJ, Schernthaner GH (2013) Do we still need pioglitazone for the treatment of type 2 diabetes? A risk-benefit critique in 2013. Diabetes Care. 36 (2): S155-S161. doi: 10.2337/dcS13-2031
- Desai D, Wong B, Huang Y, Tang D, Hemenway J, Paruchuri S, Guo H, Hsieh D, Timmins P (2015) Influence of dissolution media pH and USP basket speed on erosion and disintegration characteristics of immediate release metformin hydrochloride tablets. Pharmacy Development and Technology. 20 (5): 540-545. doi: 10.3109/ 10837450.2014.892132
- Nguyen TA, Knight R, Roughead EE, Brooks G, Mant A (2015) Policy options for pharmaceutical pricing and purchasing: issues for low- and middle-income countries. Health Policy and Planning. 30 (2): 267-280. doi: 10.1093/heapol/czt105. doi: Nil.
- Arora A, Parle A, Dahiya M, Rani R (2021) Comparative evaluation of metformin tablets available under government supply and brands available in open market in Delhi, India. IOSR Journal of Pharmacy. 11 (5): 8-20. doi: Nil.
- Afifi SA, Ahmadeen S (2012) A comparative study for evaluation of different brands of metformin hydrochloride 500 mg tablets marketed in Saudi Arabia. Life Science Journal. 9 (4): 4260-4266. doi: 10.7537 /marslsj090412.636
- Al-Arwadi RH, Gazy AAK, Soubra L, Ajami RD (2020) In vitro equivalence study of generic metformin hydrochloride tablets under biowaiver conditions. Beirut Arab University Journal - Health and Wellbeing. 2 (2): 1-12. doi: Nil.
- Olusola AM, Adekoya AI, Olanrewaju OJ, Olanrewaju OJ (2012) Comparative evaluation of physicochemical properties of some commercially available brands of metformin Hcl tablets in Lagos, Nigeria. Journal of Applied Pharmaceutical Sciences. 02 (02): 41-44. doi: Nil.
- Akasha AA, Ahdeya EA, Bsebsu ZA (2019) Comparative study between five brands of metoformin hydrochloride available in Libyan drug market. Mintage Journal of Pharmaceutical and Medical Sciences. 8 (3) 37-41. doi: Nil.
- Hamdan II, Bani Jaber KA (2010) Pharmaceutical evaluation of metformin HCl products available in the Jordanian market. Jordan Journal of Pharmaceutical Sciences. 3 (1): 1-7. doi: Nil.
- Crison JR, Timmins P, Keung A, Upreti VV, Boulton DW, Scheer BJ (2012) Biowaiver approach for biopharmaceutics classification system class 3 compound metformin hydrochloride using in silico modeling. Journal of Pharmaceutical Sciences. 101 (5): 1773-1782. doi: 10.1002/jps.23063
- Anand OM, Lawrence XY, Dale PC, Davit BM (2011) Dissolution testing for generic drugs: an FDA perspective. American Assciation for Pharmaceutical Scientists Journal. 13 (3): 328-335. doi: 10.1208/s12248-011-9272-y
Submitted date:
10/01/2022
Reviewed date:
10/24/2022
Accepted date:
10/31/2022
Publication date:
11/08/2024