COMPARATIVE STUDY BETWEEN FIVE BRANDS OF METFORMIN HYDROCHLORIDE AVAILABLE IN LIBYAN DRUG MARKET
Metformin hydrochloride is a drug of choice in the treatment of diabetes mellitus type-2 especially in obese patients. It is normally given orally as tablets in doses of 500 mg two or three times daily or 850 mg once or twice daily during or after meals.
The aim of the present study was the comparative study and evaluation between five different Metformin hydrochloride brands which are commercially available in the Libyan drug market (Metformin, Glymet, Metformin(STADA), Metforal & Dialon). To assess quality, all products were examined visually for their organoleptic properties. The physicochemical equivalence of five brands of Metformin hydrochloride tablets were determined through the evaluation of official standards according to the USP pharmacopoeia including uniformity of weight, friability, hardness, disintegration, dissolution rate and drug content. A variation of the concept of dissolution efficiency (DE), known as predicted availability equivalent (PAE), was used to predict the likely in vivo bioavailability. All the tested five brands were equivalent and complying with the official tests for weight variation, friability, hardness, disintegration and dissolution tests. The friability test was within the specified limit. All formulations were disintegrated within 15-30 min. The tested brands were identical according to their dissolution evaluation. The percentage content of active ingredient of five brands of Metformin tablets showed values within the monograph specifications (95-105%). All the brands are within their expiry dates but there is major difference in price.
The basic function groups of five metformin brands and metformin standard was identified by Infra-Red (IR) spectrophotometer. The spectroscopic investigations were revealed no any difference between Metformin five brands and showed identical peaks compared to the reference.
2. Korolkovas A. Dicionário terapêutico Guanabara. Rio de Janeiro: Guanabara Koogan; 2006. 664p.
3. International Diabetes Federation, clinical Guideline Task Force. Glucose control: Oral therapy, Global Guidelines for Type 2 Diabetes Brusseles.2005.35-8 .
4. Giovanna C, Francesca M, Marzia C, Naima Z, Poala M . Development and evaluation of an in vitro method for prediction of human drug absorption II demonstration of the method suitability. European.2006;27:354-362.
5. Bailey CJ, Day C. Metformin: its botanical background. Practical Diabetes International.2004; 21(3):115–7.
6. Alan D. The use of Medicines in the United States. IMS Institute for Healthcare Informatics .2011; 28.
7. Campbell IW. Metformin and the united kingdom prospective diabetes study: a commentary. Arq Bras Endocrinol Metabol 2000; 44(2):121-24.
8. Sambol NC, Brookes LG, Chiang J, Goodman AM, Lin ET, Liu CY, Benet LZ. Food intake and dosage level, but not tablet vs solution dosage form, affect the absorption of metformin HCl in man. Br J Clin Pharmacol 1996; 42:510-12.
9. Cheng CL, Yu LX, Lee HL, Yang CY, Lue CS, Chou CH. Biowaiwer extension potential to BCS Class III high solubility-low permeability drugs: bridging evidence for metformin immediate-release tablet. Eur J Pharm Sci 2004; 22(4):297-304.
10. Adegbolagun OA, Ololade OA, Osamah SE. Comparative evaluation of biopharmaceutical and chemical equivalence of some commercially evaluable brands of ciprofloxacin hydrochloride tablets. Tropical journal of pharmaceutical research.2007; 6:737-745.
11. Awofisayo OS, Oladoja AA, Nse E, Imo EU. Comparative Assessment of the quality control measurements of multisource ofloxacin tablets marketed in Nigeria. Dissolution Technologies. 2010;6:20-25.
12. Esiomone CO, Okoye FBC, Onah BU, Nworu CS, Omeje EO. In-vitro bioequivalence study of nine brands of artesunate tablets marketed in Nigeria. J.Vector Borne Dis.2008; 45:60-65.
13. Pamula RB, Surender G, Reddy KVS, Ujwala P, Jyosthna G, Kumar RM. Comparative in vitro evaluation of commercial metformin HCL tablets. JITPS 2010; 1:152-157.
14. Chow SJ. Pharmaceutical Validation and process controls in drug development. J Drug development.1997;31:1195-1201.
15. United States Pharmacopeia and National Formulary USP 24–NF 19. Rockville, Maryland, United States Pharmacopeial Convention, Inc., 2000:1882–1883.
Copyright (c) 2019 Abdulrhman Akasha, Eman .A. Ahdeya , Zainab .A. Bsebsu
This work is licensed under a Creative Commons Attribution 4.0 International License.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.