ABDULRHMAN. A. AKASHA, EMAN .A. AHDEYA AND ZAINAB .A. BSEBSU
Objective : 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). Methods : 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. Results : 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.Conclusion : All the available brands in local market of Libya are having, with in the specified quality range and can be interchange of found any non-compliance due to cost issue. The results have shown that all the tested brands satisfied the USP requirements.