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, 36 (3), 300–306. 4 Lawrence, D. B., Ragucci, K. R., Long, L. B., et al.: Relationship of oral antihyperglycemic (sulfonylurea or metformin) medication adherence

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glucose [ 1 ]. Chemically, metformin (MET) is 1,1-dimethyl biguanide (Figure 1 ). It decreases the gluconeogenesis process and increases the glucose uptake by muscles and fat cells. It is the cornerstone for the treatment of diabetes mellitus type

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1. Introduction Metformin (MTF) is a biguanide class drug which is orally administered for the management of type 2 diabetes. In patients with type 2 diabetes, MTF improves glucose tolerance, as well as lowers the

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UKPDS Group: Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes. United Kingdom Prospective Diabetes Study. Lancet, 1998, 352

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References 1 Rojas, L. B., Gomes, M. B.: Metformin: an old but still the best treatment for type 2 diabetes. Diabetol. Metab. Syndr., 2013, 5 (1), 6

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2010 Jermendy Gy.: A 2-es típusú diabetesben szenvedők kezelése metformin-monoterápia után – a diabetológus/belgyógyász lehetőségei

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; 352: 837–853. Erratum: Lancet 1999; 354: 602. 7 UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients

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2009 Oppelt, P. G., Mueller, A., Jentsch, K. D. és mtsai: The effect of metformin treatment for 2 years without caloric restriction on

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Journal of Thermal Analysis and Calorimetry
Authors: Ana Santos, I. Basílio, F. de Souza, A. Medeiros, Márcia Pinto, D. de Santana, and R. Macêdo

Abstract  

Thermal analysis is an essential analytical tool in development of new formulations as well as to study the interaction between drugs and excipients. This work aims to investigate the possible interactions between metformin and excipients as microcrystalline cellulose (Microcel MC101®), starch sodium glycolate (Explosol®), sodium croscarmellose (Explosel®), PVP K30, magnesium stearate, starch and lactose, usually employed in pharmaceutical products. TG, DSC and DTA techniques were used for the thermal characterization to track if the thermal properties of the drug substance were modified in the mixture. Disregard of the starch and lactose systems, no changes in thermal behavior of mixtures were found. Thermogravimetric studies (TG) of metformin and its binary mixtures showed different thermal behavior.

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Summary

A simple, rapid, precise, and accurate, stability-indicating reversed phase high performance liquid chromatographic method was developed and validated for simultaneous determination of metformin HCl and repaglinide. The chromatographic separation was achieved on YMC Pack AM ODS (5 μm, 250 mm length × 4.6 mm i.d.) column at a detector wavelength of 210 nm, using an isocratic mobile phase consisting of methanol and 10 mM potassium dihydrogen phosphate buffer (pH 2.5) in a ratio of 70:30 v/v at a flow rate of 1 mL min−1. The retention times for metformin and repaglinide were found to be 2.6 and 11.3 min, respectively. The drugs were exposed to thermal, photolytic, hydrolytic, and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. Validation of the method was carried out as per International Conference on Harmonization (ICH) guidelines. Linearity was established for metformin and repaglinide in the range of 5–200 μg mL−1 and 1–200 μg mL−1, respectively. The limits of detection were 0.3 μg mL−1 and 0.13 μg mL−1 for metformin and repaglinide, respectively. The method was found to be specific and stability-indicating as no interfering peaks of degradants and excipients were observed. The proposed method is hence suitable for application in quality-control laboratories for quantitative analysis of both the drugs individually and in combination, since it is simple and rapid with good accuracy and precision.

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