国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
Saxagliptin; Metformin hydrochloride
Bristol-Myers Squibb Australia Pty Ltd
Medicine Registered
Kombiglyze XR Product Information CV.000-810-511.2.0 1(39) KOMBIGLYZE ® XR saxagliptin/metformin hydrochloride extended release PRODUCT INFORMATION NAME OF THE MEDICINE KOMBIGLYZE XR (saxagliptin/metformin hydrochloride) modified release tablets contain two oral antihyperglycaemic drugs used in the management of type 2 diabetes: saxagliptin and metformin hydrochloride. SAXAGLIPTIN Saxagliptin is an orally-active inhibitor of the dipeptidyl peptidase 4 (DPP-4) enzyme. Saxagliptin is described chemically as (1S,3S,5S)-2-[(2S)-2-amino-2-(3- hydroxytricyclo [3.3.1.1 3,7 ] dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3- carbonitrile, monohydrate. The chemical structure of saxagliptin is: CAS number: 945667-22-1 Molecular formula: C 18 H 25 N 3 O 2 •H 2 O Molecular weight: 333.43 (monohydrate) METFORMIN HYDROCHLORIDE Metformin hydrochloride (_N,N_-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide with antihyperglycaemic effects. Kombiglyze XR Product Information CV.000-810-511.2.0 2(39) The chemical structure of metformin hydrochloride is: CAS number: 1115-70-4 Molecular formula: C 4 H 11 N 5 • HCl Molecular weight: 165.63 DESCRIPTION SAXAGLIPTIN Saxagliptin is a white to light yellow or light brown powder, non hygroscopic, crystalline. It is soluble in polyethylene glycol 400, acetone, acetonitrile, ethanol, isopropyl alcohol, methanol; sparingly soluble in water and slightly soluble in ethyl acetate. METFORMIN HYDROCHLORIDE Metformin hydrochloride is a white to off-white crystalline compound. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. KOMBIGLYZE XR KOMBIGLYZE XR i 完全なドキュメントを読む