Glyburide and Metformin (Glyburide / Metformin Hydrochloride) - Description

DESCRIPTION

Glyburide and metformin hydrochloride tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes, glyburide and metformin hydrochloride.

Glyburide is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glyburide is 1-[[ p -[2-(5-chloro- o -anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea. Glyburide is a white to off-white crystalline compound. The structural formula is represented below:

Glyburide

C₂₃H₂₈CIN₃O₅S M.W. 494.01

Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N -dimethylimidodicarbonimidic diamide monohydrochloride) is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or a-glucosidase inhibitors. It is a white to off-white crystalline compound. Metformin hydrochloride is freely soluble in water 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. The structural formula is as shown:

Metformin Hydrochloride

C₄H₁₁N₅•HCl M.W.165.63

Glyburide and metformin hydrochloride is available for oral administration in tablets containing 1.25 mg glyburide with 250 mg metformin hydrochloride, 2.5 mg glyburide with 500 mg metformin, or 5 mg glyburide with 500 mg metformin hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. In addition, the 1.25 mg/250 mg and 5 mg/500 mg strengths contain D&C yellow #10 lake, and the 2.5 mg/500 mg and 5 mg/500 mg strengths contain iron oxide red.