SPL Set ID: 2737f784-07ad-4e5a-862f-beaea31d005e
1 drug(s) with this SPL Set ID
Metformin Hydrochloride extended release tablet, USP contains the biguanide antihyperglycemic agent metformin in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown: Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 •HCl and a molecular weight of 165.63. 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. Metformin hydrochloride extended-release tablets contain 1,000 mg of metformin hydrochloride, which is equivalent to 779.86 mg metformin. Metformin hydrochloride extended-release tablets are modified release dosage forms that contain 1,000 mg of metformin HCl. Each 1,000 mg tablet contains ammonium dioxide, black iron oxide, colloidal silicon dioxide, crospovidone type B, ethyl acrylate and methyl methacrylate copolymer dispersion, glyceryl dibehenate, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate, polyvinyl alcohol, propylene glycol, shellac glaze, simethicone emulsion, talc, titanium dioxide. Metformin hydrochloride extended-release 1,000 mg tablets are formulated to gradually release metformin to the upper gastrointestinal (GI) tract. FDA approved dissolution method differs from the current USP monograph dissolution methods str