SPL Set ID: 129ff158-097f-401a-8924-d9258465c1f3
1 drug(s) with this SPL Set ID
Metformin hydrochloride extended-release tablets contain 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 500 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. Each 500 mg tablet contains hypromellose, microcrystalline cellulose, polyethylene oxide, colloidal silicon dioxide, magnesium stearate, ethylcellulose, ammonium hydroxide, medium chain triglycerides and oleic acid. The tablets are film coated with coating material containing hypromellose, FD&C Blue No.2, titanium dioxide, and triethyl citrate. Each 1,000 mg tablet contains povidone, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, eudragit RL 30D, eudragit RS 30D, triethyl citrate, talc and hypromellose. The tablets are film coated with coating material containing hypromellose, titanium dioxide, talc and triethyl citrate. Each tablet is imprinted with black pharmaceutical ink which contains shellac, ferrosoferric oxide and propylene glycol. Metformin hydrochloride extended-release tablets USP, 500 mg and 1,000 mg: FDA approved dissolution test specifications differ from USP. chemstruc