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Metformin HCl extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes.
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Metformin hydrochloride (HCI) extended-release tablets, USP are oral antihyperglycemic drugs used in the management of type 2 diabetes.
Metformin HCl, USP (N,N-dimethyl-imidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:
Metformin HCl, USP is a white to off-white crystalline compound with a molecular formula of C4H11N5 • HCl and a molecular weight of 165.63. Metformin HCl, USP 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 HCl, USP is 6.68.
Metformin HCI extended-release tablets, USP, contains 500 mg or 750 mg of metformin HCl, USP as the active ingredient.
Metformin HCI extended-release tablets, USP 500 mg contain the inactive ingredients; colloidal silicon dioxide, hypromellose, magnesium stearate and microcrystalline cellulose.
Metformin HCI extended-release tablets, USP 750 mg contain the inactive ingredients; colloidal silicon dioxide, hypromellose and magnesium stearate.
Dissolution Method: Test 10
System Components and Performance - Metformin HCI extended-release tablets, USP comprises a dual hydrophilic polymer matrix system. Metformin HCl is combined with a drug release controlling polymer to form an "inner" phase, which is then incorporated as discrete particles into an "external" phase of a second polymer. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.