METFORMIN HYDROCHLORIDE tablet extended release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Dostupné s:

Avera McKennan Hospital

INN (Mezinárodní Name):

METFORMIN HYDROCHLORIDE

Složení:

METFORMIN HYDROCHLORIDE 500 mg

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
AVERA MCKENNAN HOSPITAL
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METFORMIN HYDROCHLORIDE TABLETS USP
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP
DESCRIPTION
Metformin hydrochloride tablets USP and Metformin hydrochloride
extended-release tablets USP are
oral antihyperglycemic drugs used in the management of type 2
diabetes. Metformin hydrochloride
(_N,N_-dimethylimidodicarbonimidic diamide hydrochloride) is not
chemically or pharmacologically
related to any other classes of oral antihyperglycemic agents. The
structural formula is as shown:
Metformin hydrochloride USP is a white to off-white crystalline
compound with a molecular formula
of C H N • 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 pK of metformin is 12.4. The
pH of a 1% aqueous solution of metformin hydrochloride is 6.68.
Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg
of metformin
hydrochloride. In addition, each tablet contains the following
inactive ingredients: hypromellose,
magnesium stearate, polyethylene glycol, and povidone. In addition,
500 mg also contains colloidal
silicon dioxide.
Metformin hydrochloride extended-release tablets USP, 500 mg contain
metformin hydrochloride as the
active ingredient. In addition, each tablet contains the following
inactive ingredients: carboxy
methylcellulose sodium, colloidal silicon dioxide, hypromellose,
magnesium stearate, and
microcrystalline cellulose.
SYSTEM COMPONENTS AND PERFORMANCE - Metformin hydrochloride
extended-release tablets USP
comprise a dual hydrophilic polymer matrix system. Metformin
hydrochloride 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 rel