METFORMIN HYDROCHLORIDE tablet extended release

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

St Marys Medical Park Pharmacy

INN (Alþjóðlegt nafn):

METFORMIN HYDROCHLORIDE

Samsetning:

METFORMIN HYDROCHLORIDE 500 mg

Gerð lyfseðils:

PRESCRIPTION DRUG

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
ST MARYS MEDICAL PARK PHARMACY
----------
METFORMIN HYDROCHLORIDE EXTENDED - RELEASE TABLETS
DESCRIPTION
Metformin hydrochloride extended - release tablets 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 is a white to off-white crystalline compound
with a molecular formula of
C4H11N5•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 extended - release tablets contain 500 mg or
750 mg of metformin
hydrochloride USP as the active ingredient.
Metformin hydrochloride extended-release tablets 500 mg contain the
inactive ingredients xanthan gum,
hypromellose, sodium carbonate, povidone, talc, colloidal silicon
dioxide and magnesium stearate.
Metformin hydrochloride extended-release tablets 750 mg contain the
inactive ingredients xanthan gum,
hypromellose, sodium carbonate, povidone, talc, colloidal silicon
dioxide, magnesium stearate and
ferric oxide (red).
SYSTEM COMPONENTS AND PERFORMANCE- Metformin hydrochloride extended -
release tablets
comprises a hydrophilic polymer matrix system. Metformin hydrochloride
is combined with a drug
release controlling polymers to form a monophasic matrix system. 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