GLYBURIDE AND METFORMIN tablet film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Glyburide (UNII: SX6K58TVWC) (Glyburide - UNII:SX6K58TVWC)

Commercializzato da:

PD-Rx Pharmaceuticals, Inc.

INN (Nome Internazionale):

Glyburide

Composizione:

Glyburide 5 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

GLYBURIDE AND METFORMIN - GLYBURIDE AND METFORMIN TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS USP
RX ONLY
5710
5711
5712
DESCRIPTION
Glyburide and metformin hydrochloride tablets USP contain two oral
antihyperglycemic drugs used in
the management of type 2 diabetes, glyburide USP and metformin
hydrochloride USP.
Glyburide USP is an oral antihyperglycemic drug of the sulfonylurea
class. The chemical name for
glyburide USP is
1-[[_p_-[2-(5-chloro-_o_-anisamido)ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea.
Glyburide
USP is a white to off-white crystalline compound. The glyburide USP
used in glyburide and metformin
hydrochloride tablets USP has a particle size distribution of 25%
undersize value not more than 6 µm,
50% undersize value not more than 7 to 10 µm, and 75% undersize value
not more than 21 µm. The
structural formula is represented below:
C
H ClN O S M.W. 494.01
Metformin hydrochloride USP is an oral antihyperglycemic drug used in
the management of type 2
diabetes. Metformin hydrochloride USP (
_N,N_-dimethylimidodicarbonimidic diamide
monohydrochloride) is not chemically or pharmacologically related to
sulfonylureas,
thiazolidinediones, or α-glucosidase inhibitors. It is a white to
off-white crystalline compound.
Metformin hydrochloride USP is freely soluble in water and is
practically insoluble in acetone, ether,
and chloroform. The pK of metformin USP is 12.4. The pH of a 1%
aqueous solution of metformin
hydrochloride USP is 6.68. The structural formula is as shown:
23
28
3
5
a
C H ClN (monohydrochloride) M.W. 165.63
Each glyburide and metformin hydrochloride tablet USP, for oral
administration, contains 1.25 mg
glyburide USP with 250 mg metformin hydrochloride USP, 2.5 mg
glyburide USP with 500 mg
metformin hydrochloride USP, or 5 mg glyburide USP with 500 mg
metformin hydrochloride USP. In
addition, each tablet contains the following inactive ingredients:
copovidone, crospovidone,
hypromellose, magnesium stearate, microcrystalline cellulose,