GLIPIZIDE XL tablet extended release

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

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제품 특성 요약 제품 특성 요약 (SPC)
12-05-2018

유효 성분:

GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C)

제공처:

St Marys Medical Park Pharmacy

INN (International Name):

GLIPIZIDE

구성:

GLIPIZIDE 5 mg

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

New Drug Application Authorized Generic

제품 특성 요약

                                GLIPIZIDE XL- GLIPIZIDE TABLET, EXTENDED RELEASE
ST MARYS MEDICAL PARK PHARMACY
----------
GLIPIZIDE XL
(GLIPIZIDE)
EXTENDED-RELEASE TABLETS
_FOR ORAL USE_
DESCRIPTION
Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea
class.
The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-
methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea. The molecular
formula is C
H
N
O
S;
the molecular weight is 445.55; the structural formula is shown below:
Glipizide is a whitish, odorless powder with a pKa of 5.9. It is
insoluble in water and alcohols, but
soluble in 0.1 _N_ NaOH; it is freely soluble in dimethylformamide.
Glipizide XL is the Greenstone brand
name for glipizide GITS. Glipizide GITS (Gastrointestinal Therapeutic
System) is formulated as a
once-a-day controlled release tablet for oral use and is designed to
deliver 2.5, 5, or 10 mg of
glipizide.
Inert ingredients in the 2.5 mg, 5 mg and 10 mg formulations are:
polyethylene oxide, hypromellose,
magnesium stearate, sodium chloride, red ferric oxide, cellulose
acetate, polyethylene glycol, Opadry
blue (OY-LS-20921)(2.5 mg tablets), Opadry
white (YS-2-7063)(5 mg and 10 mg tablet) and black
ink (S-1-8106).
SYSTEM COMPONENTS AND PERFORMANCE
Glipizide XL extended-release tablet is similar in appearance to a
conventional tablet. It consists,
however, of an osmotically active drug core surrounded by a
semipermeable membrane. The core itself
is divided into two layers: an "active" layer containing the drug, and
a "push" layer containing
pharmacologically inert (but osmotically active) components. The
membrane surrounding the tablet is
permeable to water but not to drug or osmotic excipients. As water
from the gastrointestinal tract enters
the tablet, pressure increases in the osmotic layer and "pushes"
against the drug layer, resulting in the
release of drug through a small, laser-drilled orifice in the membrane
on the drug side of the tablet.
21
27
5
4
®
®
The Glipizide XL extended-release tablet is designed to provide a
controlled rate of 
                                
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