OXYBUTYNIN CHLORIDE tablet film coated extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092)

Available from:

McKesson Contract Packaging

INN (International Name):

OXYBUTYNIN CHLORIDE

Composition:

OXYBUTYNIN CHLORIDE 5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OXYBUTYNIN CHLORIDE- OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
MCKESSON CONTRACT PACKAGING
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DESCRIPTION
Oxybutynin chloride is an antispasmodic, anticholinergic agent. Each
oxybutynin chloride extended-
release tablet, USP contains 5 mg or 10 mg of oxybutynin chloride USP,
formulated as a once-a-day
controlled-release tablet for oral administration. Oxybutynin chloride
is administered as a racemate of
R- and S- enantiomers.
Chemically, oxybutynin chloride is d,l (racemic)
4-diethylamino-2-butynyl phenyl-cyclohexylglycolate
hydrochloride. The molecular formula of oxybutynin chloride is C
H NO • HCl.
Its structural formula is:
Oxybutynin chloride is a white crystalline solid with a molecular
weight of 393.9. It is readily soluble
in water and acids, but relatively insoluble in alkalis.
Oxybutynin chloride extended-release tablets contain the following
inactive ingredients: colloidal
silicon dioxide, dibasic calcium phosphate (anhydrous), hypromellose,
magnesium stearate, methacrylic
acid copolymer dispersion, polydextrose, polyethylene glycol,
polysorbate 80, povidone, sodium
hydroxide, talc, titanium dioxide, triacetin and triethyl citrate. The
5 mg strength also contains D&C
Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C
Red No. 40 Aluminum
Lake; and the 10 mg strength also contains FD&C Yellow No. 6 Aluminum
Lake.
In addition, the imprinting ink contains black iron oxide,
hypromellose and propylene glycol.
_Meets USP Dissolution Test 2._
SYSTEM COMPONENTS AND PERFORMANCE
Oxybutynin chloride extended-release tablets are formulated to deliver
oxybutynin chloride at a
controlled rate over approximately 24 hours. The dosage form is
comprised of a hydrophilic cellulose
polymer matrix tablet surrounded by an enteric coating system. The
enteric coat is insoluble in the low
pH environment of the stomach. As the tablet passes through the
stomach and enters the higher pH
environment of the small intestine, the enteric coating dissolves
and/or erodes to expose the polymer
ma