Oxytrol

Drug Description
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Oxytrol
(oxybutynin) Transdermal System Patch

DRUG DESCRIPTION

OXYTROL, oxybutynin transdermal system, is designed to deliver oxybutynin continuously and consistently over a 3- to 4-day interval after application to intact skin. OXYTROL is available as a 39 cm2 system containing 36 mg of oxybutynin. OXYTROL has a nominal in vivo delivery rate of 3.9 mg oxybutynin per day through skin of average permeability (interindividual variation in skin permeability is approximately 20%).

Oxybutynin is an antispasmodic, anticholinergic agent. Oxybutynin is administered as a racemate of R- and S-isomers. Chemically, oxybutynin is d, l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate. The empirical formula of oxybutynin is C22H31NO3. Its structural formula is:

Oxytrol (oxybutynin) structural formula illustration

Oxybutynin is a white powder with a molecular weight of 357. It is soluble in alcohol, but relatively insoluble in water.

Transdermal System Components

OXYTROL is a matrix-type transdermal system composed of three layers as illustrated in Figure 1 below. Layer 1 (Backing Film) is a thin flexible polyester/ethylene-vinyl acetate film that provides the matrix system with occlusivity and physical integrity and protects the adhesive/drug layer. Layer 2 (Adhesive/Drug Layer) is a cast film of acrylic adhesive containing oxybutynin and triacetin, USP. Layer 3 (Release Liner) is two overlapped siliconized polyester strips that are peeled off and discarded by the patient prior to applying the matrix system.

Figure 1: Side and top views of the OXYTROL system. (Not to scale)

Side View

Side View - illustration

Top View

Top View - illustration

Last updated on RxList: 11/25/2008

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