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US 2003/0157156 A1Published application
Transdermal administration of oxybutynin using hydroxide-releasing agents as permeation enhancers
OwnerTsung-Min Hsu, Eric C. Luoinventors
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Abstract
A method is provided for increasing the permeability of skin or mucosal tissue to transdermally administered oxybutynin. The method involves use of a specified amount of a hydroxide-releasing agent, the amount optimized to increase the flux of the drug through a body surface while minimizing the likelihood of skin damage, irritation or sensitization. Formulations, drug delivery systems and methods of treatment are provided as well.
Claims62
A composition of matter useful for the delivery of oxybutynin through a body surface, comprising:
- (a) a therapeutically acceptable amount of oxybutynin;
- (b) a hydroxide-releasing agent in an amount effective to enhance the flux of oxybutynin through the body surface without causing damage thereto and effective to provide a pH in the range of approximately 8.0 to 13 at the body surface during oxybutynin administration;
- and wherein the amount of hydroxide-releasing agent in the composition is the total of (a) the amount required to neutralize any acidic species in the composition plus (b) an amount equal to approximately 0.5 wt % to 25.0 wt % of the composition;
- and
- (c) a pharmaceutically acceptable carrier suitable for topical or transdermal drug administration.
2 more elements
A system for the transdermal administration of oxybutynin, comprising:
- (a) at least one reservoir containing oxybutynin and a hydroxide-releasing agent in an amount effective to enhance the flux of oxybutynin through the body surface of a human patient without causing damage thereto and effective to provide a pH in the range of approximately 8.0 to 13 at the body surface during oxybutynin administration;
- and wherein the amount of hydroxide-releasing agent in the reservoir is the total of (a) the amount required to neutralize any acidic species in the reservoir plus (b) an amount equal to approximately 0.5 wt % to 25.0 wt % of the reservoir;
- (b) a means for maintaining the system in drug and enhancer transmitting relationship to the body surface;
- and
- (c) a backing layer that serves as the outer surface of the system during use.
2 more elements
Dependencies are inferred from the claim text.