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US5411740A Expired / Lapsed US ⏱️ 0.0 years remaining

Transdermal administration of oxybutynin

Assignee: Alza Corp
•
Filing: 1994-02-08
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Granted: 1995-05-02
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Expires: 2014-02-08
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Abstract

Abstract The present invention is directed to the transdermal administration of oxybutynin together with a suitable permeation enhancer. The invention includes a transdermal drug delivery device comprising a matrix adapted to be placed in oxybutynin- and permeation enhancer-transmitting relation with the skin site. The matrix contains sufficient amounts of a permeation enhancer and of oxybutynin, in combination, to continuously administer to the skin for a predetermined period of time the oxybutynin to provide an effective therapeutic result. The invention is also directed to a method for the transdermal administration of a therapeutically effective amount of oxybutynin together with a skin permeation-enhancing amount of a suitable permeation enhancer.

Inventors

  • 👤 Eun S. Lee
  • 👤 Diane E. Nedberge
  • 👤 Su I. Yum

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-06 17:55
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/13; A61K31/135; A61K9/00; A61K9/70; A61K9/7023; A61K9/703; A61K9/7038; A61K9/7046; A61K9/7053; A61K31/21; A61K31/215; A61K31/216; A61K47/00; A61K47/06; A61K47/08; A61K47/14; A61K9/0012; A61K9/0014; A61K9/7084; A61P; A61P13/00; A61P13/02; A61P15/00; A61P25/00

Claims Analysis

Total Claims: 32
Claim 1
Independent Claim 96 words
A device for the transdermal administration, at a therapeutically effective rate, of oxybutynin, which device comprises: (a) a reservoir consisting essentially of a therapeutically effective amount of an oxybutynin base, a skin permeation-enhancing amount of a monoglyceride or a mixture of monoglycerides of fatty acids with a total monoesters content of at least 51%, and ethylene vinyl acetate copolymer having from about 9% to about 60% vinyl acetate; (b) a backing on the skin-distal surface of the reservoir; and (c) an adhesive means for maintaining the reservoir in oxybutynin- and permeation enhancer-transmitting relation with the skin.
Claim 2
Independent Claim 96 words
A device for the transdermal administration, at a therapeutically effective rate, of oxybutynin, which device comprises: (a) a reservoir consisting essentially of a therapeutically effective amount of an oxybutynin base, a skin permeation-enhancing amount of a monoglyceride or a mixture of monoglycerides of fatty acids with a total monoesters content of at least 51%, and ethylene vinyl acetate copolymer having from about 9% to about 60% vinyl acetate; (b) a backing on the skin-distal surface of the reservoir; and (c) an adhesive means for maintaining the reservoir in oxybutynin- and permeation enhancer-transmitting relation with the skin.
Claim 3
Dependent Claim 18 words
A device according to claim 1 wherein the permeation enhancer is glycerol monooleate, glycerol monolaurate or glycerol monolinoleate.
Claim 4
Dependent Claim 28 words
A device according to claim 1 wherein the oxybutynin is administered through the skin at a rate of at least 0.08 mg/hour for a predetermined period of time.
Claim 5
Dependent Claim 31 words
A device according to claim 1 wherein the oxybutynin is administered through the skin at a permeation rate of at least 12 μg/cm 2 /hr for a predetermined period of time.
Claim 6
Dependent Claim 14 words
A device according to claim 1 wherein the backing is permeable to water vapor.
Claim 7
Dependent Claim 13 words
A device according to claim 1 wherein the permeation enhancer is glycerol monooleate.
Claim 8
Dependent Claim 30 words
A device according to claim 5 wherein the means for maintaining the reservoir in relation with the skin comprises an in-line adhesive layer on the skin-proximal surface of the reservoir.
Claim 9
Independent Claim 138 words
A device for the transdermal administration at a therapeutically effective rate, of oxybutynin, which device comprises: (a) a first reservoir consisting essentially of a therapeutically effective amount of an oxybutynin base, a skin permeation-enhancing amount of a monoglyceride or mixture of monoglycerides of fatty acids with a total monoesters content of at least 51%, and ethylene vinyl acetate copolymer having from about 9% to about 60% vinyl acetate; (b) a second reservoir comprising an excess of the monoglyceride or mixture of monoglycerides of fatty acids with a total monoesters content of at least 51% (c) a rate-controlling membrane between the first reservoir and the second reservoir; (d) a backing on the skin-distal surface of the second reservoir; and (e) an adhesive means for maintaining the first and second reservoirs in oxybutynin- and permeation enhancer-transmitting relation with the skin.
Claim 10
Independent Claim 138 words
A device for the transdermal administration at a therapeutically effective rate, of oxybutynin, which device comprises: (a) a first reservoir consisting essentially of a therapeutically effective amount of an oxybutynin base, a skin permeation-enhancing amount of a monoglyceride or mixture of monoglycerides of fatty acids with a total monoesters content of at least 51%, and ethylene vinyl acetate copolymer having from about 9% to about 60% vinyl acetate; (b) a second reservoir comprising an excess of the monoglyceride or mixture of monoglycerides of fatty acids with a total monoesters content of at least 51% (c) a rate-controlling membrane between the first reservoir and the second reservoir; (d) a backing on the skin-distal surface of the second reservoir; and (e) an adhesive means for maintaining the first and second reservoirs in oxybutynin- and permeation enhancer-transmitting relation with the skin.
Claim 11
Dependent Claim 28 words
A device according to claim 8 wherein the oxybutynin is administered through the skin at a rate of at least 0.08 mg/hour for a predetermined period of time.
Claim 12
Dependent Claim 31 words
A device according to claim 8 wherein the oxybutynin is administered through the skin at a permeation rate of at least 12 μg/cm 2 /hr for a predetermined period of time.
Claim 13
Dependent Claim 14 words
A device according to claim 8 wherein the backing is permeable to water vapor.
Claim 14
Dependent Claim 31 words
A device according to claim 8 wherein the means for maintaining the reservoirs in relation with the skin comprises an in-line adhesive layer on the skin-proximal surface of the first reservoir.
Claim 15
Dependent Claim 29 words
A device according to claim 8 wherein the first reservoir also is an adhesive layer which functions as the means for maintaining the reservoirs in relation with the skin.
Claim 16
Dependent Claim 18 words
A device according to claim 8 wherein the permeation enhancer is glycerol monooleate, glycerol monolaurate or glycerol monolinoleate.
Claim 17
Independent Claim 123 words
A method for treating neurogenic bladder disorders, the method comprising the step of placing an oxybutynin transdermal delivery device onto the skin of a person, the oxybutynin transdermal delivery device comprising: (a) a reservoir consisting essentially of oxybutynin base in an amount sufficient to provide treatment of symptoms of a neurogenic bladder for a predetermined period of time, a monoglyceride or mixture of monoglycerides of fatty acids with a total monoesters content of at least 51% in a skin permeation-enhancing amount, and ethylene vinyl acetate copolymer having from about 9% to about 60% vinyl acetate; (b) a backing on the skin-distal surface of the reservoir; and (c) an adhesive means for maintaining the reservoir in oxybutynin- and permeation enhancer-transmitting relation with the skin.
Claim 18
Independent Claim 123 words
A method for treating neurogenic bladder disorders, the method comprising the step of placing an oxybutynin transdermal delivery device onto the skin of a person, the oxybutynin transdermal delivery device comprising: (a) a reservoir consisting essentially of oxybutynin base in an amount sufficient to provide treatment of symptoms of a neurogenic bladder for a predetermined period of time, a monoglyceride or mixture of monoglycerides of fatty acids with a total monoesters content of at least 51% in a skin permeation-enhancing amount, and ethylene vinyl acetate copolymer having from about 9% to about 60% vinyl acetate; (b) a backing on the skin-distal surface of the reservoir; and (c) an adhesive means for maintaining the reservoir in oxybutynin- and permeation enhancer-transmitting relation with the skin.
Claim 19
Dependent Claim 18 words
A method according to claim 15 wherein the permeation enhancer is glycerol monooleate, glycerol monolaurate or glycerol monolinoleate.
Claim 20
Dependent Claim 28 words
A method according to claim 15 wherein the oxybutynin is administered through the skin at a rate of at least 0.08 mg/hour for the predetermined period of time.
Claim 21
Dependent Claim 31 words
A method according to claim 15 wherein the oxybutynin is administered through the skin at a permeation rate of at least 12 μg/cm 2 /hr for a predetermined period of time.
Claim 22
Dependent Claim 14 words
A method according to claim 15 wherein the backing is permeable to water vapor.
Claim 23
Dependent Claim 13 words
A method according to claim 15 wherein the permeation enhancer is glycerol monooleate.
Claim 24
Dependent Claim 30 words
A method according to claim 20 wherein the means for maintaining the reservoir in relation with the skin comprises an in-line adhesive layer on the skin-proximal surface of the reservoir.
Claim 25
Independent Claim 166 words
A method for treating neurogenic bladder disorders, the method comprising the step of placing a oxybutynin transdermal delivery device onto the skin of a person, the oxybutynin transdermal delivery device comprising: (a) a first reservoir consisting essentially of oxybutynin base in an amount sufficient to provide treatment of symptoms of a neurogenic bladder for a predetermined period of time, a monoglyceride or mixture of monoglycerides of fatty acids with a total monoesters content of at least 51% in a skin permeation-enhancing amount, and ethylene vinyl acetate copolymer having from about 9% to about 60% vinyl acetate; (b) a second reservoir comprising an excess of the monoglyceride or mixture of monoglycerides of fatty acids with a total monoesters content of at least 51% (c) a rate-controlling membrane between the first reservoir and the second reservoir; (d) a backing on the skin-distal surface of the second reservoir; and (e) an adhesive means for maintaining the first and second reservoirs in oxybutynin- and permeation enhancer-transmitting relation with the skin.
Claim 26
Independent Claim 166 words
A method for treating neurogenic bladder disorders, the method comprising the step of placing a oxybutynin transdermal delivery device onto the skin of a person, the oxybutynin transdermal delivery device comprising: (a) a first reservoir consisting essentially of oxybutynin base in an amount sufficient to provide treatment of symptoms of a neurogenic bladder for a predetermined period of time, a monoglyceride or mixture of monoglycerides of fatty acids with a total monoesters content of at least 51% in a skin permeation-enhancing amount, and ethylene vinyl acetate copolymer having from about 9% to about 60% vinyl acetate; (b) a second reservoir comprising an excess of the monoglyceride or mixture of monoglycerides of fatty acids with a total monoesters content of at least 51% (c) a rate-controlling membrane between the first reservoir and the second reservoir; (d) a backing on the skin-distal surface of the second reservoir; and (e) an adhesive means for maintaining the first and second reservoirs in oxybutynin- and permeation enhancer-transmitting relation with the skin.
Claim 27
Dependent Claim 28 words
A method according to claim 22 wherein the oxybutynin is administered through the skin at a rate of at least 0.08 mg/hour for a predetermined period of time.
Claim 28
Dependent Claim 30 words
A method according to claim 22 wherein oxybutynin is administered through the skin at a permeation rate of at least 12 μg/cm 2 /hr for a predetermined period of time.
Claim 29
Dependent Claim 14 words
A method according to claim 22 wherein the backing is permeable to water vapor.
Claim 30
Dependent Claim 31 words
A method according to claim 22 wherein the means for maintaining the reservoirs in relation with the skin comprises an inline adhesive layer on the skin-proximal surface of the first reservoir.
Claim 31
Dependent Claim 29 words
A method according to claim 22 wherein the first reservoir also is an adhesive layer which functions as the means for maintaining the reservoirs in relation with the skin.
Claim 32
Dependent Claim 18 words
A device according to claim 22 wherein the permeation enhancer is glycerol monooleate, glycerol monolaurate or glycerol monolinoleate.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1998-05-01 1998-10-31 1999-05-02 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2002-05-01 2002-10-31 2003-05-02 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2006-05-01 2006-10-31 2007-05-02 $7700.00 Window Closed / Lapsed

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