US4943435A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Prolonged activity nicotine patch
Assignee: McNeil AB
•
Filing: 1988-10-28
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Granted: 1990-07-24
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Expires: 2008-10-28
Abstract
Abstract A transdermal patch for delivering nicotine for prolonged periods of 12-24 hours. The patch includes a rate-controlling membrane or monolith to keep the nicotine flux within useful and safe limits. The patch is typically replaced once a day, and can be used for smoking cessation therapy or in other situations where systemic nicotine delivery is indicated.
Inventors
- 👤 Richard W. Baker
- 👤 Frank Kochinke
- 👤 Carl Huang
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 05:46
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/70; A61K9/7023; A61K9/703; A61K9/7038; A61K9/7046; A61K9/7053; A61K31/00; A61K31/33; A61K31/395; A61K31/435; A61K31/465; A61K9/7069; A61K9/7084
Claims Analysis
Total Claims: 26
Claim 1
Independent Claim
129 words
A transdermal patch, comprising: (a) A nicotine depot layer, having a skin-facing side and a skin-distal side, said depot layer containing a sufficient quantity of nicotine to maintain a useful flux of nicotine from said patch for a total time period of 12 hours or more; (b) an occlusive backing layer in contact with and covering said depot layer on said skin-distal side; and (c) rate-controlling means for controlling diffusion of nicotine from said skin-facing side at a first flux of greater than zero but less than 2 mg/cm 2 in any hour for a first time period of greater than zero but less than 5 hours, then at a second flux between 20 and 800 μg/cm 2 .h for a second time period of 7 hours or more.
Claim 2
Dependent Claim
129 words
A transdermal patch, comprising: (a) A nicotine depot layer, having a skin-facing side and a skin-distal side, said depot layer containing a sufficient quantity of nicotine to maintain a useful flux of nicotine from said patch for a total time period of 12 hours or more; (b) an occlusive backing layer in contact with and covering said depot layer on said skin-distal side; and (c) rate-controlling means for controlling diffusion of nicotine from said skin-facing side at a first flux of greater than zero but less than 2 mg/cm 2 in any hour for a first time period of greater than zero but less than 5 hours, then at a second flux between 20 and 800 μg/cm 2 .h for a second time period of 7 hours or more.
Claim 3
Dependent Claim
22 words
The patch of claim 1, wherein said rate-controlling means comprises a nicotine-permeable polymer membrane contacting said depot layer on said skin-facing surface.
Claim 4
Dependent Claim
19 words
The patch of claim 1, wherein said rate-controlling means comprises a nicotine-permeable polymer monolith integral with said depot layer.
Claim 5
Dependent Claim
35 words
The patch of claim 1, wherein said rate-controlling means comprises a combination of a nicotine-permeable polymer monolith integral with said depot layer and a nicotine-permeable polymer membrane contacting said depot layer on said skin-facing surface.
Claim 6
Dependent Claim
18 words
The patch of claim 1, wherein said depot layer comprises a porous material with said nicotine dispersed therein.
Claim 7
Dependent Claim
12 words
The patch of claim 2, wherein said membrane is made from polyethylene.
Claim 8
Dependent Claim
12 words
The patch of claim 3, wherein said monolith is made from polyurethane.
Claim 9
Dependent Claim
13 words
The patch of claim 4, wherein said membrane is double-sided medical adhesive tape.
Claim 10
Dependent Claim
22 words
The patch of claim 1, wherein said first flux is greater than zero but less than 1 mg/cm 2 in any hour.
Claim 11
Dependent Claim
25 words
The patch of claim 1, wherein said first time period is less than 1 hour, and said second time period is 11 hours or more.
Claim 12
Dependent Claim
92 words
A transdermal patch, comprising: (a) a nicotine depot layer, having a skin-facing side and a skin-distal side, said depot layer containing a sufficient quantity of nicotine to maintain a useful flux of nicotine from said patch for a period of 12 hours or more; (b) an occlusive backing layer in contact with and covering said depot layer on said skin-distal side; and (c) rate-controlling means for controlling diffusion of nicotine from said skin-facing side at a flux between 20 and 800 μg/cm 2 .h for a period of 12 hours or more.
Claim 13
Dependent Claim
92 words
A transdermal patch, comprising: (a) a nicotine depot layer, having a skin-facing side and a skin-distal side, said depot layer containing a sufficient quantity of nicotine to maintain a useful flux of nicotine from said patch for a period of 12 hours or more; (b) an occlusive backing layer in contact with and covering said depot layer on said skin-distal side; and (c) rate-controlling means for controlling diffusion of nicotine from said skin-facing side at a flux between 20 and 800 μg/cm 2 .h for a period of 12 hours or more.
Claim 14
Independent Claim
139 words
A method of administering nicotine to an individual in need of such administration, comprising applying to the skin of said individual a transdermal patch, said patch comprising: (a) a nicotine depot layer, having a skin-facing side and a skin-distal side, said depot layer containing a sufficient quantity of nicotine to maintain a useful flux of nicotine from said patch for a total time period of 12 hours or more; (b) an occlusive backing layer in contact with and covering said depot layer on said skin-distal side; and (c) rate-controlling means for controlling diffusion of nicotine from said skin-facing side at a first flux less 2 mg/cm 2 .h for a first time period less than 5 hours, then at a second flux between 20 and 800 μg/cm 2 .h for a second time period of 7 hours or more.
Claim 15
Independent Claim
139 words
A method of administering nicotine to an individual in need of such administration, comprising applying to the skin of said individual a transdermal patch, said patch comprising: (a) a nicotine depot layer, having a skin-facing side and a skin-distal side, said depot layer containing a sufficient quantity of nicotine to maintain a useful flux of nicotine from said patch for a total time period of 12 hours or more; (b) an occlusive backing layer in contact with and covering said depot layer on said skin-distal side; and (c) rate-controlling means for controlling diffusion of nicotine from said skin-facing side at a first flux less 2 mg/cm 2 .h for a first time period less than 5 hours, then at a second flux between 20 and 800 μg/cm 2 .h for a second time period of 7 hours or more.
Claim 16
Dependent Claim
22 words
The method of claim 12, wherein said rate-controlling means comprises a nicotine-permeable polymer membrane contacting said depot layer on said skin-facing surface.
Claim 17
Dependent Claim
19 words
The method of claim 12, wherein said rate-controlling means comprises a nicotine-permeable polymer monolith integral with said depot layer.
Claim 18
Dependent Claim
35 words
The method of claim 12, wherein said rate-controlling means comprises a combination of a nicotine-permeable polymer monolith integral with said depot layer and a nicotine-permeable polymer membrane contacting said depot layer on said skin-facing surface.
Claim 19
Dependent Claim
18 words
The method of claim 12, wherein said depot layer comprises a porous material with said nicotine dispersed therein.
Claim 20
Dependent Claim
12 words
The method of claim 1, wherein said membrane is made from polyethylene.
Claim 21
Dependent Claim
12 words
The method of claim 14, wherein said monolith is made from polyurethane.
Claim 22
Dependent Claim
13 words
The method of claim 15, wherein said membrane is double-sided medical adhesive tape.
Claim 23
Dependent Claim
16 words
The method of claim 12, wherein said first flux is less than 1 mg/cm 2 .h.
Claim 24
Dependent Claim
25 words
The method of claim 12, wherein said first time period is less than 1 hour, and said second time period is 11 hours or more.
Claim 25
Independent Claim
115 words
A method of administering nicotine to an individual in need of such administration, comprising applying to the skin of said individual a transdermal patch, said patch comprising: (a) a nicotine depot layer, having a skin-facing side and a skin-distal side, said depot layer containing a sufficient quantity of nicotine to maintain a useful flux of nicotine from said patch for a period of 12 hours or more; (b) an occlusive backing layer in contact with and covering said depot layer on said skin-distal side; and (c) rate-controlling means for controlling diffusion of nicotine from said skin-facing side at a flux between 20 and 800 μg/cm 2 .h for a period of 12 hours or more.
Claim 26
Independent Claim
115 words
A method of administering nicotine to an individual in need of such administration, comprising applying to the skin of said individual a transdermal patch, said patch comprising: (a) a nicotine depot layer, having a skin-facing side and a skin-distal side, said depot layer containing a sufficient quantity of nicotine to maintain a useful flux of nicotine from said patch for a period of 12 hours or more; (b) an occlusive backing layer in contact with and covering said depot layer on said skin-distal side; and (c) rate-controlling means for controlling diffusion of nicotine from said skin-facing side at a flux between 20 and 800 μg/cm 2 .h for a period of 12 hours or more.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1993-07-23 | 1994-01-22 | 1994-07-24 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1997-07-23 | 1998-01-22 | 1998-07-24 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2001-07-23 | 2002-01-22 | 2002-07-24 | $7700.00 | Window Closed / Lapsed |