Prolonged activity nicotine patch
First Claim
Patent Images
1. 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/cm2 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 μ
g/cm2.h for a second time period of 7 hours or more.
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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.
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Citations
22 Claims
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1. A transdermal patch, comprising:
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(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/cm2 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 μ
g/cm2.h for a second time period of 7 hours or more. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 17)
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11. A transdermal patch, comprising:
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(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 μ
g/cm2.h for a period of 12 hours or more.
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12. 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:
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(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/cm2.h for a first time period less than 5 hours, then at a second flux between 20 and 800 μ
g/cm2.h for a second time period of 7 hours or more. - View Dependent Claims (13, 14, 15, 16, 18, 19, 20, 21)
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22. 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:
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(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 μ
g/cm2.h for a period of 12 hours or more.
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Specification