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Details for Patent: 5,298,257

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Details for Patent: 5,298,257

Title: Method for the treatment of withdrawal symptoms associated with smoking cessation and preparations for use in said method
Abstract:A preparation for the once-daily, percutaneous administration of nicotine comprises nicotine uniformly distributed in a solid, semi-solid or mucilaginous medium which can be placed in intimate contact with the skin, the solid, semi-solid or mucilaginous medium is formed by adding a given amount of nicotine to a solution of a solidifying or gel-forming agent or mixture thereof in a suitable solvent or mixture of solvents and mixing or heating the mixture thereby obtained so as to form the solid, semi-solid or mucilaginous medium. The preparation can be used in a method of treating withdrawal symptoms associated with smoking cessation and for combating the psychological dependence that occurs through frequent smoking.
Inventor(s): Bannon; Yvonne B. (Naas, IE), Corish; John (Leopardstown, IE), Corrigan; Owen I. (Howth, IE), Geoghegan; Edward J. (Athlone, IE), Masterson; Joseph G. (Clonsilla, IE)
Assignee: Elan Transdermal Limited (Athlone, IE)
Filing Date:Mar 19, 1992
Application Number:07/855,457
Claims:1. A once-daily transdermal preparation for the controlled release of nicotine comprising an amount of nicotine distributed in a solid, semi-solid or mucilaginous medium and being effective to treat symptoms associated with tobacco smoking cessation and an amount of an anti-irritant effective to alleviate irritation associated with the transdermal delivery of nicotine.

2. The transdermal preparation of claim 1 wherein the anti-irritant is selected from the group consisting of lidocaine, benzocaine, lignocaine, methocaine, butylaminobenzoate and procaine or a mixture thereof.

3. A method for treating the symptoms associated with tobacco smoking cessation comprising applying the transdermal preparation of claim 1 to the skin of a person in need of such treatment.

4. The method of claim 3 wherein the transdermal preparation is effective to permit controlled release of said nicotine to the skin at a rate of on the average at least 0.5 mg/hour for at least 14 hours.

5. The method of claim 3 wherein the amount of nicotine administered is sufficient to achieve in said person a plasma level of nicotine over a 24 hour period in the range of at least 5 ng/ml for at least 14 hours.

6. The method of claim 5 wherein the plasma level of nicotine over a 24 hour period is in the range of 5-30 ng/ml for at least 14 hours.

7. The method of claim 6 wherein the amount of nicotine administered is sufficient to achieve a plasma level of nicotine in the range of 2-15 ng/ml for the remaining 10 hours or less.

8. The method of claim 7 wherein the amount of nicotine administered is sufficient to achieve a plasma level of nicotine in the range of 2-15 ng/ml within one hour after administration.
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