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Claims for Patent: 4,946,853

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Claims for Patent: 4,946,853

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 thereon 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 frequency 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. (Dublin, IE)
Assignee: Elan Transdermal Limited (Athlone, IE)
Application Number:07/188,226
Patent Claims: 1. A preparation for the once-daily, percutaneous administration of nicotine which comprises nicotine uniformly distributed in a solid or semi-solid medium which can be placed in intimate contact with the skin, said solid or semi-solid medium comprising a given amount of nicotine in a solution of a solidifying or gel-forming agent or mixture thereof in a suitable solvent or mixture of solvents, said mixture thereby obtained having been mixed or heated to form said solid or semi-solid medium, wherein said medium is effective to permit controlled release of said nicotine to the skin.

2. A preparation according to claim 1, wherein the solvent used is selected from the group consisting of water, ethanol, stearyl alcohol, glycerol, ethylene glycol, propylene glycol, and silicone or a mixture thereof.

3. A preparation according to claim 1, which is in the form of a solid or semi-solid and has a surface area in the range 2 to 15 cm.sup.2.

4. A preparation according to claim 3, which has a thickness in the range 0.5 to 3 mm.

5. A preparation according to claim 1, which is in the form of a cream, gel, jelly, mucilage, ointment or paste.

6. A preparation according to claim 1, wherein the solidifying or gel-forming agent is selected from the group consisting of plant extracts, vegetable oils, gums, synthetic or natural polysaccharides, polypeptides, alginates, hydrocarbons, synthetic polymers, minerals and silicon compounds or a mixture thereof.

7. A preparation according to claim 6, wherein the solidifying or gel-forming agent is a plant extract selected from the group consisting of agar, ispaghula, psyllium, cydonia and ceratonia or a mixture thereof.

8. A preparation according to claim 6, wherein the solidifying or gel-forming agent is hydrogenated castor oil.

9. A preparation according to claim 6, wherein the solidifying or gel-forming agent is a gum selected from the group consisting of guar gum, acacia gum, ghatti gum, karaya gum and tragacanth gum or a mixture thereof.

10. A preparation according to claim 6, wherein the solidifying or gel-forming agent is a synthetic or natural polysaccharide selected from the group consisting of alkylcelluloses, hydroxyalkylcelluloses, cellulose ethers, cellulose esters, nitro celluloses, dextrin, agar, carrageenan, pectin, furcellaran and starch or starch derivatives and mixtures thereof

11. A preparation according to claim 6, wherein the solidifying or gel-forming agent is a polypeptide selected from the group consisting of zein, gelatin, collagen and polygeline or a mixture thereof.

12. A preparation according to claim 6, wherein the solidifying or gel-forming agent is an alginate selected from the group consisting of alginic acid, propylene glycol alginate and sodium alginate or a mixture thereof.

13. A preparation according to claim 6, wherein the solidifying or gel-forming agent is a hydrocarbon selected from the group consisting of soft paraffin and hard paraffin or a mixture thereof.

14. A preparation according to claim 6, wherein the solidifying or gel-forming agent is carboxyvinyl polymer.

15. A preparation according to claim 6, wherein the solidifying or gel-forming agent is a mineral selected from the group consisting of bentonite, hectorite, aluminium magnesium silicate and magnesium silicate or a mixture thereof.

16. A preparation according to claim 6, wherein the solidifying or gel-forming agent is a silicon compound selected from the group consisting of colloidal silicon dioxide, silicones, polysiloxanes and silica gels or a mixture thereof.

17. A preparation according to claim 1, which contains from 5 to 100 mg of nicotine.

18. A preparation according to claim 17, which contains from 10 to 50 mg of nicotine.

19. A preparation according to claim 1, which contains one or more additional components selected from the group consisting of an antimicrobial agent or a preservative, an antioxidant, a pH-controlling agent, a plasticizer, a surfactant, a penetration enhancer, a humectant, a local anaesthetic and a rubefacient or a mixture thereof.

20. A preparation according to claim 19, which contains an anti-microbial agent or a preservative selected from the group consisting of benzalkonium chloride, cetyltrimethylammonium bromide, benzoic acid, benzyl alcohol, the methyl-, ethyl-, propyl- and butyl-esters of para-hydroxybenzoic acid or a mixture thereof, chlorhexidine, chlorobutanol, phenylmercuric acetate, borate or nitrate, potassium sorbate, sodium benzoate, sorbic acid and mercurithiosalicylate or a mixture thereof.

21. A preparation according to claim 19, which contains an antioxidant selected from the group consisting of sodium metabisulphite, butylated hydroxyanisole and butylated hydroxytoluene or a mixture thereof.

22. A preparation according to claim 19, which contains a pH-controlling agent selected from the group consisting of citric acid and sodium citrate.

23. A preparation according to claim 19, which contains a plasticizer selected from the group consisting of diethylphthalate and tributylcitrate or a mixture thereof.

24. A preparation according to claim 19, which contains a surfactant selected from the group consisting of sodium lauryl sulphate, diethylene glycol monostearate, propylene glycol monostearate, polyethylene glycols, polysorbates and polyvinyl alcohol or a mixture thereof.

25. A preparation according to claim 19, which contains a penetration enhancer selected from the group consisting of dimethylsulphoxide, N,N-dimethylacetamide, N,N-dimethylformamide, 2-pyrrolidone, N-methyl-2-perrolidone and 1-dodecyl azacyclo-heptan-2-one or a mixture thereof.

26. A preparation according to claim 19, which contains glycerol as a humectant.

27. A preparation according to claim 19, which contains a local anaesthetic selected from the group consisting of lidocaine, benzocaine, lignocaine, methocaine, butylaminobenzoate and procaine or a mixture thereof.

28. A preparation according to claim 19, which contains a rubefacient selected from the group consisting of camphor and menthol, or a mixture thereof.

29. A preparation according to claim 1, which is adapted to be received in a receptacle of a device which can be held in contact with the skin.

30. A preparation according to claim 1, which is incorporated in self-adhesive patch bandage or a plaster.

31. A preparation according to claim 1, which includes a priming dose of nicotine in a layer of adhesive material defining the skin-contacting surface of the preparation and which layer is freely permeable to the nicotine contained in said medium.

32. A preparation according to claim 1, which includes a priming dose of nicotine in a peripheral layer of adhesive material defining part of the skin-contacting surface of the preparation.

33. A method of treating withdrawal symptoms associated with smoking cessation, which method comprises administering once-daily, percutaneously to a person in need of said treatment an amount of nicotine sufficient to maintain in said person plasma levels of nicotine substantially equivalent to trough plasma levels resulting from intermittent smoking, wherein said nicotine is distributed in a solid, semi-solid or muciloginous medium which is effective to permit controlled release of said nicotine to the skin.

34. A method according to claim 33, wherein the amount of nicotine administered is sufficient to achieve a plasma nicotine concentration in excess of 2 ng/ml within 1 hour after administration.

35. A method according to claim 33, wherein the amount of nicotine administered is sufficient to achieve a plasma nicotine concentration in excess of 5 ng/ml within 1 hour after administration.

36. A method according to claim 33, wherein the amount of nicotine administered is sufficient to achieve a plasma nicotine concentration in the range 2 to 100 ng/ml over a period from 1 to 24 hours.

37. A method according to claim 33, wherein the amount of nicotine administered is sufficient to achieve a plasma nicotine concentration in the range 5 to 30 ng/ml over a period of from 1 to 24 hours.

38. A method according to claim 33, wherein the amount of nicotine administered is progressively lowered over a period of time, such that the plasma level of nicotine is gradually lowered, thereby reducing nicotine dependency.

39. A method for combating the psychological dependence that occurs through frequent smoking, which method comprises administering once-daily, percutaneously to a person in need of said treatment an amount of nicotine sufficient to maintain in said person plasma levels of nicotine substantially equivalent to trough plasma levels resulting from intermittent smoking, wherein said nicotine is distributed in a solid, semi-solid or mucilaginous medium which is effective to permit controlled release of said nicotine to the skin.

40. A method according to claim 39, wherein the amount of nicotine administered is sufficient to achieve a plasma nicotine concentration in excess of 2 ng/ml within 1 hour after administration.

41. A method according to claim 39, wherein the amount of nicotine administered is sufficient to achieve a plasma nicotine concentration in excess of 5 ng/ml within 1 hour after administration.

42. A method according to claim 39, wherein the amount of nicotine administered is sufficient to achieve a plasma nicotine concentration in the range 2 to 100 ng/ml over a period of from 1 to 24 hours.

43. A method according to claim 39, wherein the amount of nicotine administered is sufficient to achieve a plasma nicotine concentration in the range 5 to 30 ng/ml over a period of from 1 to 24 hours.
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