Device and method for the cessation of smoking

Abstract

The present invention is directed to an oral nicotine delivery device and a method of using the device to reduce the incidence of tobacco smoking in a person. The device comprises a tubular chamber having a first end suitable for taking in liquid or gas from an external source and a second end suitable for the application of oral suction. The chamber contains nicotine and a retainer for preventing release of the nicotine from the first end of the chamber. The device delivers nicotine in non-irritating solution form.

What is claimed is:  
     
         1 . An oral nicotine delivery device comprising: 
 (a) a tubular chamber having a first end suitable for taking in a liquid from an external source and a second end suitable for oral application of suction;    (b) a nicotine granulate contained within the tubular chamber; and    (c) a retainer in the tubular chamber for preventing release of the nicotine granulate and liquid from the first end of the chamber,    wherein the liquid enters the chamber from the external source through the first end of the chamber, and then the liquid and the nicotine are delivered through the second end of the chamber, when oral suction is applied to the second end of the chamber.    
     
     
         2 . The device of  claim 1 , wherein the tubular chamber approximates the size and shape of a conventional cigarette.  
     
     
         3 . The device of  claim 1 , wherein the tubular chamber approximates the size and shape of a conventional drinking straw.  
     
     
         4 . The device of  claim 1 , wherein the retainer is fixed proximal to the first end of the chamber.  
     
     
         5 . The device of  claim 1 , wherein the retainer is transportable toward the second end of the chamber with the nicotine granulate and the liquid when suction is applied to the second end of the chamber.  
     
     
         6 . The device of  claim 1 , wherein the nicotine granulate comprises coated particles of powdered nicotine.  
     
     
         7 . The device of  claim 6 , wherein the nicotine particles are coated to enhance palatability.  
     
     
         8 . The device of  claim 1 , wherein the nicotine granulate comprises particles of powdered nicotine, the particles incorporated in spheres comprising at least one material selected from the group consisting of sugar, starch, acacia, sodium alginate, carbomer, cellulose, dextrotes, ethyl cellulose, methyl cellulose, and povidone.  
     
     
         9 . The device of  claim 1 , wherein the tubular chamber contains from about 4 milligrams to about 12 milligrams of nicotine.  
     
     
         10 . The device of  claim 1 , wherein a solution of nicotine is formed when the liquid enters the chamber and contacts the nicotine.  
     
     
         11 . The device of  claim 10 , wherein the solution is a suspension.  
     
     
         12 . The device of  claim 1 , wherein the nicotine is selected from the group consisting of levo nicotine, dextro nicotine, racemic mixtures thereof, and pharmaceutically acceptable salts thereof.  
     
     
         13 . A method for reducing the incidence of tobacco smoking by a person, comprising orally administering nicotine to the person, using an oral nicotine delivery device, the device comprising: 
 (a) a tubular chamber having a first end suitable for taking in a liquid from an external source and a second end suitable for oral application of suction;    (b) a nicotine granulate contained within the tubular chamber; and    (c) a retainer in the tubular chamber for preventing release of the nicotine granulate or liquid from the first end of the chamber,    oral administration comprising application of oral suction by the person to the second end of the chamber, wherein the liquid enters the chamber from the external source through the first end of the chamber, and then the liquid and the nicotine are delivered through the second end of the chamber into the mouth of the person.    
     
     
         14 . The method of  claim 13 , wherein a single dose of nicotine administered to the person is from about 4 milligrams to about 12 milligrams of nicotine.  
     
     
         15 . The method of  claim 13 , wherein the total daily dose of nicotine administered to the person is from about 4 milligrams to about 144 milligrams of nicotine.  
     
     
         16 . The method of  claim 13 , wherein the blood level of nicotine in the person after administration of the nicotine is at least about 5 nanograms of nicotine per 1 milliliter of blood.  
     
     
         17 . The method of  claim 16 , wherein the blood level of nicotine in the person after administration of the nicotine is from about 10 nanograms to about 50 nanograms of nicotine per 1 milliliter of blood.  
     
     
         18 . The method of  claim 13 , wherein a solution of nicotine is formed when the liquid enters the chamber and contacts the nicotine.  
     
     
         19 . The method of  claim 18 , wherein the solution has an acidic pH.  
     
     
         20 . An oral nicotine delivery device comprising: 
 (a) a tubular chamber having a first end suitable for taking in a liquid or a gas from an external source and a second end suitable for oral application of suction;    (b) a nicotine solution contained within the tubular chamber; and    (c) a retainer in the tubular chamber for preventing release of the nicotine solution from the first end of the chamber,    wherein the nicotine solution is delivered through the second end of the chamber when oral suction is applied to the second end of the chamber.    
     
     
         21 . The device of  claim 20 , wherein a liquid enters the chamber from an external source through the first end of the chamber, and then the liquid and the nicotine solution are delivered through the second end of the chamber, when oral suction is applied to the second end of the chamber.  
     
     
         22 . The device of  claim 20 , wherein a gas enters the chamber from an external source through the first end of the chamber, and then the nicotine solution is delivered through the second end of the chamber, when oral suction is applied to the second end of the chamber.  
     
     
         23 . The device of  claim 20 , wherein the tubular chamber approximates the size and shape of a conventional cigarette.  
     
     
         24 . The device of  claim 20 , wherein the tubular chamber approximates the size and shape of a conventional drinking straw.  
     
     
         25 . The device of  claim 20 , wherein the retainer is transportable toward the second end of the chamber with the nicotine solution when suction is applied to the second end of the chamber.  
     
     
         26 . The device of  claim 20 , wherein the nicotine solution is a nicotine suspension.  
     
     
         27 . The device of  claim 26 , wherein the nicotine suspension comprises a nicotine granulate.  
     
     
         28 . The device of  claim 27 , wherein the nicotine granulate comprises coated particles of powdered nicotine.  
     
     
         29 . The device of  claim 28 , wherein the nicotine particles are coated to enhance palatability.  
     
     
         30 . The device of  claim 27 , wherein the nicotine granulate comprises particles of powdered nicotine, the particles incorporated in spheres comprising at least one material selected from the group consisting of sugar, starch, acacia, sodium alginate, carbomer, cellulose, dextrotes, ethyl cellulose, methyl cellulose, and povidone.  
     
     
         31 . The device of  claim 20 , wherein the nicotine solution has an acidic pH.  
     
     
         32 . The device of  claim 20 , wherein the nicotine solution contains from about 4 milligrams to about 12 milligrams of nicotine.  
     
     
         33 . The device of  claim 20 , wherein the chamber contains from about 1 milliliter to about 5 milliliters of the nicotine solution.  
     
     
         34 . The device of  claim 20 , wherein the nicotine in the nicotine solution is selected from the group consisting of levo nicotine, dextro nicotine, racemic mixtures thereof, and pharmaceutically acceptable salts thereof.  
     
     
         35 . The device of  claim 20 , wherein the nicotine solution further comprises a flavoring.  
     
     
         36 . A method for reducing the incidence of tobacco smoking by a person, comprising orally administering nicotine to the person using an oral nicotine delivery device, the device comprising: 
 (a) a tubular chamber having a first end suitable for taking in a liquid or a gas from an external source and a second end suitable for oral application of suction;    (b) a nicotine solution contained within the tubular chamber; and    (c) a retainer in the tubular chamber for preventing release of the nicotine solution from the first end of the chamber,    oral administration comprising application of oral suction by the person to the second end of the chamber, wherein the nicotine solution is delivered through the second end of the chamber into the mouth of the person.    
     
     
         37 . The method of  claim 36 , wherein a single dose of nicotine administered to the person is from about 4 milligram to about 12 milligrams of nicotine.  
     
     
         38 . The method of  claim 36 , wherein the total daily dose of nicotine administered to the person is from about 4 milligrams to about 144 milligrams of nicotine.  
     
     
         39 . The method of  claim 36 , wherein the blood level of nicotine in the person after administration of the nicotine solution is at least about 5 nanograms of nicotine per 1 milliliter of blood.  
     
     
         40 . The method of  claim 39 , wherein the peak blood level of nicotine in the person after administration of the nicotine solution is from about 10 nanograms to about 50 nanograms of nicotine per 1 milliliter of blood.  
     
     
         41 . The method of  claim 36 , wherein the nicotine solution is a nicotine suspension.