System and Method for Controlling the Harshness of Nicotine-Based Dry Powder Formulations

Abstract

A method of controlling or electing the harshness of inhaled nicotine powder formulations is described. The method includes the steps of identifying a concentration of nicotine for a subject to inhale to achieve a desired level of harshness per inhalation, identifying the total dose of nicotine to be inhaled by the subject, and providing the subject with an amount of a formulation comprising nicotine particles having the identified concentration of nicotine, such that the total amount of nicotine particles in the formulation equals the total dose of nicotine.

What is claimed is: 
     
         1 . A method of controlling the harshness of nicotine inhaled by a subject, the method comprising the steps of:
 identifying a concentration of nicotine for a subject to inhale to achieve a desired level of harshness per inhalation,   identifying the total dose of nicotine to be inhaled by the subject, and   providing the subject with an amount of a formulation comprising nicotine particles having the identified concentration of nicotine, such that the total amount of nicotine particles in the formulation equals the total dose of nicotine.   
     
     
         2 . The method of  claim 1 , wherein the nicotine particles comprise at least one nicotine salt. 
     
     
         3 . The method of  claim 2 , wherein the at least one nicotine salt is nicotine tartrate. 
     
     
         4 . The method of  claim 1 , wherein the nicotine particles further comprise at least one sugar. 
     
     
         5 . The method of  claim 4 , wherein the at least one sugar is lactose. 
     
     
         6 . The method of  claim 1 , wherein the nicotine particles are substantially between 2-5 micron in size. 
     
     
         7 . The method of  claim 1 , wherein the concentration of nicotine is between 1.5% and 20%. 
     
     
         8 . The method of  claim 1 , wherein the formulation further comprises a stabilizing agent. 
     
     
         9 . The method of  claim 1 , wherein the formulation further comprises a cough suppressant. 
     
     
         10 . The method of  claim 1 , wherein the formulation is delivered to a subject via a dry powder inhaler. 
     
     
         11 . A method of delivering variable dosages of nicotine to a subject over a number of doses while maintaining a substantially constant level of harshness per inhalation for each dose, the method comprising the steps of:
 identifying a concentration of nicotine in a nicotine formulation for a subject to inhale to achieve a desired level of harshness per inhalation,   providing a first dose comprising an amount of a formulation comprising nicotine particles having the identified concentration of nicotine, and   providing at least one additional dose comprising an amount of a formulation comprising nicotine particles having the identified concentration of nicotine,   wherein the amount of the formulation in the at least one additional dose is less than the amount of the formulation in the first dose.   
     
     
         12 . The method of  claim 11 , wherein the total dose of nicotine is decreased per dose, while the harshness of the administered doses remains substantially constant. 
     
     
         13 . A method of delivering reduced dosages of nicotine to a subject over a number of doses, while increasing the level of harshness per inhalation for each dose, the method comprising the steps of:
 identifying a concentration of nicotine in a nicotine formulation for a subject to inhale to achieve a desired level of harshness per inhalation,   providing a first dose comprising an amount of a formulation comprising nicotine particles having the identified concentration of nicotine,   providing at least one additional dose comprising an amount of a formulation comprising nicotine particles having the identified concentration of nicotine, wherein the amount of the formulation in the at least one additional dose is less than the amount of the formulation in the first dose, and   providing at least one additional dose comprising an amount of a formulation comprising nicotine particles having the identified concentration of nicotine, wherein the amount of the formulation in the at least one additional dose is less than the amount of the formulation in the first dose.   
     
     
         14 . A kit for controlling the harshness of inhaled nicotine, the kit comprising at least an amount of a nicotine formulation comprising nicotine particles, and an instruction material identifying the method of  claim 1 . 
     
     
         15 . The kit of  claim 14 , wherein the kit further comprises a dry powder inhaler. 
     
     
         16 . A dry powder nicotine formulation suitable for inhalation comprising nicotine particles, wherein the nicotine particles are substantially between about 1-10 micron in size. 
     
     
         17 . The formulation of  claim 16 , wherein the nicotine particles are substantially between about 2-5 micron in size. 
     
     
         18 . The formulation of  claim 16 , wherein less than about 10% of the nicotine particles are less than about 1 micron in size. 
     
     
         19 . The formulation of  claim 18 , wherein less than about 10% of the nicotine particles are less than about 2 micron in size. 
     
     
         20 . The formulation of  claim 16 , wherein at least about 90% of the nicotine particles are less than about 10 micron in size. 
     
     
         21 . The formulation of  claim 20 , wherein at least about 90% of the nicotine particles are less than about 5 micron in size. 
     
     
         22 . The formulation of  claim 16 , wherein less than about 10% of the nicotine particles are less than about 1 micron in size and wherein at least about 90% of the nicotine particles are less than about 10 micron in size. 
     
     
         23 . The formulation of  claim 17 , wherein less than about 10% of the nicotine particles are less than about 2 micron in size and wherein at least about 90% of the nicotine particles are less than about 5 micron in size. 
     
     
         24 . A dry powder nicotine formulation suitable for inhalation comprising:
 a nicotine based component having particles substantially between about 1-10 micron in size; and   a cough suppressant component having particles substantially between about 5-10 micron in size.   
     
     
         25 . The formulation of  claim 24 , wherein the cough suppressant component comprises menthol or mint. 
     
     
         26 . The formulation of  claim 25 , wherein the nicotine based component particles are substantially between about 2-5 micron in size and the cough suppressant component particles are substantially between about 5-8 micron in size. 
     
     
         27 . The formulation of  claim 24 , further comprising a cough suppressant component having particles substantially between about 10-200 micron in size. 
     
     
         28 . The formulation of  claim 27 , wherein the cough suppressant component having particles substantially between about 10-200 micron in size comprises menthol or mint. 
     
     
         29 . The formulation of  claim 24 , further comprising a flavor component having particles substantially between about 10-1000 micron in size. 
     
     
         30 . The formulation of  claim 29 , wherein the flavor component comprises menthol or mint.