System for effecting smoking cessation

Abstract

A system is disclosed which makes it possible for a patient to be delivered gradually reduced amounts of nicotine over time thereby allowing the patient to be gradually weaned off of dependence on nicotine and quit smoking. The system is comprised of a means for aerosolizing a formulation and containers of formulation. The formulation is comprised of nicotine in a pharmaceutically acceptable carrier. Preferably, a plurality of containers are produced wherein the concentration of nicotine in the different containers or different groups of containers is reduced. The patient uses containers with the highest concentration initially and gradually moves towards using containers with lower and lower concentrations of nicotine until the patient's dependence on nicotine is eliminated.

1 .- 10 . (canceled)  
     
     
         11 . A method of treatment, comprising the steps of: 
 (a) providing a system comprising:    a device for creating aerosolized particles and configured to receive a container containing nicotine or a pharmacologically acceptable salt thereof to be aerosolized;    a plurality of groups of containers for use with the device, wherein each container within each group of containers is comprised of substantially the same amount of nicotine, which amount of nicotine is different from the amount of nicotine in each of the other groups of containers;    (b) over a first period of time, repeatedly using the device with a first group of containers to aerosolize the nicotine; and    (c) over a second period of time, repeatedly using the device with a second group of containers to aerosolize the nicotine, wherein the amount of nicotine in the second group of containers is different from the amount of nicotine in the first group of containers.    
     
     
         12 . The method of  claim 11 , further comprising: 
 repeating steps (b) and (c) with groups of containers of the system (a) wherein the amount of nicotine in each subsequently used group of containers is gradually changed with respect to the amount of nicotine in each prior group of containers used.    
     
     
         13 . The method of  claim 11  wherein the amount of nicotine aerosolized during the first period of time of step (b) is sufficient to produce an arterial nicotine plasma concentration within the patient which substantially corresponds to that achieved during cigarette smoking.  
     
     
         14 . The method of  claim 11  wherein the aerosolized particles comprise particles created by the system of (a) comprise a size in the range from about 0.5 to 12 μm.  
     
     
         15 . A system for aiding a patient in quitting smoking, comprising: 
 a device for creating aerosolized particles and configured to receive a container containing a nicotine or a pharmacologically acceptable salt thereof to be aerosolized;    a plurality of groups of containers for use with the device, wherein each container within each group of containers is comprised of substantially the same amount of nicotine, which amount of nicotine is different from the amount of nicotine in each of the other groups of containers.    
     
     
         16 . The system of  claim 15 , wherein the containers contain a dry powder formulation.  
     
     
         17 . The system of  claim 15 , wherein the containers contain a low boiling point propellant in a pressurized canister.  
     
     
         18 . The system of  claim 17 , wherein the the aerosolized dose is released each time at the same inspiratory flow rate and inspiratory volume.  
     
     
         19 . The system of  claim 15 , further comprising a lock-out system which prevents administration of aerosolized doses beyond a given point in order to avoid overdosing.  
     
     
         20 . The system of  claim 15 , wherein the containers contain a liquid formulation.  
     
     
         21 . A system for aiding a patient in quitting smoking, comprising: 
 a plurality of groups of containers wherein the different groups of containers contain different amounts of nicotine or a pharmacologically acceptable salt thereof.    
     
     
         22 . The system of  claim 21 , wherein each of the containers contain a dry powder formulation.  
     
     
         23 . The system of  claim 21 , wherein each of the containers contain a low boiling point propellant in a pressurized canister.  
     
     
         24 . The system of  claim 21 , wherein each of the containers contain a liquid formulation.  
     
     
         25 . The method of  claim 21  wherein a concentration of nicotine used with a first group of containers is sufficient to produce an arterial nicotine plasma concentration within the patient which substantially corresponds to that achieved during cigarette smoking.  
     
     
         26 . A method of treatment, comprising the steps of: 
 (a) providing a a plurality of groups of containers wherein the different groups of containers contain different amounts of nicotine or a pharmacologically acceptable salt thereof (b) over a first period of time, repeatedly using containers of the a first group of containers to aerosolize the nicotine; and    (c) over a second period of time, repeatedly using containers of a second group of containers to aerosolize the nicotine, wherein the amount of nicotine in the second group of containers is different from the amount of nicotine in the first group of containers.    
     
     
         27 . The method of  claim 26  wherein nicotine from each container of the first group of containers in step (b) is sufficient to produce an arterial nicotine plasma concentration within the patient which substantially corresponds to that achieved during cigarette smoking.  
     
     
         28 . The system of  claim 26 , wherein the containers of each of the groups of containers contain a low boiling point propellant in a pressurized canister.  
     
     
         29 . The system of  claim 26 , wherein the containers of each of the groups of containers contain a liquid formulation.