Method of producing a nicotine medicament and a medicament made by the method

Abstract

A method of producing a nicotine medicament for use in an inhaler comprises combining nicotine, a non-spheronized sugar and a liquid carrier including water to produce a flowable mixture and spray drying the flowable mixture at conditions to produce particles of the nicotine medicament suitable for delivery to the alveoli and lower airways of the person. Also disclosed is a nicotine medicament made by the method. The nicotine composition produced by this method is a composite particle suitable for tobacco replacement or withdrawal therapy.

1 . A method of preparing a nicotine formulation suitable for inhalation comprising:
 (a) combining nicotine, a non-spheronized pharmaceutical grade sugar and a liquid carrier to produce a flowable mixture; and,   (b) spray drying the flowable mixture to form spray dried particles.   
     
     
         2 . The method as claimed in  claim 1  wherein the liquid carrier comprises water. 
     
     
         3 . The method as claimed in  claim 1  wherein the particles are from about 0.1 to 5 μm in diameter and are physically joined together by spray drying such that the nicotine and sugar remain physically joined together during inhalation 
     
     
         4 . The method as claimed in  claim 1  wherein the flowable mixture has a ratio of non-spheronized sugar to nicotine which varies from about 1:10 to about 10:1 parts by weight. 
     
     
         5 . The method as claimed in  claim 1  wherein the flowable mixture has a ratio of non-spheronized sugar to nicotine which varies from about 3:7 to about 3:2 parts by weight. 
     
     
         6 . The method as claimed in  claim 1  wherein the flowable mixture has a concentration of non-spheronized sugar which varies from about 1 to about 10 w/v. 
     
     
         7 . The method as claimed in  claim 6  wherein the concentration of non-spheronized sugar in the flowable mixture varies from about 2 to about 5 w/v. 
     
     
         8 . The method as claimed in  claim 1  wherein the flowable mixture is dried by spray drying and produces particles that are about 0.1 to about 5 μm in diameter. 
     
     
         9 . The method as claimed in  claim 8  wherein the flowable mixture is atomized prior to being spray dried. 
     
     
         10 . The method as claimed in  claim 1  wherein the flowable mixture is dried at conditions to form spherical particles. 
     
     
         11 . The method as claimed in  claim 1  wherein the flowable mixture is dried at conditions to form spherical particles that have a dimpled surface and are about 0.5 to about 3 μm in diameter. 
     
     
         12 . The method of  claim 1  wherein the nicotine comprises a nicotine base and the pharmaceutical grade sugar is selected from the group consisting of lactose, dextrose glucose, maltose or combinations thereof. 
     
     
         13 . The method as claimed in  claim 1  wherein the flowable mixture is dried at conditions to form spherical particles that have a dimpled surface. 
     
     
         14 . A method for conducting a tobacco replacement or withdrawal therapy comprising:
 (a) preparing a flowable mixture consisting essentially of nicotine, a non-spheronized pharmaceutical grade sugar and a liquid carrier;   (b) spray drying the flowable mixture to produce a composite material at conditions to produce particles of the nicotine medicament which are suitable for delivery to the alveoli and lower airways of a person and which simulate cigarette smoke when aerosolized and inhaled; and,   (c) packaging the composite material in a container for use with an inhaler suitable for delivering a medicament to the lungs.   
     
     
         15 . The method as claimed in  claim 14  wherein the liquid carrier comprises water. 
     
     
         16 . The method as claimed in  claim 14  wherein the liquid carrier consists essentially of water. 
     
     
         17 . The method as claimed in  claim 14  wherein the flowable mixture has a ratio of non-spheronized sugar to nicotine which varies from about 1:10 to about 10:1 parts by weight. 
     
     
         18 . The method as claimed in  claim 14  wherein the flowable mixture has a ratio of non-spheronized sugar to nicotine which varies from about 3:7 to about 3:2 parts by weight. 
     
     
         19 . The method as claimed in  claim 14  wherein the flowable mixture has a concentration of non-spheronized sugar which varies from about 1 to about 10 w/v. 
     
     
         20 . The method as claimed in  claim 19  wherein the concentration of non-spheronized sugar in the flowable mixture varies from about 2 to about 5 w/v. 
     
     
         21 . The method as claimed in  claim 14  wherein the flowable mixture is dried by spray drying and produces particles that are about 0.1 to about 5 μm in diameter. 
     
     
         22 . The method as claimed in  claim 21  wherein the flowable mixture is atomized prior to being spray dried. 
     
     
         23 . The method as claimed in  claim 14  wherein the flowable mixture is dried at conditions to form spherical particles. 
     
     
         24 . The method as claimed in  claim 14  wherein the flowable mixture is dried at conditions to form spherical particles that have a dimpled surface are about 0.5 to about 3 μm in diameter. 
     
     
         25 . The method of  claim 14  wherein the nicotine comprises a nicotine base and the pharmaceutical grade sugar is selected from the group consisting of lactose, dextrose glucose, maltose or combinations thereof. 
     
     
         26 . The method of  claim 14  wherein the pharmaceutical grade sugar is selected from the group consisting of lactose, dextrose glucose, maltose or combinations thereof. 
     
     
         27 . The method as claimed in  claim 14  wherein the spray drying is operated to produce particles that are about 0.1 to about 5 μm in diameter.