Treatment method using solid amorphous particles comprising tiotropium bromide and a co-solid

Abstract

A method of treating at least one of COPD and/or asthma in a subject is provided, wherein an inhalable medicament is administered, in particular a new solid-state form of tiotropium bromide. The medicament can be in the form of solid amorphous particles containing an intimate admixture of tiotropium bromide together with a pharmaceutically acceptable co-solid having a glass transition temperature of at least -50° C., such as a sugar and/or sugar alcohol.

What is claimed is: 
     
         1 . A method for treatment of chronic obstructive pulmonary disease (COPD) in a subject, wherein the method comprises administering to the subject solid amorphous particles comprising an intimate admixture of amorphous tiotropium bromide together with a pharmaceutically acceptable amorphous co-solid selected from dextrose, fructose, glucosamine, glucose lactose, mannitol, maltitol, mannose, sorbitol, sucrose, trehalose, xylitol or combinations thereof, wherein the term intimate admixture means that substantially all of the individual particles are composed of both the tiotropium bromide and the co-solid. 
     
     
         2 . The method as claimed in  claim 1 , wherein the solid amorphous particles are administered to the subject using a dry-powder inhaler. 
     
     
         3 . The method as claimed in  claim 1 , wherein the solid amorphous particles are administered to the subject using a pressurized metered-dose inhaler. 
     
     
         4 . The method as claimed in  claim 1 , wherein the solid amorphous particles have a particle size of 1-10 microns. 
     
     
         5 . The method as claimed in  claim 1 , wherein the tiotropium bromide and co-solid are present in a weight ratio of tiotropium bromide to co-solid of from 1:1 to 1:1000. 
     
     
         6 . The method as claimed in  claim 1 , wherein an inhalable medicament comprising the solid amorphous particles and one or more pharmaceutically acceptable excipients is administered to the subject. 
     
     
         7 . The method as claimed in  claim 1 , wherein the solid amorphous particles are administered to the subject in the form of a dry powder. 
     
     
         8 . The method as claimed in  claim 1 , wherein an inhalable medicament comprising the solid amorphous particles and one or more pharmaceutically acceptable excipients is administered to the subject, the inhalable medicament is a dry powder, and the one or more pharmaceutically acceptable excipients include at least one inert carrier. 
     
     
         9 . The method as claimed in  claim 8 , wherein the at least one inert carrier includes at least one of lactose, glucose, or sodium starch glycolate. 
     
     
         10 . The method as claimed in  claim 1 , wherein the solid amorphous particles are administered to the subject in the form of an aerosol. 
     
     
         11 . The method as claimed in  claim 1 , wherein an inhalable medicament comprising the solid amorphous particles and a propellant are administered to the subject in the form of an aerosol. 
     
     
         12 . The method as claimed in  claim 1 , wherein a dose of 18 μg of tiotropium bromide based on the amount of tiotropium is administered. 
     
     
         13 . A method for treatment of asthma in a subject, wherein the method comprises administering to the subject solid amorphous particles comprising an intimate admixture of amorphous tiotropium bromide together with a pharmaceutically acceptable amorphous co-solid selected from dextrose, fructose, glucosamine, glucose lactose, mannitol, maltitol, mannose, sorbitol, sucrose, trehalose, xylitol or combinations thereof, wherein the term intimate admixture means that substantially all of the individual particles are composed of both the tiotropium bromide and the co-solid. 
     
     
         14 . The method as claimed in  claim 13 , wherein the solid amorphous particles are administered to the subject using a dry-powder inhaler. 
     
     
         15 . The method as claimed in  claim 13 , wherein the solid amorphous particles are administered to the subject using a pressurized metered-dose inhaler. 
     
     
         16 . The method as claimed in  claim 13 , wherein the solid amorphous particles have a particle size of 1-10 microns. 
     
     
         17 . The method as claimed in  claim 13 , wherein the tiotropium bromide and co-solid are present in a weight ratio of tiotropium bromide to co-solid of from 1:1 to 1:1000. 
     
     
         18 . The method as claimed in  claim 13 , wherein an inhalable medicament comprising the solid amorphous particles and one or more pharmaceutically acceptable excipients is administered to the subject. 
     
     
         19 . The method as claimed in  claim 13 , wherein the solid amorphous particles are administered to the subject in the form of a dry powder. 
     
     
         20 . The method as claimed in  claim 13 , wherein an inhalable medicament comprising the solid amorphous particles and one or more pharmaceutically acceptable excipients is administered to the subject, the inhalable medicament is a dry powder, and the one or more pharmaceutically acceptable excipients include at least one inert carrier. 
     
     
         21 . The method as claimed in  claim 20 , wherein the at least one inert carrier includes at least one of lactose, glucose, or sodium starch glycolate. 
     
     
         22 . The method as claimed in  claim 13 , wherein the solid amorphous particles are administered to the subject in the form of an aerosol. 
     
     
         23 . The method as claimed in  claim 13 , wherein an inhalable medicament comprising the solid amorphous particles and a propellant are administered to the subject in the form of an aerosol. 
     
     
         24 . The method as claimed in  claim 13 , wherein a dose of 18 μg of tiotropium bromide based on the amount of tiotropium is administered.