Method for the administration of an anticholinergic by inhalation

Abstract

An inhalation kit comprising: (a) an inhaler displaying a flow resistance of about 0.01 to 0.1 {square root}{square root over (kPa)} min/L; and (b) an inhalable powder comprising tiotropium in admixture with a physiologically acceptable excipient with an average particle size of between 10 to 500 μm, and a method of administering an inhalable powder containing tiotropium in admixture with a physiologically acceptable excipient with an average particle size of between 10 μm to 500 μm, the method comprising actuating an inhaler a flow resistance of about 0.01 to 0.1 {square root}{square root over (kPa)} min/L containing the inhalable powder.

We claim:  
     
         1 . A method of administering an inhalable powder containing tiotropium in admixture with a physiologically acceptable excipient with an average particle size of between 10 μm to 500 μm, the method comprising actuating an inhaler a flow resistance of about 0.01 to 0.1 {square root}{square root over (kPa)} min/L containing the inhalable powder.  
     
     
         2 . The method according to  claim 1 , wherein the amount of tiotropium in the inhalable powder is 0.001% to 5% of the inhalable powder.  
     
     
         3 . The method according to  claim 1 , wherein the inhaler has a flow resistance of about 0.02 to 0.06 {square root}{square root over (kPa)} min/L.  
     
     
         4 . The method according to  claim 1 , wherein the inhaler comprises: a housing containing two windows, a deck in which there are air inlet ports and which is provided with a screen secured by a screen housing, an inhalation chamber connected to the deck on which there is a push button provided with two sharpened pins and movable counter to a spring, a mouthpiece which is connected to the housing, the deck, and a cover via a spindle to enable it to be flipped open or shut, and three holes with diameters below 1 mm in the central region around the capsule chamber and underneath the screen housing and screen.  
     
     
         5 . The method according to  claim 1 , wherein the tiotropium is a chloride, bromide, iodide, methanesulfonate, p-toluenesulfonate, or methylsulfate salt.  
     
     
         6 . The method according to  claim 5 , wherein the tiotropium is crystalline tiotropium bromide monohydrate.  
     
     
         7 . An inhalation kit comprising: 
 (a) an inhaler displaying a flow resistance of about 0.01 to 0.1 {square root}{square root over (kPa)} min/L; and    (b) an inhalable powder comprising tiotropium in admixture with a physiologically acceptable excipient with an average particle size of between 10 to 500 μm.    
     
     
         8 . The inhalation kit according to  claim 7 , wherein the amount of tiotropium in the inhalable powder is 0.001% to 5% of the inhalable powder.  
     
     
         9 . The inhalation kit according to  claim 7 , wherein the flow resistance of the inhaler is about 0.02 to 0.06 {square root}{square root over (kPa)} min/L.  
     
     
         10 . The inhalation kit according to  claim 7 , wherein the inhaler comprises: a housing containing two windows, a deck in which there are air inlet ports and which is provided with a screen secured by a screen housing, an inhalation chamber connected to the deck on which there is a push button provided with two sharpened pins and movable counter to a spring, a mouthpiece which is connected to the housing, the deck, and a cover via a spindle to enable it to be flipped open or shut, and three holes with diameters below 1 mm in the central region around the capsule chamber and underneath the screen housing and screen.  
     
     
         11 . The inhalation kit according to  claim 9 , wherein the inhaler comprises: a housing containing two windows, a deck in which there are air inlet ports and which is provided with a screen secured by a screen housing, an inhalation chamber connected to the deck on which there is a push button provided with two sharpened pins and movable counter to a spring, a mouthpiece which is connected to the housing, the deck, and a cover via a spindle to enable it to be flipped open or shut, and three holes with diameters below 1 mm in the central region around the capsule chamber and underneath the screen housing and screen.  
     
     
         12 . The inhalation kit according to  claim 7 , wherein the tiotropium is a chloride, bromide, iodide, methanesulfonate, p-toluenesulfonate, or methylsulfate salt.  
     
     
         13 . The inhalation kit according to  claim 8 , wherein the tiotropium is a chloride, bromide, iodide, methanesulfonate, p-toluenesulfonate, or methylsulfate salt.  
     
     
         14 . The inhalation kit according to  claim 9 , wherein the tiotropium is a chloride, bromide, iodide, methanesulfonate, p-toluenesulfonate, or methylsulfate salt.  
     
     
         15 . The inhalation kit according to  claim 10 , wherein the tiotropium is a chloride, bromide, iodide, methanesulfonate, p-toluenesulfonate, or methylsulfate salt.  
     
     
         16 . The inhalation kit according to  claim 11 , wherein the tiotropium is a chloride, bromide, iodide, methanesulfonate, p-toluenesulfonate, or methylsulfate salt.  
     
     
         17 . The inhalation kit according to  claim 12 , wherein the tiotropium is crystalline tiotropium bromide monohydrate.  
     
     
         18 . The inhalation kit according to  claim 13 , wherein the tiotropium is crystalline tiotropium bromide monohydrate.  
     
     
         19 . The inhalation kit according to  claim 14 , wherein the tiotropium is crystalline tiotropium bromide monohydrate.  
     
     
         20 . The inhalation kit according to  claim 15 , wherein the tiotropium is crystalline tiotropium bromide monohydrate.  
     
     
         21 . The inhalation kit according to  claim 16 , wherein the tiotropium is crystalline tiotropium bromide monohydrate.