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 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 pm to 500 μm, the method comprising actuating an inhaler a flow resistance of about 0.01 to 0.1 √{square root over (kPa)} min/L containing the inhalable powder.

1 - 21 . (canceled) 
   
   
       22 . A medical product comprising a single dry powder dose of micronized tiotropium powder which is the free ammonium cation of tiotropium or the free ammonium cation of tiotropium and a counter-ion which is selected from the group consisting of chloride, bromide, iodide, methanesulfonate, p-toluenesulfonate or methylsulfate,
 said single dry powder dose being directly loaded into a container adapted for administration by a dry powder inhaler,   wherein the container is hermetically sealed,   thereby preserving at least seven of the single dry powder doses of the micronized tiotropium powder dose against environmental degradation,   wherein said hermetically sealed container prevents ingress of moisture into said container,   wherein at least seven of the single dry powder doses of the micronized tiotropium powder dose are preserved against environmental degradation for a period of at least seven days,   wherein said hermetically sealed container comprises at least one of a formed aluminum foil and a flat aluminum foil, optionally laminated with a plastic; or   wherein said hermetically sealed container comprises a base sheet and a lid sheet, wherein the base sheet and the lid sheet each comprise a flexible aluminum foil optionally laminated with at least one plastic layer, and the lid sheet and base sheet are adhered to one another by heat sealing; or   wherein said hermetically sealed container comprises a cavity formed from a laminate comprising a polyvinyl chloride base layer, an aluminum foil layer, and a polyamide layer, said laminate being hermetically sealed to an aluminum foil top layer;   wherein administration of the dry powder dose is performed by inhalation from the dry powder inhaler, and said dry powder inhaler provides a swirling airflow which distributes said dry powder dose within the airflow produced by an inhalation effort by a user, and breaks up any aggregates present in the dry powder dose, wherein when the container is introduced into the dry powder inhaler, and   when suction is applied through a mouthpiece of the inhaler, the suction produces a swirling airflow which helps to distribute the powder of the dose effectively within the airflow and to reduce the extent to which the powder is deposited on the inside of the mouthpiece,   and said airflow also assists to breakup any aggregates of the powder which may be present in the dose, providing efficient entrainment of the powder in the airflow with consequent efficient emptying of said blister.   
   
   
       23 . The medical product according to  claim 22 , wherein said tiotropium powder comprises the free ammonium cation of tiotropium and a counter-ion selected from the group consisting of chloride, bromide, iodide, methanesulfonate, p-toluenesulfonate or methyl sulfate. 
   
   
       24 . The medical product according to  claim 22 , wherein said dry powder dose further comprises a lactose excipient. 
   
   
       25 . The medical product according to  claim 22 , wherein the container forms a cavity molded from a plastic providing hermetic properties. 
   
   
       26 . The medical product according to  claim 22 , wherein said hermetically sealed container is part of the dry powder inhaler. 
   
   
       27 . The medical product according to  claim 22 , wherein said medical product is adapted for use in the treatment of a respiratory disorder.