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Claims for Patent: 8,022,082

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Claims for Patent: 8,022,082

Title: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 .mu.m, 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 .mu.m to 500 .mu.m, 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.
Inventor(s): Zierenberg; Bernd (Bingen am Rhein, DE)
Assignee: Boehringer Ingelheim Pharma GmbH & Co., KG (Ingelheim am Rhein, DE)
Application Number:11/427,173
Patent Claims: 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 .mu.m to 500 .mu.m, the method comprising actuating an inhaler with a flow resistance of about 0.01 to 0.1 {square root over (kPa)} min/L containing the inhalable powder, 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.

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 over (kPa)} min/L.

4. The method according to claim 1, wherein the tiotropium is a chloride, bromide, iodide, methanesulfonate, p-toluenesulfonate, or methylsulfate salt.

5. The method according to claim 4, wherein the tiotropium is crystalline tiotropium bromide monohydrate.

6. 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 .mu.m, 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.

7. The inhalation kit according to claim 6, wherein the amount of tiotropium in the inhalable powder is 0.001% to 5% of the inhalable powder.

8. The inhalation kit according to claim 7, wherein the tiotropium is a chloride, bromide, iodide, methanesulfonate, p-toluenesulfonate, or methylsulfate salt.

9. The inhalation kit according to claim 8, wherein the tiotropium is crystalline tiotropium bromide monohydrate.

10. The inhalation kit according to claim 6, wherein the flow resistance of the inhaler is about 0.02 to 0.06 {square root over (kPa)} min/L.

11. The inhalation kit according to claim 10, wherein the tiotropium is a chloride, bromide, iodide, methanesulfonate, p-toluenesulfonate, or methylsulfate salt.

12. The inhalation kit according to claim 11, wherein the tiotropium is crystalline tiotropium bromide monohydrate.

13. The inhalation kit according to claim 6, wherein the tiotropium is a chloride, bromide, iodide, methanesulfonate, p-toluenesulfonate, or methylsulfate salt.

14. The inhalation kit according to claim 13, wherein the tiotropium is crystalline tiotropium bromide monohydrate.
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