Method for the administration of an anticholinergic by inhalation

• US 8,022,082 B2
• Filed: 06/28/2006
• Issued: 09/20/2011
• Est. Priority Date: 04/09/2002
• Status: Active Grant

• Current Assignee: Boehringer Ingelheim Pharma GmbH & Company Kg (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: Boehringer Ingelheim Pharma GmbH & Company Kg (C.H. Boehringer Sohn AG & Co. KG)
• Inventors: Zierenberg, Bernd
• Primary Examiner(s): ALSTRUM ACEVEDO, JAMES HENRY
• Application Number:
  US11/427,173
• Publication Number:
  US 20060251586A1
• Time in Patent Office: 1,910 Days
• Field of Search: 424/46, 424/489, 514/291, 128/203.12, 128/203.15
• US Class Current: 514/291
• CPC Class Codes: A61K 31/439 the ring forming part of a bridged ring system, e.g. quinuclidine 8-azabicyclo [3.2.1] octanes A61K31/46
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• CPC Class Codes: A61K 9/145 with organic compounds
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0026 Hinged caps
• CPC Class Codes: A61M 15/0028 using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
• CPC Class Codes: A61M 15/0041 with movable piercing or cutting means
• CPC Class Codes: A61M 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 15/0051 the dosages being arranged on a tape, e.g. strips
• CPC Class Codes: A61M 15/0075 on a disc
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• CPC Class Codes: A61M 15/0091 mechanically breath-triggered
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/75 with filters

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 μm 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.

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 μ

m to 500 μ

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 μ

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.