Dry powder inhaler and methods of use

• US 9,757,395 B2
• Filed: 03/08/2013
• Issued: 09/12/2017
• Est. Priority Date: 12/20/2012
• Status: Active Grant

• Current Assignee: Vectura, Inc. (Vectura Group Ltd.)
• Original Assignee: Otitopic Inc.
• Inventors: Yadidi, Kambiz
• Primary Examiner(s): Scherbel, Todd J
• Assistant Examiner(s): Murphy, Victoria
• Application Number:
  US13/791,734
• Publication Number:
  US 20140174437A1
• Time in Patent Office: 1,649 Days
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/196 the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
• CPC Class Codes: A61K 31/60 Salicylic acid; Derivatives thereof
• CPC Class Codes: A61K 31/616 by carboxylic acids, e.g. acetylsalicylic acid
• 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: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

Methods for reducing the risk of a thromboembolic event, and a related drug delivery system are provided. In some embodiments, a dose of acetylsalicylic acid can be provided in powder form to a patient using a dry powder inhaler. The dose can be effective to reduce a risk of a thromboembolic event in a patient. A dry powder inhaler used for the method can have a mouthpiece, a reservoir for receiving the dose of acetylsalicylic acid, and an actuation member for making available the dose of acetylsalicylic acid for inhalation by a patient through the mouthpiece.

Claims

1. A method of reducing risk of a thromboembolic event,

the method consisting of the step of administering through oral inhalation to a patient in an emergency a single dose of acetylsalicylic acid formulated as a dry powder comprising dry particles, the dose effective to reduce the risk of the thromboembolic event in the patient, by a dry powder inhaler, the dry powder inhaler having a mouthpiece and an actuation member for making available the dose of the acetylsalicylic acid for inhalation by the patient to reduce the risk of the thromboembolic event, wherein the amount of the dose administered to the patient in the emergency comprises less than 60 mg of acetylsalicylic acid, and wherein the particles have a median geometric diameter ranging from 1 μ

m to about 5 μ

m.

2. The method of claim 1, wherein the dose of the acetylsalicylic acid comprises an amount from about 5 mg to about 60 mg.

3. The method of claim 1, wherein the dose of the acetylsalicylic acid comprises from about 8 mg to about 60 mg.

4. The method of claim 1, wherein the dose of the acetylsalicylic acid comprises from about 10 mg to about 40 mg.

5. The method of claim 1, wherein the dose of the acetylsalicylic acid comprises from about 15 mg to about 30 mg.

6. The method of claim 1, wherein the dose of the acetylsalicylic acid comprises about 20 mg.

7. The method of claim 1, wherein the dose of the acetylsalicylic acid comprises about 18 mg.

8. The method of claim 1, wherein the dose of the acetylsalicylic acid is administered as a preliminary treatment in response to a symptom of a thromboembolic event.

9. A drug delivery system for reducing risk of a thromboembolic event, the system comprising:

a single dose of acetylsalicylic acid in powder form comprising dry particles, the dose effective to reduce the risk of the thromboembolic event in a patient in an emergency;

a dry powder inhaler for oral inhalation, the dry powder inhaler having a mouthpiece, a reservoir for receiving the dose of acetylsalicylic acid, and an actuation member for making available the dose of the acetylsalicylic acid for inhalation by the patient through the mouthpiece,

wherein the dose of acetylsalicylic acid administered to the patient in the emergency comprises less than 60 mg of acetylsalicylic acid, and wherein the particles have a median geometric diameter ranging from about 1 μ

m to about 5 μ

m.

10. The system of claim 9, wherein the dose of the acetylsalicylic acid comprises an amount from about 5 mg to about 60 mg.

11. The system of claim 9, wherein the dose of the acetylsalicylic acid comprises from about 8 mg to about 60 mg.

12. The system of claim 9, wherein the dose of the acetylsalicylic acid comprises from about 10 mg to about 40 mg.

13. The system of claim 9, wherein the dose of the acetylsalicylic acid comprises from about 15 mg to about 30 mg.

14. The system of claim 9, wherein the dose of the acetylsalicylic acid comprises about 20 mg.

15. The system of claim 9, wherein the dose of the acetylsalicylic acid comprises about 18 mg.