Dry powder formulations and methods of use

• US 10,149,823 B2
• Filed: 07/24/2013
• Issued: 12/11/2018
• Est. Priority Date: 04/30/2013
• Status: Active Grant

• Current Assignee: Vectura, Inc. (Vectura Group Ltd.)
• Original Assignee: Otitopic Inc.
• Inventors: Yadidi, Kambiz
• Primary Examiner(s): Shomer, Isaac
• Application Number:
  US13/949,862
• Publication Number:
  US 20140322328A1
• Time in Patent Office: 1,966 Days
• Field of Search: 424489, 514958
• 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: A61K 9/14 Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51
• CPC Class Codes: A61M 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: Y10T 428/2982 Particulate matter [e.g., sphere, flake, etc.]

Abstract

A respirable dry powder can include acetylsalicylic acid or a pharmaceutically acceptable salt thereof. The dry powder can include a mixture of: (i) dry particles have a volume median geometric diameter (VMGD) less than 5 μm; and (ii) dry particles have a volume median geometric diameter (VMGD) of about 15 μm or more.

Claims

1. A method of treating thrombosis or reducing risk of a thromboembolic event in a subject in need thereof, the method comprising administering by pulmonary delivery to the subject dry particles free of excipients from within a dry powder inhaler, wherein the dry particles in the inhaler before the administering are provided in a capsule or blister and consist of acetylsalicylic acid or a pharmaceutically acceptable salt thereof, wherein the dry particles have a mass median aerodynamic diameter (MMAD) of less than 5 μ

m, and wherein the dry particles deliver at least 50% of administered acetylsalicylic acid to systemic circulation of the subject with about 15 minutes after the administering.

2. The method of claim 1, wherein the dry powder formulation delivers at least 60% of administered acetylsalicylic acid to systemic circulation of the subject within about 15 minutes of administration.

3. The method of claim 1, wherein the dry powder formulation delivers at least 70% of administered acetylsalicylic acid to systemic circulation of the subject within about 15 minutes of administration.

4. The method of claim 1, wherein the dry powder formulation delivers at least 80% of administered acetylsalicylic acid to systemic circulation of the subject within about 15 minutes of administration.

5. The method of claim 1, wherein the dose of acetylsalicylic acid administered to the subject is about 40 mg or less.

6. The method of claim 5, wherein the dose of acetylsalicylic acid administered to the subject is about 30 mg or less.

7. A method of treating thrombosis or reducing risk of a thromboembolic event in a subject in need thereof, the method comprising administering by pulmonary delivery to the subject dry particles free of excipients from within a dry powder inhaler, wherein the dry particles in the inhaler before the administering are provided in a capsule or blister and consist of acetylsalicylic acid or a pharmaceutically acceptable salt thereof, wherein the dry particles have a geometric diameter (VMGD) of less than 5 μ

m, and wherein the dry particles deliver at least 50% of administered acetylsalicylic acid to systemic circulation of the subject with about 15 minutes after the administering.

8. The method of claim 7, wherein the dry powder formulation delivers at least 60% of administered acetylsalicylic acid to systemic circulation of the subject within about 15 minutes of administration.

9. The method of claim 7, wherein the dry powder formulation delivers at least 70% of administered acetylsalicylic acid to systemic circulation of the subject within about 15 minutes of administration.

10. The method of claim 7, wherein the dry powder formulation delivers at least 80% of administered acetylsalicylic acid to systemic circulation of the subject within about 15 minutes of administration.

11. The method of claim 7, wherein the dose of acetylsalicylic acid administered to the subject is about 40 mg or less.

12. The method of claim 11, wherein the dose of acetylsalicylic acid administered to the subject is about 30 mg or less.