IP Library Granted Patent US 8,758,824
Granted Patent B2
US 8,758,824 · App. 13/504,284 · Granted Jun 24, 2014

Respirably dry powder comprising calcium lactate, sodium chloride and leucine

Inventors: Michael M. Lipp (Framingham, MA); Jean C. Sung (Cambridge, MA)
Assignee: Pulmatrix, Inc.
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Quick Facts
Patent No.
US 8,758,824
App. No.
13/504,284
Granted
Jun 24, 2014
Kind
B2
Abstract

The present invention relates to respirable dry powders that contain respirable dry particles that comprise about 20% (w/w) leucine, about 75% (w/w) calcium lactate, and about 5% (w/w) sodium chloride, or about 37.5% (w/w) leucine, about 58.6% (w/w) calcium lactate, and about 3.9% (w/w) sodium chloride, and methods for treating a subject using the respirable dry powders.

Claims (19)

1. A respirable dry powder comprising respirable dry particles that comprise on a dry basis about 20% (w/w) leucine, about 75% (w/w) calcium lactate, and about 5% (w/w) sodium chloride; or about 37.5% (w/w) leucine, about 58.6% (w/w) calcium lactate, and about 3.9% (w/w) sodium chloride.

2. The respirable dry powder of claim 1 wherein the respirable dry particles have a volume median geometric diameter (VMGD) of 5 microns or less as measured at the one bar dispersion setting on the HELOS/RODOS laser diffraction system.

3. The respirable dry powder of claim 1 , wherein the respirable dry particles have a volume median geometric diameter (VMGD) between 2 and 5 microns as measured at the one bar dispersion setting on the HELOS/RODOS laser diffraction system.

4. The respirable dry powder of claim 1 , wherein the respirable dry particles have a volume median geometric diameter (VMGD) between 1 and 3 microns as measured at the one bar dispersion setting on the HELOS/RODOS laser diffraction system.

5. The respirable dry powder of claim 1 , wherein the respirable dry powder has a Hausner ratio of at least 1.4.

6. The respirable dry powder of claim 1 , wherein the respirable dry powder has a Hausner Ratio of at least 2.0.

7. The respirable dry powder of claim 1 , wherein the respirable dry powder has a dispersibility ratio at 1 bar/4 bar of less than 1.5, as measured at the 1 bar and 4 bar dispersion settings on the HELOS/RODOS laser diffraction system.

8. The respirable dry powder of claim 1 , wherein the respirable dry powder has a dispersibility ratio at 1 bar/4 bar between 1.0 and 1.2 as measured by HELOS/RODOS laser diffraction system.

9. The respirable dry powder of claim 1 , wherein the respirable dry powder has a dispersibility ratio at 0.5 bar/4 bar of less than 1.5 as measured by HELOS/RODOS laser diffraction system.

10. The respirable dry powder of claim 1 , wherein the respirable dry powder has a Fine Particle Fraction (FPF) of less than 3.4 microns of at least 20%.

11. The respirable dry powder of claim 1 , wherein the respirable dry powder has a Fine Particle Fraction (FPF) of less than 5.6 microns of at least 40%.

12. The respirable dry powder of claim 1 , wherein a Capsule Emitted Powder Mass (CEPM) of at least about 80% of said respirable dry powder contained in a unit dose container, that contains 50 mg of said dry powder, in a dry powder inhaler is achieved when a total inhalation energy of less than about 1 Joule is applied to said dry powder inhaler.

13. The respirable dry powder of claim 12 wherein the unit dose container is at least 40% full.

14. The respirable dry powder of claim 1 , further comprising an additional therapeutic agent.

15. The respirable dry powder of claim 14 , wherein the one or more additional therapeutic agents are selected from the group consisting of LABAs, short-acting beta agonists, corticosteroids, LAMAs, antibiotics, and combinations thereof.

16. The respirable dry powder of claim 15 , where the LABA is selected from the group consisting of formoterol, salmeterol and combinations thereof; the short-acting beta agonists is albuterol; the corticosteroid is fluticasone; the LAMA is tiotropium; and the antibiotic is levofloxacin.

17. A method for treating a respiratory disease comprising administering to the respiratory tract of a patient in need thereof an effective amount of a respirable dry powder of claim 1 .

18. A method for treating or preventing an acute exacerbation of a respiratory disease comprising administering to the respiratory tract of a patient in need thereof an effective amount of a respirable dry powder of claim 1 .

19. A method for treating or preventing an infectious disease of the respiratory tract comprising administering to the respiratory tract of a patient in need thereof an effective amount of a respirable dry powder of claim 1 .

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 22, 2012
From: LIPP, MICHAEL M.; SUNG, JEAN C.
To: PULMATRIX, INC.
Reel/Frame 028426/0368 →
Continuity (4)
Provisional Application 61431205 · Jan 10, 2011
Provisional Application 61387797 · Sep 29, 2010
Provisional Application 61378146 · Aug 30, 2010
Related Publication 20130149345A1 · Jun 13, 2013