IP Library Granted Patent US 10,231,975
Granted Patent B2
US 10,231,975 · App. 15/623,168 · Granted Mar 19, 2019

Use of aerosolized levofloxacin for treating cystic fibrosis

Inventors: Jeffery S. Loutit (Los Altos, CA); Elizabeth E. Morgan (Escondido, CA); Michael N. Dudley (San Diego, CA); David C. Griffith (San Marcos, CA); Olga Lomovskaya (Mountain View, CA)
Assignee: Horizon Orphan LLC
A61K31/5383A61K9/0078A61K9/08A61K33/06A61K33/14A61K45/06Y02A50/401Y02A50/47Y02A50/471Y02A50/473Y02A50/475Y02A50/478Y02A50/481Y02A50/483
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Quick Facts
Patent No.
US 10,231,975
App. No.
15/623,168
Granted
Mar 19, 2019
Kind
B2
Abstract

Methods for treating cystic fibrosis. The method includes administering to a human in need thereof an aerosol solution comprising levofloxacin or ofloxacin and a divalent or trivalent cation. More particularly, the method includes administering the aerosol solution to a human having a pulmonary infection comprising P. aeruginosa.

Claims (20)

1. A method for treating a pulmonary Pseudomonas aeruginosa infection in a human in need thereof, the method comprising administering via inhalation 240 mg of levofloxacin twice daily for 28 days to the human to treat the pulmonary Pseudomonas aeruginosa infection; wherein the levofloxacin is in a solution comprising 90 mg/ml to 110 mg/ml of levofloxacin and 175 mM to 225 mM of a magnesium cation.

2. The method of claim 1 , wherein the magnesium cation is in the form of magnesium chloride.

3. The method of claim 2 , wherein the solution comprises 100 mg/ml of levofloxacin and 200 mM of magnesium chloride.

4. The method of claim 1 , wherein the magnesium cation is in the form of magnesium sulfate.

5. The method of claim 1 , wherein the solution is administered by a vibrating mesh nebulizer.

6. The method of claim 1 , wherein the solution has a pH from 5 to 7, and an osmolality from 300 mOsmol/kg to 500 mOsmol/kg.

7. The method of claim 1 , further comprising administering dornase alpha, azithromycin, salbutamol, pancrelipase, sodium chloride, seretide, vitamin A, vitamin D, vitamin E, vitamin K, or a combination of two or more thereof.

8. The method of claim 1 , wherein the human is a pediatric patient.

9. The method of claim 1 , wherein the human has cystic fibrosis.

10. A method for treating a pulmonary Pseudomonas aeruginosa infection in a human in need thereof, the method comprising administering via inhalation 240 mg of levofloxacin twice daily for 28 days to the human to treat the pulmonary Pseudomonas aeruginosa infection; wherein the levofloxacin is in a solution comprising 90 mg/ml to 125 mg/ml of levofloxacin and 150 mM to 250 mM of a cation, wherein the cation is a magnesium cation, a calcium cation, a zinc cation, a copper cation, an aluminum cation, or an iron cation.

11. The method of claim 10 , wherein the cation is the zinc cation.

12. The method of claim 11 , wherein the zinc cation is in the form of zinc chloride.

13. The method of claim 10 , wherein the cation is the copper cation.

14. The method of claim 13 , wherein the copper cation is in the form of copper chloride.

15. The method of claim 10 , wherein the cation is the magnesium cation.

16. The method of claim 15 , wherein the magnesium cation is in the form of magnesium chloride.

17. The method of claim 15 , wherein the magnesium cation is in the form of magnesium sulfate.

18. The method of claim 10 , wherein the solution has a pH from 5 to 7, and an osmolality from 300 mOsmol/kg to 500 mOsmol/kg.

19. The method of claim 10 , wherein the human is a pediatric patient.

20. The method of claim 19 , wherein the pediatric patient has cystic fibrosis.

Assignments (2)
RELEASE OF SECURITY INTEREST Recorded Oct 6, 2023
From: CITIBANK, N.A.
To: HORIZON THERAPEUTICS U.S. HOLDING LLC (FKA HORIZON ORPHAN LLC)
Reel/Frame 065154/0014 →
SECURITY AGREEMENT Recorded May 22, 2019
From: HORIZON ORPHAN LLC
To: CITIBANK, N.A.
Reel/Frame 050253/0855 →
Continuity (5)
Continuation 13412423 · Mar 5, 2012
Continuation PCTUS2010047903 · Sep 3, 2010
Provisional Application 61240092 · Sep 4, 2009
Provisional Application 61249231 · Oct 6, 2009
Related Publication 20180085376A1 · Mar 29, 2018