Use of aerosolized levofloxacin for treating cystic fibrosis

• US 10,231,975 B2
• Filed: 06/14/2017
• Issued: 03/19/2019
• Est. Priority Date: 09/04/2009
• Status: Expired due to Fees

• Current Assignee: Horizon Orphan, LLC (Amgen Inc.)
• Original Assignee: Horizon Orphan, LLC (Amgen Inc.)
• Inventors: Loutit, Jeffery S., Morgan, Elizabeth E., Dudley, Michael N., Griffith, David C., Lomovskaya, Olga
• Primary Examiner(s): Stevens, Mark V
• Application Number:
  US15/623,168
• Publication Number:
  US 20180085376A1
• Time in Patent Office: 643 Days
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/5383 ortho- or peri-condensed with heterocyclic ring systems
• CPC Class Codes: A61K 33/06 Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• CPC Class Codes: A61K 33/14 Alkali metal chlorides; Alkaline earth metal chlorides
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0078 for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/08 Bronchodilators
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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

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.