Methods for treating lung disorders

Patent metadata

Field	Value
Publication number	US-10507181-B2
Application number	US-201916444299-A
Country	US
Kind code	B2
Filing date	Jun 18, 2019
Priority date	Jun 14, 2017
Publication date	Dec 17, 2019
Grant date	Dec 17, 2019

Abstract

Disclosed herein are compositions and methods for treating lung disorders including lung tumors by pulmonary administration of compositions comprising taxane particles such as docetaxel or paclitaxel particles.

First claim

We claim:

1. A method for treating a lung tumor, comprising pulmonary administration to a subject with a lung tumor of an amount effective of a composition comprising taxane particles to treat the lung tumor, wherein the taxane particles comprise at least 95% of the taxane and have a mean particle size (number) of between 0.1 μm and 5 μm, wherein the taxane particles have a specific surface area (SSA) of at least 12 m 2 /g, wherein the taxane particles are present in a suspension comprising the taxane particles and a pharmaceutically acceptable carrier, wherein the suspension is aerosolized for administration, wherein the pulmonary administration comprises nebulization, and wherein the nebulization results in pulmonary delivery to the subject of aerosol droplets of the taxane particles suspension.

2. The method of claim 1 , wherein the taxane particles have a mean particle size (number) of between 0.4 μm and 3 μm.

3. The method of claim 1 , wherein the taxane particles have a mean particle size (number) of between about 0.4 μm and about 1.2 μm.

4. The method of claim 1 , wherein the taxane particles have a specific surface area (SSA) of at least 18 m 2 /g.

5. The method of claim 1 , wherein the suspension further comprises:
a polysorbate, wherein the polysorbate is present in the suspension at a concentration of between about 0.01% v/v and about 1.5% v/v.

6. The method of claim 1 , wherein the pharmaceutically acceptable carrier is saline.

7. The method of claim 5 , wherein the polysorbate is polysorbate 80.

8. The method of claim 1 , wherein the taxane is present in the suspension at a concentration between about 1 mg/ml and about 40 mg/ml.

9. The method of claim 1 , wherein the taxane particles and suspensions thereof are uncoated and exclude lipids, polymers, proteins, polyethoxylated castor oil, and/or polyethylene glycol glycerides composed of mono-, di- and triglycerides and mono- and diesters of polyethylene glycol.

10. The method of claim 1 , wherein the taxane comprises paclitaxel, docetaxel, cabazitaxel, or a pharmaceutically acceptable salt thereof.

11. The method of claim 10 , wherein the taxane comprises paclitaxel or a pharmaceutically acceptable salt thereof.

12. The method of claim 1 , wherein the taxane particles have a mean bulk density between about 0.050 g/cm 3 and about 0.12 g/cm 3 .

13. The method of claim 10 , wherein the taxane comprises docetaxel or a pharmaceutically acceptable salt thereof.

14. The method of claim 1 , wherein the taxane remains detectable in lung tissue of the subject for at least 4 days after the administering.

15. The method of claim 1 , wherein the taxane particles are in crystalline form.

16. The method of claim 1 , wherein the aerosol droplets have a mass median aerodynamic diameter (MMAD) of between about 0.5 μm to about 6 μm diameter.

17. The method of claim 1 , wherein the taxane particles reside at the tumor site after administration of the composition exposing the tumor to the taxane particles for a sustained amount of time sufficient to stimulate the endogenous immune system of the subject resulting in the production of tumoricidal cells and infiltration of the tumoricidal cells into the tumor at a level sufficient to treat the tumor.

18. The method of claim 17 , wherein the sustained amount of time is at least 4 weeks.

19. The method of claim 17 , wherein the tumoricidal cells comprise T-cells, B cells, or natural killer (NK) cells, or combinations thereof.

20. The method of claim 1 , wherein the composition is administered in two or more separate administrations.

21. The method of claim 20 , wherein the composition is administered once a week for at least two weeks.

22. The method of claim 20 , wherein the composition is administered twice a week for at least one week, wherein the two or more separate administrations are separated by at least one day.

23. The method of claim 1 , wherein the treatment of the tumor is elimination of the tumor.

Assignees

• Crititech Inc

Inventors

• Baltezor Michael
• Mcclorey Matthew
• Johnston William
• Dizerega Gere S
• Verco James

Classifications

• A61K9/10 Primary

  Dispersions; Emulsions · CPC title

• A61K31/337

  having four-membered rings, e.g. taxol · CPC title

• A61K9/1623

  Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules · CPC title

• A61K9/0078 Primary

  for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions · CPC title

• A61K47/02

  Inorganic compounds · CPC title