Methods for treating lung disorders

Patent metadata

Field	Value
Publication number	US-10398646-B2
Application number	US-201816007095-A
Country	US
Kind code	B2
Filing date	Jun 13, 2018
Priority date	Jun 14, 2017
Publication date	Sep 3, 2019
Grant date	Sep 3, 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 comprises paclitaxel or a pharmaceutically acceptable salt thereof, wherein the taxane particles comprise at least 95% of the taxane and have a mean particle size (number) of between 0.4 μm and 3 μm, wherein the taxane particles have a specific surface area (SSA) of at least 27 m 2 /g, wherein the taxane particles are present in a suspension comprising the taxane particles and a pharmaceutically acceptable carrier, wherein the suspensions are aerosolized for administration, and aerosol droplets resulting from aerosolization have a mass median aerodynamic diameter (MMAD) of between about 0.5 μm to about 6 μm diameter, wherein the pulmonary administration comprises nebulization, and wherein the nebulization results in pulmonary delivery to the subject of aerosol droplets of the taxane particle suspension.

2. The method of claim 1 , wherein the taxane particles have a mean particle size (number) of between 0.4 μm and 2 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 aerosol droplets resulting from aerosolization have a mass median aerodynamic diameter (MMAD) of between about 1 μm to about 3 μm diameter.

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 particles and suspensions thereof are uncoated and exclude lipids, polymers, proteins, polyethoxylated castor oil, and polyethylene glycol glycerides composed of mono-, di- and triglycerides and mono- and diesters of polyethylene glycol.

10. The method of claim 4 , 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.

11. The method of claim 10 , wherein the pharmaceutically acceptable carrier comprises saline.

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 1 , wherein the taxane particles are in crystalline form.

14. The method of claim 10 , wherein the particles and suspensions thereof are uncoated and exclude lipids, polymers, proteins, polyethoxylated castor oil, and polyethylene glycol glycerides composed of mono-, di- and triglycerides and mono- and diesters of polyethylene glycol.

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

16. The method of claim 15 , wherein the sustained amount of time is at least 4 weeks.

17. The method of claim 15 , wherein the tumoricidal cells comprise T-cells, B cells, or natural killer (NK) cells, or combinations thereof.

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

19. The method of claim 18 , wherein the composition administered once a week for at least two weeks.

20. The method of claim 18 , 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.

Assignees

• Crititech Inc

Inventors

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

Classifications

• A61K47/26

  Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin · CPC title

• A61K47/02

  Inorganic compounds · CPC title

• A61K9/14

  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 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

• A61K9/10 Primary

  Dispersions; Emulsions · CPC title