Auris formulations for treating otic diseases and conditions

Patent metadata

Field	Value
Publication number	US-11969501-B2
Application number	US-202117405990-A
Country	US
Kind code	B2
Filing date	Aug 18, 2021
Priority date	Apr 21, 2008
Publication date	Apr 30, 2024
Grant date	Apr 30, 2024

Abstract

Disclosed herein are compositions and methods for the treatment of otic disorders with immunomodulating agents and auris pressure modulators. In these methods, the auris compositions and formulations are administered locally to an individual afflicted with an otic disorder, through direct application of the immunomodulating and/or auris pressure modulating compositions and formulations onto the auris media and/or auris interna target areas, or via perfusion into the auris media and/or auris interna structures.

First claim

We claim:

1. A pharmaceutical composition comprising: one and no more than one growth factor selected from brain-derived neurotrophic factor (BDNF) or neurotrophin-3, or pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is a thermoreversible gel formulated for intratympanic administration, wherein the pharmaceutical composition comprises from 14% to 17% by weight of Poloxamer 407, and wherein the pharmaceutical composition provides sustained release of therapeutically effective amount of the growth factor into the ear following a single administration.

2. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition has a gelation temperature of from 20° C. to 30° C.

3. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition has a pH of from 7.0 to 8.0.

4. The pharmaceutical composition of claim 3 , wherein the pharmaceutical composition further comprises a buffering agent.

5. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition has an osmolarity of from 250 mOsm/L to 320 mOsm/L.

6. The pharmaceutical composition of claim 5 , wherein the pharmaceutical composition further comprises sodium chloride.

7. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises from 14% to 16% by weight of the poloxamer.

8. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises from 15% to 16% by weight of the poloxamer.

9. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is formulated to provide sustained release of the growth factor into an inner ear for a period of at least 3 days following a single administration.

10. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is formulated to provide sustained release of the growth factor into an inner ear for a period of at least 5 days following a single administration.

11. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is formulated to provide sustained release of the growth factor into an inner ear for a period of at least 7 days following a single administration.

12. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is formulated to provide sustained release of the growth factor into an inner ear for a period of at least 14 days following a single administration.

13. The pharmaceutical composition of claim 1 , wherein the growth factor is neurotrophin-3.

14. The pharmaceutical composition of claim 1 , wherein the growth factor is BDNF.

15. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises between about 0.1 mg/ml to about 5 mg/ml of the growth factor.

16. The pharmaceutical composition of claim 1 , wherein the growth factor is dissolved in the pharmaceutical composition.

17. The pharmaceutical composition of claim 15 , wherein the pharmaceutical composition comprises between about 0.5 mg/ml to about 5 mg/ml of the growth factor.

18. The pharmaceutical composition of claim 15 , wherein the pharmaceutical composition comprises between about 0.1 mg/ml to about 0.5 mg/ml of the growth factor.

19. The pharmaceutical composition of claim 1 , wherein the composition comprises: between about 0.1 mg/ml to about 20 mg/ml of the growth factor.

20. The pharmaceutical composition of claim 1 , wherein the composition comprises: between about 0.1 mg/ml to about 10 mg/ml of the growth factor.

Assignees

• Dompe Farm Spa
• Univ California

Inventors

• Lichter Jay
• Trammel Andrew M
• Piu Fabrice
• Ye Qiang
• Scaife Michael Christopher
• Vollrath Benedikt
• Duron Sergio G
• Dellamary Luis A
• Lebel Carl
• Harris Jeffrey P

Classifications

• A61K9/0046 Primary

  Ear · CPC title

• A61K9/06

  Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)} · CPC title

• A61K9/127

  Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant · 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

• A61K9/16

  Agglomerates; Granulates; Microbeadlets {; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction (A61K9/20 takes precedence if the final form is a tablet; microspheres with drug-free outer coating, microcapsules A61K9/50; mixture of different granules, microcapsules, (coated) microparticles A61K9/5084; nanoparticles A61K9/51)} · CPC title