IP Library › Granted Patent US 11,491,161
Granted Patent B2
US 11,491,161 · App. 17/534,282 · Granted Nov 8, 2022

Methods and compositions for treatment of pulmonary hypertension and other lung disorders

Inventors: Jeffry Weers (Half Moon Bay, CA); Alain Romero (Brisbane, CA); Hugh Smyth (West Lake Hills, TX); Robert Curtis (Santa Fe, NM); Adaani Frost (Houston, TX); Zhen Xu (Rockville, MD); Revati Shreeniwas (Palo Alto, CA); Martin Donovan (Austin, TX)
Assignee: Respira Therapeutics, Inc.
A61K31/53A61K9/008A61K9/0075A61K9/1623A61K31/192A61K31/506A61P9/12
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Quick Facts
Patent No.
US 11,491,161
App. No.
17/534,282
Granted
Nov 8, 2022
Kind
B2
Abstract

Provided herein are methods for treating pulmonary hypertension. The methods include administering to a subject in need thereof an effective amount of a vasodilator, wherein the vasodilator is administered to the subject via inhalation pro re nata using a portable inhaler. In some embodiments, the vasodilator is a PDE5 inhibitor. Pharmaceutical compositions for pro re nata administration of vasodilators are also described.

Claims (30)

1. A method of treating pulmonary arterial hypertension in a subject in need thereof, comprising administering to the subject in need thereof a therapeutically effective amount of micronized vardenafil hydrochloride trihydrate in dry powder form by oral inhalation, pro re nata, delivered by a portable inhaler.

2. The method of claim 1 , wherein the portable inhaler is a dry powder inhaler.

3. The method of claim 1 , wherein the portable inhaler is a metered dose inhaler.

4. The method of claim 1 , wherein the portable inhaler is a capsule-based inhaler.

5. The method of claim 1 , wherein the micronized vardenafil hydrochloride trihydrate has a volume weighted median diameter (Dv50) of less than 2.5 μm.

6. The method of claim 1 , wherein the micronized vardenafil hydrochloride trihydrate has a volume weighted median diameter (Dv50) of less than 2.0 μm.

7. The method of claim 1 , wherein the micronized vardenafil hydrochloride trihydrate has a volume weighted median diameter (Dv50) of less than 1.5 μm.

8. The method of claim 1 , wherein the micronized vardenafil hydrochloride trihydrate has a volume weighted median diameter (Dv50) from about 0.1 μm to about 1.5 μm.

9. The method of claim 1 , wherein the micronized vardenafil hydrochloride trihydrate has a volume weighted median diameter (Dv50) from about 0.1 μm to about 2.0 μm.

10. The method of claim 1 , wherein the micronized vardenafil hydrochloride trihydrate has a volume weighted median diameter (Dv50) from about 0.1 μm to about 2.5 μm.

11. The method of claim 1 , wherein the micronized vardenafil hydrochloride trihydrate has a volume weighted median diameter (Dv50) of about 1.8 μm.

12. The method of claim 1 , wherein the micronized vardenafil hydrochloride trihydrate has a volume weighted median diameter (Dv50) of about 2.9 μm.

13. The method of claim 4 , wherein the powder fill mass of the capsule is from about 10 mg to about 30 mg.

14. The method of claim 4 , wherein the powder fill mass of the capsule is from about 12.5 mg to about 25 mg.

15. The method of claim 4 , wherein the powder fill mass of the capsule is about 25 mg.

16. The method of claim 4 , wherein the powder fill mass of the capsule is about 30 mg.

17. The method of claim 1 , wherein the portable inhaler comprises an axially oscillating sphere positioned within a dispersion chamber of the dry powder inhaler.

18. The method of claim 17 , wherein the portable inhaler combination achieves a d a 2 Q less than 467 μm 2 L/minute when the vardenafil hydrochloride trihydrate in dry powder form is deposited on stage 4-F of a Next Generation Impactor.

19. The method of claim 1 , wherein the vardenafil hydrochloride trihydrate is administered in a nominal dose from about 0.1 mg to about 2.0 mg of vardenafil.

20. The method of claim 1 , wherein the vardenafil hydrochloride trihydrate is administered in a nominal dose from about 0.15 mg to about 0.5 mg of vardenafil.

21. The method of claim 1 , wherein the vardenafil hydrochloride trihydrate is administered in a nominal dose from about 0.1 mg to about 3.0 mg of vardenafil.

22. The method of claim 1 , wherein the vardenafil hydrochloride trihydrate is administered in a nominal dose from about 0.125 mg to about 2.5 mg of vardenafil.

23. The method of claim 1 , wherein the vardenafil hydrochloride trihydrate is administered in a nominal dose from about 0.5 mg to about 1.0 mg of vardenafil.

24. The method of claim 1 , wherein the vardenafil hydrochloride trihydrate is administered in a nominal dose of about 0.5 mg vardenafil.

25. The method of claim 1 , wherein the vardenafil hydrochloride trihydrate has a T max of 2 minutes or less following administration.

26. The method of claim 1 , wherein the vardenafil hydrochloride trihydrate has a half-life of about 2 hours on a PDE5 receptor.

27. The method of claim 1 , wherein the vardenafil hydrochloride trihydrate is administered at least 2 to 30 minutes before initiating physical activity.

28. The method of claim 27 , wherein the vardenafil hydrochloride trihydrate has a duration of action of at least 1 to 3 hours.

29. The method of claim 1 , wherein the daily treatment burden is less than 15 minutes per day.

30. The method of claim 1 , wherein the contribution of gastrointestinal absorption to systemic delivery is below 15%.

Continuity (4)
Continuation 17146173 · Jan 11, 2021
Continuation 16469524
Provisional Application 62434185 · Dec 14, 2016
Related Publication 20220079949A1 · Mar 17, 2022