IP Library › Granted Patent US 12,263,174
Granted Patent B2
US 12,263,174 · App. 17/853,005 · Granted Apr 1, 2025

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.
A61K31/53A61K9/0075A61K9/008A61K9/1623A61K31/192A61K31/506A61P9/12
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Quick Facts
Patent No.
US 12,263,174
App. No.
17/853,005
Granted
Apr 1, 2025
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 (32)

1. A method of treating pulmonary arterial hypertension, comprising administering to the subject in need thereof a therapeutically effective amount of a PDE5 inhibitor by oral inhalation;

wherein the therapeutically effective amount of the PDE5 inhibitor is delivered by a portable inhaler pro re nata.

2. The method of claim 1 , wherein the portable inhaler is one of a dry powder inhaler, a metered dose inhaler, and a capsule-based inhaler.

3. The method of claim 2 , wherein the portable inhaler comprises an axially oscillating sphere positioned within a dispersion chamber of the dry powder inhaler.

4. The method of claim 1 , wherein the PDE5 inhibitor is vardenafil, or salts or hydrates thereof.

5. The method of claim 4 , comprising vardenafil hydrochloride or hydrates thereof in the form of micronized drug particles.

6. The method of claim 5 , wherein a Dv50 of the micronized drug particles is less than 2.5 μm.

7. The method of claim 1 , wherein:

the therapeutically effective amount of a PDE5 inhibitor is delivered in a carrier-based composition that includes a powder base; and

the carrier-based composition has a powder fill mass between about 10 mg to about 30 mg.

8. The method of claim 7 , wherein the powder base comprises one or more members selected from the group consisting of lactose, mannitol, trehalose, and starch.

9. The method of claim 8 , wherein the powder base comprises at least one of:

coarse crystalline lactose monohydrate particles having a Dv50 between the range of about 50 μm to about 100 μm; and

fine crystalline lactose monohydrate carrier particles having a Dv50 of about less than 10 μm.

10. The method of claim 8 , wherein the powder base is about 70% to about 99.9% of the total composition weight of the carrier-based composition.

11. A method of treating pulmonary arterial hypertension in a subject in need thereof, comprising:

administering to the subject in need thereof a carrier-based composition for oral inhalation having a powder fill mass between about 10 mg to about 30 mg, the carrier-based composition including a therapeutically effective amount of micronized vardenafil hydrochloride trihydrate in dry powder form; and

wherein carrier-based composition is administered pro re nata by a portable inhaler.

12. The method of claim 11 , wherein the carrier-based composition further comprises a powder base including at least one of:

coarse crystalline lactose monohydrate particles having a Dv50 between the range of about 50 μm to about 100 μm; and

fine crystalline lactose monohydrate carrier particles having a Dv50 of about less than 10 μm.

13. The method of claim 11 , wherein the portable inhaler comprises an axially oscillating sphere positioned within a dispersion chamber of the dry powder inhaler.

14. The method of claim 11 , wherein the carrier-based composition is administered at least 2-30 minutes before initiating physical activity.

15. The method of claim 14 , wherein the carrier-based composition has a duration of action of at least 1 to 3 hours.

16. The method of claim 11 , wherein the micronized vardenafil hydrochloride trihydrate is administered in a nominal dose from about 0.1 mg to about 2.0 mg of vardenafil.

17. The method of claim 11 , wherein the micronized vardenafil hydrochloride trihydrate is administered in a nominal dose from about 0.15 mg to about 0.5 mg of vardenafil.

18. The method of claim 11 , wherein the micronized vardenafil hydrochloride trihydrate is administered in a nominal dose from about 0.1 mg to about 3.0 mg of vardenafil.

19. A method of treating pulmonary arterial hypertension, comprising:

administering to a subject in need thereof a carrier-based composition for oral inhalation having a powder fill mass between about 10 mg to about 30 mg, the carrier-based composition including:

(a) a therapeutically effective amount of micronized vardenafil hydrochloride trihydrate in dry powder form; and

(b) a powder base; and

wherein the carrier-based composition is delivered, pro re nata, by a portable inhaler.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 25, 2025
From: FROST, ADAANI
To: RESPIRA THERAPEUTICS, INC.
Reel/Frame 070327/0193 →
REQUEST TO CHANGE THE ASSIGNEE'S ADDRESS Recorded Feb 25, 2025
From: RESPIRA THERAPEUTICS, INC.
To: RESPIRA THERAPEUTICS, INC.
Reel/Frame 070328/0610 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 25, 2025
From: WEERS, JEFFRY; ROMERO, ALAIN; SMYTH, HUGH; CURTIS, ROBERT; XU, ZHEN; SHREENIWAS, REVATI; DONOVAN, MARTIN
To: RESPIRA THERAPEUTICS, INC.
Reel/Frame 070328/0618 →
Continuity (5)
Continuation 17534282 · Nov 23, 2021
Continuation 17146173 · Jan 11, 2021
Continuation 16469524
Provisional Application 62434185 · Dec 14, 2016
Related Publication 20220347183A1 · Nov 3, 2022
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