Methods and compositions for treatment of pulmonary hypertension and other lung disorders
Inventors
Weers, Jeffry • ROMERO, ALAIN • SMYTH, HUGH • Curtis, Robert • FROST, Adaani • Xu, Zhen • Shreeniwas, Revati • Donovan, Martin
Assignees
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Publication Number
US-12263174-B2
Publication Date
2025-04-01
Expiration Date
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.
Core Innovation
The invention relates to treating pulmonary arterial hypertension by administering, to a subject in need thereof, a therapeutically effective amount of a PDE5 inhibitor by oral inhalation delivered by a portable inhaler on a pro re nata basis. The approach emphasizes PRN/as-needed delivery in combination with a portable inhaler for pulmonary arterial hypertension treatment using inhaled PDE5 inhibitor therapy.
The disclosed compositions include dry powder, oral inhalation, and carrier-based formulations in which a therapeutically effective amount of PDE5 inhibitor is formulated for delivery by a portable inhaler. In particular embodiments, the PDE5 inhibitor includes micronized vardenafil hydrochloride trihydrate in dry powder form, with a powder fill mass within a specified range and a powder base included with the active ingredient.
The portable inhaler delivery is further characterized by dry powder inhaler internal structural features, including an axially oscillating sphere positioned within a dispersion chamber, and by aerosol targeting and fine-particle delivery metrics. The disclosed parameters support minimizing systemic exposure and enabling acute hemodynamic boost and improvements in exercise tolerance and related symptomatic measures associated with pulmonary arterial hypertension and related settings described in the document.
Claims Coverage
The independent claim set includes three independent claims, directed to PRN oral inhalation of a PDE5 inhibitor using a portable inhaler, with two additional independent claims specifying carrier-based dry powder composition requirements focused on micronized vardenafil hydrochloride trihydrate and powder fill mass.
Portable inhaled PDE5 inhibitor pro re nata for pulmonary arterial hypertension
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.
Carrier-based micronized vardenafil hydrochloride trihydrate dry powder with defined powder fill mass, delivered PRN by portable inhaler
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, wherein carrier-based composition is administered pro re nata by a portable inhaler.
Carrier-based dry powder composition including micronized vardenafil hydrochloride trihydrate and powder base, delivered PRN by portable inhaler with defined powder fill mass
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; wherein the carrier-based composition is delivered, pro re nata, by a portable inhaler.
Across the independent claims, the core coverage is PRN treatment of pulmonary arterial hypertension using oral inhalation of a PDE5 inhibitor via a portable inhaler, with further claim coverage that specifies carrier-based dry powder formulations containing micronized vardenafil hydrochloride trihydrate, a defined powder fill mass range, and a powder base, together with portable inhaler delivery.
Stated Advantages
Minimizes systemic exposure.
Provides rapid/acute symptom improvement.
Provides improvements in exercise tolerance.
Provides performance and quality of life rationale for inhaled PRN vasodilator therapy.
Documented Applications
Treating pulmonary arterial hypertension in a subject in need thereof, including PRN/as-needed delivery using a portable inhaler and oral inhalation of PDE5 inhibitor therapy.
Treating pulmonary hypertension settings described in the document using lung-targeted inhaled vasodilators delivered via a portable inhaler, with focus on acute hemodynamic boost and exercise tolerance improvement.
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