Inhalable Formulations For Treating Pulmonary Hypertension And Methods Of Using Same

Abstract

The present invention is directed to an inhalable formulation for the treatment of pulmonary hypertension in a mammal (e.g., humans), wherein the formulation comprises at least one hypertension reducing agent, including but not limited to an angiotensin converting enzyme inhibitor, angiotensin receptor blocker, beta-blocker, calcium-channel blocker or vasodilator, or any combination thereof. The formulations of the present invention may be a solution or suspension, and preferably are suitable for administration via nebulization. The present invention is also directed to a method and kit for treating a mammal suffering from pulmonary hypertension.

1 . An inhalable formulation for the treatment of pulmonary hypertension, said formulation comprising about 0.001 mg/ml to about 20 mg/ml of a hypertension reducing agent, wherein said pulmonary hypertension reducing agent comprises at least one ACE inhibitor and wherein said formulation is suitable for administration via inhalation to a mammal in need thereof. 
     
     
         2 . The formulation of  claim 1 , wherein said formulation is suitable for administration via nebulization. 
     
     
         3 . The formulation of  claim 2  comprising about 0.1 mg/ml to about 15 mg/ml of said pulmonary hypertension reducing agent. 
     
     
         4 . The formulation of  claim 2  comprising about 1 mg/ml to about 10 mg/ml of said pulmonary hypertension reducing agent. 
     
     
         5 . The formulation of  claim 2 , wherein said formulation is a sterile solution. 
     
     
         6 . The formulation of  claim 5 , wherein said solution is isotonic and has a pH of about 3 to about 8. 
     
     
         7 . The formulation of  claim 2 , wherein said formulation is an aqueous sterile suspension. 
     
     
         8 . The formulation of  claim 2 , wherein said formulation comprises a preservative. 
     
     
         9 . The formulation of  claim 2 , wherein said formulation is preservative-free. 
     
     
         10 . The formulation of  claim 2 , wherein said ACE inhibitor is at least one of the group consisting of benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril and trandolapril. 
     
     
         11 . A method of treating pulmonary hypertension in a mammal, said method comprising the step of administering to said mammal a formulation comprising about 0.001 mg/ml to about 20 mg/ml of a hypertension reducing agent, wherein said hypertension reducing agent comprise at least one ACE inhibitor, and wherein said formulation is suitable for administration via inhalation. 
     
     
         12 . The method of  claim 11 , wherein said formulation is administered via nebulization to said mammal. 
     
     
         13 . The method of  claim 12 , wherein said formulation is administered via jet nebulizer, ultrasonic nebulizer or breath-actuated nebulizer to said mammal. 
     
     
         14 . The method of  claim 12 , wherein said formulation is premeasured, premixed and prepackaged. 
     
     
         15 . The method of  claim 12 , wherein said formulation is sterile and stable. 
     
     
         16 . The method of  claim 12 , said method further comprising the step of administering to said mammal an anticoagulant. 
     
     
         17 . The method of  claim 12 , said method further comprising the step of administering to said mammal an inotropic agent. 
     
     
         18 . The method of  claim 12 , said method further comprising the step of administering to said mammal low-flow supplemental oxygen therapy. 
     
     
         19 . The method of  claim 12 , said method further comprising the step of administering to said mammal a diuretic. 
     
     
         20 . The method of  claim 12 , said method further comprising the step of administering to said mammal a low salt diet.