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Claims for Patent: 8,778,366

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Claims for Patent: 8,778,366

Title:Enalapril compositions
Abstract: Provided herein are stable enalapril powder compositions for oral liquid formulation. Also provided herein are methods of using enalapril oral liquid formulations for the treatment of certain diseases including hypertension, heart failure and asymptomatic left ventricular dysfunction.
Inventor(s): Rajewski; Lian G. (Lawrence, KS), Rajewski; Roger A. (Lawrence, KS), Haslam; John L. (Lawrence, KS), Heppert; Kathleen (Lawrence, KS), Beckloff; Michael C. (Leawood, KS), Segrave; Frank (Dublin, OH), Mauro; Robert (Miller Place, NY), Colabuono; Peter (Las Vegas, NV)
Assignee: University of Kanasas (Lawrence, KS) Silvergate Pharmaceuticals, Inc. (Dublin, OH)
Application Number:13/914,452
Patent Claims: 1. A method of treating hypertension in a subject in need comprising administering to that subject a therapeutically effective amount of a pharmaceutical powder that is reconstituted into an oral liquid formulation, the powder consisting of: (a) about 14% (w/w) enalapril or a pharmaceutically acceptable salt thereof, (b) about 85% (w/w) mannitol, and (c) about 1% (w/w) colloidal silicon dioxide, wherein, when the powder is reconstituted into an oral liquid, the liquid is homogenous and stable for at least 12 weeks at about 25.+-.5.degree. C. and 60.+-.10% relative humidity.

2. The method of claim 1, wherein the hypertension is primary (essential) hypertension.

3. The method of claim 1, wherein the hypertension is secondary hypertension.

4. The method of claim 1, wherein the subject has blood pressure values greater than or equal to 140/90 mm Hg.

5. The method of claim 1, wherein the subject is an adult.

6. The method of claim 1, wherein the subject elderly.

7. The method of claim 1, wherein the subject is a child.

8. The method of claim 1, wherein the enalapril or pharmaceutically acceptable salt thereof is enalapril maleate.

9. The method of claim 1, wherein the powder is stable for at least six months at ambient, accelerated or refrigerated conditions.

10. The method of claim 1, wherein the powder comprises about 150 mg enalapril, about 890 mg mannitol and 10 mg colloidal silicon dioxide.

11. The method of claim 1, wherein the enalapril oral liquid further administered in combination with an agent selected from the group consisting of diuretics, beta blockers, alpha blockers, mixed alpha and beta blockers, calcium channel blockers, angiotensin II receptor antagonists, ACE inhibitors, aldosterone antagonists and alpha-2 agonists.

12. A method of treating prehypertension in a subject in need comprising administering to that subject a therapeutically effective amount of a pharmaceutical powder that is reconstituted into an oral liquid formulation, the powder consisting of: (a) about 14% (w/w) enalapril or a pharmaceutically acceptable salt thereof, (b) about 85% (w/w) mannitol, and (c) about 1% (w/w) colloidal silicon dioxide, wherein, when the powder is reconstituted into an oral liquid, the liquid is homogenous and stable for at least 12 weeks at about 25.+-.5.degree. C. and 60.+-.10% relative humidity.

13. The method of claim 12, wherein the subject has blood pressure values of about 120-139/80-89 mm Hg.

14. A method of treating heart failure in a subject in need comprising administering to that subject a therapeutically effective amount of a pharmaceutical powder that is reconstituted into an oral liquid formulation, the powder consisting of: (a) about 14% (w/w) enalapril or a pharmaceutically acceptable salt thereof, (b) about 85% (w/w) mannitol, and (c) about 1% (w/w) colloidal silicon dioxide, wherein, when the powder is reconstituted into an oral liquid, the liquid is homogenous and stable for at least 12 weeks at about 25.+-.5.degree. C. and 60.+-.10% relative humidity.

15. A method of treating left ventricular dysfunction in a subject in need comprising administering to that subject a therapeutically effective amount of a pharmaceutical powder that is reconstituted into an oral liquid formulation, the powder consisting of: (a) about 14% (w/w) enalapril or a pharmaceutically acceptable salt thereof, (b) about 85% (w/w) mannitol, and (c) about 1% (w/w) colloidal silicon dioxide, wherein, when the powder is reconstituted into an oral liquid, the liquid is homogenous and stable for at least 12 weeks at about 25.+-.5.degree. C. and relative humidity.
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