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Last Updated: September 21, 2021

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Claims for Patent: 9,968,553


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Summary for Patent: 9,968,553
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: SILVERGATE PHARMACAUTICALS, INC. (Greenwood Village, CO) UNIVERSITY OF KANSAS (Lawrence, KS)
Application Number:15/850,732
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,968,553
Patent Claims: 1. A method of treating hypertension or prehypertension in a subject, the method comprising administering to that subject a pharmaceutical powder that is reconstituted into an oral liquid formulation, the powder consisting essentially of: (a) enalapril or a pharmaceutically acceptable salt thereof, (b) a stability agent, and (c) 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 55.+-.10% relative humidity.

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

3. The method of claim 1, wherein the stability agent is lactose, sucrose, or mannitol.

4. The method of claim 1, wherein the powder consists essentially of: (a) about 14% (w/w) enalapril or a pharmaceutically acceptable salt thereof, (b) about 85% (w/w) of the stability agent, and (c) about 1% (w/w) colloidal silicon dioxide.

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

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

7. The method of claim 1, wherein the hypertension is primary hypertension.

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

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

10. The method of claim 1, wherein the subject has blood pressure values of about 120-139/80-89 mm Hg.

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

12. The method of claim 1, wherein the subject is elderly.

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

14. A method of treating hypertension or prehypertension in a subject, the method comprising administering to that subject a pharmaceutical powder that is reconstituted into an oral liquid formulation, the powder consisting essentially of: (a) enalapril or a pharmaceutically acceptable salt thereof, (b) mannitol, and (c) 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 55.+-.10% relative humidity.

15. The method of claim 14, wherein the enalapril or pharmaceutically acceptable salt thereof is enalapril maleate.

16. The method of claim 14, wherein the hypertension is primary hypertension.

17. The method of claim 14, wherein the hypertension is secondary hypertension.

18. The method of claim 14, wherein the subject has blood pressure values greater than or equal to 140/90 mm Hg.

19. The method of claim 14, wherein the subject has blood pressure values of about 120-139/80-89 mm Hg.

20. The method of claim 14, wherein the subject is an adult.

21. The method of claim 14, wherein the subject is elderly.

22. The method of claim 14, wherein the subject is a child.

23. A method of treating heart failure or left ventricular dysfunction in a subject, the method comprising administering to that subject a pharmaceutical powder that is reconstituted into an oral liquid formulation, the powder consisting essentially of: (a) enalapril or a pharmaceutically acceptable salt thereof, (b) a stability agent, and (c) 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 55.+-.10% relative humidity.

24. The method of claim 23, wherein the enalapril or pharmaceutically acceptable salt thereof is enalapril maleate.

25. The method of claim 23, wherein the stability agent is lactose, sucrose, or mannitol.

26. The method of claim 23, wherein the powder consists essentially of: (a) about 14% (w/w) enalapril or a pharmaceutically acceptable salt thereof, (b) about 85% (w/w) of the stability agent, and (c) about 1% (w/w) colloidal silicon dioxide.

27. The method of claim 23, wherein the powder consists essentially of about 150 mg enalapril, about 890 mg mannitol, and 10 mg colloidal silicon dioxide.

28. The method of claim 23, wherein the powder is stable for at least six months at ambient, accelerated or refrigerated conditions.

29. A method of treating heart failure or left ventricular dysfunction in a subject, the method comprising administering to that subject a pharmaceutical powder that is reconstituted into an oral liquid formulation, the powder consisting essentially of: (a) enalapril or a pharmaceutically acceptable salt thereof, (b) mannitol, and (c) 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 55.+-.10% relative humidity.

30. The method of claim 29, wherein the enalapril or pharmaceutically acceptable salt thereof is enalapril maleate.

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