Claims for Patent: 9,463,183

Summary for Patent: 9,463,183

Title:	Lisinopril formulations
Abstract:	Provided herein are stable lisinopril oral liquid formulations. Also provided herein are methods of using lisinopril oral liquid formulations for the treatment of certain diseases including hypertension, heart failure and acute myocardial infarction.
Inventor(s):	Mosher; Gerold L. (Kansas City, MO), Miles; David W. (Kansas City, MO)
Assignee:	SILVERGATE PHARMACEUTICALS, INC. (Greenwood Village, CO)
Application Number:	14/934,752
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,463,183
Patent Claims:	1. A stable oral liquid formulation, comprising: (i) about 1 mg/ml lisinopril or a pharmaceutically acceptable salt or solvate thereof; (ii) about 150 mg/ml of a sweetener that is xylitol; (iii) a buffer comprising about 0.86 mg/ml citric acid and about 1.44 mg/ml sodium citrate; (iv) about 0.8 mg/ml of a preservative that is sodium benzoate; and (v) water; wherein the pH of the formulation is between about 4 and about 5; and wherein the formulation is stable at about 25.+-.5.degree. C. for at least 12 months. 2. The formulation of claim 1, wherein the lisinopril is lisinopril dihydrate. 3. The formulation of claim 1, wherein the pH is about 4.9. 4. The formulation of claim 1, wherein the formulation is stable at about 25.+-.5.degree. C. for at least 18 months. 5. The formulation of claim 1, wherein the formulation is stable at about 25.+-.5.degree. C. for at least 24 months. 6. A stable oral liquid formulation, comprising: (i) about 0.7% (w/w of solids) lisinopril or a pharmaceutically acceptable salt or solvate thereof; (ii) about 97.3% (w/w of solids) of a sweetener that is xylitol; (iii) a buffer comprising about 0.01 molar citrate; (iv) about 0.52% (w/w of solids) of a preservative that is sodium benzoate; and (v) water; wherein the pH of the formulation is between about 4 and about 5; and wherein the formulation is stable at about 25.+-.5.degree. C. for at least 12 months. 7. The formulation of claim 6, wherein the lisinopril is lisinopril dihydrate. 8. The formulation of claim 6, wherein the buffer comprises citric acid and sodium citrate. 9. The formulation of claim 6, wherein the pH is about 4.9. 10. The formulation of claim 6, wherein the formulation is stable at about 25.+-.5.degree. C. for at least 18 months. 11. The formulation of claim 6, wherein the formulation is stable at about 25.+-.5.degree. C. for at least 24 months. 12. A stable oral liquid formulation, consisting of: (i) about 1 mg/ml lisinopril or a pharmaceutically acceptable salt or solvate thereof; (ii) about 150 mg/ml of a sweetener that is xylitol; (iii) a buffer comprising about 0.86 mg/ml citric acid and about 1.44 mg/ml sodium citrate; (iv) about 0.8 mg/ml of a preservative that is sodium benzoate; (v) and water; wherein the pH of the formulation is between about 4 and about 5 adjusted by sodium hydroxide or hydrochloric acid; and wherein the formulation is stable at about 25.+-.5.degree. C. for at least 12 months. 13. The formulation of claim 12, wherein the pH is about 4.9.