Claims for Patent: 11,395,828

Summary for Patent: 11,395,828

Title:	Spironolactone aqueous compositions
Abstract:	Disclosed herein is a stable, ready-to-use liquid formulation comprising spironolactone and its method of use.
Inventor(s):	Pipho; Anthony (Winterville, NC), DeHart; Michael Paul (Winterville, NC)
Assignee:	CMP DEVELOPMENT LLC (Farmville, NC)
Application Number:	17/383,761
Patent Claims:	1. A method of treating an adult patient having heart failure, hypertension, or edema, said method comprising: administering to the patient in need thereof a ready-to-use liquid formulation comprising: micronized spironolactone in an amount of about 5 mg/mL; xanthan gum in an amount to provide a formulation viscosity of from 100 cP to 300 cP, glycerin in an amount of from 18 mg/mL to 24 mg/mL; a sufficient amount of a citrate buffer to maintain a pH of the formulation from 4.5 to 5.5 and a water vehicle. 2. The method of claim 1, wherein the micronized spironolactone has a median volume particle size of not more than about 9.6 .mu.m. 3. The method of claim 1, wherein the micronized spironolactone has a median volume particle size of about 3.6 .mu.m to about 9.6 .mu.m. 4. The method of claim 1, wherein the xanthan gum is present in an amount of from 1.3 mg/mL to 3.6 mg/mL. 5. The method of claim 1, wherein the xanthan gum is present in an amount of from 1.8 mg/mL to 3.6 mg/mL. 6. The method of claim 1, wherein the glycerin is present in an amount of from 18 mg/mL to 22 mg/mL. 7. The method of claim 1, wherein the citrate buffer is present in an amount of from about 10 mM to about 100 mM. 8. The method of claim 1, wherein the ready-to-use liquid formulation has a formulation viscosity that ranges from 120 cP to 170 cP. 9. The method of claim 1, wherein the ready-to-use liquid formulation has a formulation viscosity that ranges from 150 cP to 170 cP. 10. The method of claim 1, which further comprises administering to the adult patient having heart failure about 4 mL of the ready-to-use liquid formulation once daily or once every other day, wherein said patient has a serum potassium level of .ltoreq.5.0 mEq/L and an estimated glomular filtration rate >50 mL/min/1.73 m.sup.2. 11. The method of claim 1, which further comprises administering to the adult patient having heart failure about 7.5 mL of the ready-to-use liquid formulation once daily or once every other day, wherein said patient has a serum potassium level of .ltoreq.5.0 mEq/L and an estimated glomular filtration rate >50 mL/min/1.73 m.sup.2. 12. A method of treating an adult patient having heart failure, hypertension, or edema, said method comprising: administering to the patient in need thereof a ready-to-use liquid formulation comprising: micronized spironolactone in an amount of about 5 mg/mL; xanthan gum in an amount to provide a formulation viscosity of from 100 cP to 300 cP, a dispersing agent consisting of glycerin in an amount of from 18 mg/mL to 24 mg/mL, a sufficient amount of a citrate buffer to maintain a pH of the formulation from 4.5 to 5.5 and a water vehicle. 13. The method of claim 12, wherein the micronized spironolactone has a median volume particle size of not more than about 9.6 .mu.m. 14. The method of claim 12, wherein the spironolactone has a median volume particle size of about 3.6 .mu.m to about 9.6 .mu.m. 15. The method of claim 12, wherein the xanthan gum is present in an amount of from 1.3 mg/mL to 3.6 mg/mL. 16. The method of claim 12, wherein the xanthan gum is present in an amount of from 1.8 mg/mL to 3.6 mg/mL. 17. The method of claim 12, wherein the glycerin is present in an amount of from 18 mg/mL to 22 mg/mL. 18. The method of claim 12, wherein the citrate buffer is present in an amount of from about 10 mM to about 100 mM. 19. The method of claim 12, wherein the ready-to-use liquid formulation has a viscosity that ranges from 120 cP to 170 cP. 20. The method of claim 12, wherein the ready-to-use liquid formulation has a formulation viscosity that ranges from 150 cP to 170 cP. 21. The method of claim 12, which further comprises administering to the adult patient having heart failure about 4 mL of the ready-to-use liquid formulation once daily or once every other day, wherein said patient has a serum potassium level of .ltoreq.5.0 mEq/L and an estimated glomular filtration rate >50 mL/min/1.73 m.sup.2. 22. The method of claim 12, which further comprises administering to the adult patient having heart failure about 7.5 mL of the ready-to-use liquid formulation once daily or once every other day, wherein said patient has a serum potassium level of .ltoreq.5.0 mEq/L and an estimated glomular filtration rate >50 mL/min/1.73 m.sup.2. 23. The method of claim 1, which further comprises administering to the adult patient having heart failure about 2 mL of the ready-to-use liquid formulation once daily or once every other day wherein said patient has a serum potassium level of .ltoreq.5.0 mEq/L and an estimated glomular filtration rate (eGFR) between 30 to 50 mL/min/1.73 m.sup.2. 24. The method of claim 12, which further comprises administering to the adult patient having heart failure about 2 mL of the ready-to-use liquid formulation once daily or once every other day wherein said patient has a serum potassium level of .ltoreq.5.0 mEq/L and an estimated glomular filtration rate (eGFR) between 30 to 50 mL/min/1.73 m.sup.2. 25. The method of claim 1, which further comprises administering to the adult patient having hypertension about 4 mL of the ready-to-use liquid formulation once daily in a single or a divided dose, wherein the hypertension is essential hypertension. 26. The method of claim 12, which further comprises administering to the adult patient having hypertension about 4 mL of the ready-to-use liquid formulation once daily in a single or a divided dose, wherein the hypertension is essential hypertension. 27. The method of claim 1, which further comprises administering to the adult patient having an essential hypertension about 15 mL of the ready-to-use liquid formulation once daily in a single or a divided dose, wherein the hypertension is essential hypertension. 28. The method of claim 12, which further comprises administering to the adult patient having an essential hypertension about 15 mL of the ready-to-use liquid formulation once daily in a single or a divided dose, wherein the hypertension is essential hypertension. 29. The method of claim 1, which further comprises administering to the adult patient having edema about 15 mL of the ready-to-use liquid formulation once daily. 30. The method of claim 12, which further comprises administering to the adult patient having edema about 15 mL of the ready-to-use liquid formulation once daily.