Claims for Patent: 11,253,474

Summary for Patent: 11,253,474

Title:	Pharmaceutical solution of amlodipine
Abstract:	Disclosed herein is a liquid pharmaceutical formulation substantially free of water, comprising: (i) amlodipine or a pharmaceutically acceptable salt thereof, (ii) at least one pharmaceutically acceptable excipient, and (iii) a sufficient amount of a vehicle comprising glycerin. Also disclosed herein is a liquid pharmaceutical formulation substantially free of water and ethanol, comprising: (i) amlodipine or a pharmaceutically acceptable salt thereof, (ii) at least one pharmaceutically acceptable excipient, and (iii) a sufficient amount of a vehicle comprising glycerin.
Inventor(s):	Mandal; Jayanta Kumar (Ahmedabad, IN), Patel; Malay (Amedabad, IN), Nagar; Swati (Amreli, IN), DeHart; Michael Paul (Winterville, NC)
Assignee:	LIQMEDS WORLDWIDE LIMITED (Haynes, GB)
Application Number:	17/183,553
Patent Claims:	1. A liquid pharmaceutical formulation, comprising: about 0.10% w/w to about 0.12% w/w of amlodipine besylate, at least one pharmaceutically acceptable excipient, and a vehicle comprising about 80% w/w to about 96% w/w glycerin; wherein the liquid pharmaceutical formulation has a water content of less than or equal to about 5% w/w. 2. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises about 4% w/w to about 7% w/w of a sweetening agent; about 0.01% w/w to about 0.05% w/w of an antioxidant; optionally about 0.006% w/w to about 0.010% w/w of a flavoring agent; optionally about 2% w/w to about 4% w/w ethanol. 3. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises about 4% w/w to about 7% w/w of a sweetening agent; about 0.03% w/w to about 0.04% w/w of an antioxidant; optionally about 0.006% w/w to about 0.010% w/w of a flavoring agent; optionally about 2% w/w to about 4% w/w ethanol. 4. The formulation of claim 1 comprising about 0.11% w/w of amlodipine besylate; wherein the at least one pharmaceutically acceptable excipient comprises about 4% w/w to about 7% w/w of a sweetening agent; about 0.01% w/w to about 0.05% w/w of an antioxidant; optionally about 0.006% w/w to about 0.010% w/w of a flavoring agent; optionally about 2% w/w to about 4% w/w ethanol. 5. The formulation of claim 1 comprising about 0.11% w/w of amlodipine besylate; wherein the at least one pharmaceutically acceptable excipient comprises about 4% w/w to about 7% w/w of a sweetening agent comprising maltitol; about 0.01% w/w to about 0.05% w/w of an antioxidant comprising butylated hydroxyanisole; optionally about 0.006% w/w to about 0.010% w/w of a flavoring agent; optionally about 2% w/w to about 4% w/w ethanol. 6. The formulation of claim 1 comprising about 0.11% w/w of amlodipine besylate; wherein the at least one pharmaceutically acceptable excipient comprises about 5% w/w to about 7% w/w of a sweetening agent comprising maltitol; about 0.03% w/w of an antioxidant comprising butylated hydroxyanisole; optionally about 0.008% w/w to about 0.010% w/w of a flavoring agent; optionally about 2% w/w to about 4% w/w ethanol. 7. The formulation of claim 1 comprising about 0.11% w/w of amlodipine besylate; wherein the at least one pharmaceutically acceptable excipient comprises about 5% w/w to about 7% w/w of a sweetening agent comprising maltitol; about 0.03% w/w of an antioxidant comprising butylated hydroxyanisole; optionally about 0.008% w/w to about 0.010% w/w of a flavoring agent; about 2.5% w/w ethanol; and wherein the vehicle comprises about 80% w/w to about 92% w/w glycerin. 8. The formulation of claim 1 comprising about 0.11% w/w of amlodipine besylate; wherein the at least one pharmaceutically acceptable excipient comprises about 6% w/w of a sweetening agent comprising maltitol; about 0.03% w/w of an antioxidant comprising butylated hydroxyanisole; about 0.008% w/w to about 0.010% w/w of a flavoring agent; about 2.5% w/w ethanol; and wherein the vehicle comprises about 80% w/w to about 92% w/w glycerin. 9. The formulation of claim 1 comprising about 0.11% w/w of amlodipine besylate; wherein the at least one pharmaceutically acceptable excipient comprises about 11% w/w of a liquid maltitol syrup comprising maltitol; about 0.03% w/w of an antioxidant comprising butylated hydroxyanisole; about 0.008% w/w to about 0.010% w/w of a flavoring agent; about 2.5% w/w ethanol; and wherein the vehicle comprises about 80% w/w to about 92% w/w glycerin. 10. A container comprising written material and a bottle comprising the formulation of claim 1. 11. A method for the treatment of a condition, which comprises administering to a patient in need thereof a therapeutically effective amount of the formulation of claim 1; wherein the condition is treatment of hypertension, the symptomatic treatment of chronic stable angina, the treatment of vasospastic angina, or the treatment of a coronary artery disease; and wherein the patient is an adult patient or a pediatric patient. 12. A method for the treatment of a condition, which comprises administering to a patient in need thereof a therapeutically effective amount of the formulation of claim 1, wherein the condition is treatment of hypertension; and wherein the patient is an adult patient or a pediatric patient. 13. A method for the treatment of a condition, which comprises administering to a patient in need thereof a therapeutically effective amount of the formulation of claim 1; wherein the condition is the symptomatic treatment of chronic stable angina; and wherein the patient is an adult patient or a pediatric patient. 14. A method for the treatment of a condition, which comprises administering to a patient in need thereof a therapeutically effective amount of the formulation of claim 1; wherein the condition is the treatment of vasospastic angina; and wherein the patient is an adult patient or a pediatric patient. 15. A method for the treatment of a condition, which comprises administering to a patient in need thereof a therapeutically effective amount of the formulation of claim 1; wherein the condition is treatment of a coronary artery disease; and wherein the patient is an adult patient or a pediatric patient. 16. The formulation of claim 1, wherein the liquid pharmaceutical formulation has a water content of less than or equal to about 4% w/w. 17. The formulation of claim 1, wherein the liquid pharmaceutical formulation has a water content of less than or equal to about 3% w/w. 18. The formulation of claim 9, wherein the liquid pharmaceutical formulation has a water content of less than or equal to about 4% w/w. 19. The formulation of claim 9, wherein the liquid pharmaceutical formulation has a water content of less than or equal to about 3% w/w.