Claims for Patent: 11,458,095

Summary for Patent: 11,458,095

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):	Jayanta Kumar Mandal, Malay Patel, Swati NAGAR, Michael Paul DeHart
Assignee:	Liqmeds Worldwide Ltd , FTF Pharma Pvt Ltd , CMP Development LLC
Application Number:	US17/575,693
Patent Claims:	1. A liquid pharmaceutical formulation, comprising: from about 0.10% w/w to about 0.12% w/w of amlodipine besylate, at least one pharmaceutically acceptable excipient, and a vehicle comprising from 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 and an ethanol 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: from about 0.01% w/w to about 0.07% w/w of an antioxidant; from about 0.005% w/w to about 0.015% w/w of a flavoring agent; and from about 1% w/w to about 15% w/w of a glycol. 3. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 0.02% w/w to about 0.06% w/w of an antioxidant; from about 0.007% w/w to about 0.013% w/w of a flavoring agent; and from about 5% w/w to about 9% w/w of a glycol. 4. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 0.03% w/w to about 0.05% w/w of an antioxidant; from about 0.009% w/w to about 0.011% w/w of a flavoring agent; and from about 6% w/w to about 8% w/w of a glycol comprising propylene glycol. 5. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 0.03% w/w to about 0.04% w/w of an antioxidant comprising butylated hydroxyanisole; from about 0.009% w/w to about 0.011% w/w of a flavoring agent; and from about 6% w/w to about 8% w/w of a glycol comprising propylene glycol. 6. The formulation of claim 1 wherein the at least one pharmaceutically acceptable excipient comprises: from about 0.03% w/w to about 0.04% w/w of an antioxidant comprising butylated hydroxyanisole; from about 0.009% w/w to about 0.011% w/w of a flavoring agent; and from about 6% w/w to about 8% w/w of propylene glycol; and wherein the vehicle comprises from about 91% w/w to about 95% w/w of glycerin. 7. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 0.03% w/w to about 0.04% w/w of an antioxidant comprising butylated hydroxyanisole; and from about 6% w/w to about 7% w/w of propylene glycol; and wherein the vehicle comprises from about 92% w/w to about 94% w/w of glycerin. 8. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 0.03% w/w to about 0.04% w/w of an antioxidant comprising butylated hydroxyanisole; from about 0.01% w/w of a flavoring agent; and from about 6% w/w to about 7% w/w of propylene glycol; and wherein the vehicle comprises from about 92% w/w to about 94% w/w of glycerin. 9. A container comprising written material and a bottle comprising the formulation of claim 1. 10. A method for the treatment of a condition selected from among hypertension, chronic stable angina, vasospastic angina, or a coronary artery disease in an adult patient or pediatric patient in need thereof, said method comprising administering to the patient in need thereof a therapeutically effective amount of the formulation of claim 1. 11. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 4% w/w to about 8% w/w of a sweetening agent; from about 0.01% w/w to about 0.05% w/w of an antioxidant; from about 0.004% w/w to about 0.012% w/w of a flavoring agent; and from about 1% w/w to about 15% w/w of a glycol. 12. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 4% w/w to about 8% w/w of a sweetening agent; from about 0.02% w/w to about 0.05% w/w of an antioxidant; from about 0.006% w/w to about 0.010% w/w of a flavoring agent; and from about 2% w/w to about 14% w/w of a glycol. 13. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 5% w/w to about 7% w/w of a sweetening agent; from about 0.02% w/w to about 0.05% w/w of an antioxidant; from about 0.006% w/w to about 0.010% w/w of a flavoring agent; and from about 2% w/w to about 12% w/w of a glycol. 14. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 5% w/w to about 7% w/w of a sweetening agent comprising maltitol; from about 0.02% w/w to about 0.05% w/w of an antioxidant comprising butylated hydroxyanisole; from about 0.006% w/w to about 0.010% w/w of a flavoring agent; and from about 2% w/w to about 10% w/w of a glycol comprising propylene glycol. 15. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 5% w/w to about 6% w/w of a sweetening agent comprising maltitol; from about 0.02% w/w to about 0.05% w/w of an antioxidant comprising butylated hydroxyanisole; from about 0.006% w/w to about 0.010% w/w of a flavoring agent; and from about 2% w/w to about 8% w/w of a glycol comprising propylene glycol. 16. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 5% to about 6% w/w of a sweetening agent comprising maltitol; from about 0.02% w/w to about 0.05% w/w of an antioxidant comprising butylated hydroxyanisole; from about 0.006% w/w to about 0.010% w/w of a flavoring agent; and from about 2% w/w to about 8% w/w of a glycol comprising propylene glycol; and wherein the vehicle comprises about 80% w/w to about 90% w/w of glycerin. 17. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 10% w/w to about 12% w/w of a sweetening agent comprising liquid maltitol; from about 0.02% w/w to about 0.05% w/w of an antioxidant comprising butylated hydroxyanisole; from about 0.006% w/w to about 0.010% w/w of a flavoring agent; and from about 2% w/w to about 8% w/w of a glycol comprising propylene glycol; and wherein the vehicle comprises about 80% w/w to about 90% w/w of glycerin. 18. A container comprising written material and a bottle comprising the formulation of claim 17. 19. A method for the treatment of a condition selected from among hypertension, chronic stable angina, vasospastic angina, or a coronary artery disease in an adult patient or pediatric patient in need thereof, said method comprising administering to the patient in need thereof a therapeutically effective amount of the formulation of claim 17. 20. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 0.1% w/w to about 0.3% w/w of a sweetening agent, from about 0.02% w/w to about 0.06% w/w of an antioxidant; from about 0.004% w/w to about 0.014% w/w of a flavoring agent; and from about 4% w/w to about 22% w/w of a glycol. 21. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 0.1% w/w to about 0.3% w/w of a sweetening agent, from about 0.02% w/w to about 0.06% w/w of an antioxidant; from about 0.006% w/w to about 0.012% w/w of a flavoring agent; and from about 6% w/w to about 20% w/w of a glycol. 22. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 0.1% w/w to about 0.3% w/w of a sweetening agent, from about 0.02% w/w to about 0.06% w/w of an antioxidant; from about 0.008% w/w to about 0.012% w/w of a flavoring agent; and from about 10% w/w to about 16% w/w of a glycol. 23. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 0.1% w/w to about 0.3% w/w of a sweetening agent; from about 0.02% w/w to about 0.06% w/w of an antioxidant comprising butylated hydroxyanisole; from about 0.008% w/w to about 0.012% w/w of a flavoring agent; and from about 12% w/w to about 14% w/w of a glycol comprising propylene glycol. 24. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 0.18% w/w of a sweetener comprising glycyrrhizic acid; from about 0.02% w/w to about 0.06% w/w of an antioxidant comprising butylated hydroxyanisole; from about 0.008% w/w to about 0.012% w/w of a flavoring agent; and from about 10% w/w to about 16% w/w of a glycol comprising propylene glycol. 25. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 0.18% w/w of a sweetener comprising glycyrrhizic acid; from about 0.02% w/w to about 0.06% w/w of an antioxidant comprising butylated hydroxyanisole; from about 0.008% w/w to about 0.012% w/w of a flavoring agent; and from about 10% w/w to about 16% w/w of a glycol comprising propylene glycol; and wherein the vehicle comprises about 80% w/w to about 92% w/w of glycerin. 26. The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises: from about 0.18% w/w of a sweetener comprising glycyrrhizic acid; from about 0.02% w/w to about 0.06% w/w of an antioxidant comprising butylated hydroxyanisole; from about 0.008% w/w to about 0.012% w/w of a flavoring agent; and from about 12% w/w to about 14% w/w of a glycol comprising propylene glycol; and wherein the vehicle comprises about 84% w/w to about 88% w/w of glycerin. 27. A container comprising written material and a bottle comprising the formulation of claim 26. 28. A method for the treatment of a condition selected from among hypertension, chronic stable angina, vasospastic angina, or a coronary artery disease in an adult patient or pediatric patient in need thereof, said method comprising administering to the patient in need thereof a therapeutically effective amount of the formulation of claim 26. 29. The formulation of claim 1, wherein the liquid pharmaceutical formulation has a water content of less than or equal to about 4% w/w and an ethanol content of less than or equal to about 4% w/w. 30. The formulation of claim 1, wherein the liquid pharmaceutical formulation has a water content of less than or equal to about 3% w/w and an ethanol content of less than or equal to about 3% w/w.