Claims for Patent: 11,896,586

Summary for Patent: 11,896,586

Title:	Apixaban formulations
Abstract:	Apixaban pharmaceutical formulation is provided. Also provided is a use of the apixaban formulation in treatment of a thromboembolic disorder.
Inventor(s):	Sherif Ibrahim Farag Badawy, Timothy D. Stevens, Daniel Kuntz, Brett Waybrant
Assignee:	Pfizer Corp SRL , Bend Research Inc , Bristol Myers Squibb Co
Application Number:	US17/047,428
Patent Claims:	1. A treated core comprising: a core substrate; and apixaban and a carrier on the core substrate, wherein the treated core comprises from about 0.001% w/w to about 0.20% w/w apixaban, and wherein the apixaban and the carrier are in a layer formed on a surface of the core substrate. 2. The treated core of claim 1, wherein the apixaban and the carrier are applied to the surface of the core substrate by a spray-layered dispersion. 3. The treated core of claim 1, wherein the core substrate is a sugar bead or sphere, or a microcrystalline cellulose, lactose, or mannitol particle. 4. The treated core of claim 1, wherein the core substrate is a sugar bead or sphere. 5. The treated core of claim 4, wherein the sugar bead or sphere comprises sugar syrup, corn starch, and/or sucrose. 6. The treated core of claim 1, wherein the carrier is hydroxypropylcellulose and/or hypromellose. 7. The treated core of claim 1, having a core size from about 150 microns to about 355 microns. 8. A formulation comprising at least one said treated core of claim 1. 9. The formulation of claim 8, which has an apixaban content from about 0.09% w/w to about 0.11% w/w. 10. The formulation of claim 8, which has a carrier content from about 9% w/w to about 11% w/w. 11. The formulation of claim 8, which has a core substrate content from about 89% w/w to about 91% w/w. 12. The formulation of claim 8, which has an apixaban content of about 0.1% w/w. 13. The formulation of claim 8, wherein the at least one said treated core is in a capsule. 14. The formulation of claim 13, wherein the capsule is a gelatin capsule or an HPMC capsule. 15. The formulation of claim 13, wherein the capsule is a sprinkle capsule. 16. The formulation of claim 13, wherein the capsule comprises about 0.1 mg apixaban. 17. A method of treating a thromboembolic disorder in a subject in need thereof comprising: dispersing and/or dissolving at least one said treated core of claim 1 in a liquid carrier; and administering the liquid carrier to the subject. 18. The method of claim 17, wherein the liquid carrier is a food or beverage. 19. The method of claim 17, wherein the subject is a neonate. 20. The formulation according to claim 8, wherein the formulation comprises about 0.1 mg to about 0.4 mg of apixaban. 21. The formulation of claim 20, which has a carrier content from about 9% w/w to about 11% w/w. 22. The formulation of claim 20, which has a core substrate content from about 89% w/w to about 91% w/w. 23. The formulation of claim 20, which has an apixaban content of about 0.1% w/w to about 0.4% w/w. 24. The formulation of claim 20, wherein the formulation comprises about 0.1 mg of apixaban. 25. The formulation of claim 20, wherein the formulation comprises about 0.2 mg of apixaban. 26. The formulation of claim 20, wherein the formulation comprises about 0.3 mg of apixaban. 27. The formulation of claim 20, wherein the formulation comprises about 0.4 mg of apixaban. 28. The formulation of claim 20, wherein the at least one treated core is in a capsule. 29. The formulation of claim 28, wherein the capsule is a sprinkle capsule. 30. A treated core comprising: a core substrate; and apixaban and a carrier on the core substrate, wherein the treated core comprises from about 0.001% w/w to about 0.20% w/w apixaban, wherein the apixaban and the carrier are in a layer formed on a surface of the core substrate, and wherein the apixaban and the carrier are applied to the surface of the core substrate by a spray-layered dispersion process carried out with a concentration of apixaban in a solvent below a solubility limit. 31. The treated core of claim 30, wherein the core substrate is a sugar bead or sphere, or a microcrystalline cellulose, lactose, or mannitol particle. 32. The treated core of claim 30, having a core size from about 150 microns to about 355 microns. 33. A formulation comprising at least one said treated core of claim 30. 34. The formulation of claim 33, which has an apixaban content from about 0.09% w/w to about 0.11% w/w. 35. The formulation of claim 33, which has a carrier content from about 9% w/w to about 11% w/w. 36. The formulation of claim 33, which has a core substrate content from about 89% w/w to about 91% w/w. 37. A method of treating a thromboembolic disorder in a subject in need thereof comprising: dispersing and/or dissolving at least one said treated core of claim 30 in a liquid carrier; and administering the liquid carrier to the subject. 38. The method of claim 37, wherein the liquid carrier is a food or beverage. 39. The formulation according to claim 33, wherein the formulation comprises about 0.1 mg to about 0.4 mg of apixaban. 40. The formulation of claim 33, wherein the formulation comprises about 0.1 mg of apixaban. 41. The formulation of claim 33, wherein the formulation comprises about 0.2 mg of apixaban. 42. The formulation of claim 33, wherein the formulation comprises about 0.3 mg of apixaban. 43. The formulation of claim 33, wherein the formulation comprises about 0.4 mg of apixaban. 44. The formulation of claim 39, wherein the at least one treated core is in a capsule. 45. The formulation of claim 44, wherein the capsule is a sprinkle capsule.