Claims for Patent: 10,231,927

Summary for Patent: 10,231,927

Title:	Methotrexate composition
Abstract:	A Methotrexate composition for oral administration is provided comprising a pharmaceutically acceptable salt of Methotrexate and an aqueous carrier agent. The Methotrexate salt is substantially or completely soluble in the aqueous carrier agent, forming an aqueous solution. There is also provided a method of manufacturing a Methotrexate composition for oral administration, comprising mixing a pharmaceutically acceptable salt of Methotrexate with an aqueous carrier agent until the Methotrexate salt is substantially or completely soluble in the carrier agent to form an aqueous solution.
Inventor(s):	Tierney; Carl (Leeds, GB), Powell; Stacey (Leeds, GB), Braybrooke; Peter (Leeds, GB), Jones; Geraint (Leeds, GB)
Assignee:	Rosemont Pharmaceuticals Ltd. (Leeds, GB)
Application Number:	15/821,242
Patent Claims:	1. A method of treating rheumatoid arthritis in a patient; the method comprising administering to the patient in need thereof a methotrexate composition for oral administration consisting of a pharmaceutically acceptable salt of methotrexate, purified water, one or more buffer agents to adjust the pH of the composition to 6 to 7, and at least one agent selected from the group consisting of preserving agents, flavoring compounds, and sweetening agents. 2. The method of claim 1, wherein the patient has difficulty swallowing. 3. The method of claim 2, wherein the patient is a child. 4. The method of claim 2, wherein the patient is elderly. 5. The method of claim 1, wherein the rheumatoid arthritis is polyarthritic forms of active juvenile idiopathic arthritis. 6. The method of claim 1, wherein the one or more buffer agents comprise any or any combination of citric acid, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate, disodium hydrogen phosphate, trometamol (Tris), hydrochloric acid, ascorbic acid, sodium ascorbate, any of the abovementioned sodium salts replaced with potassium salts. 7. The method of claim 1, wherein the composition comprises two or more buffer agents to form a buffer system. 8. The method of claim 1, wherein the buffer agents have a strength between 2 to 200 millimolar. 9. The method of claim 1, wherein the buffer agents have a strength between 2 to 20 millimolar. 10. The method of claim 1, wherein the preserving agents comprise any or any combination of sodium methyl hydroxybenzoate, sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate, sodium benzoate, or potassium sorbate. 11. The method of claim 1, wherein the one or more flavoring compounds and/or sweetening agents comprises sucralose, acesulfame K, any other water soluble sweetener, or raspberry flavor 545742E. 12. The method of claim 1, wherein a pharmaceutically acceptable dosage of the methotrexate salt used is in the range of 0.05 mg/1 ml to 20 mg/1 ml. 13. A method of treating leukemia in a patient; the method comprising administering to the patient in need thereof a methotrexate composition for oral administration consisting of a pharmaceutically acceptable salt of methotrexate, purified water, one or more buffer agents to adjust the pH of the composition to 6 to 7, and at least one agent selected from the group consisting of preserving agents, flavoring compounds, and sweetening agents. 14. The method of claim 13, wherein the patient has difficulty swallowing. 15. The method of claim 14, wherein the patient is a child. 16. The method of claim 14, wherein the patient is elderly. 17. The method of claim 13, wherein the leukemia is acute. 18. The method of claim 13, wherein the one or more buffer agents comprise any or any combination of citric acid, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate, disodium hydrogen phosphate, trometamol (Tris), hydrochloric acid, ascorbic acid, sodium ascorbate, any of the abovementioned sodium salts replaced with potassium salts. 19. The method of claim 13, wherein the composition comprises two or more buffer agents to form a buffer system. 20. The method of claim 13, wherein the buffer agents have a strength between 2 to 200 millimolar. 21. The method of claim 13, wherein the buffer agents have a strength between 2 to 20 millimolar. 22. The method of claim 13, wherein the preserving agents comprise any or any combination of sodium methyl hydroxybenzoate, sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate, sodium benzoate, or potassium sorbate. 23. The method of claim 13, wherein the one or more flavoring compounds and/or sweetening agents comprises sucralose, acesulfame K, any other water soluble sweetener, or raspberry flavor 545742E. 24. The method of claim 13, wherein a pharmaceutically acceptable dosage of the methotrexate salt used is in the range of 0.05 mg/1 ml to 20 mg/1 ml.