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Last Updated: March 21, 2025

Claims for Patent: 10,610,485

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Summary for Patent: 10,610,485

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:	16/266,305
Patent Claims:	1. A Methotrexate composition for oral administration, said composition consisting of a pharmaceutically acceptable salt of Methotrexate, a citrate buffer system, a preserving agent, a sweetening agent, and purified water, wherein a pharmaceutically acceptable dosage of the Methotrexate salt used in the composition is in the range of 0.05 mg/1 ml to 20 mg/1 ml, and wherein the pH of the composition is 6 to 7. 2. The Methotrexate composition according to claim 1 wherein the pharmaceutically acceptable salt of Methotrexate used is Methotrexate disodium. 3. The Methotrexate composition according to claim 1 wherein the pH of the composition is in the range of pH 6.1-6.5. 4. The Methotrexate composition according to claim 1 wherein the pH of the composition is in the range of pH 6.25+/-0.15. 5. The Methotrexate composition according to claim 1 wherein the citrate buffer system comprises Citric Acid and Sodium Citrate. 6. The Methotrexate composition according to claim 1 wherein the citrate buffer system has a strength between 2 to 200 millimolar. 7. The Methotrexate composition according to claim 1 wherein the preserving agent comprises any or any combination of Sodium Methyl Hydroxybenzoate, Sodium Ethyl Hydroxybenzoate, Sodium Propyl Hydroxybenzoate, Sodium Benzoate or Potassium Sorbate. 8. The Methotrexate composition according to claim 1 wherein the preserving agent comprises Sodium Methyl Hydroxybenzoate or Sodium Propyl Hydroxybenzoate. 9. The Methotrexate composition according to claim 1 wherein the sweetening agent comprises Sucralose, Acesulfame K, or any other water soluble sweetener. 10. The Methotrexate composition according to claim 1 wherein the sweetening agent comprises Sucralose. 11. The Methotrexate composition according to claim 1 wherein the pharmaceutically acceptable dosage of the Methotrexate salt used in the composition is 10 mg/5 ml. 12. The Methotrexate composition according to claim 1 wherein a pharmaceutically acceptable dosage of the Methotrexate salt used is equivalent to 2.5 mg/1 ml methotrexate base. 13. The Methotrexate composition according to claim 1 wherein the citrate buffer system has a strength between 2 to 20 millimolar.

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