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Last Updated: September 20, 2020

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Claims for Patent: 9,855,215

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Summary for Patent: 9,855,215
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:15/019,244
Patent Claims: 1. A Methotrexate composition for oral administration, said composition consisting of a pharmaceutically acceptable salt of Methotrexate, purified water, one or more buffer agents to adjust the pH of the composition wherein the pH of the composition is 6 to 7, and at least one agent selected from the group consisting of preserving agents, flavouring compounds, and sweetening agents.

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 3 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 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.

6. The Methotrexate composition according to claim 1 wherein the composition comprises two or more buffer agents to form a buffer system.

7. The Methotrexate composition according to claim 6 wherein the two or more buffer agents are any of a Citric Acid-Sodium Citrate Buffer, Citric Acid Monohydrate-Disodium Dihydrogen Phosphate, Sodium Dihydrogen Phosphate - Disodium Hydrogen Phosphate Buffer, Trometamol (Tris)-Hydrochloric Acid Buffer, Trometamol (Tris)-Citric Acid Buffer, Ascorbic Acid-Sodium Ascorbate Buffer, any of the abovementioned sodium salts replaced with potassium salts.

8. The Methotrexate composition according to claim 6 wherein the two or more buffer agents comprise Citric acid monohydrate and Disodium hydrogen phosphate.

9. The Methotrexate composition according to claim 1 wherein the buffer agents have a strength between 2 to 200 millimolar, and optionally between 2 to 20 millimolar.

10. The Methotrexate composition according to claim 1 wherein said preserving agent or agents comprise any or any combination of Sodium Methyl Hydroxybenzoate, Sodium Ethyl Hydroxybenzoate, Sodium Propyl Hydroxybenzoate, Sodium Benzoate or Potassium Sorbate.

11. The Methotrexate composition according to claim 1 wherein the one or more flavouring compounds and/or sweetening agents comprises Sucralose, Acesulfame K, any other water soluble sweetener or Raspberry Flavour 545742E.

12. The Methotrexate composition according to claim 1 wherein the pharmaceutically acceptable dosage of the Methotrexate salt used is 2.5mg/5ml, 5mg/5ml, 10mg/5ml or in the range of 0.05mg/1ml to 20mg/1ml.

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