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Claims for Patent: 8,664,231

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Claims for Patent: 8,664,231

Title:Concentrated methotrexate solutions
Abstract: Concentrated methotrexate solutions are described which are suitable for the use of an active substance in the production of a parenterally administered medicament for the treatment of inflammatory autoimmune diseases. The methotrexate is added to a pharmaceutically acceptable solvent at a concentration of more than 30 mg/ml. The invention also relates to a ready-made syringe and a carpule containing such a pharmaceutical solution formulation, as well as a pen injector comprising such a carpule and/or a ready-made syringe.
Inventor(s): Will; Heiner (Hamburg, DE)
Assignee: Medac Gesellschaft fuer Klinische Spezialpraepararate mbH (Wedel, DE)
Application Number:12/374,528
Patent Claims: 1. A method for the treatment of inflammatory autoimmune diseases in a patient in need thereof, comprising subcutaneously administering to said patient a medicament comprising methotrexate in a pharmaceutically acceptable solvent at a concentration of more than 30 mg/ml.

2. The method according to claim 1, wherein the methotrexate is present at a concentration of more than 30 mg/ml to 100 mg/ml.

3. The method according to claim 2, wherein the methotrexate is present at a concentration of about 50 mg/ml.

4. The method according to claim 1, wherein the pharmaceutically acceptable solvent is selected from water, water for injection purposes, water comprising isotonization additives and sodium chloride solution.

5. The method according to claim 1, wherein the inflammatory autoimmune disease is selected from rheumatoid arthritis, juvenile arthritides, vasculitides, collagenoses, Crohn's disease, colitis ulcerosa, bronchial asthma, Alzheimer's disease, multiple sclerosis, Bechterew's disease, joint arthroses, or psoriasis.

6. The method according to claim 5, wherein the inflammatory autoimmune disease is rheumatoid arthritis.

7. The method according to claim 1, wherein the medicament is present in a form suitable for patient self-administration.

8. The method according to claim 1, wherein the medicament is contained in an injection device for a single application.

9. The method according to claim 8, wherein the injection device contains a dosage of 5 to 40 mg of methotrexate.

10. The method according to claim 8 or 9, wherein the injection device is a ready-made syringe.

11. The method according to claim 1, wherein the medicament is contained in a storage container.

12. The method according to claim 11, wherein the storage container contains a total dosage amount of 5 to 5,000 mg.

13. The method according to claim 11, wherein the storage container is an injection bottle, a vial, a bag, a glass ampoule, or a carpule.

14. The method according to claim 13, wherein the storage container is a carpule and wherein said carpule is suitable for administering the medicament by means of an injection device.

15. The method according to claim 14, wherein the carpule and the pen injector are provided such that multiple applications of single dosages can be administered.

16. The method according to claim 15, wherein the single dosages per application can be adjusted to 5 to 40 mg each of methotrexate.

17. The method according to claim 4, wherein the sodium chloride solution is isotonic sodium chloride solution.

18. The method according to claim 6, wherein rheumatoid arthritis is juvenile rheumatoid arthritis.

19. The method according to claim 9, wherein the injection device contains a dosage selected from 5.0, 7.5, 10.0, 12.5, 15.0, 17.5, 20.0, 22.5, 25.0, 27.5, 30.0, 32.5, 35.0, 37.5 or 40.0 mg of methotrexate.

20. The method according to claim 14, wherein the injection device is a pen injector.

21. The method according to claim 16, wherein the single dosages of methotrexate per application is adjusted to be 5.0, 7.5, 10.0, 12.5, 15.0, 17.5, 20.0, 22.5, 25.0, 27.5, 30.0, 32.5, 35.0, 37.5 or 40.0 mg.

22. The method according to claim 1, wherein the methotrexate is present at a concentration of from 40 mg/ml to 80 mg/ml.
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