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 25 mg/ml.

What is claimed is: 
     
         1 . A method for treating an inflammatory autoimmune disease in a patient in need thereof, the method comprising subcutaneously administering to said patient a pharmaceutical solution comprising methotrexate in a pharmaceutically acceptable solvent at a concentration of 50 to 150 mg/ml. 
     
     
         2 . The method according to  claim 1 , wherein said methotrexate is present at a concentration of 50 to 100 mg/ml. 
     
     
         3 . The method according to  claim 1 , wherein said methotrexate is present at a concentration of 50 to 75 mg/ml. 
     
     
         4 . The method according to  claim 1 , wherein said methotrexate is present at a concentration of about 50 mg/ml. 
     
     
         5 . 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. 
     
     
         6 . The method according to  claim 1 , wherein the pharmaceutically acceptable solvent is isotonic sodium chloride solution. 
     
     
         7 . The method according to  claim 1 , wherein the pharmaceutical solution further comprises a preservative. 
     
     
         8 . 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, and psoriasis. 
     
     
         9 . The method according to  claim 8 , wherein the inflammatory autoimmune disease is rheumatoid arthritis. 
     
     
         10 . The method according to  claim 9 , wherein rheumatoid arthritis is juvenile rheumatoid arthritis. 
     
     
         11 . The method according to  claim 1 , wherein the pharmaceutical solution is contained in an injection device. 
     
     
         12 . The method according to  claim 11 , wherein the injection device is a pen injector. 
     
     
         13 . The method according to  claim 11 , wherein the injection device contains a dosage of 5 to 40 mg of methotrexate and said dosage is administered to the patient. 
     
     
         14 . The method according to  claim 11 , wherein the injection device contains a dosage of 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 and said dosage is administered to the patient. 
     
     
         15 . The method according to  claim 11 , wherein the injection device contains a dosage of 5 to 22.5 mg of methotrexate and said dosage is administered to the patient. 
     
     
         16 . The method according to  claim 11 , wherein the injection device contains a dosage of 5.0, 7.5, 10.0, 12.5, 15.0, 17.5, 20.0, or 22.5 mg of methotrexate and said dosage is administered to the patient. 
     
     
         17 . The method according to  claim 11 , wherein the injection device is a ready-made syringe. 
     
     
         18 . The method according to  claim 17 , wherein said ready-made syringe is a disposable syringe. 
     
     
         19 . The method according to  claim 1 , wherein the pharmaceutical solution is contained in a storage container. 
     
     
         20 . The method according to  claim 19 , wherein the storage container contains a total dosage amount of 5 to 5,000 mg. 
     
     
         21 . The method according to  claim 19 , wherein the storage container is an injection bottle, a vial, a bag, a glass ampoule, or a carpule. 
     
     
         22 . The method according to  claim 19 , wherein the storage container is a carpule. 
     
     
         23 . The method according to  claim 22 , wherein said carpule provides the pharmaceutical solution for administration by means of an injection device. 
     
     
         24 . The method according to  claim 23 , wherein the injection device is a pen injector. 
     
     
         25 . The method according to  claim 22 , wherein said carpule contains a total dosage amount of 5 to 5,000 mg. 
     
     
         26 . The method according to  claim 23 , wherein the carpule and the injection device are effective to provide administration of multiple applications of single dosages. 
     
     
         27 . The method according to  claim 26 , wherein the single dosages per application are adjusted to 5 to 40 mg of methotrexate. 
     
     
         28 . The method according to  claim 27 , wherein the single dosages of methotrexate per application are adjusted to 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. 
     
     
         29 . The method according to  claim 26 , wherein the single dosages per application are adjusted to 5 to 22.5 mg of methotrexate. 
     
     
         30 . The method according to  claim 26 , wherein the single dosages per application are adjusted to 5.0, 7.5, 10.0, 12.5, 15.0, 17.5, 20.0, or 22.5 mg of methotrexate.