Claims for Patent: 11,813,246
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Summary for Patent: 11,813,246
| Title: | Pharmaceutical composition |
| Abstract: | The invention concerns pharmaceutical compositions containing a hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide and solvates, crystalline forms and amorphous forms thereof, to the use of said compositions as a medicament; and to processes for the preparation of said compositions. |
| Inventor(s): | Nicola Frances Bateman, Paul Richard Gellert, Kathryn Jane Hill |
| Assignee: | AstraZeneca AB, Array Biopharma Inc |
| Application Number: | US17/313,312 |
| Patent Claims: |
1. A pharmaceutical composition consisting of: (i) from 15 to 25 parts of a hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide; and (ii) from 75 to 85 parts of d-alpha-tocopheryl polyethylene glycol 1000 succinate (Vitamin E TPGS); wherein both parts are by weight and the sum of the parts (i)+(ii)=100; and wherein the hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide is dispersed within the Vitamin E TPGS, and the composition is semi-solid or solid at ambient temperature. 2. A pharmaceutical composition according to claim 1, consisting of: (i) from 18 to 22 parts of a hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide; and (ii) from 78 to 82 parts of Vitamin E TPGS; wherein both parts are by weight and the sum of the parts (i)+(ii)=100; and wherein the hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide is dispersed within the Vitamin E TPGS, and the composition is semi-solid or solid at ambient temperature. 3. A pharmaceutical composition according to claim 2, consisting of: (i) from 19 to 21 parts of a hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide; and (ii) from 79 to 81 parts of Vitamin E TPGS; wherein both parts are by weight and the sum of the parts (i)+(ii)=100; and wherein the hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide is dispersed within the Vitamin E TPGS, and the composition is semi-solid or solid at ambient temperature. 4. The pharmaceutical composition according to claim 1, wherein the composition contains 30.25+/−2 mg of a hydrogen sulphate salt of 6-(4-bromo-2-chlorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide. 5. The pharmaceutical composition according to claim 1, wherein the composition contains 12.1+/−2 mg of a hydrogen sulphate salt of 6-(4-bromo-2-chlorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide. 6. An oral capsule filled with the pharmaceutical composition of claim 1. 7. An oral capsule filled with the pharmaceutical composition of claim 4. 8. An oral capsule filled with the pharmaceutical composition of claim 5. |
