Novel pharmaceutical composition
AssigneeGlaxosmithkline Intellectual Property (No.2) Limited
InventorsDouglas J. DeMARINI, Francisco Henriquez, Ngocdiep T. Le, Lihong Wang
Life of this patent
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Abstract
Disclosed are novel pharmaceutical compositions containing N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide dimethyl sulfoxide solvate, methods of using the compositions in therapy and processes for preparing the same.
Claims17
A pharmaceutical tablet comprising:
- a) an amount of a drug, which is N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide dimethyl sulfoxide solvate, selected from:
- about 0.5635 mg, about 1.127 mg, and about 2.254 mg;
- wherein,
- b) the drug particles are micronized.
The pharmaceutical tablet comprising:
- a) an amount of a drug, which is N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide dimethyl sulfoxide solvate, selected from:
- about 0.5635 mg, about 1.127 mg, and about 2.254 mg;
- wherein,
- b) at least 50% of the drug particles have a particle size of 30 micron or less.
A process for preparing pharmaceutical tablets containing an amount of a drug, which is N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide dimethyl sulfoxide solvate, in an amount selected from:
- about 0.5635 mg, about 1.127 mg, and about 2.254 mg, which process comprises the steps of;
- admixing:
- N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide dimethyl sulfoxide solvate,
- one or more excipients, where the excipients are substantially free of water, and
- further excipients,
- to form a mixture;
- and
- compressing the mixture into tablets;
- provided:
- each tablet contains N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide dimethyl sulfoxidein solvate in an amount selected from:
- about 0.5635 mg, about 1.127 mg, and about 2.254 mg;
- and
- at least 50% of the drug particles have a particle size of 30 micron or less.
Dependencies are inferred from the claim text.