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Last Updated: March 29, 2024

Claims for Patent: 8,771,648


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Summary for Patent: 8,771,648
Title:(Trimethoxyphenylamino) pyrimidinyl formulations
Abstract: There are provided pharmaceutical compositions comprising greater than 15% w/w of a compound of Formula (I) as defined herein and/or hydrate thereof and an amount of one or more effervescent agents that is sufficient to provide satisfactory in vitro dissolution; and further comprising one or more pharmaceutically acceptable ingredients; and to processes for obtaining them. ##STR00001##
Inventor(s): Gururajan; Bindhumadhavan (Molndal, SE), Alhusban; Farhan Abdul Karim (Macclesfield, GB), Gabbott; Ian Paul (Macclesfield, GB), Simpson; David Bradley Brook (Macclesfield, GB), Sievwright; Dawn (Macclesfield, GB)
Assignee: Rigel Pharmaceuticals, Inc. (South San Francisco, CA)
Application Number:13/559,805
Patent Claims: 1. A solid pharmaceutical composition comprising greater than 15% w/w of the compound of Formula (I): ##STR00006## wherein each X.sup.+ represents a monovalent cation; and/or a hydrate thereof; and an amount of one or more effervescent agents that is sufficient to provide satisfactory in vitro dissolution at low pH; and further comprising one or more pharmaceutically acceptable ingredients.

2. The solid pharmaceutical composition according to claim 1 comprising greater than or equal to 25% w/w of the compound of Formula (I) and/or hydrate thereof.

3. The solid pharmaceutical composition according to claim 1 comprising less than or equal to 20% w/w of the effervescent agent.

4. The solid pharmaceutical composition according to claim 1 wherein the effervescent agent is sodium hydrogen carbonate.

5. The solid pharmaceutical composition according to claim 1 wherein each X.sup.+ in the compound of Formula (I) represents a sodium cation (Na.sup.+).

6. The solid pharmaceutical composition according to claim 1 wherein the compound of Formula (I) is in the form of an hexahydrate.

7. The solid pharmaceutical composition according to claim 1 wherein the compound of Formula (I) is in the form of Formula (II): ##STR00007##

8. A unit dosage form comprising greater than or equal to 60 mg of the compound of Formula (I): ##STR00008## wherein each X.sup.+ represents a monovalent cation; and/or a hydrate thereof; and less than or equal to 110 mg of one or more effervescent agents that is sufficient to provide satisfactory in vitro dissolution at low pH; and further comprising one or more pharmaceutically acceptable ingredients.

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