(Trimethoxyphenylamino) pyrimidinyl formulations
View Patent ↗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.
1. A solid pharmaceutical composition comprising greater than 15% w/w of the compound of Formula (I):
wherein each X + 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 + in the compound of Formula (I) represents a sodium cation (Na + ).
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):
8. A unit dosage form comprising greater than or equal to 60 mg of the compound of Formula (I):
wherein each X + 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.