Claims for Patent: 11,833,151

Summary for Patent: 11,833,151

Title:	Pharmaceutical composition including sodium alkyl sulfate
Abstract:	The object of the present invention is to improve the dissolution and the absorption of (S)-1-(3-(4-amino-3-((3,5-dimethoxyphenyl)ethynyl-1H-pyrazolo[3,4-d]pyrimidin-1-yl-1-pyrrolidinyl)-2-propen-1-one effective as an antitumor agent from a pharmaceutical formulation comprising the same. Provided is a pharmaceutical composition comprising (S)-1-(3-(4-amino-3-((3,5-dimethoxyphenyl)ethynyl-1H-pyrazolo[3,4-d]pyrimidin-1-yl-1-pyrrolidinyl)-2-propen-1-one in combination with sodium alkyl sulfate having an alkyl group containing 10 to 18 carbon atoms, in particular, with sodium lauryl sulfate.
Inventor(s):	Kenji Kusumoto, Sadahiro Miyamura
Assignee:	Taiho Pharmaceutical Co Ltd
Application Number:	US16/982,377
Patent Claims:	1. A pharmaceutical composition comprising (S)-1-(3-(4-amino-3-((3,5-dimethoxyphenyl)ethynyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)-1-pyrrolidinyl)-2-propen-1-one having the following structure, or a pharmaceutically acceptable salt thereof, and sodium lauryl sulfate: 2. The composition according to claim 1, comprising sodium lauryl sulfate in a range of 0.05 to 15 parts by mass, relative to 1 part by mass of (S)-1-(3-(4-amino-3-((3,5-dimethoxyphenyl)ethynyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)-1-pyrrolidinyl)-2-propen-1-one. 3. The composition according to claim 1, comprising sodium lauryl sulfate in a range of 0.2 to 5 parts by mass, relative to 1 part by mass of (S)-1-(3-(4-amino-3-((3,5-dimethoxyphenyl)ethynyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)-1-pyrrolidinyl)-2-propen-1-one. 4. The composition according to claim 1, further comprising at least one compound selected from the group consisting of crospovidone, carmellose sodium, and carmellose calcium. 5. The composition according to claim 4, comprising crospovidone. 6. The composition according to claim 1, further comprising at least one compound selected from the group consisting of D-mannitol and lactose. 7. The composition according to claim 1, in the form of syrup, a powder, a granule, a tablet, or a capsule. 8. A method for producing a pharmaceutical composition comprising (S)-1-(3-(4-amino-3-((3,5-dimethoxyphenyl)ethynyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)-1-pyrrolidinyl)-2-propen-1-one or a pharmaceutically acceptable salt thereof, wherein the method comprises adding sodium lauryl sulfate to (S)-1-(3-(4-amino-3-((3,5-dimethoxyphenyl)ethynyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)-1-pyrrolidinyl)-2-propen-1-one or a pharmaceutically acceptable salt thereof. 9. The pharmaceutical composition according to claim 1, wherein said sodium lauryl sulfate is in an amount sufficient to increase the dissolution and/or absorption of said (S)-1-(3-(4-amino-3-((3,5-dimethoxyphenyl)ethynyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)-1-pyrrolidinyl)-2-propen-1-one or a pharmaceutically acceptable salt thereof. 10. The pharmaceutical composition according to claim 1, wherein said sodium lauryl sulfate is in an amount sufficient to increase the lubricative property and/or flowability of said (S)-1-(3-(4-amino-3-((3,5-dimethoxyphenyl)ethynyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)-1-pyrrolidinyl)-2-propen-1-one or a pharmaceutically acceptable salt thereof.