Title:
DOSAGE FORM COMPOSITIONS COMPRISING AN INHIBITOR OF BRUTON'S TYROSINE KINASE
Document Type and Number:
Japanese Patent JP2023036772
Kind Code:
A
Abstract:
To provide a composition capable of reducing the risk of pH-dependent solubility associated with an inhibitor of Bruton's tyrosine kinase, which is (S)-2-(3'-(hydroxymethyl)-1-methyl-5-((5-(2-methyl-4-(oxetan-3-yl)piperazin-1-yl)pyridin-2-yl)amino)-6-oxo-1,6-dihydro-[3,4'-bipyridin]-2'-yl)-7,7-dimethyl-2,3,4,6,7,8-hexahydro-1H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-1-one, and providing an improved bioavailability in patients exhibiting achlorhydria.SOLUTION: Provided is a tablet composition comprising the free base of the compound and fumaric acid. The weight ratio of the free base to fumaric acid is from about 1:5 to about 3:1. Also provided is an amorphous solid dispersion composition comprising at least one polymer and the free base.SELECTED DRAWING: None
Inventors:
Mao, Chen
Kou, Derwen
Chan, Po Chan
Kou, Derwen
Chan, Po Chan
Application Number:
JP2022203410A
Publication Date:
March 14, 2023
Filing Date:
December 20, 2022
Export Citation:
Assignee:
F. HOFFMANN-LA ROCHE AKTIENGESELLSCHAFT
International Classes:
A61K31/4985; A61K9/20; A61K9/26; A61K47/26; A61K47/32; A61K47/38; A61P1/04; A61P3/00; A61P5/00; A61P7/04; A61P9/00; A61P11/06; A61P13/12; A61P17/00; A61P19/02; A61P25/00; A61P29/00; A61P31/12; A61P35/00; A61P35/02; A61P37/02; A61P37/06; A61P37/08; C07D487/04
Attorney, Agent or Firm:
Patent Attorney Corporation Tsukuni