US 12,138,351 B2
Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or pharmaceutically acceptable salt, hydrate, or solvate thereof
Jacqueline Maximilien, Antwerp (BE); and Gopal Rajan, Antwerp (BE)
Assigned to Janssen Biotech, Inc., Horsham, PA (US)
Filed by Janssen Biotech, Inc., Horsham, PA (US)
Filed on Apr. 13, 2021, as Appl. No. 17/228,753.
Claims priority of provisional application 63/014,277, filed on Apr. 23, 2020.
Claims priority of provisional application 63/009,623, filed on Apr. 14, 2020.
Prior Publication US 2021/0322323 A1, Oct. 21, 2021
Int. Cl. A61K 9/28 (2006.01); A61K 9/00 (2006.01); A61K 9/20 (2006.01); A61K 31/5377 (2006.01)
CPC A61K 9/284 (2013.01) [A61K 9/0053 (2013.01); A61K 9/2009 (2013.01); A61K 9/2018 (2013.01); A61K 9/2054 (2013.01); A61K 31/5377 (2013.01); C07B 2200/13 (2013.01)] 28 Claims
 
1. A pharmaceutical composition for oral administration comprising: N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yl)pirimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide (Lazertinib) or a pharmaceutically acceptable salt, hydrate, and/or solvate thereof as an active ingredient; and a combination of (i) a cellulose derivative and (ii) a sugar or polyol as diluents, wherein the cellulose derivative and the sugar or polyol are present in the pharmaceutical composition in a weight ratio of 1:0.20 to 1:0.30, wherein the combination is a dry blend of the cellulose derivative and the sugar or polyol in the absence of a solvent.