US 12,220,417 B2
Pharmaceutical compositions comprising (S)-2-(2,6-dioxopiperidin-3-yl)-4-((2-fluoro-4-((3-morpholinoazetidin-1-yl)methyl)benzyl)amino)isoindoline-1,3-dione and methods of using the same
Sreenivas S. Bhat, Kendall Park, NJ (US); Fabien Boulineau, Summit, NJ (US); Donna Carroll, Summit, NJ (US); Tracy Lee Gaebele, Green Brook, NJ (US); Yuchuan Gong, Summit, NJ (US); Isabel Minjung Hong, Summit, NJ (US); Zhengmao Li, Livingston, NJ (US); and Ye Tian, Summit, NJ (US)
Assigned to Celgene Corporation, Summit, NJ (US)
Filed by Celgene Corporation, Summit, NJ (US)
Filed on Nov. 7, 2022, as Appl. No. 17/982,024.
Application 17/982,024 is a division of application No. 17/075,447, filed on Oct. 20, 2020, granted, now 11,504,378.
Claims priority of provisional application 62/923,927, filed on Oct. 21, 2019.
Prior Publication US 2023/0285400 A1, Sep. 14, 2023
Int. Cl. A61K 31/5377 (2006.01); A61K 9/16 (2006.01); A61K 9/48 (2006.01); A61K 47/02 (2006.01); A61K 47/12 (2006.01); A61K 47/26 (2006.01); A61K 47/32 (2006.01); A61K 47/36 (2006.01); A61K 47/38 (2006.01); A61K 47/42 (2017.01)
CPC A61K 31/5377 (2013.01) [A61K 9/1694 (2013.01); A61K 9/4816 (2013.01); A61K 9/485 (2013.01); A61K 9/4858 (2013.01); A61K 9/4866 (2013.01); A61K 47/02 (2013.01); A61K 47/12 (2013.01); A61K 47/26 (2013.01); A61K 47/32 (2013.01); A61K 47/36 (2013.01); A61K 47/38 (2013.01); A61K 47/42 (2013.01)] 20 Claims
 
1. A process for preparing a pharmaceutical composition comprising the steps of:
(i) mixing Compound 1:

OG Complex Work Unit Chemistry
or an enantiomer, mixture of enantiomers, tautomer, or pharmaceutically acceptable salt thereof, with a first portion of one or more excipients (intragranular excipient) and water to form wet granules;
(ii) drying and then milling the granules; and
(iii) mixing the milled granules with the remaining of the one or more excipients (extragranular excipient) to form a final blend of the pharmaceutical composition,
wherein the one or more excipients comprise a carrier or diluent, and
wherein the carrier or diluent is a mixture of mannitol and starch, a mixture of mannitol and cellulose, or cellulose.