Other

Takeda Pharmaceutical Company Limited

Roche Palo Alto LLC

Sumitomo Pharma Switzerland Gmbh

F. Hoffmann-la Roche Ag

Michael Thomas Brandl

Dimitrios Stefanidis

Kondamraj Birudaraj

Navnit Hargovindas Shah

Wantanee Phuapradit

Petinka I Vlahova

Tsuyoshi Sasaki

Patricia Andres

Hashim Ahmed

Shridhar Hegde

Felix Sana

Thomas Vernon Alfredson

Shridar Hegde

This disclosure relates to novel crystalline forms of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N'-methoxyurea. It also relates to methods of making the disclosed crystalline forms, pharmaceutical compositions and kits comprising them, and methods of treatment and uses comprising their administration.

Crystalline forms of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N'-methoxyurea

The present invention relates to a method of forming granules of (2R,3S,4R,5R)-5-(4-amino-2-oxo-2H-pyrimidin-1-yl)-2-azido-3,4-bis-iso-butyryloxy-tetrahydro-furan-2-ylmethyl isobutyrate; hydrochloride salt (I), comprising mixing I, with a granulating amount of a granulating liquid, and a polyethylene glycol (PEG)/polypropylene glycol (PPG) block copolymer as a binder and solubility enhancer to form wet granules which are then dried to remove the granulating liquid. 

Pharmaceutical composition and process

The present invention relates to a pharmaceutical composition comprising a solid suspension prepared by hot melt extrusion of isobutyric acid (2R,3S,4R,5R)-5-(4-amino-2-oxo-2H-pyrimidin-1-yl)-2-azido-3,4-bis-iso-butyryloxy-tetrahydro-furan-2-ylmethyl ester; hydrochloride salt (I) and a polyethylene glycol (PEG)/polypropylene glycol (PPG) block copolymer. 

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Redwood City, CA, United States of America

Michael Thomas Brandl