596883 The disclosure provides solid pharmaceutical compositions of 4-{ [9-chloro-7-(2-fluoro-6-methoxyphenyl)-5H-pyrimido[5,4-d][2]benzazepin-2-yl]amino} -2-methoxybenzoic acid (MLN-8237, Alisertib) produced by a process of: (a-1) wet granulating 4-{ [9-chloro-7-(2-fluoro-6-methoxyphenyl)-5H-pyrimido[5,4-d][2]benzazepin-2-yl]amino} -2-methoxybenzoic acid or a pharmaceutically acceptable salt thereof, or a crystalline form thereof, and optionally one or more pharmaceutically acceptable excipients selected from surfactants, binders, and disintegrants in the presence of a suitable solvent to form a wet mixture； (a-2) drying the wet mixture from step (a-1), to form dried granules； (a-3) milling the dried granules from step (a-2), to form milled granules； and (a-4) blending the milled granules from step (a-3) with a buffer and optionally one or more pharmaceutically acceptable excipients independently selected from the group consisting of surfactants, binders, disintegrants, lubricants and glidants； wherein a filler is added during step (a-1), during step (a-4), or during both steps (a-1) and (a-4). The compositions disclosed are useful in the treatment of cancer.
