Solid pharmaceutical compositions and processes for their production

A method of preparing a pharmaceutical composition comprising the steps of:

• (a-1) wet granulating at least one active ingredient that is the compound sodium 4-{[9-chloro-7-(2-fluoro-6-methoxyphenyl)-5H-pyrimido[5,4-d][2]benzazepin-2-yl]amino}-2-methoxybenzoate, or a crystalline form thereof, and optionally one or more pharmaceutically acceptable excipients independently selected from the group consisting of 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 that is sodium bicarbonate 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);
• and
• wherein the method further comprises the step of (c-1) tableting the resulting mixture from step (a-4) to form a tablet.