Process of preparing pharmaceutical compositions for the treatment of cftr mediated diseases

A continuous process for preparing a tablet comprising Compound 1 Form I and a solid dispersion comprising substantially amorphous Compound 2 comprising the steps of:

• a) mixing Compound 1 Form I, a solid dispersion comprising substantially amorphous Compound 2, a filler, and a disintegrant in a blender to form a blend;
• b) preparing a granulation solution with water, a binder, and a surfactant;
• c) feeding the blend from step a) into a continuous twin screw granulator while adding the granulation solution from step b) to produce granules;
• d) drying the granules from step c) and milling them;
• e) blending the milled granules from step d) with a filler, disintegrant, and lubricant to form a blend;
• and
• f) compressing the blend from step e) into a tablet;
• wherein at least one of the above steps comprises process analytical technology.