Formulations of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
AssigneeVertex Pharmaceuticals Incorporated
InventorMarinus Jacobus Verwijs
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Abstract
A pharmaceutical composition comprising Compound 1, (3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid), and at least one excipient selected from: a filler, a disintegrant, a surfactant, a binder, and a lubricant, the composition being suitable for oral administration to a patient in need thereof to treat a CFTR mediated disease such as Cystic Fibrosis. Processes of preparing pharmaceutical compositions comprising Compound 1 are also disclosed.
Claims6
1-52. (canceled)
A continuous process for preparing a tablet comprising 3-(6-(1-(2,2-Difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid, comprising the steps of:
- a) mixing 3-(6-(1-(2,2-Difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid, 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;
- f) compressing the blend from step e) into a tablet;
- and
- g) optionally coating the tablet from step f).
The process of claims 1 and 2, wherein the tablet further comprises N-(5-hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-1H-quinoline-3-carboxamide.
Dependencies are inferred from the claim text.