Pharmaceutical formulations of ivacaftor
AssigneeBoston Biopharma, Inc.
InventorsAhmad Hashem, Maria Cauchi
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Abstract
The present invention relates to a solid oral pharmaceutical composition comprising ivacaftor or a pharmaceutically acceptable salt thereof, as well as methods for making and using such compositions. Compositions comprised Micronized ivacaftor having D90 not more than 25 μm and D50 not more than 15 μm for tablets and for Granules/mini tablets D90 not more than 5 μm
Claims10
A pharmaceutical solid oral composition comprising micronized ivacaftor or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable excipient.
A process for the preparation of a pharmaceutical solid oral immediate-release composition in the form of mini-tablets or granules, comprising the steps of dry granulating a primary blend comprising a therapeutically effective amount of ivacaftor, or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable excipient to form granules;
- and compressing said granules into a plurality of mini-tablets;
- wherein the process is performed without the use of a liquid solvent and the resulting mini-tablets are substantially free of a solid dispersion.
A process for the preparation of a pharmaceutical solid oral immediate-release composition comprising ivacaftor, or a pharmaceutically acceptable salt thereof, the process comprising the steps of:
- (a) dry granulating a primary blend comprising ivacaftor and at least one intragranular excipient to form granules;
- (b) mixing said granules with at least one extra granular excipient to form a final blend;
- (c) compressing the final blend into core tablets;
- and
- (d) coating the core tablets with a film-coating suspension;
- wherein the process is performed without a liquid solvent during the granulation steps, and the resulting composition is substantially free of a solid dispersion.
A pharmaceutical solid oral composition, comprising ivacaftor in a micronized amorphous form.
Dependencies are inferred from the claim text.