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US 2026/0083679 A1Published application
Adagrasib solid pharmaceutical compositions
AssigneeMirati Therapeutics, Inc.
InventorsCletus Nunes, Mehrdad Kheiripour, Monika Gavireddi
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Abstract
Pharmaceutical compositions in solid form comprising adagrasib, suitable for oral dosage to treat subjects having cancer; as well as methods of manufacturing the compositions, and methods of treating cancer.
Claims26
A tablet formulation for oral administration in a human comprising
- (a) 200 mg of adagrasib;
- (b) one or more diluents;
- (c) a disintegrant;
- (d) a glidant;
- and
- (e) a lubricant;
- wherein:
- (i) the tablet formulation comprises a film coat,
- (ii) the tablet formulation is an immediate release tablet formulation,
- (iii) a single oral dose of the tablet formulation provides a Cmax for adagrasib in the human that is lower as compared to a Cmax for adagrasib in the human provided by a single oral dose of a capsule formulation comprising the same amount of adagrasib, and
- (iv) a gastrointestinal disorder in the human administered the tablet formulation is lower as compared to the gastrointestinal disorder in humans administered the capsule formulation.
8 more elements
A tablet formulation for oral administration in a human comprising
- (a) a single oral dose of 200 mg or 600 mg of adagrasib;
- and
- (b) a film coat;
- wherein:
- (i) the tablet formulation is an immediate release tablet formulation,
- (ii) the single oral dose of the tablet formulation provides an AUC0→∞ for adagrasib in the human that is lower as compared to the AUC0→∞ for adagrasib in the human provided by a single oral dose of a capsule formulation comprising the same amount of adagrasib, and
- (iii) the single oral dose of the tablet formulation provides a Tmax of less than about 6.5 hours.
4 more elements
A tablet formulation for oral administration in a human comprising
- (a) 200 mg of adagrasib;
- (b) optionally, one or more diluents;
- (c) a disintegrant;
- (d) a glidant;
- and
- (e) a lubricant;
- wherein:
- (i) the tablet formulation comprises a film coat,
- (ii) the tablet formulation is an immediate release tablet formulation,
- (iii) a single oral dose of the tablet formulation provides a Cmax for adagrasib in the human that is lower as compared to a Cmax for adagrasib in the human provided by a single oral dose of a capsule formulation comprising the same amount of adagrasib, and
- (iv) a gastrointestinal disorder in the human administered the tablet formulation is lower as compared to the gastrointestinal disorder in humans administered the capsule formulation.
8 more elements
A tablet formulation for oral administration in a human comprising
- (a) a single oral dose of 200 mg or 600 mg of adagrasib;
- (b) optionally, one or more diluents;
- (c) a disintegrant;
- (d) a glidant;
- (e) a lubricant;
- and
- (f) a film coat;
- wherein:
- (i) the tablet formulation is an immediate release tablet formulation,
- (ii) the single oral dose of the tablet formulation provides an AUC 0→∞ for adagrasib in the human that is lower as compared to the AUC 0→∞ for adagrasib in the human provided by a single oral dose of a capsule formulation comprising the same amount of adagrasib, and
- (ii) the single oral dose of the tablet formulation provides a Tmax of less than about 6.5 hours.
8 more elements
Dependencies are inferred from the claim text.