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US 12,758,544 B2Granted
Pharmaceutical formulation
AssigneeHoffmann-La Roche Inc.
InventorLeonie Flurina Claude Wagner-Hattler
Life of this patent
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Abstract
Disclosed herein are pharmaceutical compositions and dosage forms including N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino) benzamide that are useful in the treatment of subjects having cancer. The present disclosure also provides methods for preparing these pharmaceutical compositions and dosage forms, and methods of treating subjects having cancer utilizing the pharmaceutical compositions and dosage forms provided herein.
Claims7
A pharmaceutical composition comprising:
- 1) An intragranular layer comprising:
- a) 25 ±5% by weight of N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino)-benzamide, also known as entrectinib;
- b) between 0.5% and 1.0% by weight of colloidal silicon dioxide;
- c) between 1.0% and 3.0% by weight of sodium stearyl fumarate;
- d) between 2.0% and 6.0% by weight of croscarmellose sodium;
- e) between 20% and 60% by weight of microcrystalline cellulose;
- f) between 4.42% and 10.32% by weight of tartaric acid:
- 2) An extragranular layer comprising:
- a) between 0.2% and 0.8% by weight of colloidal silicon dioxide;
- b) between 5% and 15% by weight of mannitol;
- c) between 0.25% and 1.0% by weight of magnesium stearate;
- and
- d) between 1.0% and 3.0% by weight of croscarmellose sodium.
10 more elements
Dependencies are inferred from the claim text.