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US 12,746,229 B2Granted
Oral formulations and uses thereof
AssigneeInventisbio Co., Ltd.
InventorsXing Dai, Xiaomei Wang, Yanqin Liu, Yueheng Jiang, Yaolin Wang
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Abstract
Provided herein are compounds, salts, crystalline forms, and pharmaceutical compositions that are related to Selective Estrogen Receptor Degraders, as well as methods of preparing the same. Also provided herein are methods of using the compounds, salts, crystalline forms, and pharmaceutical compositions for the treatment of diseases or disorders, such as breast cancer.
Claims20
A pharmaceutical composition comprising a meglumine salt of Compound FA represented by the structure below:
- wherein the meglumine salt of Compound FA is in a crystalline Form I characterized by an X-ray powder diffraction (XRPD) pattern having the following peaks:
- 4.7, 9.1, 10.0, 17.6, 18.2, 19.0, 21.5, and 23.7 degrees 2 theta, ±0.2°, wherein the meglumine salt of Compound FA is in an amount equivalent to about 10 mg, about 20 mg, about 30 mg, about 40 mg, about 50 mg, about 75 mg, about 100 mg, about 150 mg, about 200 mg, about 250 mg, about 300 mg, about 400 mg, or about 500 mg of Compound FA.
A tablet comprising:
- a) a meglumine salt of Compound FA in an amount of about 10% to about 80% by weight;
- b) a surfactant in an amount of about 0.1% to about 10% by weight,
- c) a diluent in an amount of about 15% to about 70% by weight,
- d) a binder in an amount of about 0.1% to about 10% by weight,
- e) a disintegrant in an amount of about 0.1% to about 10% by weight, and
- f) a lubricant in an amount of about 0.1% to about 5% by weight,
- wherein the meglumine salt of Compound FA is represented by the structure below:
- and wherein the meglumine salt of Compound FA is in a crystalline Form I characterized by an X-ray powder diffraction (XRPD) pattern having the following peaks:
- 4.7, 9.1, 10.0, 17.6, 18.2, 19.0, 21.5, and 23.7 degrees 2 theta, ±0.2°.
6 more elements
A granule comprising
- a) a meglumine salt of Compound FA in an amount of about 10% to about 80% by weight;
- b) a surfactant in an amount of about 0.1% to about 10% by weight,
- c) a diluent in an amount of about 15% to about 70% by weight,
- d) a binder in an amount of about 0.1% to about 10% by weight, and
- e) a disintegrant in an amount of about 0.1% to about 10% by weight,
- wherein the meglumine salt of Compound FA is represented by the structure below:
- and wherein the meglumine salt of Compound FA is in a crystalline Form I characterized by an X-ray powder diffraction (XRPD) pattern having the following peaks:
- 4.7, 9.1, 10.0, 17.6, 18.2, 19.0, 21.5, and 23.7 degrees 2 theta, ±0.2°.
5 more elements
A process comprising:
- a) wet granulating a mixture of a meglumine salt of Compound FA, surfactant, diluent, binder, and disintegrant to form wet granules;
- b) optionally drying the wet granules to form dried granules;
- and
- c) optionally dry milling the dried granules to form dry milled granules,
- wherein the meglumine salt of Compound FA is represented by the structure below:
- and wherein the meglumine salt of Compound FA in a crystalline Form I characterized by an X-ray powder diffraction (XRPD) pattern having the following peaks:
- 4.7, 9.1, 10.0, 17.6, 18.2, 19.0, 21.5, and 23.7 degrees 2 theta, ±0.2°.
4 more elements
Dependencies are inferred from the claim text.