LACTATE SALT OF 4-[6-METHOXY-7-(3-PIPERIDIN-1-YL-PROPOXY)QUINAZOLIN-4-YL]PIPERAZINE-1-CARBOXYLIC ACID(4-ISOPROPOXYPHENYL)-AMIDE AND PHARMACEUTICAL COMPOSITIONS THEREOF FOR THE TREATMENT OF CANCER AND OTHER DISEASES OR DISORDERS
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Abstract
This invention provides a compound of formula (I):
or a crystalline form thereof, or a pharmaceutical composition thereof, or an oral pharmaceutical dosage form thereof; processes for the synthesis or manufacture of the compound of formula (I), or a crystalline form thereof, or a pharmaceutical composition thereof, or an oral pharmaceutical dosage form thereof; and the use of said compound, or a crystalline form thereof, or a pharmaceutical composition thereof, or an oral pharmaceutical dosage form thereof, for the treatment of patients suffering from or subject to diseases, disorders or conditions involving cell survival, proliferation, and migration, including cardiovascular disease (e.g., arteriosclerosis and vascular reobstruction), cancer, (e.g., AML and malignant glioma)glomerulosclerosis, fibrotic disease and inflammation.
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Citations
44 Claims
- 1. The compound of formula (I):
- 18. A pharmaceutical composition comprising the compound of formula (I):
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39. A process for the bulk production of an oral pharmaceutical dosage form of the compound of formula (I), or a crystalline form thereof, wherein the oral pharmaceutical dosage form is a tablet, comprising the steps of:
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(a-1) blending the compound of formula (I), or a crystalline form thereof, and sieved first lubricant; (a-2) blending the resulting mixture from step (a-1) with sieved first disintegrant, and sieved filler; (a-3) sieving the resulting mixture from step (a-2), then further blending; (a-4) roller compacting the resulting mixture from step (a-3) to a ribbon; (a-5) milling the resulting ribbon from step (a-4); (a-6) blending the resulting granules from step (a-5) with sieved glidant, and sieved second disintegrant; (a-7) blending the resulting mixture from step (a-6) with sieved second lubricant; (a-8) tableting the resulting mixture from step (a-7); and (a-9) optionally film coating the resulting tablets from step (a-8). - View Dependent Claims (40)
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Specification