Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate
AssigneePfizer Inc.
InventorChristopher Scott Seadeek
Life of this patent
Estimating the term…
Abstract
This invention relates to a crystalline form of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate, and to pharmaceutical compositions thereof, to intermediates and methods for the production and isolation of such crystalline forms and compositions, and to methods of using such crystalline forms and compositions in the treatment of abnormal cell growth in mammals, especially humans.
Claims40
A method of treating a hematologic malignancy in a mammal having said hematologic malignancy, comprising administering to the mammal a pharmaceutical composition comprising a therapeutically effective amount of a crystalline form of 1-(2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate, having the structure:
- and having a powder X-ray diffraction pattern comprising peaks at 2θ values of:
- 11.6, 12.1 and 19.6°2θ±0.2°2θ, and a pharmaceutically acceptable excipient.
A method of treating a hematologic malignancy in a mammal having said hematologic malignancy, comprising administering to the mammal a pharmaceutical composition comprising a therapeutically effective amount of a crystalline form of 1-(2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate, having the structure:
- and having:
- (a) a powder X-ray diffraction pattern comprising peaks at 2θ values of:
- 11.6 and 12.1°2θ±0.2°2θ;
- and (b) a Raman spectrum comprising wavenumber (cm−1) values of:
- 1612 and 2219 cm−1±2 cm−1, and a pharmaceutically acceptable excipient.
A method of treating a hematologic malignancy in a mammal having said hematologic malignancy, comprising administering to the mammal a pharmaceutical composition comprising a therapeutically effective amount of a crystalline form of 1-(2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate, having the structure:
- and having:
- (a) a powder X-ray diffraction pattern comprising peaks at 28 values of:
- 11.6 and 12.1°2θ±0.2°2θ;
- (b) a Raman spectrum comprising wavenumber (cm−1) values of:
- 1612 and 2219 cm−1±2 cm−1;
- and (c) a13C solid state NMR spectrum comprising a resonance (ppm) value of:
- 148.3 ppm±0.2 ppm, and a pharmaceutically acceptable excipient.
A method of treating a hematologic malignancy in a mammal having said hematologic malignancy, comprising administering to the mammal a pharmaceutical composition comprising a therapeutically effective amount of a crystalline form of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate, having the structure:
- and having:
- (a) a powder X-ray diffraction pattern comprising peaks at 28 values of:
- 11.6 and 12.1°2θ±0.2°2θ;
- and (b) a13C solid state NMR spectrum comprising a resonance (ppm) value of:
- 148.3 ppm±0.2 ppm, and a pharmaceutically acceptable excipient.
Dependencies are inferred from the claim text.