Crystal Form of Dabrafenib and Preparation Method and Use Thereof
AssigneeHangzhou Pushai Pharmaceutical Technology Co., Ltd.
InventorsHaiping LAO, Xiaoxia SHENG, Xiaohong Sheng
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Abstract
The invention relates to a new crystal form of dabrafenib and preparation method thereof. With respect to known crystal forms, the new crystal form has the advantage of being more stable at room temperature or in aqueous systems, and has low hygroscopicity, and thus is more suitable for a wet granulation process or being prepared into a suspension. The present invention also relates to a pharmaceutical composition and formulations comprising the new crystal form, and their use in the treatment of Raf family kinase-related diseases.
Claims30
Crystal Form VI of Dabrafenib with the structural formula shown below, and Crystal Form VI is a hydrate,
- wherein the Crystal Form VI of Dabrafenib is characterized by a X-ray powder diffraction pattern measured using Cu—Kα radiation having the specific peaks at the diffraction angle 2θ of 10.4˜0.2°, 17.6˜0.2°, 21.6±0.2° and 25.1±0.2°.
Crystal Form VII of Dabrafenib with the structural formula shown below,
- wherein the Crystal Form VII of Dabrafenib is characterized by a X-ray powder diffraction pattern measured using Cu—Kα radiation having the specific peaks at the diffraction angle 2θ of 7.9±0.2°, 14.5±0.2°, 19.4±0.2° and 24.3±0.2°.
A pharmaceutical composition comprising a therapeutically effective amount of Crystal Form VI of Dabrafenib and at least a pharmaceutical acceptable excipient,
- wherein the Crystal Form VI of Dabrafenib is characterized by a X-ray powder diffraction pattern measured using Cu—Kα radiation having the specific peaks at the diffraction angle 2θ of 10.4±0.2°, 17.6±0.2°, 21.6±0.2° and 25.1±0.2°.
A pharmaceutical composition comprising a therapeutically effective amount of Crystal Form VII of Dabrafenib and at least a pharmaceutical acceptable excipient,
- wherein the Crystal Form VII of Dabrafenib is characterized by a X-ray powder diffraction pattern measured using Cu—Kα radiation having the specific peaks at the diffraction angle 2θ of 7.9±0.2°, 14.5±0.2°, 19.4±0.2° and 24.3±0.2°.
Dependencies are inferred from the claim text.