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New crystal form of tini-type medicines

A technology of crystal form and Ni crystal, applied in the field of new crystal forms of tinib drugs and their preparation, can solve the problems of difficult industrialized large-scale production and obtaining high-purity products, moisture absorption, thermodynamic instability, etc.

Active Publication Date: 2014-06-04
SUNSHINE LAKE PHARM CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] U.S. Patent No. 6,573,293 discloses sunitinib and its preparation method. U.S. application US20030069298 discloses the L-malate of sunitinib, its crystal form I, crystal form II and the preparation method of these crystal forms, but these crystals There are some defects in the form, such as moisture absorption and thermodynamic instability; the crystal form I is prepared in acetonitrile slurry, and it is difficult to industrialize large-scale production and obtain high-purity products

Method used

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  • New crystal form of tini-type medicines
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  • New crystal form of tini-type medicines

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Embodiment Construction

[0023] In the first aspect, the present invention provides substantially pure crystal forms B and C of sunitinib, which are stable and non-hygroscopic, and are very beneficial to industrial operation and production.

[0024] The substantially pure crystal form B of sunitinib has the following characteristics: in its X-ray powder diffraction pattern, there is a peak at a position of about 8.76 degrees in 2θ;

[0025] In some embodiments, its X-ray powder diffraction pattern has peaks at one or more positions at about 8.76, 17.51 ​​and 26.11 degrees 2Θ;

[0026] In some embodiments, its X-ray powder diffraction pattern has peaks at one or more positions at about 8.76, 17.20, 17.51 ​​and 26.11 degrees 2Θ;

[0027] In some embodiments, its X-ray powder diffraction pattern has peaks at one or more of positions at about 3.96, 8.76, 17.51, 21.28, 26.11 and 28.04 degrees 2Θ;

[0028] In some embodiments, its X-ray powder diffraction pattern is about 3.96, 8.76, 9.25, 9.56, 10.34, 15....

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Abstract

The invention relates to the field of medicine chemistry. On one hand, the invention relates to a new crystal form of sunitinib, and the crystal form of the sunitinib is a crystal form B or a crystal form C basically pure. On the other hand, the invention relates to a new crystal form of sunitinib L-malate, and the crystal form of the sunitinib L-malate is a crystal form D basically pure. The new crystal forms are non-moisture-absorbing and are beneficial to operation and / preparation of preparations in industrial production. The invention also provides a preparation method of the crystal forms.

Description

technical field [0001] The invention relates to the field of medicinal chemistry, in particular to a new crystal form of tinib and a preparation method thereof. Background technique [0002] Sunitinib, its structure is as shown in formula (I), and its L-malate structure is as shown in formula (II): [0003] [0004] It can be used to treat diseases such as advanced renal cell carcinoma. [0005] Drug polymorphism is a common phenomenon in drug research and development, and is an important factor affecting drug quality. Different crystal forms of the same drug may have significant differences in appearance, solubility, melting point, fluidity, dissolution, bioequivalence, etc. These differences in properties can affect the production process and also affect the stability and bioavailability of the drug. The degree and curative effect have different effects. [0006] U.S. Patent No. 6,573,293 discloses sunitinib and its preparation method. U.S. application US20030069298 ...

Claims

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Application Information

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IPC IPC(8): C07D403/06C07C59/245C07C51/43
CPCC07D403/06
Inventor 曾纪森沈安雄寇景平
Owner SUNSHINE LAKE PHARM CO LTD
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