The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Date of Patent:
Dec. 26, 2017

Filed:

Jun. 30, 2017
Applicants:

Utopharm (Shanghai) Co., Ltd, Shanghai, CN;

Junzhi Luo, Shanghai, CN;

Inventors:

Junzhi Luo, Shanghai, CN;

Jing Nian, Shanghai, CN;

Siyuan Gao, Shanghai, CN;

Assignee:

Other;

Attorneys:
Primary Examiner:
Assistant Examiner:
Int. Cl.
CPC ...
A61K 31/40 (2006.01); C07D 209/46 (2006.01); A61K 31/4035 (2006.01); G01N 25/48 (2006.01); G01N 23/20 (2006.01); G01N 21/35 (2014.01);
U.S. Cl.
CPC ...
C07D 209/46 (2013.01); A61K 31/4035 (2013.01); G01N 23/2005 (2013.01); G01N 25/4866 (2013.01); G01N 2021/3595 (2013.01);
Abstract

A stable Crystalline Form II of non-solvate of Apremilast (Formula I), methods of making Form II, pharmaceutical compositions comprising Form II, and their uses are disclosed. Also discloses are mixed crystals comprising Form Hand Form B and methods of making the same. The crystalline forms are characterized using X-ray powder diffractometry (XRPD), infrared spectroscopy (IR), differential scanning calorimetry (DSC), and thermal gravimetric analysis (TG). As compared with Forms A, B, C, D, E, F, and G reported in prior art references, Apremilast Form II of the present invention is more stable to temperature, light, and humidity, and is more suitable for long term storage; the crystallization solvents are safe and can be easily removed; the Form II has a white or off white appearance, and can be directly used in preparation processing; the preparation methods are simple and easy to reproduce, and are suitable for industrialized production.


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