Title:
CRYSTAL FORM OF VALNEMULIN HYDROCHLORIDE HYDRATE, PREPARATION METHOD THEREFOR, AND PHARMACEUTICAL COMPOSITION CONTAINING CRYSTAL FORM
Document Type and Number:
WIPO Patent Application WO/2020/258660
Kind Code:
A1
Abstract:
The present application relates to a crystal form of a valnemulin hydrochloride hydrate, a preparation method therefor, and a pharmaceutical composition containing the crystal form. Specifically, the present application relates to a crystal form of a valnemulin hydrochloride hydrate, wherein the crystal form shows characteristic peaks 2 θ at 9.2+/-0.2°, 9.5+/-0.2°, 10.3+/-0.2°, 11.8+/-0.2°, 12.3+/-0.2°, 12.8+/-0.2°, 15.1+/-0.2°, 17.5+/-0.2°, and 18.2+/-0.2° in an X-ray powder diffraction pattern. The crystal form of the valnemulin hydrochloride hydrate has a high bulk density, no hygroscopicity, and good stability. The present application also provides a method for preparing the above crystal form of the valnemulin hydrochloride hydrate and a pharmaceutical composition containing the crystal form, wherein the composition can be used for preparing various preparations, such as a soluble powder, an oral liquid, a sustained-release particle, an injection, and other dosage forms, and has broad clinical application prospects.
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Inventors:
LI YALING (CN)
WU YANZI (CN)
WANG BIAO (CN)
LI QIFENG (CN)
XIA XUELIN (CN)
LIU AILING (CN)
LI SHOUJUN (CN)
FU CHUNXIANG (CN)
WU YANZI (CN)
WANG BIAO (CN)
LI QIFENG (CN)
XIA XUELIN (CN)
LIU AILING (CN)
LI SHOUJUN (CN)
FU CHUNXIANG (CN)
Application Number:
PCT/CN2019/117679
Publication Date:
December 30, 2020
Filing Date:
November 12, 2019
Export Citation:
Assignee:
TIANJIN RINGPU BIO TECH CO LTD (CN)
RINGPU TIANJIN BIO PHARM CO LTD (CN)
RINGPU TIANJIN BIO PHARM CO LTD (CN)
International Classes:
C07C319/28; A61K31/22; A61P31/04; C07C323/52
Foreign References:
| CN110294697A | 2019-10-01 | |||
| CN104876841A | 2015-09-02 | |||
| CN108892629A | 2018-11-27 | |||
| CN104876841A | 2015-09-02 |
Other References:
OUYANG JINBO, NA BING, ZHOU LIMIN, XIAO SAIJIN, XIONG GUOXUAN, JIN TIANXIANG: "Crystal structures and phase transformation of two novel solvates of valnemulin hydrochloride", CRYSTENGCOMM, vol. 20, no. 5, 7 February 2018 (2018-02-07), pages 563 - 569, XP055774588, DOI: 10.1039/C7CE01524K
OUYANG JINBO; NA BING; LIU ZHIRONG; ZHOU LIMIN; HAO HONGXUN: "Determination of Solubility and Nucleation Kinetics of Valnemulin Hydrochloride Solvate", JOURNAL OF SOLUTION CHEMISTRY, PLENUM PUBLISHING, NEW YORK, NY,, US, vol. 48, no. 4, 27 March 2019 (2019-03-27), US, pages 413 - 426, XP036761817, ISSN: 0095-9782, DOI: 10.1007/s10953-019-00861-7
OUYANG JINBO; NA BING; LIU ZHIRONG; ZHOU LIMIN; HAO HONGXUN: "Determination of Solubility and Nucleation Kinetics of Valnemulin Hydrochloride Solvate", JOURNAL OF SOLUTION CHEMISTRY, PLENUM PUBLISHING, NEW YORK, NY,, US, vol. 48, no. 4, 27 March 2019 (2019-03-27), US, pages 413 - 426, XP036761817, ISSN: 0095-9782, DOI: 10.1007/s10953-019-00861-7
Attorney, Agent or Firm:
BEYOND ATTORNEYS AT LAW (CN)
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