Title:
METHOD FOR PREPARING PROGESTERONE PARTICULATE, PREPARED PROGESTERONE PARTICULATE AND INJECTION THEREOF
Document Type and Number:
WIPO Patent Application WO/2020/135352
Kind Code:
A1
Abstract:
Disclosed is a method for preparing a progesterone particulate, especially a crystal or powder. The method comprises: step 1, dissolving progesterone in a solvent to provide a progesterone solution; step 2, pumping the progesterone solution into a high-speed shearing progesterone precipitation solvent at a predetermined speed to precipitate progesterone; and step 3, separating the precipitate and freeze-drying same to obtain the progesterone particulate, wherein the progesterone particulate being a progesterone crystal or progesterone powder. By using the method of the present invention, a micron-sized progesterone crystal or powder having good stability can be obtained. The progesterone injection prepared by using same not only achieves a sustained release effect of at least 5 days, but also has good stability. The method of the present invention is simple to operate, has low cost, and is easily scaled up for industrial production.
Inventors:
LIANG XIANGYONG (CN)
LI MING (CN)
SU ZHENGXING (CN)
GUO DALTON (CN)
YI CONG (CN)
WEI WEI (CN)
LI DAN (CN)
ZHAO DONG (CN)
WANG JINGYI (CN)
LI MING (CN)
SU ZHENGXING (CN)
GUO DALTON (CN)
YI CONG (CN)
WEI WEI (CN)
LI DAN (CN)
ZHAO DONG (CN)
WANG JINGYI (CN)
Application Number:
PCT/CN2019/127555
Publication Date:
July 02, 2020
Filing Date:
December 23, 2019
Export Citation:
Assignee:
SICHUAN KELUN PHARM RES INST CO LTD (CN)
HUNAN KELUN PHARMACEUTICAL RES CO LTD (CN)
HUNAN KELUN PHARMACEUTICAL RES CO LTD (CN)
International Classes:
A61K31/57; C07J7/00
Foreign References:
| CN107198677A | 2017-09-26 | |||
| CN1780670A | 2006-05-31 |
Other References:
DOAA RAGAB ET AL: "Crystallization of Progesterone for Pulmonary Drug Delivery", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 99, no. 3, 18 August 2009 (2009-08-18), pages 1123 - 1137, XP055714431, ISSN: 0022-3549, DOI: 10.1002/jps.21896
JAVIER A. FALCON ET AL: "In Situ Monitoring of Antisolvent Addition Crystallization with Principal Components Analysis of Raman Spectra", CRYSTAL GROWTH & DESIGN, vol. 4, no. 3, 10 April 2004 (2004-04-10), pages 457 - 463, XP055714436, ISSN: 1528-7483, DOI: 10.1021/cg034206y
EUNBI CHO ET AL: "Enhanced Dissolution of Megestrol Acetate Microcrystals Prepared by Antisolvent Precipitation Process Using Hydrophilic Additives", INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 396, no. 1-2, 30 August 2010 (2010-08-30), pages 91 - 98, XP027169576, ISSN: 0378-5173, DOI: 10.1016/j.ijpharm.2010.06.016
ROBERT W LANCASTER ET AL: "The Polymorphism of Progesterone: Stabilization of a ‘Disappearing’ Polymorph by Co-Crystallization", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 96, no. 12, 1 December 2007 (2007-12-01), pages 3419 - 3431, XP055714443, ISSN: 0022-3549, DOI: 10.1002/jps.20983
JAVIER A. FALCON ET AL: "In Situ Monitoring of Antisolvent Addition Crystallization with Principal Components Analysis of Raman Spectra", CRYSTAL GROWTH & DESIGN, vol. 4, no. 3, 10 April 2004 (2004-04-10), pages 457 - 463, XP055714436, ISSN: 1528-7483, DOI: 10.1021/cg034206y
EUNBI CHO ET AL: "Enhanced Dissolution of Megestrol Acetate Microcrystals Prepared by Antisolvent Precipitation Process Using Hydrophilic Additives", INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 396, no. 1-2, 30 August 2010 (2010-08-30), pages 91 - 98, XP027169576, ISSN: 0378-5173, DOI: 10.1016/j.ijpharm.2010.06.016
ROBERT W LANCASTER ET AL: "The Polymorphism of Progesterone: Stabilization of a ‘Disappearing’ Polymorph by Co-Crystallization", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 96, no. 12, 1 December 2007 (2007-12-01), pages 3419 - 3431, XP055714443, ISSN: 0022-3549, DOI: 10.1002/jps.20983
Attorney, Agent or Firm:
CHINA PAT INTELLECTUAL PROPERTY OFFICE (CN)
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