Title:
BPA LYOPHILIZED PREPARATION AND PREPARATION METHOD THEREFOR
Document Type and Number:
WIPO Patent Application WO/2020/216334
Kind Code:
A1
Abstract:
Disclosed is a method for preparing a BPA lyophilized preparation, comprising a solution formulating process and a freeze drying process; wherein the solution formulating process comprises: (1) dissolving BPA and a polyol in an aqueous solution by means of a base to obtain a clear solution; and (2) adjusting the clear solution back to 7.5 < pH ≤ 8.5 by means of an acid to obtain a BPA solution; and the freeze drying process comprises: (3) sub-packaging the BPA solution and freeze drying same under the conditions of a vacuum degree of 10-20 Pa to obtain the lyophilized preparation. The BPA lyophilized preparation prepared by means of the method has a good stability and a low impurity content.
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Inventors:
LIU YUANHAO (CN)
CHEN LAMEI (CN)
WU XIAOMING (CN)
JI HONGFENG (CN)
LI YAJING (CN)
HE JING (CN)
WANG DONGCHUN (CN)
CHEN LAMEI (CN)
WU XIAOMING (CN)
JI HONGFENG (CN)
LI YAJING (CN)
HE JING (CN)
WANG DONGCHUN (CN)
Application Number:
PCT/CN2020/086745
Publication Date:
October 29, 2020
Filing Date:
April 24, 2020
Export Citation:
Assignee:
NEUBORON MEDTECH LTD (CN)
International Classes:
A61K51/00; A61K101/00
Domestic Patent References:
| WO2000057887A1 | 2000-10-05 | |||
| WO2004030661A2 | 2004-04-15 |
Foreign References:
| CN103100094A | 2013-05-15 | |||
| US5935944A | 1999-08-10 | |||
| CN103100094A | 2013-05-15 |
Other References:
HALBERT GAVIN; ELLIOTT MOIRA; FORD STEVEN; DICK LINDSAY; SCHMIDT ELKE: "Improved pharmaceutical stability of a boronphenylalanine mannitol formulation for boron neutron capture therapy,", EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 48, no. 4-5, 23 January 2013 (2013-01-23), pages 735 - 739, XP029000008, ISSN: 0928-0987, DOI: 10.1016/j.ejps.2013.01.008
HENRIKSSON R; CAPALA J; MICHANEK A; LINDAHL S A; SALFORD L G; FRANZEN L; BLOMQUIST E; WESTLIN J E; BERGENHEIM A T: "Boron neutron capture therapy (BNCT) for glioblastoma multiforme: A phase II study evaluating a prolonged high-dose of boronophenylalanine (BPA),", RADIOTHERAPY AND ONCOLOGY, vol. 88, no. 2, 31 August 2008 (2008-08-31), pages 183 - 191, XP023904041, ISSN: 0167-8140, DOI: 10.1016/j.radonc.2006.04.015
ROLF F. BARTH, ALBERT H. SOLOWAY AND RALPH G. FAIRCHILD: "Boron neutron capture therapy for cancer", CANCER, vol. 37, no. 7, 31 December 2018 (2018-12-31), CN, pages 289 - 307, XP009523962, ISSN: 1000-467X
HENRIKSSON R; CAPALA J; MICHANEK A; LINDAHL S A; SALFORD L G; FRANZEN L; BLOMQUIST E; WESTLIN J E; BERGENHEIM A T: "Boron neutron capture therapy (BNCT) for glioblastoma multiforme: A phase II study evaluating a prolonged high-dose of boronophenylalanine (BPA),", RADIOTHERAPY AND ONCOLOGY, vol. 88, no. 2, 31 August 2008 (2008-08-31), pages 183 - 191, XP023904041, ISSN: 0167-8140, DOI: 10.1016/j.radonc.2006.04.015
ROLF F. BARTH, ALBERT H. SOLOWAY AND RALPH G. FAIRCHILD: "Boron neutron capture therapy for cancer", CANCER, vol. 37, no. 7, 31 December 2018 (2018-12-31), CN, pages 289 - 307, XP009523962, ISSN: 1000-467X
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