Title:
MEDICINE PRODUCTION METHOD INCLUDING STEP OF FREEZE-DRYING WITH MIXED SOLVENT
Document Type and Number:
WIPO Patent Application WO/2022/138598
Kind Code:
A1
Abstract:
The present invention addresses the problem of providing a medicine production method including a freeze-drying method by which the concentration of a residual solvent can be reduced with respect to a wide range of substrate concentrations ranging from a low to a high concentration. The medicine production method according to the present invention comprises (1) a step in which a liquid mixture comprising water, an organic solvent, and a substance to be freeze-dried is prepared and (2) a step in which the liquid mixture is subjected to freeze-drying, the proportion of the mass of the organic solvent to the total mass of the water and the organic solvent in step (1) being 68-99 mass%.
Inventors:
GOTO ATSUMI (JP)
ENOMOTO TARO (JP)
ENOMOTO TARO (JP)
Application Number:
PCT/JP2021/047164
Publication Date:
June 30, 2022
Filing Date:
December 21, 2021
Export Citation:
Assignee:
CHUGAI PHARMACEUTICAL CO LTD (JP)
International Classes:
A61K9/19; A61K38/13; F26B5/06
Foreign References:
| JP2019511484A | 2019-04-25 |
Other References:
VAN DROOGE D J, HINRICHS W L J, FRIJLINK H W: "Incorporation of lipophilic drugs in sugar glasses by lyophilization using a mixture of water and tertiary butyl alcohol as solvent.", JOURNAL OF PHARMACEUTICAL SCIENCES, AMERICAN CHEMICAL SOCIETY AND AMERICAN PHARMACEUTICAL ASSOCIATION, US, vol. 93, no. 3, 1 March 2004 (2004-03-01), US , pages 713 - 725, XP002445775, ISSN: 0022-3549, DOI: 10.1002/jps.10590
BIOPOLYMERS, vol. 55, no. 3, 2000, pages 227 - 250
JOURNAL OF PHARMACEUTICAL MACHINERY AND ENGINEERING, vol. 24, no. 2, 2015, pages 15
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 15, 2002, pages 115 - 133
JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 107, 2018, pages 2005 - 2012
JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 108, 2019, pages 399 - 415
ICHQ3C GUIDELINE, Q3C(R8) IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS, 25 March 2020 (2020-03-25)
JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 91, 2002, pages 1147 - 1155
PHARMACEUTICAL RESEARCH, vol. 25, no. 12, December 2008 (2008-12-01), pages 2799 - 2806
ACTA PHARMACEUTICAL SINICA, vol. 42, no. 3, 2007, pages 314 - 317
BIOPOLYMERS, vol. 55, no. 3, 2000, pages 227 - 250
JOURNAL OF PHARMACEUTICAL MACHINERY AND ENGINEERING, vol. 24, no. 2, 2015, pages 15
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 15, 2002, pages 115 - 133
JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 107, 2018, pages 2005 - 2012
JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 108, 2019, pages 399 - 415
ICHQ3C GUIDELINE, Q3C(R8) IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS, 25 March 2020 (2020-03-25)
JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 91, 2002, pages 1147 - 1155
PHARMACEUTICAL RESEARCH, vol. 25, no. 12, December 2008 (2008-12-01), pages 2799 - 2806
ACTA PHARMACEUTICAL SINICA, vol. 42, no. 3, 2007, pages 314 - 317
Attorney, Agent or Firm:
HASEGAWA, Yoshiki et al. (JP)
Download PDF:
Previous Patent: WIRE HARNESS
Next Patent: SUBSTRATE TREATMENT METHOD, MANUFACTURING METHOD OF SEMICONDUCTOR DEVICE, SUBSTRATE TREATMENT DEVICE...
Next Patent: SUBSTRATE TREATMENT METHOD, MANUFACTURING METHOD OF SEMICONDUCTOR DEVICE, SUBSTRATE TREATMENT DEVICE...