Title:
SOLID DISPERSION, PHARMACEUTICAL PREPARATION CONTAINING SOLID DISPERSION, AND METHODS RESPECTIVELY FOR PRODUCING THESE PRODUCTS
Document Type and Number:
WIPO Patent Application WO/2024/005197
Kind Code:
A1
Abstract:
Provided are: a solid dispersion comprising at least one compound selected from the group consisting of a hetero ring derivative represented by general formula [1], a tautomer of the hetero ring derivative, and a pharmaceutically acceptable salt of the hetero ring derivative or the tautomer, and a pharmaceutically acceptable polymer; and a pharmaceutical preparation containing the solid dispersion.
Inventors:
KAWARADA KOSUKE (JP)
MISAWA RYUJI (JP)
MISAWA RYUJI (JP)
Application Number:
PCT/JP2023/024443
Publication Date:
January 04, 2024
Filing Date:
June 30, 2023
Export Citation:
Assignee:
NIPPON SHINYAKU CO LTD (JP)
International Classes:
A61K31/4184; A61K9/10; A61K9/20; A61K31/343; A61K31/423; A61K47/32; A61K47/38; A61P1/04; A61P9/10; A61P11/00; A61P11/06; A61P15/00; A61P17/00; A61P17/06; A61P19/02; A61P19/06; A61P19/10; A61P25/06; A61P29/00; A61P31/04; A61P31/10; A61P31/12; A61P31/16; A61P31/18; A61P35/00; A61P37/08
Domestic Patent References:
| WO2013024898A1 | 2013-02-21 |
Other References:
"Passing down formulation techniques by formulation experts vol. 1. Formulation design and manufacturing method of orally administered formulations", 20 May 2013, JIHO INC., JP, ISBN: 978-4-8407-4441-6, article OKADA, HIROAKI ET AL.: "Chapter 3: Previous research and recent research examples on poorly soluble drugs", pages: 238 - 241, XP009552449
"Leading Edge Technologies for Oral Delivery of Poorly Soluble Drugs", 6 July 2016, CMC PUBLISHING, JP, ISBN: 978-4-7813-1169-2, article KAWAKAMI, KOHSAKU: "1.5 Amorphous solid dispersion", pages: 5 - 7, XP009552450
"Improvement of gastrointestinal and transmucosal absorption of poorly absorbable drugs and development of novel dosage forms of these drugs", 2 April 2012, CMC PUBLISHING CO, LTD., JP, ISBN: 978-4-7813-0495-3, article YAMAMOTO, AKIRA: "Passage; Improvement of gastrointestinal and transmucosal absorption of poorly absorbable drugs and development of novel dosage forms of these drugs", pages: 34 - 40, XP009552451
"Know-how collection on properties, section, and usage of additives", 31 January 2012, TECHNICAL INFORMATION INSTITUTE CO., LTD. , JP, ISBN: 978-4-86104-421-2, article YUTAKA YABA: "Section 7: Methodology and additive selection method for improving solubility and dissolution of poorly water-soluble drugs: 1. Method D using solid dispersion", pages: 160 - 164, XP009552453
10 February 1995, pp. 172-174. Hashida, Mitsuru. Design and evaluation of orally administered formulations. Yakuji Jihosha KK.
"Recent progress in Physicochemical characterization and formulation technologies for poorly soluble drugs", 29 January 2010, CMC PUBLISHING COO=., LTD, JP, ISBN: 978-4-7813-0197-6, article KAWAKAMI, KOHSAKU.: "2.3 Formulation technology for poorly water-soluble drugs // 2.4 Formulation design policy for poorly water-soluble drugs and points to note in drug development // 2.5 Conclusion", pages: 13 - 20, XP009552454
EDITED BY JAPAN PHARMACEUTICAL ADDITIVES ASSOCIATION: "Japanese Pharmaceutical Excipients Directory 2016", 18 February 2016, JAPAN PHARMACEUTICAL ADDITIVES ASSOCIATION , JP , ISBN: 978-4-8408-1329-7, article EDITED BY JAPAN PHARMACEUTICAL EXCIPIENTS ASSOCIATION: "Passage; Pharmaceutical excipients dictionary 2016. ", pages: 18 - 19, XP009552455
EDITED BY JAPAN PHARMACEUTICAL ADDITIVES ASSOCIATION: "Japanese Pharmaceutical Excipients Directory 2016", 18 February 2016, JAPAN PHARMACEUTICAL ADDITIVES ASSOCIATION , JP , ISBN: 978-4-8408-1329-7, article EDITED BY JAPAN PHARMACEUTICAL EXCIPIENTS ASSOCIATION: "Passage; Pharmaceutical excipients dictionary 2016", pages: 423 - 425, XP009552456
EDITED BY JAPAN PHARMACEUTICAL ADDITIVES ASSOCIATION: "Japanese Pharmaceutical Excipients Directory 2016", 18 February 2016, JAPAN PHARMACEUTICAL ADDITIVES ASSOCIATION , JP , ISBN: 978-4-8408-1329-7, article EDITED BY JAPAN PHARMACEUTICAL EXCIPIENTS ASSOCIATION: "Passage; Pharmaceutical excipients dictionary 2016", pages: 556 - 559, XP009552457
"Leading Edge Technologies for Oral Delivery of Poorly Soluble Drugs", 6 July 2016, CMC PUBLISHING, JP, ISBN: 978-4-7813-1169-2, article KAWAKAMI, KOHSAKU: "1.5 Amorphous solid dispersion", pages: 5 - 7, XP009552450
"Improvement of gastrointestinal and transmucosal absorption of poorly absorbable drugs and development of novel dosage forms of these drugs", 2 April 2012, CMC PUBLISHING CO, LTD., JP, ISBN: 978-4-7813-0495-3, article YAMAMOTO, AKIRA: "Passage; Improvement of gastrointestinal and transmucosal absorption of poorly absorbable drugs and development of novel dosage forms of these drugs", pages: 34 - 40, XP009552451
"Know-how collection on properties, section, and usage of additives", 31 January 2012, TECHNICAL INFORMATION INSTITUTE CO., LTD. , JP, ISBN: 978-4-86104-421-2, article YUTAKA YABA: "Section 7: Methodology and additive selection method for improving solubility and dissolution of poorly water-soluble drugs: 1. Method D using solid dispersion", pages: 160 - 164, XP009552453
10 February 1995, pp. 172-174. Hashida, Mitsuru. Design and evaluation of orally administered formulations. Yakuji Jihosha KK.
"Recent progress in Physicochemical characterization and formulation technologies for poorly soluble drugs", 29 January 2010, CMC PUBLISHING COO=., LTD, JP, ISBN: 978-4-7813-0197-6, article KAWAKAMI, KOHSAKU.: "2.3 Formulation technology for poorly water-soluble drugs // 2.4 Formulation design policy for poorly water-soluble drugs and points to note in drug development // 2.5 Conclusion", pages: 13 - 20, XP009552454
EDITED BY JAPAN PHARMACEUTICAL ADDITIVES ASSOCIATION: "Japanese Pharmaceutical Excipients Directory 2016", 18 February 2016, JAPAN PHARMACEUTICAL ADDITIVES ASSOCIATION , JP , ISBN: 978-4-8408-1329-7, article EDITED BY JAPAN PHARMACEUTICAL EXCIPIENTS ASSOCIATION: "Passage; Pharmaceutical excipients dictionary 2016. ", pages: 18 - 19, XP009552455
EDITED BY JAPAN PHARMACEUTICAL ADDITIVES ASSOCIATION: "Japanese Pharmaceutical Excipients Directory 2016", 18 February 2016, JAPAN PHARMACEUTICAL ADDITIVES ASSOCIATION , JP , ISBN: 978-4-8408-1329-7, article EDITED BY JAPAN PHARMACEUTICAL EXCIPIENTS ASSOCIATION: "Passage; Pharmaceutical excipients dictionary 2016", pages: 423 - 425, XP009552456
EDITED BY JAPAN PHARMACEUTICAL ADDITIVES ASSOCIATION: "Japanese Pharmaceutical Excipients Directory 2016", 18 February 2016, JAPAN PHARMACEUTICAL ADDITIVES ASSOCIATION , JP , ISBN: 978-4-8408-1329-7, article EDITED BY JAPAN PHARMACEUTICAL EXCIPIENTS ASSOCIATION: "Passage; Pharmaceutical excipients dictionary 2016", pages: 556 - 559, XP009552457
Attorney, Agent or Firm:
HASEGAWA Yoshiki et al. (JP)
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