Title:
PROCESS FOR PREPARING FORM III OF RITONAVIR
Document Type and Number:
WIPO Patent Application WO/2024/050019
Kind Code:
A3
Abstract:
The present disclosure is related to a polymorphic form of ritonavir prepared by novel methods that require less time to produce the polymorphic form, the methods of preparing the polymorphic form, pharmaceutical compositions comprising the polymorphic form produced by the provided methods, and corresponding methods of treatment with the polymorphic form produced by the provided methods.
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Inventors:
RADOCEA ADRIAN (US)
CROOM JORDAN (US)
CHAN LARRY R (US)
BHAVSAR AMI S (US)
SMITH PAMELA A (US)
BYRN STEPHEN R (US)
PARENT STEPHAN D (US)
PURCELL DALE K (US)
CROOM JORDAN (US)
CHAN LARRY R (US)
BHAVSAR AMI S (US)
SMITH PAMELA A (US)
BYRN STEPHEN R (US)
PARENT STEPHAN D (US)
PURCELL DALE K (US)
Application Number:
PCT/US2023/031719
Publication Date:
April 18, 2024
Filing Date:
August 31, 2023
Export Citation:
Assignee:
VARDA SPACE IND INC (US)
International Classes:
C07D417/12; A61K31/427; A61P31/14; A61P31/18
Domestic Patent References:
| WO2008041176A2 | 2008-04-10 |
Foreign References:
| US7148359B2 | 2006-12-12 |
Other References:
YAO ET AL.: "Ritonavir Form III: A New Polymorph After 24 Years", CHEMRXIV, 18 August 2022 (2022-08-18), pages 1 - 17, XP093117430, Retrieved from the Internet DOI: 10.26434/chemrxiv-2022-35fwp
KAWAKAMI ET AL.: "Relationship between Crystallization Tendencies during Cooling from Melt and Isothermal Storage: Toward a General Understanding of Physical Stability of Pharmaceutical Glasses", MOL. PHARMACEUTICS, vol. 11, no. 6, 25 April 2014 (2014-04-25), US, pages 1835 - 1843, XP093116658, ISSN: 1543-8384, DOI: 10.1021/mp400679m
CHEMBURKAR ET AL.: "Dealing with the Impact of Ritonavir Polymorphs on the Late Stages of Bulk Drug Process Development", ORGANIC PROCESS RESEARCH & DEVELOPMENT, vol. 4, no. 5, 21 June 2000 (2000-06-21), US, pages 413 - 417, XP093117689, ISSN: 1083-6160, DOI: 10.1021/op000023y
PARENT ET AL.: "Ritonavir Form III: Lightning strikes twice at the same time, 137 miles apart", CHEMRXIV, 8 September 2022 (2022-09-08), pages 1 - 18, XP093116650, Retrieved from the Internet [retrieved on 20240108], DOI: 10.26434/chemrxiv-2022-49tzw
PARENT ET AL.: "Ritonavir Form III: A Coincidental Concurrent Discovery", CRYS. GROWTH DES., vol. 23, no. 1, 21 December 2022 (2022-12-21), US, pages 320 - 325, XP093116629, ISSN: 1528-7483, Retrieved from the Internet DOI: 10.1021/acs.cgd.2c01017
LI ET AL.: "Ritonavir Revisited: Melt Crystallization Can Easily Find the Late-Appearing Polymorph II and Unexpectedly Discover a New Polymorph III", MOL. PHARMACEUTICS, vol. 20, no. 8, 14 July 2023 (2023-07-14), US, pages 3854 - 3863, XP093116642, ISSN: 1543-8384, Retrieved from the Internet DOI: 10.1021/acs.molpharmaceut.2c00994
SNELL; HELLIWELL: "Microgravity as an environment for macromolecular crystallization - an outlook in the era of space stations and commercial space flight", CRYSTALLOGRAPHY REVIEWS, vol. 27, no. 1, 8 April 2021 (2021-04-08), GB, pages 3 - 46, XP093117846, ISSN: 0889-311X, DOI: 10.1080/0889311X.2021.1900833
KAWAKAMI ET AL.: "Relationship between Crystallization Tendencies during Cooling from Melt and Isothermal Storage: Toward a General Understanding of Physical Stability of Pharmaceutical Glasses", MOL. PHARMACEUTICS, vol. 11, no. 6, 25 April 2014 (2014-04-25), US, pages 1835 - 1843, XP093116658, ISSN: 1543-8384, DOI: 10.1021/mp400679m
CHEMBURKAR ET AL.: "Dealing with the Impact of Ritonavir Polymorphs on the Late Stages of Bulk Drug Process Development", ORGANIC PROCESS RESEARCH & DEVELOPMENT, vol. 4, no. 5, 21 June 2000 (2000-06-21), US, pages 413 - 417, XP093117689, ISSN: 1083-6160, DOI: 10.1021/op000023y
PARENT ET AL.: "Ritonavir Form III: Lightning strikes twice at the same time, 137 miles apart", CHEMRXIV, 8 September 2022 (2022-09-08), pages 1 - 18, XP093116650, Retrieved from the Internet
PARENT ET AL.: "Ritonavir Form III: A Coincidental Concurrent Discovery", CRYS. GROWTH DES., vol. 23, no. 1, 21 December 2022 (2022-12-21), US, pages 320 - 325, XP093116629, ISSN: 1528-7483, Retrieved from the Internet
LI ET AL.: "Ritonavir Revisited: Melt Crystallization Can Easily Find the Late-Appearing Polymorph II and Unexpectedly Discover a New Polymorph III", MOL. PHARMACEUTICS, vol. 20, no. 8, 14 July 2023 (2023-07-14), US, pages 3854 - 3863, XP093116642, ISSN: 1543-8384, Retrieved from the Internet
SNELL; HELLIWELL: "Microgravity as an environment for macromolecular crystallization - an outlook in the era of space stations and commercial space flight", CRYSTALLOGRAPHY REVIEWS, vol. 27, no. 1, 8 April 2021 (2021-04-08), GB, pages 3 - 46, XP093117846, ISSN: 0889-311X, DOI: 10.1080/0889311X.2021.1900833
Attorney, Agent or Firm:
MORALES, Carl A. et al. (US)
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