Title:
RAPID RECONSTITUTION FOR LYOPHILIZED-PHARMACEUTICAL SUSPENSIONS
Document Type and Number:
WIPO Patent Application WO/2011/082196
Kind Code:
A3
Abstract:
A method of preparing and reconstituting a sterile, lyophilized pharmaceutical active for rapid reconstitution by evacuating a lyophilized pharmaceutical active-containing container until the pressure within the container is less than about 300 Torr and hermetically sealing the evacuated container. The sterile, lyophilized pharmaceutical active can be prepared by flash freezing a pharmaceutical active-containing composition then lyophilizing the composition. The hermetically sealed lyophilized pharmaceutical active can be reconstituted by adding at least the total volume of liquid necessary for reconstitution of the sterile, lyophilized pharmaceutical active to the sterile, lyophilized pharmaceutical active, sealed under a pressure of less than about 300 Torr, in less than about 10 seconds to yield, within about 5 minutes, an administrable pharmaceutical active-containing composition. One aspect of the herein described sterile, lyophilized pharmaceutical active is a packaged sterile pharmaceutical active comprising an evacuated, hermetically sealed container having disposed therein a sterile, lyophilized pharmaceutical active, sealed under a pressure of less than about 300 Torr.
Inventors:
KUU WEI Y (US)
Application Number:
PCT/US2010/062289
Publication Date:
September 15, 2011
Filing Date:
December 29, 2010
Export Citation:
Assignee:
BAXTER INT (US)
BAXTER HEALTHCARE SA (CH)
KUU WEI Y (US)
BAXTER HEALTHCARE SA (CH)
KUU WEI Y (US)
International Classes:
A61K31/337; A61K9/19; A61K38/38
Domestic Patent References:
| WO2006081320A2 | 2006-08-03 | |||
| WO2007027819A2 | 2007-03-08 | |||
| WO2002053174A2 | 2002-07-11 |
Foreign References:
| US20060134221A1 | 2006-06-22 |
Other References:
TATTINI VIRGILIO JR ET AL: "Influence of cooling rate on the structural and phase changes during lyophilization of bovine serum albumin", REVISTA BRASILEIRA DE CIENCIAS FARMACEUTICAS, vol. 42, no. 1, January 2006 (2006-01-01), pages 127 - 136, XP009149556, ISSN: 1516-9332
MAKHAEVA G F ET AL: "A stable preparation of hen brain neuropathy target esterase for rapid biochemical assessment of neurotoxic potential of organophosphates", CHEMICO-BIOLOGICAL INTERACTIONS, ELSEVIER SCIENCE IRLAND, IR, vol. 119-120, 14 May 1999 (1999-05-14), pages 551 - 557, XP027424526, ISSN: 0009-2797, [retrieved on 19990514], DOI: DOI:10.1016/S0009-2797(99)00069-1
MAKHAEVA G F ET AL: "A stable preparation of hen brain neuropathy target esterase for rapid biochemical assessment of neurotoxic potential of organophosphates", CHEMICO-BIOLOGICAL INTERACTIONS, ELSEVIER SCIENCE IRLAND, IR, vol. 119-120, 14 May 1999 (1999-05-14), pages 551 - 557, XP027424526, ISSN: 0009-2797, [retrieved on 19990514], DOI: DOI:10.1016/S0009-2797(99)00069-1
Attorney, Agent or Firm:
MUCZYNSKI, Michael et al. (Gerstein & Borun LLP233 S. Wacker Drive,6300 Willis Towe, Chicago IL, US)
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