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WO2011082196A3 - Rapid reconstitution for lyophilized-pharmaceutical suspensions - Google Patents

Rapid reconstitution for lyophilized-pharmaceutical suspensions Download PDF

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Publication number
WO2011082196A3
WO2011082196A3 PCT/US2010/062289 US2010062289W WO2011082196A3 WO 2011082196 A3 WO2011082196 A3 WO 2011082196A3 US 2010062289 W US2010062289 W US 2010062289W WO 2011082196 A3 WO2011082196 A3 WO 2011082196A3
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical active
sterile
lyophilized pharmaceutical
lyophilized
less
Prior art date
Application number
PCT/US2010/062289
Other languages
French (fr)
Other versions
WO2011082196A2 (en
Inventor
Wei Y. Kuu
Original Assignee
Baxter International Inc.
Baxter Healthcare S.A.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US29099809P priority Critical
Priority to US61/290,998 priority
Application filed by Baxter International Inc., Baxter Healthcare S.A. filed Critical Baxter International Inc.
Publication of WO2011082196A2 publication Critical patent/WO2011082196A2/en
Publication of WO2011082196A3 publication Critical patent/WO2011082196A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38Albumins

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.
PCT/US2010/062289 2009-12-30 2010-12-29 Rapid reconstitution for lyophilized-pharmaceutical suspensions WO2011082196A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US29099809P true 2009-12-30 2009-12-30
US61/290,998 2009-12-30

Publications (2)

Publication Number Publication Date
WO2011082196A2 WO2011082196A2 (en) 2011-07-07
WO2011082196A3 true WO2011082196A3 (en) 2011-09-15

Family

ID=44146708

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2010/062289 WO2011082196A2 (en) 2009-12-30 2010-12-29 Rapid reconstitution for lyophilized-pharmaceutical suspensions

Country Status (2)

Country Link
US (1) US20110155620A1 (en)
WO (1) WO2011082196A2 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8371039B2 (en) 2009-12-30 2013-02-12 Baxter International Inc. Thermal shielding to optimize lyophilization process for pre-filled syringes or vials
EP2773778A4 (en) * 2011-10-31 2015-07-15 Merck Sharp & Dohme Methods of preparing lyophilized spherical-shaped pellets of biological materials
JP5814094B2 (en) * 2011-11-30 2015-11-17 ふたみ青果株式会社 Freeze drying method and apparatus according to the far-infrared heater
US9731076B2 (en) 2012-06-29 2017-08-15 Ethicon, Inc. Multi-compartment pre-filled mixing syringes with bypass
MX2016009347A (en) * 2014-01-20 2017-02-02 Ucb Biopharma Sprl Process for reconstitution of a solid form of a pharmaceutical composition.

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002053174A2 (en) * 2000-12-29 2002-07-11 Pbl Biomedical Laboratories Controlled release pharmaceutical systems
US20060134221A1 (en) * 2004-12-03 2006-06-22 Vical Incorporated Methods for producing block copolymer/amphiphilic particles
WO2006081320A2 (en) * 2005-01-27 2006-08-03 Human Genome Sciences, Inc. Pharmaceutical formulation
WO2007027819A2 (en) * 2005-08-31 2007-03-08 Abraxis Bioscience, Llc. Compositions comprising poorly water soluble pharmaceutical agents and antimicrobial agents

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2768341B1 (en) 1997-09-18 2000-04-14 Lab Francais Du Fractionnement placebo pharmaceutical composition lyophilizable FOR imitate a medicament, in particular a basic protein or polypeptide

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002053174A2 (en) * 2000-12-29 2002-07-11 Pbl Biomedical Laboratories Controlled release pharmaceutical systems
US20060134221A1 (en) * 2004-12-03 2006-06-22 Vical Incorporated Methods for producing block copolymer/amphiphilic particles
WO2006081320A2 (en) * 2005-01-27 2006-08-03 Human Genome Sciences, Inc. Pharmaceutical formulation
WO2007027819A2 (en) * 2005-08-31 2007-03-08 Abraxis Bioscience, Llc. Compositions comprising poorly water soluble pharmaceutical agents and antimicrobial agents

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
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, DOI: DOI:10.1016/S0009-2797(99)00069-1 [retrieved on 1999-05-14] *
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), pages 127-136, XP009149556, ISSN: 1516-9332 *

Also Published As

Publication number Publication date
WO2011082196A2 (en) 2011-07-07
US20110155620A1 (en) 2011-06-30

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