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WO2008144365A3 - Method for making dry powder compositions containing ds-rna based on supercritical fluid technology - Google Patents

Method for making dry powder compositions containing ds-rna based on supercritical fluid technology Download PDF

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Publication number
WO2008144365A3
WO2008144365A3 PCT/US2008/063655 US2008063655W WO2008144365A3 WO 2008144365 A3 WO2008144365 A3 WO 2008144365A3 US 2008063655 W US2008063655 W US 2008063655W WO 2008144365 A3 WO2008144365 A3 WO 2008144365A3
Authority
WO
WIPO (PCT)
Prior art keywords
supercritical fluid
powder compositions
dry powder
compositions containing
fluid technology
Prior art date
Application number
PCT/US2008/063655
Other languages
French (fr)
Other versions
WO2008144365A2 (en
Inventor
Andrew Geall
Sushma Kommareddy
Gerhard Muhrer
Vishal Saxena
Ranjit Thakur
Original Assignee
Novartis Ag
Andrew Geall
Sushma Kommareddy
Gerhard Muhrer
Vishal Saxena
Ranjit Thakur
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
Application filed by Novartis Ag, Andrew Geall, Sushma Kommareddy, Gerhard Muhrer, Vishal Saxena, Ranjit Thakur filed Critical Novartis Ag
Publication of WO2008144365A2 publication Critical patent/WO2008144365A2/en
Publication of WO2008144365A3 publication Critical patent/WO2008144365A3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/111—General methods applicable to biologically active non-coding nucleic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2310/00—Structure or type of the nucleic acid
    • C12N2310/10—Type of nucleic acid
    • C12N2310/14—Type of nucleic acid interfering nucleic acids [NA]
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2320/00—Applications; Uses
    • C12N2320/30—Special therapeutic applications
    • C12N2320/32—Special delivery means, e.g. tissue-specific

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Plant Pathology (AREA)
  • Biophysics (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

A manufacturing process for making powder compositions comprising double stranded nucleic acid molecules. The inventive process may be used to form particles from a supercritical fluid based antisolvent process that can be subsequently used for pharmaceutical administration, especially parenteral administration.
PCT/US2008/063655 2007-05-17 2008-05-15 Method for making dry powder compositions containing ds-rna based on supercritical fluid technology WO2008144365A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US93850407P 2007-05-17 2007-05-17
US60/938,504 2007-05-17

Publications (2)

Publication Number Publication Date
WO2008144365A2 WO2008144365A2 (en) 2008-11-27
WO2008144365A3 true WO2008144365A3 (en) 2009-02-19

Family

ID=39651059

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2008/063655 WO2008144365A2 (en) 2007-05-17 2008-05-15 Method for making dry powder compositions containing ds-rna based on supercritical fluid technology

Country Status (1)

Country Link
WO (1) WO2008144365A2 (en)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8680069B2 (en) 2011-12-16 2014-03-25 Moderna Therapeutics, Inc. Modified polynucleotides for the production of G-CSF
US8710200B2 (en) 2011-03-31 2014-04-29 Moderna Therapeutics, Inc. Engineered nucleic acids encoding a modified erythropoietin and their expression
US9095552B2 (en) 2012-04-02 2015-08-04 Moderna Therapeutics, Inc. Modified polynucleotides encoding copper metabolism (MURR1) domain containing 1
US9220755B2 (en) 2012-04-02 2015-12-29 Moderna Therapeutics, Inc. Modified polynucleotides for the production of proteins associated with blood and lymphatic disorders
US9428535B2 (en) 2011-10-03 2016-08-30 Moderna Therapeutics, Inc. Modified nucleosides, nucleotides, and nucleic acids, and uses thereof
US9447164B2 (en) 2010-08-06 2016-09-20 Moderna Therapeutics, Inc. Engineered nucleic acids and methods of use thereof

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103429606A (en) 2010-10-01 2013-12-04 现代治疗公司 Engineered nucleic acids and methods of use thereof
US9464124B2 (en) 2011-09-12 2016-10-11 Moderna Therapeutics, Inc. Engineered nucleic acids and methods of use thereof
US9283287B2 (en) 2012-04-02 2016-03-15 Moderna Therapeutics, Inc. Modified polynucleotides for the production of nuclear proteins
US9572897B2 (en) 2012-04-02 2017-02-21 Modernatx, Inc. Modified polynucleotides for the production of cytoplasmic and cytoskeletal proteins
SMT202200337T1 (en) 2012-11-26 2022-09-14 Modernatx Inc Terminally modified rna
US8980864B2 (en) 2013-03-15 2015-03-17 Moderna Therapeutics, Inc. Compositions and methods of altering cholesterol levels
EP3052106A4 (en) 2013-09-30 2017-07-19 ModernaTX, Inc. Polynucleotides encoding immune modulating polypeptides
CA2926218A1 (en) 2013-10-03 2015-04-09 Moderna Therapeutics, Inc. Polynucleotides encoding low density lipoprotein receptor

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6630121B1 (en) * 1999-06-09 2003-10-07 The Regents Of The University Of Colorado Supercritical fluid-assisted nebulization and bubble drying
WO2004066806A2 (en) * 2003-01-24 2004-08-12 The Regents Of The University Of California Aerosol device to deliver bioactive agent
US6893664B1 (en) * 1996-06-17 2005-05-17 Powderject Research Limited Particle delivery techniques
US20050181059A1 (en) * 2003-09-30 2005-08-18 Spherics, Inc. Nanoparticulate therapeutic biologically active agents
WO2005089718A2 (en) * 2004-03-23 2005-09-29 Novartis Ag Pharmaceutical compositions
WO2006105361A2 (en) * 2005-03-31 2006-10-05 Calando Pharmaceuticals, Inc. Inhibitors of ribonucleotide reductase subunit 2 and uses thereof
WO2007072106A1 (en) * 2005-12-22 2007-06-28 Institut National De La Sante Et De La Recherche Medicale (Inserm) Method for preparing particles from an emulsion in supercritical or liquid co2
WO2007080127A2 (en) * 2006-01-12 2007-07-19 Devgen N.V. Dsrna as insect control agent
WO2008021451A2 (en) * 2006-08-14 2008-02-21 Aktiv-Dry Llc Human-powered dry powder inhaler and dry powder inhaler compositions

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6893664B1 (en) * 1996-06-17 2005-05-17 Powderject Research Limited Particle delivery techniques
US6630121B1 (en) * 1999-06-09 2003-10-07 The Regents Of The University Of Colorado Supercritical fluid-assisted nebulization and bubble drying
WO2004066806A2 (en) * 2003-01-24 2004-08-12 The Regents Of The University Of California Aerosol device to deliver bioactive agent
US20050181059A1 (en) * 2003-09-30 2005-08-18 Spherics, Inc. Nanoparticulate therapeutic biologically active agents
WO2005089718A2 (en) * 2004-03-23 2005-09-29 Novartis Ag Pharmaceutical compositions
WO2006105361A2 (en) * 2005-03-31 2006-10-05 Calando Pharmaceuticals, Inc. Inhibitors of ribonucleotide reductase subunit 2 and uses thereof
WO2007072106A1 (en) * 2005-12-22 2007-06-28 Institut National De La Sante Et De La Recherche Medicale (Inserm) Method for preparing particles from an emulsion in supercritical or liquid co2
WO2007080127A2 (en) * 2006-01-12 2007-07-19 Devgen N.V. Dsrna as insect control agent
WO2008021451A2 (en) * 2006-08-14 2008-02-21 Aktiv-Dry Llc Human-powered dry powder inhaler and dry powder inhaler compositions

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
JOVANOVIC N ET AL: "Stabilization of proteins in dry powder formulations using supercritical fluid technology", PHARMACEUTICAL RESEARCH, NEW YORK, NY, US, vol. 21, no. 11, 1 November 2004 (2004-11-01), pages 1955 - 1969, XP002404648, ISSN: 0724-8741 *
JUNG J ET AL: "Particle design using supercritical fluids: Literature and patent survey", JOURNAL OF SUPERCRITICAL FLUIDS, PRA PRESS, US, vol. 20, no. 3, 1 August 2001 (2001-08-01), pages 179 - 219, XP004735157, ISSN: 0896-8446 *
OKAMOTO H ET AL: "Stability of chitosan-pDNA complex powder prepared by supercritical carbon dioxide process", INTERNATIONAL JOURNAL OF PHARMACEUTICS, ELSEVIER BV, NL, vol. 290, no. 1-2, 16 February 2005 (2005-02-16), pages 73 - 81, XP004967392, ISSN: 0378-5173 *

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9447164B2 (en) 2010-08-06 2016-09-20 Moderna Therapeutics, Inc. Engineered nucleic acids and methods of use thereof
US8710200B2 (en) 2011-03-31 2014-04-29 Moderna Therapeutics, Inc. Engineered nucleic acids encoding a modified erythropoietin and their expression
US9428535B2 (en) 2011-10-03 2016-08-30 Moderna Therapeutics, Inc. Modified nucleosides, nucleotides, and nucleic acids, and uses thereof
US9271996B2 (en) 2011-12-16 2016-03-01 Moderna Therapeutics, Inc. Formulation and delivery of PLGA microspheres
US9186372B2 (en) 2011-12-16 2015-11-17 Moderna Therapeutics, Inc. Split dose administration
US8680069B2 (en) 2011-12-16 2014-03-25 Moderna Therapeutics, Inc. Modified polynucleotides for the production of G-CSF
US9295689B2 (en) 2011-12-16 2016-03-29 Moderna Therapeutics, Inc. Formulation and delivery of PLGA microspheres
US8754062B2 (en) 2011-12-16 2014-06-17 Moderna Therapeutics, Inc. DLIN-KC2-DMA lipid nanoparticle delivery of modified polynucleotides
US9114113B2 (en) 2012-04-02 2015-08-25 Moderna Therapeutics, Inc. Modified polynucleotides encoding citeD4
US9149506B2 (en) 2012-04-02 2015-10-06 Moderna Therapeutics, Inc. Modified polynucleotides encoding septin-4
US9192651B2 (en) 2012-04-02 2015-11-24 Moderna Therapeutics, Inc. Modified polynucleotides for the production of secreted proteins
US9220755B2 (en) 2012-04-02 2015-12-29 Moderna Therapeutics, Inc. Modified polynucleotides for the production of proteins associated with blood and lymphatic disorders
US9301993B2 (en) 2012-04-02 2016-04-05 Moderna Therapeutics, Inc. Modified polynucleotides encoding apoptosis inducing factor 1
US9095552B2 (en) 2012-04-02 2015-08-04 Moderna Therapeutics, Inc. Modified polynucleotides encoding copper metabolism (MURR1) domain containing 1

Also Published As

Publication number Publication date
WO2008144365A2 (en) 2008-11-27

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