WO2006079722A3 - Compositions pour la lyophilisation de proteines - Google Patents

Compositions pour la lyophilisation de proteines Download PDF

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Publication number
WO2006079722A3
WO2006079722A3 PCT/FR2006/000177 FR2006000177W WO2006079722A3 WO 2006079722 A3 WO2006079722 A3 WO 2006079722A3 FR 2006000177 W FR2006000177 W FR 2006000177W WO 2006079722 A3 WO2006079722 A3 WO 2006079722A3
Authority
WO
WIPO (PCT)
Prior art keywords
compositions
freeze
proteins
drying
drying proteins
Prior art date
Application number
PCT/FR2006/000177
Other languages
English (en)
Other versions
WO2006079722A2 (fr
Inventor
Stephanie Passot
Fernanda Fonseca
Michele Marin
Original Assignee
Agronomique Inst Nat Rech
Stephanie Passot
Fernanda Fonseca
Michele Marin
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 Agronomique Inst Nat Rech, Stephanie Passot, Fernanda Fonseca, Michele Marin filed Critical Agronomique Inst Nat Rech
Priority to EP06709174A priority Critical patent/EP1843753A2/fr
Publication of WO2006079722A2 publication Critical patent/WO2006079722A2/fr
Publication of WO2006079722A3 publication Critical patent/WO2006079722A3/fr

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
    • A61K9/19—Particulate 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La présente invention a pour objet l'utilisation de compositions liquides dans le cadre de la mise en oeuvre du procédé de lyophilisation sur des protéines, en vue de la stabilisation de ces protéines, lesdites compositions comprenant : un agent de charge ayant une température d'effondrement comprise entre -180C et 00C, un agent stabilisateur, une solution tampon, et, le cas échéant, un agent surfactant non ionique.
PCT/FR2006/000177 2005-01-26 2006-01-26 Compositions pour la lyophilisation de proteines WO2006079722A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP06709174A EP1843753A2 (fr) 2005-01-26 2006-01-26 Compositions pour la lyophilisation de proteines

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR05/00791 2005-01-26
FR0500791A FR2881139A1 (fr) 2005-01-26 2005-01-26 Composition pour la lyophilisation de proteines

Publications (2)

Publication Number Publication Date
WO2006079722A2 WO2006079722A2 (fr) 2006-08-03
WO2006079722A3 true WO2006079722A3 (fr) 2006-10-19

Family

ID=34954854

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/FR2006/000177 WO2006079722A2 (fr) 2005-01-26 2006-01-26 Compositions pour la lyophilisation de proteines

Country Status (3)

Country Link
EP (1) EP1843753A2 (fr)
FR (1) FR2881139A1 (fr)
WO (1) WO2006079722A2 (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2699435A1 (fr) * 2007-09-14 2009-03-19 Sanofi Pasteur Biologics Co. Compositions pharmaceutiques contenant les anatoxines a et b de clostridium difficile
AU2015201233B2 (en) * 2007-09-14 2017-02-23 Sanofi Pasteur Biologics, Llc Pharmaceutical compositions containing clostridium difficile toxoids a and b
EP2248518B1 (fr) 2009-04-17 2013-01-16 Merz Pharma GmbH & Co. KGaA Formulation pour stabiliser des protéines, des peptides et ses mélanges.
FR2954349A1 (fr) 2009-12-22 2011-06-24 Agronomique Inst Nat Rech Sulfatase modifiant selectivement les glycosaminoglycanes
ES2639617T3 (es) 2010-10-12 2017-10-27 Merz Pharma Gmbh & Co. Kgaa Formulación adecuada para estabilizar proteínas, que carece de excipientes de mamíferos

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4343897A (en) * 1979-02-05 1982-08-10 Boehringer Mannheim Gmbh Reagent for the determination of lipase and process for preparing same
EP0391444A2 (fr) * 1989-04-07 1990-10-10 Syntex (U.S.A.) Inc. Formulation d'interleukin-1
WO1999030688A1 (fr) * 1997-12-13 1999-06-24 Anthony Auffret Procedes de lyophilisation de solutions
WO2000048635A1 (fr) * 1999-02-22 2000-08-24 Baxter International Inc. Nouvelles formulations de facteur viii sans albumine
WO2001039836A1 (fr) * 1999-12-01 2001-06-07 Natco Pharma Limited Composition pharmaceutique lyophilisee a action rapide s'administrant par voie orale utilisee pour traiter la migraine
WO2003087327A2 (fr) * 2002-04-11 2003-10-23 Medimmune Vaccines, Inc. Conservation de matieres bio-actives au moyen de mousse lyophilisee
US20040002451A1 (en) * 2002-06-20 2004-01-01 Bruce Kerwin Compositions of pegylated soluble tumor necrosis factor receptors and methods of preparing
US20040248778A1 (en) * 2001-10-05 2004-12-09 Oliver Gloger Stable galenic freeze-dried pharmaceutical preparation of recombined carbohydrate-binding polypeptides

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4343897A (en) * 1979-02-05 1982-08-10 Boehringer Mannheim Gmbh Reagent for the determination of lipase and process for preparing same
EP0391444A2 (fr) * 1989-04-07 1990-10-10 Syntex (U.S.A.) Inc. Formulation d'interleukin-1
WO1999030688A1 (fr) * 1997-12-13 1999-06-24 Anthony Auffret Procedes de lyophilisation de solutions
WO2000048635A1 (fr) * 1999-02-22 2000-08-24 Baxter International Inc. Nouvelles formulations de facteur viii sans albumine
WO2001039836A1 (fr) * 1999-12-01 2001-06-07 Natco Pharma Limited Composition pharmaceutique lyophilisee a action rapide s'administrant par voie orale utilisee pour traiter la migraine
US20040248778A1 (en) * 2001-10-05 2004-12-09 Oliver Gloger Stable galenic freeze-dried pharmaceutical preparation of recombined carbohydrate-binding polypeptides
WO2003087327A2 (fr) * 2002-04-11 2003-10-23 Medimmune Vaccines, Inc. Conservation de matieres bio-actives au moyen de mousse lyophilisee
US20040002451A1 (en) * 2002-06-20 2004-01-01 Bruce Kerwin Compositions of pegylated soluble tumor necrosis factor receptors and methods of preparing

Non-Patent Citations (7)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "Tris(hydroxymethyl)aminomethane hydrochloride", INTERNET ATICLE, XP002344501, Retrieved from the Internet <URL:http://www.chemexper.com/chemicals/supplier/cas/1185-53-1.html> [retrieved on 20050908] *
ANONYMOUS: "Tris(hydroxymethyl)aminomethane", INTERNET ARTICLE, XP002344502, Retrieved from the Internet <URL:http://www.chemexper.com/chemicals/supplier/cas/77-86-1.html> [retrieved on 20050908] *
CARPENTER JOHN F ET AL: "Rational design of stable lyophilized protein formulations: theory and practice.", PHARMACEUTICAL BIOTECHNOLOGY. 2002, vol. 13, 2002, pages 109 - 133, XP009053337, ISSN: 1078-0467 *
CHANG B S ET AL: "Use of Subambient Thermal Analysis to Optimize Protein Lyophilization", CRYOBIOLOGY, ACADEMIC PRESS INC, US, vol. 29, 1992, pages 632 - 656, XP002947696, ISSN: 0011-2240 *
NAIL S L ET AL: "FUNDAMENTALS OF FREEZE-DRYING", PHARMACEUTICAL BIOTECHNOLOGY, KLUWER, DORDRECHT, NL, vol. 14, 2002, pages 281 - 360, XP001181137, ISSN: 1078-0467 *
PASSOT S ET AL: "Physical characterisation of formulations for the development of two stable freeze-dried proteins during both dried and liquid storage", EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, ELSEVIER SCIENCE PUBLISHERS B.V., AMSTERDAM, NL, vol. 60, no. 3, August 2005 (2005-08-01), pages 335 - 348, XP004967315, ISSN: 0939-6411 *
ZENG XIAN MING ET AL: "Effects of molecular weight of polyvinylpyrrolidone on the glass transition and crystallization of co-lyophilized sucrose", INTERNATIONAL JOURNAL OF PHARMACEUTICS (KIDLINGTON), vol. 218, no. 1-2, 7 May 2001 (2001-05-07), pages 63 - 73, XP002344500, ISSN: 0378-5173 *

Also Published As

Publication number Publication date
EP1843753A2 (fr) 2007-10-17
WO2006079722A2 (fr) 2006-08-03
FR2881139A1 (fr) 2006-07-28

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