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WO2006081320A3 - Pharmaceutical formulation - Google Patents

Pharmaceutical formulation Download PDF

Info

Publication number
WO2006081320A3
WO2006081320A3 PCT/US2006/002696 US2006002696W WO2006081320A3 WO 2006081320 A3 WO2006081320 A3 WO 2006081320A3 US 2006002696 W US2006002696 W US 2006002696W WO 2006081320 A3 WO2006081320 A3 WO 2006081320A3
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical formulation
temperature
glass transition
collapse
formulation
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2006/002696
Other languages
French (fr)
Other versions
WO2006081320A2 (en
Inventor
James D Colandene
Thomas M Spitznagel
Alma Creagh
John S Vrettos
Linda M Maldonado
Melissa D Perkins
Adeola O Grillo
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Human Genome Sciences Inc
Original Assignee
Human Genome Sciences Inc
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 Human Genome Sciences Inc filed Critical Human Genome Sciences Inc
Publication of WO2006081320A2 publication Critical patent/WO2006081320A2/en
Publication of WO2006081320A3 publication Critical patent/WO2006081320A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61K47/06—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
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)

Abstract

Lyophilization processes for a pharmaceutical formulation are provided in which the temperature of the product during the primary drying stage is above the glass transition temperature (Tg') of the formulation or above the glass transition temperature (Tg') and the collapse onset temperature (TO), but below the collapse temperature (Tc). A pharmaceutical formulation that includes a protein concentration of at least about 20 mg/mL is also provided. Additionally, a pharmaceutical formulation that includes little or no crystalline bulking agent and/or at least about 2% w/v disaccharide.
PCT/US2006/002696 2005-01-27 2006-01-26 Pharmaceutical formulation Ceased WO2006081320A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US64701105P 2005-01-27 2005-01-27
US60/647,011 2005-01-27

Publications (2)

Publication Number Publication Date
WO2006081320A2 WO2006081320A2 (en) 2006-08-03
WO2006081320A3 true WO2006081320A3 (en) 2006-10-12

Family

ID=36741034

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/002696 Ceased WO2006081320A2 (en) 2005-01-27 2006-01-26 Pharmaceutical formulation

Country Status (1)

Country Link
WO (1) WO2006081320A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2729972C (en) 2008-08-05 2018-11-20 Wyeth Llc Lyophilization above collapse
US20110155620A1 (en) * 2009-12-30 2011-06-30 Baxter International Inc. Rapid reconstitution for lyophilized-pharmaceutical suspensions
EP2916090A1 (en) * 2014-02-04 2015-09-09 Project Pharmaceutics GmbH Flowable lyophilisate
GB2542391A (en) * 2015-09-17 2017-03-22 Annexin Pharmaceuticals Ab Process of manufacture
EP4210679A1 (en) * 2020-09-14 2023-07-19 Amgen Inc. Method of making lyophilized protein formulations

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4565651A (en) * 1982-10-07 1986-01-21 The Green Cross Corporation Method of lyophilizing cold insoluble globulin
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US20010014326A1 (en) * 1995-07-27 2001-08-16 Genentech, Inc. Protein formulation
US20040180827A1 (en) * 2003-01-08 2004-09-16 Chiron Corporation Stabilized lyophilized compositions comprising tissue factor pathway inhibitor or tissue factor pathway inhibitor variants

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4565651A (en) * 1982-10-07 1986-01-21 The Green Cross Corporation Method of lyophilizing cold insoluble globulin
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US20010014326A1 (en) * 1995-07-27 2001-08-16 Genentech, Inc. Protein formulation
US20040180827A1 (en) * 2003-01-08 2004-09-16 Chiron Corporation Stabilized lyophilized compositions comprising tissue factor pathway inhibitor or tissue factor pathway inhibitor variants

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
BORQUE L. ET AL.: "Addition of Sucrose Avoids Effect of Lyophilization on Determinations of Lipoprotein(a) in Serum", CLINICAL CHEMISTRY, vol. 39, no. 3, 1993, pages 553 - 554, XP003000311 *
FONSECA F. ET AL.: "Collapse Temperature of Freeze-Dried Lactobacillus bulgaricus Suspensions and Protective Media", BIOTECHNOLOGY PROGRESS, vol. 20, no. 1, 2004, pages 229 - 238, XP003000312 *
RAMBHATLA S. ET AL.: "Cake Shrinkage During Freeze Drying: A Combined Experimental and Theoretical Study", PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, vol. 1, 2005, pages 33 - 40, XP008068192 *
SGOUTAS D.S. ET AL.: "Effect of Lyophilization on Determination of Lipoprotein(a) in Serum", CLINICAL CHEMISTRY, vol. 38, no. 7, 1992, pages 1355 - 1360, XP003000310 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
US9085619B2 (en) 2007-11-30 2015-07-21 Abbvie Biotechnology Ltd. Anti-TNF antibody formulations

Also Published As

Publication number Publication date
WO2006081320A2 (en) 2006-08-03

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121 Ep: the epo has been informed by wipo that ep was designated in this application
122 Ep: pct application non-entry in european phase

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