WO1998044948A3 - Intravenous immune globulin formulation containing a non-ionic surface active agent with improved pharmacokinetic properties - Google Patents

Intravenous immune globulin formulation containing a non-ionic surface active agent with improved pharmacokinetic properties Download PDF

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Publication number
WO1998044948A3
WO1998044948A3 PCT/CA1998/000325 CA9800325W WO9844948A3 WO 1998044948 A3 WO1998044948 A3 WO 1998044948A3 CA 9800325 W CA9800325 W CA 9800325W WO 9844948 A3 WO9844948 A3 WO 9844948A3
Authority
WO
WIPO (PCT)
Prior art keywords
immune globulin
active agent
surface active
ionic surface
formulation containing
Prior art date
Application number
PCT/CA1998/000325
Other languages
French (fr)
Other versions
WO1998044948A2 (en
WO1998044948B1 (en
Inventor
Hugh W Price
B Michael R Woloski
Original Assignee
Cangene Corp
Hugh W Price
B Michael R Woloski
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 Cangene Corp, Hugh W Price, B Michael R Woloski filed Critical Cangene Corp
Priority to AU69149/98A priority Critical patent/AU6914998A/en
Priority to EP98914750A priority patent/EP0973549A2/en
Publication of WO1998044948A2 publication Critical patent/WO1998044948A2/en
Publication of WO1998044948A3 publication Critical patent/WO1998044948A3/en
Publication of WO1998044948B1 publication Critical patent/WO1998044948B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/34—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood group antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Abstract

Addition of a non-ionic surface active agent to an immune globulin formulation extends the serum half-life of relatively pure and non-aggregated immune globulin suitable for intravenous injectionor infusion. The non-ionic surface active agent may be a sorbitan ester or a polyoxyethylene sorbitan ester of a fatty acid. Formulations of the present invention is therapeutically advantageous over conventional formulations in that an extended serum half-life of the immune globulin improves its therapeutic effectiveness, reduces the frequency of drug administration and/or lowers the therapeutic effective dosage required and cost of treatment.
PCT/CA1998/000325 1997-04-07 1998-04-07 Intravenous immune globulin formulation containing a non-ionic surface active agent with improved pharmacokinetic properties WO1998044948A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU69149/98A AU6914998A (en) 1997-04-07 1998-04-07 Intravenous immune globulin formulation containing a non-ionic surface active agent with improved pharmacokinetic properties
EP98914750A EP0973549A2 (en) 1997-04-07 1998-04-07 Intravenous immune globulin formulation containing a non-ionic surface active agent with improved pharmacokinetic properties

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US4192197P 1997-04-07 1997-04-07
US60/041,921 1997-04-07

Publications (3)

Publication Number Publication Date
WO1998044948A2 WO1998044948A2 (en) 1998-10-15
WO1998044948A3 true WO1998044948A3 (en) 1999-02-11
WO1998044948B1 WO1998044948B1 (en) 1999-04-01

Family

ID=21919058

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CA1998/000325 WO1998044948A2 (en) 1997-04-07 1998-04-07 Intravenous immune globulin formulation containing a non-ionic surface active agent with improved pharmacokinetic properties

Country Status (3)

Country Link
EP (1) EP0973549A2 (en)
AU (1) AU6914998A (en)
WO (1) WO1998044948A2 (en)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7914801B1 (en) * 2002-03-21 2011-03-29 The United States Of America As Represented By The Secretary Of Agriculture Metabolizable oil emulsion adjuvants and vaccines for enhancing immuno-properties of antibodies and their subpopulations
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
MY150740A (en) 2002-10-24 2014-02-28 Abbvie Biotechnology Ltd Low dose methods for treating disorders in which tnf? activity is detrimental
FR2853551B1 (en) * 2003-04-09 2006-08-04 Lab Francais Du Fractionnement STABILIZING FORMULATION FOR IMMUNOGLOBULIN G COMPOSITIONS IN LIQUID FORM AND LYOPHILIZED FORM
NZ580379A (en) 2007-03-29 2012-10-26 Abbott Lab Crystalline anti-human il-12 antibodies
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
FR2961107B1 (en) * 2010-06-15 2012-07-27 Lab Francais Du Fractionnement HUMAN IMMUNOGLOBULIN COMPOSITION STABILIZED

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0073371A2 (en) * 1981-08-24 1983-03-09 Miles Laboratories, Inc. Intravenously injectable immune serum globulin and method of preparing same
EP0278422A2 (en) * 1987-02-06 1988-08-17 Green Cross Corporation y-Globulin injectable solutions
EP0318081A1 (en) * 1987-11-27 1989-05-31 Akzo N.V. Stabilization of antibodies
WO1995001155A1 (en) * 1993-07-01 1995-01-12 Unilever N.V. Oral compositions
CA2151409A1 (en) * 1995-05-05 1996-11-06 Juan Carlos Rodriguez Formulation for stabilizing human immunoglobulins
EP0764447A2 (en) * 1995-09-22 1997-03-26 Bayer Corporation Preparation of virally inactivated intravenously injectable immune serum globulin

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA1064396A (en) 1975-02-18 1979-10-16 Myer L. Coval Fractional precipitation of gamma globulin with polyethylene glycol
JPH0778025B2 (en) 1990-03-20 1995-08-23 日本赤十字社 Method for producing immunoglobulin G
FR2708467B1 (en) 1993-07-30 1995-10-20 Pasteur Merieux Serums Vacc Stabilized immunoglobulin preparations and process for their preparation.

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0073371A2 (en) * 1981-08-24 1983-03-09 Miles Laboratories, Inc. Intravenously injectable immune serum globulin and method of preparing same
EP0278422A2 (en) * 1987-02-06 1988-08-17 Green Cross Corporation y-Globulin injectable solutions
EP0318081A1 (en) * 1987-11-27 1989-05-31 Akzo N.V. Stabilization of antibodies
WO1995001155A1 (en) * 1993-07-01 1995-01-12 Unilever N.V. Oral compositions
CA2151409A1 (en) * 1995-05-05 1996-11-06 Juan Carlos Rodriguez Formulation for stabilizing human immunoglobulins
EP0764447A2 (en) * 1995-09-22 1997-03-26 Bayer Corporation Preparation of virally inactivated intravenously injectable immune serum globulin

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
KALEVI J.A. ET AL.: "Modulation of antibody kinetics by the cell membrane active agent tween 80 in vivo", ANTICANCER RESEARCH, vol. 16, no. 6b, 1996, pages 3542 - 3550, XP002085447 *
See also references of EP0973549A2 *

Also Published As

Publication number Publication date
WO1998044948A2 (en) 1998-10-15
AU6914998A (en) 1998-10-30
WO1998044948B1 (en) 1999-04-01
EP0973549A2 (en) 2000-01-26

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