WO1998044948B1 - 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

Info

Publication number
WO1998044948B1
WO1998044948B1 PCT/CA1998/000325 CA9800325W WO9844948B1 WO 1998044948 B1 WO1998044948 B1 WO 1998044948B1 CA 9800325 W CA9800325 W CA 9800325W WO 9844948 B1 WO9844948 B1 WO 9844948B1
Authority
WO
WIPO (PCT)
Prior art keywords
sorbitan
immune globulin
polyoxyethylene
preparation according
surface active
Prior art date
Application number
PCT/CA1998/000325
Other languages
French (fr)
Other versions
WO1998044948A3 (en
WO1998044948A2 (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 EP98914750A priority Critical patent/EP0973549A2/en
Priority to AU69149/98A priority patent/AU6914998A/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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Biophysics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

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.

Claims

AMENDED CLAIMS[received by the International Bureau on 8 February 1999 (08.02.99); original claims 17-21 replaced by amended claims 18-22; remaining claims unchanged (4 pages)]
1. An immune globulin preparation comprising an immune globulin and at least one non-ionic surface active agent, said one or more non-ionic surface active agent(s) in a concentration sufficient to increase the serum half-life of the immune globulin.
2. The preparation according to claim 1 wherein the immune globulin is anti-Rh0D immune globulin.
3. The preparation according to claim 2 wherein the anti-
Rh0D immune globulin has an IgG purity of greater than about 95% and a monomeric protein content of greater than about 94%.
4. The preparation according to claim 3 which is aqueous.
5. The preparation according to claim 1 wherein the immune globulin is anti-c immune globulin.
6. The preparation according to claim 5 wherein the anti-c immune globulin has an IgG purity of greater than about 95% and a monomeric protein content of greater than about 94%.
7. The preparation according to claim 6 which is aqueous.
8. The preparation according to claim 1 wherein the concentration of the immune globulin is about 2 weight percent to about 10 weight percent.
9. The preparation according to claim 1 wherein the one or more non-ionic surface active agent(s) is(are) a sorbitan ester of a fatty acid. 33
10. The preparation according to claim 9 wherein the nonionic surface active agent(s) is(are) selected from the group consisting of sorbitan monolaurate, sorbitan monopalmitate, sorbitan monostearate, sorbitan tristearate, sorbitan monooleate, and sorbitan trioleate.
11. The preparation according to claim 1 wherein the one or more non-ionic surface active agent(s) is(are) a polyoxyethylene sorbitan ester of a fatty acid.
12. The preparation according to claim 11 wherein the nonionic surface active agent(s) is(are) selected from the group consisting of polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (4) sorbitan monolaurate, polyoxyethylene (20) sorbitan monopalmitate, polyoxyethylene (20) sorbitan monostearate, polyoxyethylene (4) sorbitan monostearate, polyoxyethylene (20) sorbitan tristearate, polyoxyethylene (20) sorbitan monooleate, polyoxyethylene (5) sorbitan monooleate, and polyoxyethylene (20) sorbitan trioleate.
13. The preparation according to claim 1 wherein two or more non-ionic surface active agents are selected from the group consisting of polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (4) sorbitan monolaurate, polyoxyethylene (20) sorbitan monopalmitate; polyoxyethylene (20) sorbitan monostearate, polyoxyethylene (4) sorbitan monostearate, polyoxyethylene (20) sorbitan tristearate, polyoxyethylene (20) sorbitan monooleate, polyoxyethylene (5) sorbitan monooleate, and polyoxyethylene (20) sorbitan trioleate, sorbitan monolaurate, sorbitan monopalmitate, sorbitan monostearate, sorbitan tristearate, sorbitan monooleate, and sorbitan trioleate.
14. The preparation according to claim 1 wherein the concentration of the one or more non-ionic surface active agent(s) is(are) about 0.01 weight percent to about 0.5 weight percent. 34
15. The preparation according to claim 1 wherein the aqueous immune globulin preparation is lyophilized to form a dry powder preparation.
16. An aqueous immune globulin preparation wherein the immune globulin has an increased serum half-life comprising: about 3-8% human anti-Rh0D immune globulin with an IgG purity of greater than 95% and a monomeric protein content of greater than 94%; sodium chloride at about 0.25% (w/v); very low level buffer with essentially no ionic strength; Polysorbate 80 at about 0.01% to about 0.5% (w/v); and L-glycine at about 0.1M.
17. The preparation according to claim 1 wherein the one or more non-ionic surface agents are selected from the group consisting of glyceryl monooleate; and a polyvinyl alcohol.
18. A use of an immune globulin preparation according to any one of claims 1 to 17 to increase the serum half-life of an immune globulin.
19. A use of an immune globulin preparation according to any one of claims 1 to 17 to reduce the elevation of neutrophil counts.
20. A method of increasing the serum half-life of an immune globulin comprising administering an immune globulin preparation according to claims 1 to 17 to an animal in need thereof.
21. A method of reducing the elevation of neutrophil counts in a recipient of immune globulin comprising administering an immune globulin preparation according to claims 1 to 17 to an animal in need thereof. O O
22. A method according to claim 20 or 21 wherein said immune globulin preparation is administered intravenously.
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
EP98914750A EP0973549A2 (en) 1997-04-07 1998-04-07 Intravenous immune globulin formulation containing a non-ionic surface active agent with improved pharmacokinetic properties
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

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 WO1998044948A3 (en) 1999-02-11
WO1998044948B1 true 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)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8846046B2 (en) 2002-10-24 2014-09-30 Abbvie Biotechnology Ltd. Low dose methods for treating disorders in which TNFα activity is detrimental
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
US8911741B2 (en) 2002-08-16 2014-12-16 Abbvie Biotechnology Ltd. Formulation of human antibodies for treating TNF-alpha associated disorders

Families Citing this family (4)

* 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
FR2853551B1 (en) 2003-04-09 2006-08-04 Lab Francais Du Fractionnement STABILIZING FORMULATION FOR IMMUNOGLOBULIN G COMPOSITIONS IN LIQUID FORM AND LYOPHILIZED FORM
KR20100014674A (en) 2007-03-29 2010-02-10 아보트 러보러터리즈 Crystalline anti-human il-12 antibodies
FR2961107B1 (en) * 2010-06-15 2012-07-27 Lab Francais Du Fractionnement HUMAN IMMUNOGLOBULIN COMPOSITION STABILIZED

Family Cites Families (9)

* 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
US4396608A (en) * 1981-08-24 1983-08-02 Cutter Laboratories Intravenously injectable immune serum globulin
JP2547556B2 (en) * 1987-02-06 1996-10-23 株式会社 ミドリ十字 Liquid formulation of r-globulin
ATE65410T1 (en) * 1987-11-27 1991-08-15 Akzo Nv STABILIZATION OF ANTIBODIES.
JPH0778025B2 (en) 1990-03-20 1995-08-23 日本赤十字社 Method for producing immunoglobulin G
AU7345094A (en) * 1993-07-01 1995-01-24 Unilever Plc Oral compositions
FR2708467B1 (en) 1993-07-30 1995-10-20 Pasteur Merieux Serums Vacc Stabilized immunoglobulin preparations and process for their preparation.
CA2151409C (en) * 1995-05-05 2000-08-15 Juan Carlos Rodriguez Formulation for stabilizing human immunoglobulins
US6686191B1 (en) * 1995-09-22 2004-02-03 Bayer Healthcare Llc Preparation of virally inactivated intravenously injectable immune serum globulin

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8940305B2 (en) 2002-08-16 2015-01-27 Abbvie Biotechnology Ltd. Formulation of human antibodies for treating TNF-α associated disorders
US9220781B2 (en) 2002-08-16 2015-12-29 Abbvie Biotechnology Ltd Formulation of human antibodies for treating TNF-alpha associated disorders
US8911741B2 (en) 2002-08-16 2014-12-16 Abbvie Biotechnology Ltd. Formulation of human antibodies for treating TNF-alpha associated disorders
US8916158B2 (en) 2002-08-16 2014-12-23 Abbvie Biotechnology Ltd. Formulation of human antibodies for treating TNF-α associated disorders
US8916157B2 (en) 2002-08-16 2014-12-23 Abbvie Biotechnology Ltd. Formulation of human antibodies for treating TNF-α associated disorders
US8932591B2 (en) 2002-08-16 2015-01-13 Abbvie Biotechnology Ltd. Formulation of human antibodies for treating TNF-α associated disorders
US9327032B2 (en) 2002-08-16 2016-05-03 Abbvie Biotechnology Ltd Formulation of human antibodies for treating TNF-alpha associated disorders
US9114166B2 (en) 2002-08-16 2015-08-25 Abbvie Biotechnology Ltd. Formulation of human antibodies for treating TNF-α associated disorders
US9302011B2 (en) 2002-08-16 2016-04-05 Abbvie Biotechnology Ltd Formulation of human antibodies for treating TNF-α associated disorders
US9272042B2 (en) 2002-08-16 2016-03-01 Abbvie Biotechnology Ltd Formulation of human antibodies for treating TNF-alpha associated disorders
US9272041B2 (en) 2002-08-16 2016-03-01 Abbvie Biotechnology Ltd Formulation of human antibodies for treating TNF-alpha associated disorders
US9289497B2 (en) 2002-08-16 2016-03-22 Abbvie Biotechnology Ltd Formulation of human antibodies for treating TNF-alpha associated disorders
US9295725B2 (en) 2002-08-16 2016-03-29 Abbvie Biotechnology Ltd Formulation of human antibodies for treating TNF-alpha associated disorders
US8846046B2 (en) 2002-10-24 2014-09-30 Abbvie Biotechnology Ltd. Low dose methods for treating disorders in which TNFα activity is detrimental
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same

Also Published As

Publication number Publication date
EP0973549A2 (en) 2000-01-26
WO1998044948A3 (en) 1999-02-11
AU6914998A (en) 1998-10-30
WO1998044948A2 (en) 1998-10-15

Similar Documents

Publication Publication Date Title
JP2888969B2 (en) Stabilized hydrophobic protein preparation
JP3827713B2 (en) Pharmaceutical preparation comprising coagulation factor VIII
JP5946448B2 (en) Sustained human growth hormone conjugate liquid formulation
US4690952A (en) Pharmaceutical compositions for nasal administration comprising calcitonin and an absorption-promoting substance
JP5753692B2 (en) Protein preparation
TW400234B (en) Pharmaceutical compositions for subcutaneous, intramuscular or intradermal administration containing coagulation factor VIII or factor IX and additive
EP1808438A3 (en) Purification and stabilization of peptide and proteins in pharmaceutical agents
WO2000051629A1 (en) Preparations stabilized over long time
KR20110085917A (en) Liquid formulations for long-acting g-csf conjugate
Nakada et al. The effect of additives on the oral mucosal absorption of human calcitonin in rats
WO1998044948B1 (en) Intravenous immune globulin formulation containing a non-ionic surface active agent with improved pharmacokinetic properties
JP2001501619A (en) Pharmaceutical composition containing mpl ligand
CN111375057A (en) Pharmaceutical formulation comprising anti-Her 2 monoclonal antibody
US5491150A (en) Supplementary therpeutic agents for the treatment of immunodeficiency syndrome
JP3047948B2 (en) Composition for nasal administration of peptides
WO2008066322A1 (en) A stable hsa-free and antioxidant-free pharmaceutical composition comprising interferon-beta
JPH09255586A (en) Biologically active peptide composition for nasal absorption
EP2470197A1 (en) Compositions for absorption and sustained action of leptin-related peptides
CN115518151A (en) Human immunodeficiency virus neutralizing antibody preparation and application thereof
JPH05186343A (en) Liquid agent containing vitamin a and tocopherols
JP2535329B2 (en) Antibacterial agent
JPH0651641B2 (en) Gamma interferon composition
WO1999045953A1 (en) Heparin cofactor ii-containing compositions and method for stabilizing the same
EP3744319A1 (en) A stable lyophilized formulation for hybrid fc fused g-csf
KR20230035600A (en) Low-Dose Pharmaceutical Compositions of GHRH Analogues and Their Uses

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A2

Designated state(s): AL AM AT AU AZ BA BB BG BR BY CA CH CN CU CZ DE DK EE ES FI GB GE GH GM GW HU ID IL IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MD MG MK MN MW MX NO NZ PL PT RO RU SD SE SG SI SK SL TJ TM TR TT UA UG US UZ VN YU ZW

AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): GH GM KE LS MW SD SZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE BF BJ CF CG CI CM GA GN ML MR NE SN TD TG

DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
121 Ep: the epo has been informed by wipo that ep was designated in this application
AK Designated states

Kind code of ref document: B1

Designated state(s): AL AM AT AU AZ BA BB BG BR BY CA CH CN CU CZ DE DK EE ES FI GB GE GH GM GW HU ID IL IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MD MG MK MN MW MX NO NZ PL PT RO RU SD SE SG SI SK SL TJ TM TR TT UA UG US UZ VN YU ZW

AL Designated countries for regional patents

Kind code of ref document: B1

Designated state(s): GH GM KE LS MW SD SZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE BF BJ CF CG CI CM GA GN ML MR NE SN TD TG

WWE Wipo information: entry into national phase

Ref document number: 1998914750

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 09402446

Country of ref document: US

WWP Wipo information: published in national office

Ref document number: 1998914750

Country of ref document: EP

REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

NENP Non-entry into the national phase in:

Ref country code: JP

Ref document number: 1998542188

Format of ref document f/p: F

NENP Non-entry into the national phase in:

Ref country code: CA

WWW Wipo information: withdrawn in national office

Ref document number: 1998914750

Country of ref document: EP