ES2052615T3 - Soluciones inyectables de gamma-globulina. - Google Patents

Soluciones inyectables de gamma-globulina.

Info

Publication number
ES2052615T3
ES2052615T3 ES88101689T ES88101689T ES2052615T3 ES 2052615 T3 ES2052615 T3 ES 2052615T3 ES 88101689 T ES88101689 T ES 88101689T ES 88101689 T ES88101689 T ES 88101689T ES 2052615 T3 ES2052615 T3 ES 2052615T3
Authority
ES
Spain
Prior art keywords
gamma
globulin
injectable solutions
increase
injectable solution
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.)
Expired - Lifetime
Application number
ES88101689T
Other languages
English (en)
Inventor
Yutaka Hirao
Kazuo Takechi
Katuhiro Uriyu
Yahiro Uemura
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.)
GC Biopharma Corp
Original Assignee
Green Cross Corp Korea
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 Green Cross Corp Korea filed Critical Green Cross Corp Korea
Application granted granted Critical
Publication of ES2052615T3 publication Critical patent/ES2052615T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

LA INVENCION SE REFIERE A UNA SOLUCION INYECTABLE POR VIA INTRAVENOSA DE GAMMA-GLOBULINA NO MODIFICADA QUIMICAMENTE, QUE TIENE ESTRUCTURA MOLECULAR COMPLETA. LA CITADA SOLUCION CONTIENE SORBITOL COMO ESTABILIZANTE Y TIENE UNA CONDUCTIVIDAD ELECTRICA BAJA Y UN PH DE ALREDEDOR DE 5,5 + - 0,2. LA SOLUCION INYECTABLE NO CAUSA INCREMENTO DE GAMMA-GLOBULINA POLIMERA, ELEVACION DEL TITULO DE ANTICOMPLEMENTOS, O EMPEORAMIENTO DE LAS ACTIVIDADES DE GAMMA-GLOBULINA, NI DURANTE LA CONSERVACION NI EN LA ADMINISTRACION A ORGANISMOS VIVOS.
ES88101689T 1987-02-06 1988-02-05 Soluciones inyectables de gamma-globulina. Expired - Lifetime ES2052615T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP62027031A JP2547556B2 (ja) 1987-02-06 1987-02-06 r−グロブリンの液状製剤

Publications (1)

Publication Number Publication Date
ES2052615T3 true ES2052615T3 (es) 1994-07-16

Family

ID=12209701

Family Applications (1)

Application Number Title Priority Date Filing Date
ES88101689T Expired - Lifetime ES2052615T3 (es) 1987-02-06 1988-02-05 Soluciones inyectables de gamma-globulina.

Country Status (7)

Country Link
US (1) US4876088A (es)
EP (1) EP0278422B1 (es)
JP (1) JP2547556B2 (es)
KR (1) KR960008653B1 (es)
CA (1) CA1331135C (es)
DE (1) DE3889938T2 (es)
ES (1) ES2052615T3 (es)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5945098A (en) * 1990-02-01 1999-08-31 Baxter International Inc. Stable intravenously-administrable immune globulin preparation
US5258177A (en) * 1991-12-10 1993-11-02 Alpha Therapeutic Corporation IgA preparation and process of making the same
JPH07238036A (ja) * 1994-02-28 1995-09-12 Green Cross Corp:The 静注用グロブリン液状組成物のグロブリン二量体増加抑制方法
ES2091161B1 (es) * 1995-04-12 1997-05-16 Grifols Grupo Sa Procedimiento para la produccion de gammaglobulina intramuscular inactivada por pasteurizacion.
US5837519A (en) * 1996-11-21 1998-11-17 Bayer Corporation Dry-heat viral inactivation under controlled moisture conditions
TW541179B (en) * 1997-03-19 2003-07-11 Green Cross Corp Process for preparing immunoglobulin preparation
AU6914998A (en) * 1997-04-07 1998-10-30 Cangene Corporation Intravenous immune globulin formulation containing a non-ionic surface active agent with improved pharmacokinetic properties
CN1149100C (zh) 1997-10-23 2004-05-12 三菱制药株式会社 可室温贮存的免疫球蛋白静脉注射制剂
UA64742C2 (uk) * 1997-12-24 2004-03-15 Альфа Терапевтик Корпорейшн СПОСІБ ОДЕРЖАННЯ РОЗЧИНУ <font face="Symbol">g</font>-ГЛОБУЛІНУ, ПРИЗНАЧЕНОГО ДЛЯ ВНУТРІШНЬОВЕННОГО ВВЕДЕННЯ, І ПРОДУКТ, ЩО ОДЕРЖУЄТЬСЯ У ЦЕЙ СПОСІБ (ВАРІАНТИ)
DK2270044T3 (en) * 1998-06-09 2015-01-26 Csl Behring Ag Liquid immunoglobulin G (IgG) product
ES2184594B1 (es) * 2001-01-17 2004-01-01 Probitas Pharma Sa Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
CN101721362B (zh) 2002-02-14 2018-07-03 中外制药株式会社 包含抗体的溶液制剂
JP2005320248A (ja) * 2002-04-22 2005-11-17 Mitsubishi Pharma Corp 免疫グロブリン製剤の製造方法
US20060104968A1 (en) 2003-03-05 2006-05-18 Halozyme, Inc. Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminogly ycanases
US20050136055A1 (en) * 2003-12-22 2005-06-23 Pfizer Inc CD40 antibody formulation and methods
EP1712240B1 (en) * 2003-12-25 2015-09-09 Kyowa Hakko Kirin Co., Ltd. Stable water-based medicinal preparation containing antibody
BRPI0611901A2 (pt) 2005-06-14 2012-08-28 Amgen, Inc composição, liofilizado, kit, e, processo para preparar uma composição
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
TWI489994B (zh) 2008-03-17 2015-07-01 Baxter Healthcare Sa 供免疫球蛋白及玻尿酸酶之皮下投藥之用的組合及方法
AR078161A1 (es) * 2009-09-11 2011-10-19 Hoffmann La Roche Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento.
HUE028832T2 (en) * 2009-09-17 2017-01-30 Baxalta Inc Stable co-formulation of hyaluronidase and immunoglobulin, as well as a process for its preparation
ES2381828B1 (es) 2012-03-20 2012-11-16 Grifols, S.A. PROCEDIMIENTO PARA OBTENER UNA COMPOSICION DE IgG MEDIANTE TRATAMIENTO TERMICO
PT3528787T (pt) 2016-10-21 2026-03-11 Amgen Inc Formulações farmacêuticas e métodos para produzir as mesmas

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5840532B2 (ja) * 1975-04-08 1983-09-06 カブシキガイシヤ ミドリジユウジ Iga オヨビ igm ノネツアンテイカホウ
JPS553721A (en) * 1978-06-21 1980-01-11 Morinaga Milk Ind Co Ltd Production of powder of colostrum
US4440679A (en) * 1980-03-05 1984-04-03 Cutter Laboratories, Inc. Pasteurized therapeutically active protein compositions
EP0035204B2 (en) * 1980-03-05 1991-05-22 Miles Inc. Pasteurized therapeutically active protein compositions
US4477432A (en) * 1981-05-01 1984-10-16 Cutter Laboratories, Inc. Oral immune globulin
US4396608A (en) * 1981-08-24 1983-08-02 Cutter Laboratories Intravenously injectable immune serum globulin
US4412990A (en) * 1982-07-02 1983-11-01 Cutter Laboratories, Inc. Composition having enhanced opsonic activity
US4439421A (en) * 1982-08-30 1984-03-27 Baxter Travenol Laboratories, Inc. Stabilized gamma globulin concentrate
JPH0669961B2 (ja) * 1984-09-25 1994-09-07 株式会社ミドリ十字 免疫グロブリンの加熱処理方法
JPH07103045B2 (ja) * 1986-07-09 1995-11-08 株式会社ミドリ十字 非化学修飾γ−グロブリンの加熱処理方法
CA1310267C (en) * 1986-07-09 1992-11-17 Yutaka Hirao Process for heat treating chemically unmodified _-globulin

Also Published As

Publication number Publication date
CA1331135C (en) 1994-08-02
JP2547556B2 (ja) 1996-10-23
EP0278422B1 (en) 1994-06-08
EP0278422A3 (en) 1990-04-04
KR880009635A (ko) 1988-10-04
DE3889938T2 (de) 1994-11-03
DE3889938D1 (de) 1994-07-14
EP0278422A2 (en) 1988-08-17
US4876088A (en) 1989-10-24
KR960008653B1 (ko) 1996-06-28
JPS63192724A (ja) 1988-08-10

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