AR082257A1 - Composicion de inmunoglobulinas humanas concentradas, procedimiento - Google Patents

Composicion de inmunoglobulinas humanas concentradas, procedimiento

Info

Publication number
AR082257A1
AR082257A1 ARP110102592A ARP110102592A AR082257A1 AR 082257 A1 AR082257 A1 AR 082257A1 AR P110102592 A ARP110102592 A AR P110102592A AR P110102592 A ARP110102592 A AR P110102592A AR 082257 A1 AR082257 A1 AR 082257A1
Authority
AR
Argentina
Prior art keywords
pharmaceutical composition
immunoglobulins
liquid pharmaceutical
human
surfactant
Prior art date
Application number
ARP110102592A
Other languages
English (en)
Original Assignee
Lab Francais Du Fractionnement
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 Lab Francais Du Fractionnement filed Critical Lab Francais Du Fractionnement
Publication of AR082257A1 publication Critical patent/AR082257A1/es

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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/39—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
    • 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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Abstract

La solicitud se refiere a una composición de inmunoglobulinas G humanas caracterizada porque la concentración en inmunoglobulinas G humanas es de al menos 230 g/L, de utilidad en particular para una administración por vía subcutánea.Reivindicación 1: Procedimiento de preparación de una composición farmacéutica líquida que comprende inmunoglobulinas G humanas (IgG), que comprende las siguientes etapas: a) proporcionar una preparación de lgG; b) añadir a la preparación al menos un tensioactivo y/o al menos un aminoácido; c) proceder a una concentración de lgG por ultrafiltración, d) después añadir un tensioactivo, que puede ser idéntico o diferente al tensioactivo de la etapa b). Reivindicación 13: Procedimiento de preparación de una composición farmacéutica líquida de acuerdo con una de las reivindicaciones 1 a 12, caracterizado porque la ultrafiltración de la etapa c) se realiza a una temperatura inferior a 30ºC, con preferencia inferior a 25ºC. Reivindicación 16: Composición farmacéutica líquida susceptible de ser obtenida por el procedimiento de acuerdo con una de las reivindicaciones 1 a 15, en la que la composición farmacéutica obtenida está en un pH comprendido entre 4,2 y 5,5. Reivindicación 19: Composición farmacéutica líquida de acuerdo con la reivindicación 18 que comprende inmunoglobulinas G humanas concentradas entre 230 y 350 g/L, con preferencia a aproximadamente 250 g/L, con preferencia a aproximadamente 250 g/L; glicina; eventualmente tampón de acetato de sodio; polisorbato, con preferencia polisorbato 80, o un poloxámero.
ARP110102592A 2010-07-19 2011-07-18 Composicion de inmunoglobulinas humanas concentradas, procedimiento AR082257A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR1055825A FR2962650B1 (fr) 2010-07-19 2010-07-19 Composition d'immunoglobulines humaines concentrees

Publications (1)

Publication Number Publication Date
AR082257A1 true AR082257A1 (es) 2012-11-21

Family

ID=43530307

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP110102592A AR082257A1 (es) 2010-07-19 2011-07-18 Composicion de inmunoglobulinas humanas concentradas, procedimiento

Country Status (11)

Country Link
US (2) US9186401B2 (es)
EP (2) EP2595654A1 (es)
JP (1) JP2013534540A (es)
KR (1) KR20140012011A (es)
CN (1) CN103118705A (es)
AR (1) AR082257A1 (es)
AU (1) AU2011287458A1 (es)
BR (1) BR112013001301A2 (es)
CA (1) CA2805685A1 (es)
FR (1) FR2962650B1 (es)
WO (1) WO2012017156A1 (es)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2977893B1 (fr) 2011-07-11 2015-02-20 Lab Francais Du Fractionnement Procede de preparation d'un concentre d'immunoglobulines polyvalentes
FR2995213A1 (fr) * 2012-09-12 2014-03-14 Lfb Biotechnologies Seringue contenant une composition, notamment pharmaceutique, comprenant des immunoglobulines, son procede de fabrication et son utilisation
CN106715587B (zh) * 2014-09-08 2019-05-28 三菱瓦斯化学株式会社 热塑性树脂组合物和使用其的成型体
FR3045387A1 (fr) * 2015-12-18 2017-06-23 Lab Francais Du Fractionnement Composition d’immunoglobulines humaines concentrees
ES2770674T3 (es) * 2016-06-10 2020-07-02 Octapharma Ag Composición de inmunoglobulinas de alta concentración para aplicaciones farmacéuticas
WO2018131893A1 (ko) * 2017-01-11 2018-07-19 ㈜셀트리온 안정한 액체 제제
US20200055922A1 (en) * 2017-04-21 2020-02-20 Csl Behring Ag Immunoglobulin products for use in the treatment of chronic inflammatory demyelinating polyneuropathy
KR102208378B1 (ko) * 2017-08-17 2021-01-28 주식회사 녹십자 항-egfr 항체를 포함하는 약학 제제
GB201719447D0 (en) 2017-11-23 2018-01-10 Ucb Biopharma Sprl Pharmaceutical composition
FR3081328B1 (fr) * 2018-05-24 2021-01-01 Lab Francais Du Fractionnement Composition d'immunoglobulines humaines concentrees
MA55033A (fr) 2019-02-18 2021-12-29 Lilly Co Eli Formulation d'anticorps thérapeutique

Family Cites Families (13)

* 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
SE501476C2 (sv) 1992-10-21 1995-02-27 Nilsson Carl O Lennart Cylinderbultmekanism vid repetergevär
FR2824568B1 (fr) * 2001-05-11 2004-04-09 Lab Francais Du Fractionnement Procede de preparation de concentres d'immunoglobulines humaines a usage therapeutique
US6893639B2 (en) * 2001-10-19 2005-05-17 Hemacare Corporation Method for high yield purification of immune globulins from blood plasma and blood plasma intermediates
FR2853551B1 (fr) * 2003-04-09 2006-08-04 Lab Francais Du Fractionnement Formulation stabilisante pour compositions d'immunoglobulines g sous forme liquide et sous forme lyophilisee
DE10327634B4 (de) 2003-06-20 2005-06-09 Sennheiser Electronic Gmbh & Co Kg Mikrofon
FR2895263B1 (fr) * 2005-12-26 2008-05-30 Lab Francais Du Fractionnement Concentre d'immunoglobines g (lg) appauvri en anticorps anti-a et anti-b, et en igg polyreactives
JP5099930B2 (ja) * 2007-06-19 2012-12-19 旭化成株式会社 免疫グロブリン１量体の分離方法
WO2009009406A1 (en) * 2007-07-06 2009-01-15 Smithkline Beecham Corporation Antibody formulations
US8772461B2 (en) * 2008-04-15 2014-07-08 Grifols Therapeutics Inc. Two-stage ultrafiltration/diafiltration
FR2940617B1 (fr) 2008-12-30 2012-04-20 Fractionnement Et Des Biotechonologies Lab Franc Composition d'immunoglobulines g
TWI445714B (zh) * 2009-05-27 2014-07-21 Baxter Int 產製用於皮下使用之高濃度免疫球蛋白製備物之方法
EP2361636A1 (en) * 2010-02-26 2011-08-31 CSL Behring AG Immunoglobulin preparation and storage system for an immunoglobulin preparation

Also Published As

Publication number Publication date
US9186401B2 (en) 2015-11-17
EP2595654A1 (fr) 2013-05-29
FR2962650A1 (fr) 2012-01-20
WO2012017156A1 (fr) 2012-02-09
FR2962650B1 (fr) 2013-04-05
EP3150225A1 (fr) 2017-04-05
US20130121991A1 (en) 2013-05-16
AU2011287458A1 (en) 2013-02-28
CN103118705A (zh) 2013-05-22
BR112013001301A2 (pt) 2016-05-17
CA2805685A1 (fr) 2012-02-09
KR20140012011A (ko) 2014-01-29
JP2013534540A (ja) 2013-09-05
US20160030563A1 (en) 2016-02-04

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