AR014772A1 - Una formulacion acuosa que permite la estabilizacion de conjugados de peg-interferon alfa durante y despues de la liofilizacion, proceso para producir un polvo liofilizado, un polvo liofilizado, un proceso para producir una solucion de los conjudados peg-interferon-alfa y un articulo de manufactura - Google Patents

Una formulacion acuosa que permite la estabilizacion de conjugados de peg-interferon alfa durante y despues de la liofilizacion, proceso para producir un polvo liofilizado, un polvo liofilizado, un proceso para producir una solucion de los conjudados peg-interferon-alfa y un articulo de manufactura

Info

Publication number
AR014772A1
AR014772A1 ARP990101323A ARP990101323A AR014772A1 AR 014772 A1 AR014772 A1 AR 014772A1 AR P990101323 A ARP990101323 A AR P990101323A AR P990101323 A ARP990101323 A AR P990101323A AR 014772 A1 AR014772 A1 AR 014772A1
Authority
AR
Argentina
Prior art keywords
peg
powder
liofilized
produce
manufacture
Prior art date
Application number
ARP990101323A
Other languages
English (en)
Original Assignee
Schering Corp
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=21957085&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR014772(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Schering Corp filed Critical Schering Corp
Publication of AR014772A1 publication Critical patent/AR014772A1/es

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Classifications

    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • 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
    • 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
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
    • A61K38/212—IFN-alpha
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
    • 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
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Formulaciones acuosas que comprenden conjugados de PEG-inteferon alfa, un buffer, un estabilizante, un crioprotector y un solvente; proceso deliofilizacion, un polvo biofilizado y un artículo de fabricacion. Dichas formulaciones previenenla pérdida y el dano conjugados de PEG - interferonalfa durante y después de la liofilizacion; protegen los conjugados de PEG - interferon alfa contra la pérdida y degradacion durante el proceso deliofilizacion, así como también contra ladegradacio n durante el posterior almacenamiento; y son adecuadas para la proteccion de conjungados de PEG -interferon alfa contra varios tipos de degradacion, incluyendo, pero no limitándose, a la pérdida de actividad biologica ycambios en el gra do y/onaturaleza de la conjugacion. Un conjugado de PEG - interferonalfa preferido capaz de ser protegido en dichas formulaciones es un conjugado de interferon alfa-2b- polietilenglicol (12.000).
ARP990101323A 1998-03-26 1999-03-25 Una formulacion acuosa que permite la estabilizacion de conjugados de peg-interferon alfa durante y despues de la liofilizacion, proceso para producir un polvo liofilizado, un polvo liofilizado, un proceso para producir una solucion de los conjudados peg-interferon-alfa y un articulo de manufactura AR014772A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US4890798A 1998-03-26 1998-03-26

Publications (1)

Publication Number Publication Date
AR014772A1 true AR014772A1 (es) 2001-03-28

Family

ID=21957085

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP990101323A AR014772A1 (es) 1998-03-26 1999-03-25 Una formulacion acuosa que permite la estabilizacion de conjugados de peg-interferon alfa durante y despues de la liofilizacion, proceso para producir un polvo liofilizado, un polvo liofilizado, un proceso para producir una solucion de los conjudados peg-interferon-alfa y un articulo de manufactura

Country Status (26)

Country Link
EP (1) EP1066059B1 (es)
JP (3) JP3643034B2 (es)
KR (1) KR100420642B1 (es)
CN (1) CN1191863C (es)
AR (1) AR014772A1 (es)
AT (1) ATE297761T1 (es)
AU (1) AU754002B2 (es)
BR (1) BR9909087A (es)
CA (1) CA2324467C (es)
CO (1) CO5080738A1 (es)
CZ (1) CZ302005B6 (es)
DE (1) DE69925820T2 (es)
ES (1) ES2241272T3 (es)
HK (1) HK1029754A1 (es)
HU (1) HU228877B1 (es)
ID (1) ID28470A (es)
IL (2) IL138221A0 (es)
MY (1) MY119227A (es)
NO (1) NO329916B1 (es)
NZ (1) NZ506631A (es)
PE (1) PE20000338A1 (es)
PL (1) PL193286B1 (es)
PT (1) PT1066059E (es)
SK (1) SK285284B6 (es)
TW (2) TWI243057B (es)
WO (1) WO1999048535A1 (es)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8623868B2 (en) 2002-02-22 2014-01-07 Merck Sharp & Dohme Corp. Processes of making and using pharmaceutical formulations of antineoplastic agents

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1066059B1 (en) * 1998-03-26 2005-06-15 Schering Corporation Formulations for protection of peg-interferon alpha conjugates
US6362162B1 (en) 1999-04-08 2002-03-26 Schering Corporation CML Therapy
JP4721488B2 (ja) * 1999-04-08 2011-07-13 シェーリング コーポレイション 腎細胞ガン処置
US6923966B2 (en) 1999-04-08 2005-08-02 Schering Corporation Melanoma therapy
US6605273B2 (en) 1999-04-08 2003-08-12 Schering Corporation Renal cell carcinoma treatment
US20020009428A1 (en) * 2000-01-24 2002-01-24 Zaknoen Sara L. Combination therapy for cancer
EP1908477A3 (en) * 2000-01-24 2008-06-11 Schering Corporation Combination of temozolomide and pegylated interferon-alpha for treating cancer
KR100353392B1 (ko) * 2000-03-13 2002-09-18 선바이오(주) 높은 생체 활성도를 갖는 생체 활성 단백질과 ｐｅｇ의결합체 제조방법
KR100777195B1 (ko) 2000-04-03 2007-11-19 산텐 세이야꾸 가부시키가이샤 송달성 물질 및 이를 이용한 약물 송달 시스템
AU2008201682B2 (en) * 2004-02-02 2011-02-24 Ambrx, Inc. Modified human interferon polypeptides and their uses
DE602005022895D1 (de) * 2004-08-12 2010-09-23 Schering Corp Stabile pegylierte interferon-formulierung
WO2009080699A2 (en) 2007-12-20 2009-07-02 Merck Serono S.A. Peg-interferon-beta formulations
KR101303388B1 (ko) * 2010-10-26 2013-09-03 한미사이언스 주식회사 지속형 인터페론 알파 결합체의 액상 제제
JP2015535238A (ja) * 2012-10-26 2015-12-10 ルピン・リミテッドＬｕｐｉｎ Ｌｉｍｉｔｅｄ ペグインターフェロンα−２ｂの安定な医薬組成物
KR101736870B1 (ko) 2014-08-20 2017-05-18 한국코러스 주식회사 인터페론 접합체를 포함하는 복합체 및 이의 제조방법
EP3463308B1 (en) 2016-06-01 2021-12-01 Servier IP UK Limited Formulations of polyalkylene oxide-asparaginase and methods of making and using the same
CN112358541B (zh) * 2020-11-25 2022-04-01 广州迪澳医疗科技有限公司 一种重组人γ-干扰素的冻干保护剂

Family Cites Families (12)

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Publication number Priority date Publication date Assignee Title
CA2024046A1 (en) * 1989-09-28 1991-03-29 Alberto Ferro Stabilized leukocyte-interferons
US5382657A (en) * 1992-08-26 1995-01-17 Hoffmann-La Roche Inc. Peg-interferon conjugates
DK0730470T3 (da) * 1993-11-10 2002-06-03 Enzon Inc Forbedrede interferonpolymerkonjugater
US5766582A (en) * 1994-10-11 1998-06-16 Schering Corporation Stable, aqueous alfa interferon solution formulations
US5738846A (en) * 1994-11-10 1998-04-14 Enzon, Inc. Interferon polymer conjugates and process for preparing the same
WO1996024369A1 (en) * 1995-02-06 1996-08-15 Genetics Institute, Inc. Formulations for il-12
TW426523B (en) * 1995-04-06 2001-03-21 Hoffmann La Roche Interferon solution
CA2226575C (en) * 1995-07-27 2011-10-18 Genentech, Inc. Stabile isotonic lyophilized protein formulation
US5908621A (en) * 1995-11-02 1999-06-01 Schering Corporation Polyethylene glycol modified interferon therapy
JP2000507917A (ja) * 1995-11-02 2000-06-27 シェーリング コーポレイション 持続的低用量サイトカイン注入治療
TW517067B (en) * 1996-05-31 2003-01-11 Hoffmann La Roche Interferon conjugates
EP1066059B1 (en) * 1998-03-26 2005-06-15 Schering Corporation Formulations for protection of peg-interferon alpha conjugates

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8623868B2 (en) 2002-02-22 2014-01-07 Merck Sharp & Dohme Corp. Processes of making and using pharmaceutical formulations of antineoplastic agents

Also Published As

Publication number Publication date
HU228877B1 (en) 2013-06-28
DE69925820D1 (de) 2005-07-21
WO1999048535A1 (en) 1999-09-30
JP2005104985A (ja) 2005-04-21
IL138221A (en) 2007-12-03
CA2324467C (en) 2002-11-05
PE20000338A1 (es) 2000-05-16
KR100420642B1 (ko) 2004-03-02
BR9909087A (pt) 2000-12-05
AU754002B2 (en) 2002-10-31
PL345568A1 (en) 2001-12-17
AU3181299A (en) 1999-10-18
CZ302005B6 (cs) 2010-09-01
MY119227A (en) 2005-04-30
JP2003221345A (ja) 2003-08-05
KR20010034654A (ko) 2001-04-25
HUP0101749A3 (en) 2001-12-28
PT1066059E (pt) 2005-10-31
NO20004785L (no) 2000-09-25
JP4580744B2 (ja) 2010-11-17
SK285284B6 (sk) 2006-10-05
SK14262000A3 (sk) 2001-04-09
HK1029754A1 (en) 2001-04-12
ES2241272T3 (es) 2005-10-16
NZ506631A (en) 2003-03-28
DE69925820T2 (de) 2006-05-18
CN1295484A (zh) 2001-05-16
NO329916B1 (no) 2011-01-24
CA2324467A1 (en) 1999-09-30
ID28470A (id) 2001-05-24
IL138221A0 (en) 2001-10-31
TWI250024B (en) 2006-03-01
NO20004785D0 (no) 2000-09-25
PL193286B1 (pl) 2007-01-31
JP2002507583A (ja) 2002-03-12
CN1191863C (zh) 2005-03-09
EP1066059B1 (en) 2005-06-15
TW200536557A (en) 2005-11-16
EP1066059A1 (en) 2001-01-10
TWI243057B (en) 2005-11-11
JP3643034B2 (ja) 2005-04-27
HUP0101749A2 (hu) 2001-11-28
CO5080738A1 (es) 2001-09-25
CZ20003315A3 (cs) 2001-04-11
ATE297761T1 (de) 2005-07-15

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