CO5080738A1 - Formulaciones para la proteccion de conjugados de peginter- feron alfa - Google Patents

Formulaciones para la proteccion de conjugados de peginter- feron alfa

Info

Publication number
CO5080738A1
CO5080738A1 CO99017875A CO99017875A CO5080738A1 CO 5080738 A1 CO5080738 A1 CO 5080738A1 CO 99017875 A CO99017875 A CO 99017875A CO 99017875 A CO99017875 A CO 99017875A CO 5080738 A1 CO5080738 A1 CO 5080738A1
Authority
CO
Colombia
Prior art keywords
formulations
conjugates
peg
present
interferon
Prior art date
Application number
CO99017875A
Other languages
English (en)
Inventor
Douglas F Kline
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=CO5080738(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 CO5080738A1 publication Critical patent/CO5080738A1/es

Links

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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Virology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biotechnology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • AIDS & HIV (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Other Resins Obtained By Reactions Not Involving Carbon-To-Carbon Unsaturated Bonds (AREA)

Abstract

La presente invención proporciona formulaciones que previenen la pérdida y el daño de conjugac1-os de PEG - interferón alfa durante y después de la liofilización. Las formulaciones de la presente invención protegen los conjugados de PEG - interferón alta contra la pérdida y degradación durante el proceso de liofilización, así como también contra la degradación durante el posterior almacenamiento. Las formulaciones de la presente invención son adecuadas para la protección de conjugados de PEG -interferón alfa contra varios tipos de degradación, incluyendo, pero no limitándose, a la pérdida de actividad biológica y cambios en el grado y/o naturaleza de la conjugación. Un conjugado de PEG - interferón alfa preferido capaz de ser protegido en las formulaciones de la presente invención es un conjugado de interferón alfa-2b - polietilenglicol (12.000).
CO99017875A 1998-03-26 1999-03-24 Formulaciones para la proteccion de conjugados de peginter- feron alfa CO5080738A1 (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
CO5080738A1 true CO5080738A1 (es) 2001-09-25

Family

ID=21957085

Family Applications (1)

Application Number Title Priority Date Filing Date
CO99017875A CO5080738A1 (es) 1998-03-26 1999-03-24 Formulaciones para la proteccion de conjugados de peginter- feron alfa

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)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ID28470A (id) * 1998-03-26 2001-05-24 Schering Corp Formulasi-formulasi untuk perlindungan terhadap konjugasi polietilen glikol-interferon alfa
US6362162B1 (en) 1999-04-08 2002-03-26 Schering Corporation CML Therapy
US6605273B2 (en) 1999-04-08 2003-08-12 Schering Corporation Renal cell carcinoma treatment
NZ514629A (en) * 1999-04-08 2004-02-27 Schering Corp PEGylated interferon-alpha administered at about 4.5- 9.0 micrograms/kg/week as a renal cell carcinoma treatment
US6923966B2 (en) 1999-04-08 2005-08-02 Schering Corporation Melanoma therapy
AU2001232951A1 (en) * 2000-01-24 2001-07-31 Schering Corporation Combination of temozolomide and pegylated interferon-alpha for treating 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
CA2404737C (en) 2000-04-03 2010-06-29 Santen Pharmaceutical Co., Ltd. Drug delivering substance containing polyalkylene glycol and phospholipid covalently bonded to drug
SG161101A1 (en) 2002-02-22 2010-05-27 Schering Corp Pharmaceutical formulations of antineoplastic agents, in particular temozolomide processes of making and using the same
AU2008201682B2 (en) * 2004-02-02 2011-02-24 Ambrx, Inc. Modified human interferon polypeptides and their uses
MX2007001663A (es) * 2004-08-12 2007-04-10 Schering Corp Formulacion de interferon pegilado estable.
JP5563475B2 (ja) 2007-12-20 2014-07-30 メルク セローノ ソシエテ アノニム Ｐｅｇインターフェロン−ベータ製剤
KR101303388B1 (ko) * 2010-10-26 2013-09-03 한미사이언스 주식회사 지속형 인터페론 알파 결합체의 액상 제제
KR20150074167A (ko) * 2012-10-26 2015-07-01 루핀 리미티드 Ｐｅｇ 인터페론 알파-2ｂ의 안정한 약학 조성물
KR101736870B1 (ko) * 2014-08-20 2017-05-18 한국코러스 주식회사 인터페론 접합체를 포함하는 복합체 및 이의 제조방법
MX2018014916A (es) 2016-06-01 2019-07-18 Servier Ip Uk Ltd Formulaciones de oxido de polialquileno-asparaginasa y metodos de preparacion y uso del mismo.
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)

* Cited by examiner, † Cited by third party
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
NZ276943A (en) * 1993-11-10 1998-02-26 Schering Corp Substituted For Alpha-interferon conjugated to a non-antigenic polymer (preferably a polyalkylene oxide) and its preparation
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
JP2000510813A (ja) * 1995-02-06 2000-08-22 ジェネテイックス・インスティテュート・インコーポレイテッド Ｉｌ−１２用処方
JP2758154B2 (ja) * 1995-04-06 1998-05-28 エフ・ホフマン−ラ ロシユ アーゲー インターフェロンを含む液体製剤
CN100360184C (zh) * 1995-07-27 2008-01-09 基因技术股份有限公司 稳定等渗的冻干蛋白质制剂
US5908621A (en) * 1995-11-02 1999-06-01 Schering Corporation Polyethylene glycol modified interferon therapy
EP0858343B1 (en) * 1995-11-02 2004-03-31 Schering Corporation Continuous low-dose cytokine infusion therapy
TW517067B (en) * 1996-05-31 2003-01-11 Hoffmann La Roche Interferon conjugates
ID28470A (id) * 1998-03-26 2001-05-24 Schering Corp Formulasi-formulasi untuk perlindungan terhadap konjugasi polietilen glikol-interferon alfa

Also Published As

Publication number Publication date
PE20000338A1 (es) 2000-05-16
HUP0101749A2 (hu) 2001-11-28
NO20004785D0 (no) 2000-09-25
TWI250024B (en) 2006-03-01
EP1066059A1 (en) 2001-01-10
NO329916B1 (no) 2011-01-24
SK14262000A3 (sk) 2001-04-09
KR20010034654A (ko) 2001-04-25
TWI243057B (en) 2005-11-11
ES2241272T3 (es) 2005-10-16
HUP0101749A3 (en) 2001-12-28
KR100420642B1 (ko) 2004-03-02
ATE297761T1 (de) 2005-07-15
HK1029754A1 (en) 2001-04-12
CZ20003315A3 (cs) 2001-04-11
JP2003221345A (ja) 2003-08-05
CZ302005B6 (cs) 2010-09-01
BR9909087A (pt) 2000-12-05
PL193286B1 (pl) 2007-01-31
NZ506631A (en) 2003-03-28
JP3643034B2 (ja) 2005-04-27
IL138221A0 (en) 2001-10-31
SK285284B6 (sk) 2006-10-05
AU3181299A (en) 1999-10-18
WO1999048535A1 (en) 1999-09-30
JP2005104985A (ja) 2005-04-21
DE69925820T2 (de) 2006-05-18
IL138221A (en) 2007-12-03
HU228877B1 (en) 2013-06-28
JP2002507583A (ja) 2002-03-12
TW200536557A (en) 2005-11-16
CA2324467C (en) 2002-11-05
EP1066059B1 (en) 2005-06-15
AU754002B2 (en) 2002-10-31
ID28470A (id) 2001-05-24
PL345568A1 (en) 2001-12-17
NO20004785L (no) 2000-09-25
CN1295484A (zh) 2001-05-16
CN1191863C (zh) 2005-03-09
JP4580744B2 (ja) 2010-11-17
MY119227A (en) 2005-04-30
CA2324467A1 (en) 1999-09-30
AR014772A1 (es) 2001-03-28
DE69925820D1 (de) 2005-07-21
PT1066059E (pt) 2005-10-31

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