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ES2148568T3 - Formulaciones de disoluciones acuosas estables de interferon alfa. - Google Patents

Formulaciones de disoluciones acuosas estables de interferon alfa.

Info

Publication number
ES2148568T3
ES2148568T3 ES95935151T ES95935151T ES2148568T3 ES 2148568 T3 ES2148568 T3 ES 2148568T3 ES 95935151 T ES95935151 T ES 95935151T ES 95935151 T ES95935151 T ES 95935151T ES 2148568 T3 ES2148568 T3 ES 2148568T3
Authority
ES
Spain
Prior art keywords
stable aqueous
interferon
aqueous solutions
alpha interferon
alpha
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
ES95935151T
Other languages
English (en)
Inventor
Pui-Ho C Yuen
Douglas F Kline
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.)
Merck Sharp and Dohme LLC
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
Application filed by Schering Corp filed Critical Schering Corp
Application granted granted Critical
Publication of ES2148568T3 publication Critical patent/ES2148568T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • 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]
    • 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
    • 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
    • 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
    • A61P31/20—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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Virology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Dermatology (AREA)
  • Biotechnology (AREA)
  • Molecular Biology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

SE MUESTRAN FORMULACIONES DE SOLUCION ACUOSA ESTABLE QUE CONTIENEN INTERFERON TIPO ALFA, P.E. INTERFERON ALFA-2A E INTERFERON ALFA-2B, UN AMORTIGUADOR PARA MANTENER EL PH EN LA GAMA DE 4.5-7.1, POLISORBATO 80 COMO ESTABILIZADOR, DISODIO DE EDETATO COMO AGENTE QUELANTE, CLORURO DE SODIO COMO AGENTE TONIFICANTE, Y M-CRESOL COMO PRESERVANTE ANTIMICROBIANO QUE MANTIENE UNA ALTA ESTABILIDAD QUIMICA, FISICA Y BIOLOGICA DEL INTERFERON TIPO ALFA PARA UN DILATADO PERIODO DE ALMACENAMIENTO DE AL MENOS 24 MESES.
ES95935151T 1994-10-11 1995-10-10 Formulaciones de disoluciones acuosas estables de interferon alfa. Expired - Lifetime ES2148568T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US08/329,813 US5766582A (en) 1994-10-11 1994-10-11 Stable, aqueous alfa interferon solution formulations

Publications (1)

Publication Number Publication Date
ES2148568T3 true ES2148568T3 (es) 2000-10-16

Family

ID=23287133

Family Applications (2)

Application Number Title Priority Date Filing Date
ES99119434T Expired - Lifetime ES2198830T3 (es) 1994-10-11 1995-10-10 Uso de agentes quelatantes de metal para estabilizar preparaciones que contienen interferon.
ES95935151T Expired - Lifetime ES2148568T3 (es) 1994-10-11 1995-10-10 Formulaciones de disoluciones acuosas estables de interferon alfa.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ES99119434T Expired - Lifetime ES2198830T3 (es) 1994-10-11 1995-10-10 Uso de agentes quelatantes de metal para estabilizar preparaciones que contienen interferon.

Country Status (25)

Country Link
US (2) US5766582A (es)
EP (2) EP0970703B1 (es)
JP (2) JP3978228B2 (es)
KR (1) KR100401401B1 (es)
CN (1) CN1102408C (es)
AT (2) ATE245033T1 (es)
AU (1) AU708337B2 (es)
BR (1) BR9509313A (es)
CA (1) CA2201749C (es)
CZ (1) CZ296961B6 (es)
DE (2) DE69531314T2 (es)
DK (1) DK0777495T3 (es)
ES (2) ES2198830T3 (es)
FI (2) FI116558B (es)
GR (1) GR3034619T3 (es)
HK (1) HK1008813A1 (es)
HU (1) HU225494B1 (es)
NO (1) NO320604B1 (es)
NZ (1) NZ294464A (es)
PL (1) PL183797B1 (es)
PT (1) PT777495E (es)
RU (1) RU2157236C2 (es)
SK (1) SK282949B6 (es)
UA (1) UA42028C2 (es)
WO (1) WO1996011018A1 (es)

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US20030190307A1 (en) 1996-12-24 2003-10-09 Biogen, Inc. Stable liquid interferon formulations
US6180096B1 (en) 1998-03-26 2001-01-30 Schering Corporation Formulations for protection of peg-interferon alpha conjugates
ATE297761T1 (de) * 1998-03-26 2005-07-15 Schering Corp Zubereitungen zur stabilisierung von peg- interferon alpha konjugaten
PT956861E (pt) 1998-05-15 2002-08-30 Schering Corp Terapia combinada compreendendo ribavirina e interferao alfa em doentes sem tratamento antiviral anterior tendo infeccao cronica pelo virus da hepatite c
US6281337B1 (en) 1998-11-12 2001-08-28 Schering Corporation Methods for conversion of protein isoforms
SI1894944T1 (sl) 1998-11-12 2010-11-30 Schering Corp Postopki za pretvorbo izooblik interferona in njihovi proizvodi
US7402559B2 (en) * 1999-03-24 2008-07-22 Msh Pharma, Incorporated Composition and method of treatment for urogenital conditions
US6923966B2 (en) * 1999-04-08 2005-08-02 Schering Corporation Melanoma therapy
EP2025344B1 (en) 1999-04-08 2011-01-26 Schering Corporation Melanoma Therapy
US6362162B1 (en) 1999-04-08 2002-03-26 Schering Corporation CML Therapy
DK1043025T3 (da) * 1999-04-08 2005-07-04 Schering Corp Behandling af nyrecellekarcinom
US6605273B2 (en) 1999-04-08 2003-08-12 Schering Corporation Renal cell carcinoma treatment
KR100740794B1 (ko) * 1999-04-09 2007-07-20 오르토-맥네일 파마슈티칼, 인코퍼레이티드 에리트로포이에틴의 약제학적 제형
KR100399156B1 (ko) * 1999-11-19 2003-09-26 주식회사 엘지생명과학 α-인터페론의 용액제형
CN1175901C (zh) * 1999-12-06 2004-11-17 天津华立达生物工程有限公司 一种稳定的干扰素水溶液
CN1286969C (zh) * 1999-12-14 2006-11-29 热生物之星公司 多肽和抗原的稳定稀释剂
JP4536194B2 (ja) * 2000-02-17 2010-09-01 大日本住友製薬株式会社 安定な注射用製剤
CN1245215C (zh) 2001-02-28 2006-03-15 四川省生物工程研究中心 重组高效复合干扰素用作乙型肝炎表面抗原和e抗原抑制剂
MXPA03009121A (es) * 2001-04-04 2004-11-22 Johnson & Johnson Dispositivo de suministro de electrotransporte transdermico que incluye una composicion de reserva compatible antimicrobiana.
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LT4947B (lt) 2001-09-26 2002-08-26 Biotechnologijos Institutas Interferono alfa farmacinė kompozicija
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US20040175359A1 (en) * 2002-11-12 2004-09-09 Desjarlais John Rudolph Novel proteins with antiviral, antineoplastic, and/or immunomodulatory activity
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MX2007001663A (es) 2004-08-12 2007-04-10 Schering Corp Formulacion de interferon pegilado estable.
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BR112015024659A8 (pt) 2013-04-03 2019-12-17 Sanofi Sa formulação farmacêutica aquosa, seu uso, método de tratamento de diabetes mellitus e artigo de fabricação
US9388239B2 (en) 2014-05-01 2016-07-12 Consejo Nacional De Investigation Cientifica Anti-human VEGF antibodies with unusually strong binding affinity to human VEGF-A and cross reactivity to human VEGF-B
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JP6445169B2 (ja) * 2014-09-23 2018-12-26 エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ α型インターフェロンを含有する安定したベンジルアルコールフリーの水溶液製剤
PE20171622A1 (es) 2014-12-12 2017-11-02 Sanofi Aventis Deutschland Formulacion de relacion fija de insulina glargina/lixisenatida
TWI748945B (zh) 2015-03-13 2021-12-11 德商賽諾菲阿凡提斯德意志有限公司 第２型糖尿病病患治療
TW201705975A (zh) 2015-03-18 2017-02-16 賽諾菲阿凡提斯德意志有限公司 第２型糖尿病病患之治療
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Also Published As

Publication number Publication date
DE69518084D1 (de) 2000-08-24
NO320604B1 (no) 2005-12-27
JP2006193536A (ja) 2006-07-27
FI117377B (fi) 2006-09-29
HK1008813A1 (en) 1999-05-21
AU708337B2 (en) 1999-08-05
UA42028C2 (uk) 2001-10-15
NO971633L (no) 1997-04-10
ATE245033T1 (de) 2003-08-15
US5766582A (en) 1998-06-16
NO971633D0 (no) 1997-04-10
KR100401401B1 (ko) 2004-02-18
SK43997A3 (en) 1997-10-08
PL183797B1 (pl) 2002-07-31
PL319603A1 (en) 1997-08-18
CN1102408C (zh) 2003-03-05
JPH10506912A (ja) 1998-07-07
GR3034619T3 (en) 2001-01-31
US5935566A (en) 1999-08-10
DK0777495T3 (da) 2000-11-06
AU3727995A (en) 1996-05-02
EP0777495A1 (en) 1997-06-11
FI20055562L (fi) 2005-10-19
WO1996011018A1 (en) 1996-04-18
JP3978228B2 (ja) 2007-09-19
FI971486L (fi) 1997-04-10
MX9702578A (es) 1997-07-31
CN1160355A (zh) 1997-09-24
DE69531314T2 (de) 2004-05-13
HUT77287A (hu) 1998-03-30
CA2201749A1 (en) 1996-04-18
BR9509313A (pt) 1998-01-27
KR970706017A (ko) 1997-11-03
PT777495E (pt) 2000-12-29
NZ294464A (en) 1999-03-29
EP0970703A1 (en) 2000-01-12
HU225494B1 (en) 2007-01-29
SK282949B6 (sk) 2003-01-09
EP0777495B1 (en) 2000-07-19
FI971486A0 (fi) 1997-04-10
EP0970703B1 (en) 2003-07-16
DE69518084T2 (de) 2001-03-22
ATE194774T1 (de) 2000-08-15
ES2198830T3 (es) 2004-02-01
FI116558B (fi) 2005-12-30
CA2201749C (en) 1999-06-15
CZ110497A3 (en) 1997-09-17
CZ296961B6 (cs) 2006-08-16
RU2157236C2 (ru) 2000-10-10
DE69531314D1 (de) 2003-08-21

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