BRPI0410488B8 - Composição farmacêutica líquida estabilizada e livre de hsa, método para preparação de composição farmacêutica líquida estabilizada e livre de hsa, e recipiente vedado hermeticamente - Google Patents

Composição farmacêutica líquida estabilizada e livre de hsa, método para preparação de composição farmacêutica líquida estabilizada e livre de hsa, e recipiente vedado hermeticamente

Info

Publication number
BRPI0410488B8
BRPI0410488B8 BRPI0410488A BRPI0410488A BRPI0410488B8 BR PI0410488 B8 BRPI0410488 B8 BR PI0410488B8 BR PI0410488 A BRPI0410488 A BR PI0410488A BR PI0410488 A BRPI0410488 A BR PI0410488A BR PI0410488 B8 BRPI0410488 B8 BR PI0410488B8
Authority
BR
Brazil
Prior art keywords
pharmaceutical composition
hsa
liquid pharmaceutical
free
stabilized liquid
Prior art date
Application number
BRPI0410488A
Other languages
English (en)
Inventor
Del Rio Alessandra
Fabrizio Samaritani
Original Assignee
Ares Trading Sa
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 Ares Trading Sa filed Critical Ares Trading Sa
Publication of BRPI0410488A publication Critical patent/BRPI0410488A/pt
Publication of BRPI0410488B1 publication Critical patent/BRPI0410488B1/pt
Publication of BRPI0410488B8 publication Critical patent/BRPI0410488B8/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/21Interferons [IFN]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/21Interferons [IFN]
    • A61K38/215IFN-beta
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/12Keratolytics, e.g. wart or anti-corn preparations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/20Antivirals for DNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Oncology (AREA)
  • Virology (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

composição farmacêutica líquida estabilizada livre de hsa, método para preparação de composição farmacêutica líquida estabilizada livre de hsa, recipiente vedado hermeticamente e kit para administração de múltiplas doses de composição farmacêutica líquida estabilizada livre de hsa, descreve uma composição farmacêutica líquida estabilizada livre de hsa, que é composta de um interferon (ifn), caracterizada pelo fato de que a referida formulação seja uma solução que seja composta de um tampão, um surfactante, um agente de isotonicidade e um antioxidante. preferivelmente, o interferon é um recombinante humano ifn-beta.
BRPI0410488A 2003-05-01 2004-04-29 Composição farmacêutica líquida estabilizada e livre de hsa, método para preparação de composição farmacêutica líquida estabilizada e livre de hsa, e recipiente vedado hermeticamente BRPI0410488B8 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP03101210.7 2003-05-01
EP03101210 2003-05-01
US53016903P 2003-12-17 2003-12-17
US60/530,169 2003-12-17
PCT/EP2004/004806 WO2004096263A2 (en) 2003-05-01 2004-04-29 Human serum albumin-free stabilized interferon liquid formulations

Publications (3)

Publication Number Publication Date
BRPI0410488A BRPI0410488A (pt) 2006-06-13
BRPI0410488B1 BRPI0410488B1 (pt) 2021-06-22
BRPI0410488B8 true BRPI0410488B8 (pt) 2021-09-08

Family

ID=36908159

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0410488A BRPI0410488B8 (pt) 2003-05-01 2004-04-29 Composição farmacêutica líquida estabilizada e livre de hsa, método para preparação de composição farmacêutica líquida estabilizada e livre de hsa, e recipiente vedado hermeticamente

Country Status (29)

Country Link
US (1) US8309069B2 (pt)
EP (1) EP1617861B1 (pt)
JP (2) JP4870550B2 (pt)
KR (1) KR101116058B1 (pt)
CN (1) CN1816347B (pt)
AR (1) AR044147A1 (pt)
AU (2) AU2004233603B2 (pt)
BR (1) BRPI0410488B8 (pt)
CA (1) CA2521560A1 (pt)
DK (1) DK1617861T3 (pt)
EA (2) EA200800327A1 (pt)
ES (1) ES2417061T3 (pt)
HK (1) HK1088847A1 (pt)
HR (1) HRP20130512T1 (pt)
IL (1) IL171709A (pt)
ME (1) ME00404B (pt)
MX (1) MXPA05011718A (pt)
MY (1) MY151121A (pt)
NO (1) NO335674B1 (pt)
NZ (2) NZ542912A (pt)
PL (1) PL1617861T3 (pt)
PT (1) PT1617861E (pt)
RS (1) RS52869B (pt)
SG (1) SG159389A1 (pt)
SI (1) SI1617861T1 (pt)
TW (1) TWI272948B (pt)
UA (2) UA80331C2 (pt)
WO (1) WO2004096263A2 (pt)
ZA (2) ZA200508124B (pt)

Families Citing this family (22)

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JP4658961B2 (ja) * 2003-12-11 2011-03-23 アレス トレーディング エス.エー. 安定化されたインターフェロン液体製剤
ZA200609412B (en) * 2004-05-17 2008-07-30 Ares Trading Sa Hydrogel interferon formulations
ATE543506T1 (de) 2004-06-01 2012-02-15 Ares Trading Sa Methode zur stabilisierung von proteinen
US7731948B2 (en) * 2004-06-01 2010-06-08 Ares Trading S.A. Stabilized interferon liquid formulations
PT1951395E (pt) * 2005-09-14 2012-03-21 Ares Trading Sa Método para a determinação quantitativa de poloxâmeros
EA020805B1 (ru) 2006-05-24 2015-01-30 Мерк Сероно С.А. Применение комбинации кладрибина и бета-интерферона для лечения рассеянного склероза
WO2008066322A1 (en) * 2006-11-28 2008-06-05 Daewoong Co., Ltd. A stable hsa-free and antioxidant-free pharmaceutical composition comprising interferon-beta
WO2008065752A1 (fr) * 2006-11-30 2008-06-05 National University Corporation Hokkaido University Agent immunothérapeutique contenant un arndi en tant que principe actif
US8945529B2 (en) * 2007-03-30 2015-02-03 Helix Biopharma Corporation Biphasic lipid-vesicle compositions
WO2008145323A1 (en) * 2007-05-31 2008-12-04 F. Hoffmann-La Roche Ag Pharmaceutical formulation for interferons
SI2234645T1 (sl) * 2007-12-20 2012-07-31 Merck Serono Sa Formulacije peg interferon beta
WO2014064652A2 (en) 2012-10-26 2014-05-01 Lupin Limited Stable pharmaceutical composition of peginterferon alpha-2b
US8986732B2 (en) 2013-08-12 2015-03-24 Helix Biopharma Corporation Biphasic lipid-vesicle compositions and methods for treating cervical dysplasia by intravaginal delivery
US10159646B2 (en) 2013-08-12 2018-12-25 Altum-Avro Pharma Partnership Biphasic lipid-vesicle compositions and methods for treating cervical dysplasia by intravaginal delivery
EP3200767A1 (en) * 2014-09-23 2017-08-09 F.Hoffmann-La Roche Ag Stable, benzyl alcohol-free aqueous solution formulations containing alpha-type interferon
US9925233B2 (en) 2015-01-30 2018-03-27 Par Pharmaceutical, Inc. Vasopressin formulations for use in treatment of hypotension
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ZA200609412B (en) 2004-05-17 2008-07-30 Ares Trading Sa Hydrogel interferon formulations
ATE543506T1 (de) 2004-06-01 2012-02-15 Ares Trading Sa Methode zur stabilisierung von proteinen

Also Published As

Publication number Publication date
PL1617861T3 (pl) 2013-10-31
ME00404B (me) 2011-10-10
US20070059285A1 (en) 2007-03-15
ES2417061T3 (es) 2013-08-05
CN1816347B (zh) 2010-07-21
RS52869B (sr) 2013-12-31
AR044147A1 (es) 2005-08-24
CA2521560A1 (en) 2004-11-11
ZA200508124B (en) 2009-02-25
WO2004096263A3 (en) 2004-12-02
ZA200708484B (en) 2008-10-29
EP1617861B1 (en) 2013-05-29
BRPI0410488B1 (pt) 2021-06-22
RS20050821A (en) 2007-12-31
AU2004233603A1 (en) 2004-11-11
CN1816347A (zh) 2006-08-09
UA94032C2 (ru) 2011-04-11
MEP60408A (en) 2011-05-10
HRP20130512T1 (hr) 2013-07-31
TWI272948B (en) 2007-02-11
SI1617861T1 (sl) 2013-09-30
EP1617861A2 (en) 2006-01-25
UA80331C2 (en) 2007-09-10
MXPA05011718A (es) 2006-01-23
KR20060011976A (ko) 2006-02-06
NZ566625A (en) 2010-02-26
AU2009201261A1 (en) 2009-04-23
EA200501699A1 (ru) 2006-06-30
EA200800327A1 (ru) 2008-10-30
JP4870550B2 (ja) 2012-02-08
PT1617861E (pt) 2013-08-28
EA009995B1 (ru) 2008-06-30
AU2004233603B2 (en) 2009-02-26
MY151121A (en) 2014-04-30
DK1617861T3 (da) 2013-07-29
NO20055666L (no) 2005-11-30
JP2006525280A (ja) 2006-11-09
JP5346065B2 (ja) 2013-11-20
NZ542912A (en) 2008-04-30
WO2004096263A2 (en) 2004-11-11
HK1088847A1 (en) 2006-11-17
BRPI0410488A (pt) 2006-06-13
US8309069B2 (en) 2012-11-13
KR101116058B1 (ko) 2012-04-12
TW200503754A (en) 2005-02-01
IL171709A (en) 2016-03-31
SG159389A1 (en) 2010-03-30
JP2011225599A (ja) 2011-11-10
NO335674B1 (no) 2015-01-19

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