EA199600024A3 - Жидкая стабильная фармацевтическая композиция, содержащая уратоксидазу и лиофилизат для её получения - Google Patents

Жидкая стабильная фармацевтическая композиция, содержащая уратоксидазу и лиофилизат для её получения

Info

Publication number
EA199600024A3
EA199600024A3 EA199600024A EA199600024A EA199600024A3 EA 199600024 A3 EA199600024 A3 EA 199600024A3 EA 199600024 A EA199600024 A EA 199600024A EA 199600024 A EA199600024 A EA 199600024A EA 199600024 A3 EA199600024 A3 EA 199600024A3
Authority
EA
Eurasian Patent Office
Prior art keywords
preparation
composition containing
liquid composition
lyophilized
containing urate
Prior art date
Application number
EA199600024A
Other languages
English (en)
Other versions
EA199600024A2 (ru
EA000024B1 (ru
Inventor
Клод Алеман
Ален Байоль
Тьерри Брёль
Патрис Дюпэн
Original Assignee
Санофи
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 Санофи filed Critical Санофи
Publication of EA199600024A2 publication Critical patent/EA199600024A2/ru
Publication of EA199600024A3 publication Critical patent/EA199600024A3/ru
Publication of EA000024B1 publication Critical patent/EA000024B1/ru

Links

Classifications

    • 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
    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/44—Oxidoreductases (1)
    • A61K38/443—Oxidoreductases (1) acting on CH-OH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)
    • 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
    • A61K47/16—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
    • A61K9/14—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/06—Antigout agents, e.g. antihyperuricemic or uricosuric agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Изобретение относится к жидкой фармацевтической стабильной композиции, содержащей уратоксидазу и 0,1-10 мг/мл блоксополимера этиленоксида с пропиленоксидом общей формулы НО(CHCHO)(CH(CH)CHO)(CHCHO)Н в водной буферированной среде. Эта композиция может быть получена путем растворения лиофилизата в водном растворителе. Изобретение относится также к лиофилизату, содержащему уратоксидазу и блоксополимер этиленоксида с пропиленоксидом при соотношении блоксополимера к уратоксидазе 0,01-50.
EA199600024A 1995-05-11 1996-05-07 Фармацевтическая композиция, содержащая в качестве активного начала уратоксидазу, и лиофилизат для ее получения EA000024B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR9505606A FR2733914B1 (fr) 1995-05-11 1995-05-11 Composition de liquide stable contenant de l'urate oxydase et composition lyophilisee pour sa preparation
US08/644,163 US5811096A (en) 1995-05-11 1996-05-10 Stable liquid composition containing urate oxidase and lyophilized composition for its preparation

Publications (3)

Publication Number Publication Date
EA199600024A2 EA199600024A2 (ru) 1996-12-30
EA199600024A3 true EA199600024A3 (ru) 1997-03-31
EA000024B1 EA000024B1 (ru) 1997-12-30

Family

ID=26231954

Family Applications (1)

Application Number Title Priority Date Filing Date
EA199600024A EA000024B1 (ru) 1995-05-11 1996-05-07 Фармацевтическая композиция, содержащая в качестве активного начала уратоксидазу, и лиофилизат для ее получения

Country Status (24)

Country Link
US (1) US5811096A (ru)
EP (1) EP0742013B1 (ru)
JP (1) JP2950775B2 (ru)
CN (1) CN1090972C (ru)
AT (1) ATE183925T1 (ru)
AU (1) AU710288B2 (ru)
BR (1) BR1100337A (ru)
CA (1) CA2175971C (ru)
CZ (1) CZ290799B6 (ru)
DE (1) DE69604009T2 (ru)
DK (1) DK0742013T3 (ru)
EA (1) EA000024B1 (ru)
ES (1) ES2137635T3 (ru)
FR (1) FR2733914B1 (ru)
GR (1) GR3031896T3 (ru)
HU (1) HU225147B1 (ru)
IL (1) IL118171A (ru)
NO (1) NO315261B1 (ru)
NZ (1) NZ286554A (ru)
PL (1) PL184135B1 (ru)
SG (1) SG42355A1 (ru)
SI (1) SI0742013T1 (ru)
TW (1) TW420614B (ru)
ZA (1) ZA963683B (ru)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030166525A1 (en) * 1998-07-23 2003-09-04 Hoffmann James Arthur FSH Formulation
ES2245114T3 (es) 1998-08-06 2005-12-16 Mountain View Pharmaceuticals, Inc. Conjugados de peg-oxidasa de urato y su uso.
US6783965B1 (en) * 2000-02-10 2004-08-31 Mountain View Pharmaceuticals, Inc. Aggregate-free urate oxidase for preparation of non-immunogenic polymer conjugates
FR2782455B3 (fr) * 1998-08-20 2000-09-15 Sanofi Sa Composition pharmaceutique injectable a base d'un sel pharmaceutiquement acceptable du clopidogrel ou de ticlopidine
WO2004075913A1 (ja) * 2003-02-28 2004-09-10 Chugai Seiyaku Kabushiki Kaisha タンパク質含有安定化製剤
AU2004226666B9 (en) * 2003-04-02 2010-04-08 Ares Trading S.A. Liquid pharmaceutical formulations of FSH and LH together with a non-ionic surfactant
JP4871124B2 (ja) * 2003-06-20 2012-02-08 アレス トレーディング ソシエテ アノニム 凍結乾燥ｆｓｈ／ｌｈ製剤
US9534013B2 (en) 2006-04-12 2017-01-03 Horizon Pharma Rheumatology Llc Purification of proteins with cationic surfactant
US20080159976A1 (en) * 2005-04-11 2008-07-03 Jacob Hartman Methods for lowering elevated uric acid levels using intravenous injections of PEG-uricase
CN101194016B (zh) 2005-04-11 2012-09-05 萨文特医药公司 尿酸氧化酶的变体形式及其用途
PT3321359T (pt) 2005-04-11 2021-03-11 Horizon Pharma Rheumatology Llc Formas variantes de urato-oxidase e a sua utilização
US8148123B2 (en) * 2005-04-11 2012-04-03 Savient Pharmaceuticals, Inc. Methods for lowering elevated uric acid levels using intravenous injections of PEG-uricase
CN1864744B (zh) * 2005-05-18 2010-09-29 杭州北斗生物技术有限公司 含有尿酸氧化酶的药用制剂
JP2008545665A (ja) * 2005-05-23 2008-12-18 ユニベルシテ ドゥ ジュネーブ 高体温による処置のための注入可能な超常磁性ナノ粒子および高体温インプラントを形成するための使用
SG10201408480RA (en) 2009-06-25 2015-02-27 Crealta Pharmaceuticals Llc Methods for preventing or predicting infusion reactions or antibody-mediated loss of response, by monitoring serum uric acid levels during pegylated uricase therapy
CN105412942B (zh) * 2015-12-23 2019-02-26 沈阳三生制药有限责任公司 聚乙二醇化的重组产朊假丝酵母尿酸氧化酶冻干注射剂
EP3443346B1 (en) * 2016-04-13 2023-08-30 Medimmune, LLC Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
KR101744900B1 (ko) * 2017-01-20 2017-06-08 주식회사 대웅 보툴리눔 독소를 포함하는 안정한 액상 조성물

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3928137A (en) * 1971-10-20 1975-12-23 Mallinckrodt Inc Reagent formulation for uric acid assay
US3997470A (en) * 1971-10-20 1976-12-14 Mallinckrodt, Inc. Surfactant containing reagent formulations for assaying biological specimens and methods of preparing same
JPS51104807A (en) * 1975-03-12 1976-09-17 Hitachi Ltd Teepurekoodano ootoribaasuseigyokairo
JPS5417027A (en) * 1977-07-07 1979-02-08 Canon Inc Image forming system
DE3126759A1 (de) * 1981-07-07 1983-01-27 Boehringer Mannheim Gmbh, 6800 Mannheim Loesliche leber-uricase, verfahren zu ihrer herstellung und verwendung
JPS60224499A (ja) * 1984-04-23 1985-11-08 Toyobo Co Ltd 安定なウリカ−ゼ製剤
DE3743405A1 (de) * 1987-05-14 1988-11-24 Boehringer Mannheim Gmbh Verfahren zur bestimmung von fructosamin
JPH0243471A (ja) * 1988-08-03 1990-02-14 Iwataro Moriyama 立体駐車装置

Also Published As

Publication number Publication date
NO961915L (no) 1996-11-12
DE69604009D1 (de) 1999-10-07
CA2175971A1 (en) 1996-11-12
BR1100337A (pt) 2000-07-25
CN1147961A (zh) 1997-04-23
PL314147A1 (en) 1996-11-12
NO961915D0 (no) 1996-05-10
AU710288B2 (en) 1999-09-16
NZ286554A (en) 1998-09-24
CA2175971C (en) 2003-12-30
JPH0925242A (ja) 1997-01-28
IL118171A (en) 2000-08-31
JP2950775B2 (ja) 1999-09-20
HUP9601241A2 (en) 1997-04-28
EP0742013B1 (fr) 1999-09-01
DK0742013T3 (da) 2000-03-06
TW420614B (en) 2001-02-01
SG42355A1 (en) 1997-08-15
ES2137635T3 (es) 1999-12-16
NO315261B1 (no) 2003-08-11
CZ290799B6 (cs) 2002-10-16
CZ135096A3 (en) 1996-12-11
HU225147B1 (en) 2006-07-28
HU9601241D0 (en) 1996-07-29
EA199600024A2 (ru) 1996-12-30
SI0742013T1 (en) 1999-12-31
FR2733914A1 (fr) 1996-11-15
IL118171A0 (en) 1996-09-12
HUP9601241A3 (en) 2000-06-28
AU5213996A (en) 1996-11-21
EA000024B1 (ru) 1997-12-30
PL184135B1 (pl) 2002-09-30
GR3031896T3 (en) 2000-02-29
EP0742013A1 (fr) 1996-11-13
ATE183925T1 (de) 1999-09-15
MX9601756A (es) 1997-07-31
CN1090972C (zh) 2002-09-18
US5811096A (en) 1998-09-22
ZA963683B (en) 1997-11-10
FR2733914B1 (fr) 1997-08-01
DE69604009T2 (de) 2000-04-06

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Legal Events

Date Code Title Description
MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

Designated state(s): RU

MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

Designated state(s): AM AZ KZ KG MD TJ TM

PD4A Registration of transfer of a eurasian patent in accordance with the succession in title
TC4A Change in name of a patent proprietor in a eurasian patent

Designated state(s): RU

MK4A Patent expired

Designated state(s): BY