ES2057731T3 - Preparaciones que contienen gonadotropinas estabilizadas. - Google Patents

Preparaciones que contienen gonadotropinas estabilizadas.

Info

Publication number
ES2057731T3
ES2057731T3 ES91200483T ES91200483T ES2057731T3 ES 2057731 T3 ES2057731 T3 ES 2057731T3 ES 91200483 T ES91200483 T ES 91200483T ES 91200483 T ES91200483 T ES 91200483T ES 2057731 T3 ES2057731 T3 ES 2057731T3
Authority
ES
Spain
Prior art keywords
preparations
lyophilized
stabilizer
exposed
dicarboxylic acid
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
ES91200483T
Other languages
English (en)
Inventor
Andreas Leo Johannes De Meere
Marinus Arie De Ruiter
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.)
Akzo Nobel NV
Original Assignee
Akzo Nobel NV
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 Akzo Nobel NV filed Critical Akzo Nobel NV
Application granted granted Critical
Publication of ES2057731T3 publication Critical patent/ES2057731T3/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
    • 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
    • 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
    • A61K38/22—Hormones
    • A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • 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
    • 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
    • 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
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Reproductive Health (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Urology & Nephrology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)

Abstract

SE EXPONEN PREPARADOS QUE CONTIENEN GONADATROPINA LIOFILIZADA QUE CONTIENEN UN ESTABILIZADOR DE UNA SAL DE ACIDO DICARBOXILICO. LAS PROTEINAS INDIVIDUALES (POR EJEMPLO, LH, TSH, FSH, O HCG) ESTAN MEZCLADAS CON EL ESTABILIZADOR EN FORMA LIOFILIZADA, Y SON CAPACES, AL MENOS PARCIALMENTE, DE ESTABILIZACION MEDIANTE DICHO ESTABILIZADOR. LOS PREPARADOS CONTIENEN UNA CANTIDAD SUFICIENTE DE SAL DE ACIDO DICARBOXILICO COMO PARA ESTABILIZAR LA PROTEINA EN UNA FORMA CONGELADA-DESECADA DURANTE EL TIEMPO DESEADO A LA TEMPERATURA DESEADA. LAS TIPICAS SALES DE ACIDO DICARBOXILICO EXPUESTAS SON LAS SALES DE LOS ACIDOS CITRICO, TARTARICO Y ASPARTICO. LOS PREPARADOS INCLUYEN PREFERENTEMENTE UN DISACARIDO NO REDUCTOR PARA AUMENTAR LA TEMPERATURA DE COLAPSO DE LA SOLUCION QUE SE HA DE LIOFILIZAR. SE EXPONEN TAMBIEN METODOS DE FABRICACION DE LOS PREPARADOS EN FORMA LIOFILIZADA Y LOS PREPARADOS INYECTABLES RESULTANTES.
ES91200483T 1990-03-20 1991-03-06 Preparaciones que contienen gonadotropinas estabilizadas. Expired - Lifetime ES2057731T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP90200665 1990-03-20

Publications (1)

Publication Number Publication Date
ES2057731T3 true ES2057731T3 (es) 1994-10-16

Family

ID=8204967

Family Applications (1)

Application Number Title Priority Date Filing Date
ES91200483T Expired - Lifetime ES2057731T3 (es) 1990-03-20 1991-03-06 Preparaciones que contienen gonadotropinas estabilizadas.

Country Status (15)

Country Link
EP (1) EP0448146B1 (es)
JP (1) JP3031570B2 (es)
KR (1) KR100221123B1 (es)
AT (1) ATE107172T1 (es)
AU (1) AU631730B2 (es)
CA (1) CA2037884C (es)
DE (1) DE69102465T2 (es)
DK (1) DK0448146T3 (es)
ES (1) ES2057731T3 (es)
FI (1) FI101194B1 (es)
ID (1) ID905B (es)
IE (1) IE64738B1 (es)
NZ (1) NZ237458A (es)
PT (1) PT97074B (es)
ZA (1) ZA911659B (es)

Families Citing this family (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1250075B (it) * 1991-12-18 1995-03-30 Serono Cesare Ist Ricerca Composizioni farmaceutiche contenenti gonadotropine.
WO1994025005A1 (en) * 1993-04-28 1994-11-10 Akzo Nobel N.V. Lyospheres comprising gonadotropin
JP4165878B2 (ja) * 1993-06-03 2008-10-15 株式会社林原生物化学研究所 トレハロース遊離酵素とその製造方法並びに用途
US5556771A (en) * 1995-02-10 1996-09-17 Gen-Probe Incorporated Stabilized compositions of reverse transcriptase and RNA polymerase for nucleic acid amplification
PT814841E (pt) * 1995-03-21 2002-03-28 Applied Research Systems Formulacoes liquidas de hcg
IL120202A (en) 1996-03-07 2001-03-19 Akzo Nobel Nv Container with freeze-dried vaccine components
IL122732A0 (en) * 1997-01-15 1998-08-16 Akzo Nobel Nv Liquid gonadotropin-containing formulation its preparation and a device containing same
US20030166525A1 (en) 1998-07-23 2003-09-04 Hoffmann James Arthur FSH Formulation
IL140984A0 (en) * 1998-07-23 2002-02-10 Lilly Co Eli Fsh and fsh variant formulations, products and methods
JP2002541213A (ja) 1999-04-13 2002-12-03 インヘール セラピューティック システムズ， インコーポレイテッド 不妊症の処置のための乾燥粉末処方物の肺投与
NZ525243A (en) 2000-10-31 2005-01-28 Pharma Mar S A lyophilised formulation comprising kahalalide F, a peptide isolated from a herbivorous marine species of mollusc, Elysia rufescens, to treat cancer
CA2433037C (en) 2000-12-28 2010-12-21 Takeda Chemical Industries, Ltd. Sustained-release preparation
GB0207092D0 (en) * 2002-03-26 2002-05-08 Sod Conseils Rech Applic Stable pharmaceutical composition containing factor VIII
DK1610822T4 (en) 2003-04-02 2019-01-14 Ares Trading Sa Liquid pharmaceutical FSH and LH formulations together with a nonionic surfactant
US20040248784A1 (en) 2003-06-03 2004-12-09 Marco Filicori Unitary combinations of FSH and hCG
EP1638595B1 (en) 2003-06-20 2013-03-20 Ares Trading S.A. Freeze-dried fsh / lh formulations
DE10333317A1 (de) * 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA)
WO2005113147A2 (en) 2004-04-08 2005-12-01 Biomatrica, Inc. Integration of sample storage and sample management for life science
CN101495136A (zh) * 2006-02-15 2009-07-29 英克隆系统公司 抗体配制品
BRPI0818324B8 (pt) * 2007-11-01 2021-05-25 Merck Serono Sa formulação líquida contendo hormônio luteinizante (lh) ou uma variante do mesmo, seu uso, sua forma de apresentação, processo para a sua preparação e composição farmacêutica
CN101269215B (zh) * 2008-05-15 2011-03-23 上海天伟生物制药有限公司 一种糖蛋白激素组合物
EP2430195B1 (en) 2009-05-11 2019-01-23 Biomatrica, INC. Compositions and methods for biological sample storage
WO2012018639A2 (en) 2010-07-26 2012-02-09 Biomatrica, Inc. Compositions for stabilizing dna, rna and proteins in saliva and other biological samples during shipping and storage at ambient temperatures
EP2598660B1 (en) 2010-07-26 2017-03-15 Biomatrica, INC. Compositions for stabilizing dna, rna and proteins in blood and other biological samples during shipping and storage at ambient temperatures
DK2635297T3 (da) 2010-11-05 2019-05-06 Baxalta GmbH En ny variant af antihæmofil faktor viii, der har en øget specifik aktivitet
CN102293756A (zh) * 2011-08-24 2011-12-28 蚌埠丰原涂山制药有限公司 一种尿促性素冻干粉针剂及其制备方法
RS63930B1 (sr) 2011-10-28 2023-02-28 Prothena Biosciences Ltd Humanizovana antitela koja prepoznaju alfa-sinuklein
DK2807188T3 (da) 2012-01-27 2019-10-07 Prothena Biosciences Ltd Humaniserede antistoffer, der genkender alpha-synuclein
UA118441C2 (uk) 2012-10-08 2019-01-25 Протена Біосаєнсиз Лімітед Антитіло, що розпізнає альфа-синуклеїн
US9725703B2 (en) 2012-12-20 2017-08-08 Biomatrica, Inc. Formulations and methods for stabilizing PCR reagents
US10513555B2 (en) * 2013-07-04 2019-12-24 Prothena Biosciences Limited Antibody formulations and methods
ES2786373T3 (es) 2014-06-10 2020-10-09 Biomatrica Inc Estabilización de trombocitos a temperaturas ambiente
KR20250047404A (ko) 2015-12-08 2025-04-03 바이오매트리카 인코포레이티드 적혈구 침강 속도의 감소

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3932943A (en) * 1970-08-14 1976-01-20 E. I. Du Pont De Nemours And Company Method of preparation of lyophilized biological products
IT1057895B (it) * 1975-02-17 1982-03-30 Serono Lab Gonadotropina corionica umana parzialmente desalinizzata per indurre l'ouvulazione
DE3467706D1 (en) * 1983-04-28 1988-01-07 Armour Pharma Pharmaceutical preparation containing purified fibronectin
GB8604983D0 (en) * 1986-02-28 1986-04-09 Biocompatibles Ltd Protein preservation
US5059587A (en) * 1987-08-03 1991-10-22 Toyo Jozo Company, Ltd. Physiologically active peptide composition for nasal administration

Also Published As

Publication number Publication date
FI101194B (fi) 1998-05-15
PT97074A (pt) 1991-10-31
PT97074B (pt) 1998-10-30
CA2037884A1 (en) 1991-09-21
FI101194B1 (fi) 1998-05-15
JPH04217630A (ja) 1992-08-07
HK1002494A1 (en) 1998-08-28
CA2037884C (en) 2003-10-21
KR910016340A (ko) 1991-11-05
AU7362391A (en) 1991-09-26
KR100221123B1 (ko) 1999-09-15
DK0448146T3 (da) 1994-10-24
DE69102465T2 (de) 1995-03-02
ATE107172T1 (de) 1994-07-15
ID905B (id) 1996-09-10
JP3031570B2 (ja) 2000-04-10
NZ237458A (en) 1992-02-25
IE910732A1 (en) 1991-09-25
FI911309A0 (fi) 1991-03-18
IE64738B1 (en) 1995-09-06
DE69102465D1 (de) 1994-07-21
AU631730B2 (en) 1992-12-03
EP0448146A1 (en) 1991-09-25
ZA911659B (en) 1991-12-24
EP0448146B1 (en) 1994-06-15
FI911309L (fi) 1991-09-21

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