DE69834495T2 - Stabilisierte partikel in flüssigen formulierungen - Google Patents

Stabilisierte partikel in flüssigen formulierungen Download PDF

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Publication number
DE69834495T2
DE69834495T2 DE69834495T DE69834495T DE69834495T2 DE 69834495 T2 DE69834495 T2 DE 69834495T2 DE 69834495 T DE69834495 T DE 69834495T DE 69834495 T DE69834495 T DE 69834495T DE 69834495 T2 DE69834495 T2 DE 69834495T2
Authority
DE
Germany
Prior art keywords
formulation according
microparticles
formulation
biomolecular
continuous phase
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
DE69834495T
Other languages
German (de)
English (en)
Other versions
DE69834495D1 (de
Inventor
Jaap Kampinga
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.)
Quadrant Drug Delivery Ltd
Original Assignee
Quadrant Drug Delivery Ltd
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=10809442&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DE69834495(T2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Quadrant Drug Delivery Ltd filed Critical Quadrant Drug Delivery Ltd
Application granted granted Critical
Publication of DE69834495D1 publication Critical patent/DE69834495D1/de
Publication of DE69834495T2 publication Critical patent/DE69834495T2/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
    • 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
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1816Erythropoietin [EPO]
    • 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
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/465Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Wood Science & Technology (AREA)
  • Biomedical Technology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Dispersion Chemistry (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
DE69834495T 1997-03-18 1998-03-18 Stabilisierte partikel in flüssigen formulierungen Expired - Lifetime DE69834495T2 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB9705588.3A GB9705588D0 (en) 1997-03-18 1997-03-18 Stable particle in liquid formulations
GB9705588 1997-03-18
PCT/GB1998/000817 WO1998041188A2 (en) 1997-03-18 1998-03-18 Stable particle in liquid formulations

Publications (2)

Publication Number Publication Date
DE69834495D1 DE69834495D1 (de) 2006-06-14
DE69834495T2 true DE69834495T2 (de) 2006-09-07

Family

ID=10809442

Family Applications (1)

Application Number Title Priority Date Filing Date
DE69834495T Expired - Lifetime DE69834495T2 (de) 1997-03-18 1998-03-18 Stabilisierte partikel in flüssigen formulierungen

Country Status (14)

Country Link
US (1) US6669963B1 (enExample)
EP (1) EP1007000B1 (enExample)
JP (1) JP2002504090A (enExample)
CN (1) CN1256626A (enExample)
AT (1) ATE325605T1 (enExample)
AU (1) AU722627B2 (enExample)
BR (1) BR9808920A (enExample)
CA (1) CA2293682C (enExample)
DE (1) DE69834495T2 (enExample)
EA (1) EA001873B1 (enExample)
GB (1) GB9705588D0 (enExample)
NO (1) NO994508L (enExample)
NZ (1) NZ337666A (enExample)
WO (1) WO1998041188A2 (enExample)

Families Citing this family (55)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU3570495A (en) 1994-09-22 1996-04-09 Quadrant Holdings Cambridge Limited Compositions for use in rehydration and nutrition during athletic exercise and methods of making same
US6565885B1 (en) 1997-09-29 2003-05-20 Inhale Therapeutic Systems, Inc. Methods of spray drying pharmaceutical compositions
US20060165606A1 (en) 1997-09-29 2006-07-27 Nektar Therapeutics Pulmonary delivery particles comprising water insoluble or crystalline active agents
US6309623B1 (en) 1997-09-29 2001-10-30 Inhale Therapeutic Systems, Inc. Stabilized preparations for use in metered dose inhalers
US6946117B1 (en) * 1997-09-29 2005-09-20 Nektar Therapeutics Stabilized preparations for use in nebulizers
US6433040B1 (en) 1997-09-29 2002-08-13 Inhale Therapeutic Systems, Inc. Stabilized bioactive preparations and methods of use
AU2945199A (en) * 1998-03-18 1999-10-11 Ronai, Peter Amorphous glasses for stabilising sensitive products
US6190701B1 (en) 1999-03-17 2001-02-20 Peter M. Ronai Composition and method for stable injectable liquids
US6102896A (en) * 1999-09-08 2000-08-15 Cambridge Biostability Limited Disposable injector device
DE19943491B4 (de) * 1999-09-10 2010-04-01 Südzucker AG Mannheim/Ochsenfurt Verbesserte Komprimate
AU2046101A (en) * 1999-11-22 2001-06-04 Universal Preservation Technologies, Inc. Preservation and formulation of bioactive materials for storage and delivery in hydrophobic carriers
US7871598B1 (en) 2000-05-10 2011-01-18 Novartis Ag Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use
US6653062B1 (en) 2000-07-26 2003-11-25 Wisconsin Alumni Research Foundation Preservation and storage medium for biological materials
GB0024271D0 (en) * 2000-09-25 2000-11-15 Colaco Camilo Improved methods and compositions for pulmonary delivery of actives
RU2259817C2 (ru) * 2000-10-13 2005-09-10 Кембридж Байостэбилити Лтд. Композиция для доставки стабильных инъецируемых жидкостей и способ доставки
DK1452171T3 (da) * 2000-10-13 2010-04-06 Nova Bio Pharma Technologies Ltd Farmaceutiske væskesuspensioner
AU1198601A (en) * 2000-10-13 2002-04-29 Cambridge Biostability Ltd Composition and method for stable injectable liquids
WO2002032398A2 (en) * 2000-10-16 2002-04-25 Massachusetts Institute Of Technology Lipid-protein-sugar particles for drug delivery
US7153472B1 (en) 2000-11-22 2006-12-26 Quadrant Drug Delivery Limited Preservation and formulation of bioactive materials for storage and delivery in hydrophobic carriers
US6623762B2 (en) 2001-02-16 2003-09-23 Cambridge Biostability Ltd. Composition and method for controlled release injections
FR2825276B1 (fr) * 2001-05-31 2004-11-26 Seppic Sa Adujvant d'immunite sous forme solide et vaccin le contenant
ES2322132T3 (es) * 2001-07-02 2009-06-17 Asahi Kasei Pharma Corporation Metodo de estabilizacion de fosfatasa alcalina.
CN100436466C (zh) * 2001-08-10 2008-11-26 株式会社林原生物化学研究所 海藻糖或麦芽糖醇和金属离子化合物的缔合物
GB2379390B (en) 2001-09-11 2005-01-26 Caretek Medical Ltd A novel drug delivery technology
WO2003053411A1 (en) 2001-12-19 2003-07-03 Nektar Therapeutics Pulmonary delivery of aminoglycosides
US7943179B2 (en) 2003-09-23 2011-05-17 Massachusetts Institute Of Technology pH triggerable polymeric particles
PL1675573T4 (pl) * 2003-10-23 2016-04-29 Otsuka Pharma Co Ltd Sterylny preparat do wstrzykiwań arypiprazolu o kontrolowanym uwalnianiu i sposób
FR2873386B1 (fr) 2004-07-22 2011-01-14 Agence Francaise De Securite Sanitaire Des Aliments Afssa Composition vaccinale contre le rhodococcus equi
US20060045891A1 (en) * 2004-08-24 2006-03-02 Lovalenti Phillip M Density-matched suspension vehicles and pharmaceutical suspensions
US20060142630A1 (en) * 2004-12-29 2006-06-29 Attila Meretei Systems and methods for treating a thrombus in a blood vessel
US7515971B1 (en) * 2005-09-09 2009-04-07 Pacesetter, Inc. Left atrial pressure sensor lead
GB2430880A (en) * 2005-10-04 2007-04-11 Cambridge Biostability Ltd Pharmaceutical compositions stabilized in glassy particles
GB0523638D0 (en) 2005-11-21 2005-12-28 Cambridge Biostability Ltd Pharmaceutical device for the administration of substances to patients
US8946200B2 (en) 2006-11-02 2015-02-03 Southwest Research Institute Pharmaceutically active nanosuspensions
DE102006056790B3 (de) * 2006-12-01 2008-01-17 IfP Privates Institut für Produktqualität GmbH Laboreinmalartikel für Analyse und Diagnosik
EP1930396B1 (de) * 2006-12-04 2011-07-06 Merck Patent GmbH Furochromanderivate
WO2008092084A2 (en) 2007-01-26 2008-07-31 Centocor, Inc. Injectable non-aqueous suspension with high concentration of therapeutic agent
NO2170279T3 (enExample) * 2007-07-31 2018-05-26
CA2716546A1 (en) * 2008-02-25 2009-09-03 Novavax, Inc. Sugar glassified virus like particles (vlps)
US8404850B2 (en) 2008-03-13 2013-03-26 Southwest Research Institute Bis-quaternary pyridinium-aldoxime salts and treatment of exposure to cholinesterase inhibitors
US8722706B2 (en) 2008-08-15 2014-05-13 Southwest Research Institute Two phase bioactive formulations of bis-quaternary pyridinium oxime sulfonate salts
US8309134B2 (en) 2008-10-03 2012-11-13 Southwest Research Institute Modified calcium phosphate nanoparticle formation
WO2011007327A2 (en) * 2009-07-16 2011-01-20 Koninklijke Philips Electronics N.V. Suspension for therapeutic use and device for delivering said suspension
US8293299B2 (en) 2009-09-11 2012-10-23 Kraft Foods Global Brands Llc Containers and methods for dispensing multiple doses of a concentrated liquid, and shelf stable Concentrated liquids
CN102115737B (zh) * 2009-12-31 2015-06-03 深圳迈瑞生物医疗电子股份有限公司 稳定碱性磷酸酶或其标记物的试剂和方法
US9028873B2 (en) 2010-02-08 2015-05-12 Southwest Research Institute Nanoparticles for drug delivery to the central nervous system
CN102269762B (zh) 2010-06-04 2014-12-10 深圳迈瑞生物医疗电子股份有限公司 结合物的制备方法及相关试剂盒
CN102269761A (zh) 2010-06-04 2011-12-07 深圳迈瑞生物医疗电子股份有限公司 一种碱性磷酸酶结合物的合成工艺
US20120222979A1 (en) 2011-03-04 2012-09-06 Elwha LLC, a limited liability company of the State of Delaware Glassy compositions
AU2012304887B2 (en) 2011-09-09 2016-07-07 Kraft Foods Group Brands Llc Shelf stable, brewed beverage concentrates and methods of making the same
HK1198689A1 (en) 2011-10-25 2015-05-29 Prothena Biosciences Limited Antibody formulations and methods
US11013248B2 (en) 2012-05-25 2021-05-25 Kraft Foods Group Brands Llc Shelf stable, concentrated, liquid flavorings and methods of preparing beverages with the concentrated liquid flavorings
US10525057B2 (en) 2013-09-24 2020-01-07 Otsuka Pharmaceutical Co., Ltd. Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
US10863754B2 (en) 2014-07-03 2020-12-15 Kraft Foods Group Brands Llc Low water coffee and tea beverage concentrates and methods for making the same
CN111558046A (zh) * 2020-05-27 2020-08-21 华润昂德生物药业有限公司 海藻糖在制备重组人促红素液体制剂中的应用及重组人促红素液体制剂、制备方法和应用

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3970765A (en) * 1975-07-03 1976-07-20 General Foods Corporation Method for producing sucrose fixed volatile flavors
US4031255A (en) * 1975-07-03 1977-06-21 General Foods Corporation Fixing acetaldehyde in sucrose
GB1490814A (en) * 1975-07-22 1977-11-02 Cadbury Ltd Heat-resistant chocolate product and method of manufacturing same
JPS562908A (en) * 1979-06-20 1981-01-13 Nikken Kagaku Kk Preparation of stable live bacterial pharmaceutical remedy
EP0140255B1 (en) * 1983-10-14 1991-05-15 Sumitomo Pharmaceuticals Company, Limited Sustained-release injections
WO1989003671A1 (fr) * 1987-10-29 1989-05-05 Dainippon Pharmaceutical Co., Ltd. Preparation a liberation entretenue
US5250429A (en) * 1991-09-20 1993-10-05 Pharmacia P-L Biochemicals Inc. Glassified restriction enzymes
US5424289A (en) * 1993-07-30 1995-06-13 Alza Corporation Solid formulations of therapeutic proteins for gastrointestinal delivery
US5955448A (en) 1994-08-19 1999-09-21 Quadrant Holdings Cambridge Limited Method for stabilization of biological substances during drying and subsequent storage and compositions thereof
ATE252373T1 (de) 1994-08-04 2003-11-15 Elan Drug Delivery Ltd Feste verabreichungssysteme zur gesteuerten freisetzung von darin eingebauten molekülen sowie verfahren zu deren herstellung
US6290991B1 (en) * 1994-12-02 2001-09-18 Quandrant Holdings Cambridge Limited Solid dose delivery vehicle and methods of making same
US5593824A (en) * 1994-09-02 1997-01-14 Pharmacia Biotech, Inc. Biological reagent spheres
GB9508691D0 (en) * 1995-04-28 1995-06-14 Pafra Ltd Stable compositions
HUP9901716A3 (en) 1995-06-07 2000-04-28 Quadrant Holdings Cambridge Methods for stably incorporating substances within dry, foamed glass matrices and compositions obtained thereby
US5958455A (en) 1996-02-09 1999-09-28 Quadrant Holdings Cambridge Ltd Oral solid dosage forms, methods of making same and compositions thereof
US5762961A (en) 1996-02-09 1998-06-09 Quadrant Holdings Cambridge Ltd. Rapidly soluble oral solid dosage forms, methods of making same, and compositions thereof
US5766520A (en) 1996-07-15 1998-06-16 Universal Preservation Technologies, Inc. Preservation by foam formation

Also Published As

Publication number Publication date
EP1007000B1 (en) 2006-05-10
NO994508D0 (no) 1999-09-17
WO1998041188A2 (en) 1998-09-24
CN1256626A (zh) 2000-06-14
JP2002504090A (ja) 2002-02-05
AU722627B2 (en) 2000-08-10
NO994508L (no) 1999-11-17
GB9705588D0 (en) 1997-05-07
EA199900835A1 (ru) 2000-04-24
CA2293682C (en) 2007-01-16
BR9808920A (pt) 2000-08-01
ATE325605T1 (de) 2006-06-15
DE69834495D1 (de) 2006-06-14
EP1007000A2 (en) 2000-06-14
EA001873B1 (ru) 2001-10-22
CA2293682A1 (en) 1998-09-24
AU6510198A (en) 1998-10-12
WO1998041188A3 (en) 1998-12-10
US6669963B1 (en) 2003-12-30
NZ337666A (en) 2001-04-27

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8363 Opposition against the patent