DE69415684T2 - Verfahren zur herstellung von mikrospharen mit einer wirbelschichtstufe - Google Patents

Verfahren zur herstellung von mikrospharen mit einer wirbelschichtstufe

Info

Publication number
DE69415684T2
DE69415684T2 DE69415684T DE69415684T DE69415684T2 DE 69415684 T2 DE69415684 T2 DE 69415684T2 DE 69415684 T DE69415684 T DE 69415684T DE 69415684 T DE69415684 T DE 69415684T DE 69415684 T2 DE69415684 T2 DE 69415684T2
Authority
DE
Germany
Prior art keywords
fluidized layer
producing microspheres
microspheres
producing
fluidized
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
DE69415684T
Other languages
English (en)
Other versions
DE69415684D1 (de
Inventor
Jeffrey Cleland
Andrew Jones
Michael Powell
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.)
Genentech Inc
Original Assignee
Genentech Inc
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 Genentech Inc filed Critical Genentech Inc
Publication of DE69415684D1 publication Critical patent/DE69415684D1/de
Application granted granted Critical
Publication of DE69415684T2 publication Critical patent/DE69415684T2/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • A61K38/22Hormones
    • A61K38/27Growth hormone [GH], i.e. somatotropin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • A61K39/21Retroviridae, e.g. equine infectious anemia virus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/39Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • 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
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55555Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55566Emulsions, e.g. Freund's adjuvant, MF59
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55577Saponins; Quil A; QS21; ISCOMS
    • 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
    • C12N2740/00Reverse transcribing RNA viruses
    • C12N2740/00011Details
    • C12N2740/10011Retroviridae
    • C12N2740/16011Human Immunodeficiency Virus, HIV
    • C12N2740/16111Human Immunodeficiency Virus, HIV concerning HIV env
    • C12N2740/16134Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Endocrinology (AREA)
  • Communicable Diseases (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
DE69415684T 1993-10-22 1994-10-13 Verfahren zur herstellung von mikrospharen mit einer wirbelschichtstufe Expired - Lifetime DE69415684T2 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US14225793A 1993-10-22 1993-10-22
US14331393A 1993-10-25 1993-10-25
PCT/US1994/011678 WO1995011009A1 (en) 1993-10-22 1994-10-13 Method for preparing microspheres comprising a fluidized bed drying step

Publications (2)

Publication Number Publication Date
DE69415684D1 DE69415684D1 (de) 1999-02-11
DE69415684T2 true DE69415684T2 (de) 1999-06-10

Family

ID=26839915

Family Applications (1)

Application Number Title Priority Date Filing Date
DE69415684T Expired - Lifetime DE69415684T2 (de) 1993-10-22 1994-10-13 Verfahren zur herstellung von mikrospharen mit einer wirbelschichtstufe

Country Status (9)

Country Link
EP (1) EP0724433B1 (de)
JP (1) JP3841309B2 (de)
AT (1) ATE175110T1 (de)
AU (1) AU8017494A (de)
CA (1) CA2172508C (de)
DE (1) DE69415684T2 (de)
DK (1) DK0724433T3 (de)
UY (1) UY23846A1 (de)
WO (1) WO1995011009A1 (de)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2153418T3 (es) * 1993-02-23 2001-03-01 Genentech Inc Estabilizacion de polipeptidos tratados con solventes organicos por medio de excipientes.
CZ293764B6 (cs) 1993-11-19 2004-07-14 Janssen Pharmaceutica N. V. Farmaceutický prostředek s dostatečným a dlouhodobým uvolňováním léčiva, biodegradovatelné a biokompatibilní mikročástice, způsob jejich výroby a použití
US6117455A (en) * 1994-09-30 2000-09-12 Takeda Chemical Industries, Ltd. Sustained-release microcapsule of amorphous water-soluble pharmaceutical active agent
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
EP0765660A3 (de) * 1995-09-28 1998-09-23 Takeda Chemical Industries, Ltd. Mikrokapseln enthaltend 2-Piperazinon-1-essigsäure Verbindungen
US6270795B1 (en) 1995-11-09 2001-08-07 Microbiological Research Authority Method of making microencapsulated DNA for vaccination and gene therapy
EP0862419B2 (de) 1995-11-09 2010-11-17 Microbiological Research Authority Mikroverkapselte dna zur impfung und gentherapie
DE19545257A1 (de) * 1995-11-24 1997-06-19 Schering Ag Verfahren zur Herstellung von morphologisch einheitlichen Mikrokapseln sowie nach diesem Verfahren hergestellte Mikrokapseln
GB2310801A (en) * 1996-03-04 1997-09-10 Merck & Co Inc Process for removing an organic solvent from lactide-glycoside copolymer microspheres
US6190702B1 (en) 1996-03-28 2001-02-20 Takeda Chemical Industries, Ltd. Sustained-released material prepared by dispersing a lyophilized polypeptide in an oil phase
DK0904063T3 (da) * 1996-05-07 2002-12-16 Alkermes Inc Fremgangsmåde til fremstilling af mikropartikler
JP5220248B2 (ja) * 1997-08-29 2013-06-26 アンチジェニックス・インコーポレイテッド アジュバントqs−21および賦形剤としてポリソルベートまたはシクロデキストリンを含む組成物
ATE233097T1 (de) 1997-11-07 2003-03-15 Chiron Corp Verfahren zur herstellung von igf-i formulierungen mit verzögerter freisetzung
SE9801288D0 (sv) 1998-04-14 1998-04-14 Astra Ab Vaccine delivery system and metod of production
GB9810236D0 (en) * 1998-05-13 1998-07-08 Microbiological Res Authority Improvements relating to encapsulation of bioactive agents
AU1226901A (en) * 1999-10-22 2001-05-08 Amgen, Inc. Biodegradable microparticles with novel erythropoietin stimulating protein
EP1853228A4 (de) * 2005-03-01 2012-07-18 Sun Pharma Advanced Res Co Ltd Verfahren zur herstellung von mikrokugeln oder mikrokapseln
US20170079962A1 (en) 2009-11-11 2017-03-23 Rapamycin Holdings, Llc Oral Rapamycin Preparation and Use for Stomatitus
CA2784287C (en) * 2009-12-22 2017-07-18 Evonik Degussa Corporation Emulsion-based process for preparing microparticles and workhead assembly for use with same
UA111162C2 (uk) 2010-08-04 2016-04-11 Флекшен Терап'Ютікс, Інк. Ін'єкційна композиція ацетоніду триамцинолону для лікування болю
AU2012290683B2 (en) * 2011-08-04 2017-07-13 Flexion Therapeutics, Inc. Corticosteroids for the treatment of joint pain
CA2933908C (en) 2013-12-31 2024-01-30 Rapamycin Holdings, Llc Oral rapamycin nanoparticle preparations and use
JPWO2023277051A1 (de) * 2021-06-30 2023-01-05

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3773919A (en) * 1969-10-23 1973-11-20 Du Pont Polylactide-drug mixtures
IT1214629B (it) * 1985-08-29 1990-01-18 Formenti Farmaceutici Spa Procedimento di microincapsulazione di un medicamento,medicamento cosi'preparato,e composizioni farmaceutiche che lo comprendono
US5075109A (en) * 1986-10-24 1991-12-24 Southern Research Institute Method of potentiating an immune response
IL84167A (en) * 1986-10-24 1991-04-15 Southern Res Inst Oral delivery of bioactive agents to and through the peyer's patch by use of microencapsulation
ES2102347T3 (es) * 1987-02-20 1997-08-01 Genentech Inc Metodos y composiciones para la utilizacion de polipeptidos env y anticuerpos anti-env de hiv.
JP2813630B2 (ja) * 1987-02-20 1998-10-22 ジェネンテク,インコーポレイテッド ヒト免疫不全ウイルスのエンベロープポリペプチドおよびその抗体
DK171073B1 (da) * 1988-08-24 1996-05-28 Allied Colloids Ltd Polymere sammensætninger og metoder til deres fremstilling
US5008116A (en) * 1988-11-14 1991-04-16 Frederick Cahn Immunostimulatory microsphere
US4990336A (en) * 1989-02-08 1991-02-05 Biosearch, Inc. Sustained release dosage form
US5126147A (en) * 1990-02-08 1992-06-30 Biosearch, Inc. Sustained release dosage form
FR2658432B1 (fr) * 1990-02-22 1994-07-01 Medgenix Group Sa Microspheres pour la liberation controlee des substances hydrosolubles et procede de preparation.
AU8303691A (en) * 1991-04-24 1992-12-21 United States Of America, As Represented By The Secretary Of The Army, The Oral-intestinal vaccines against diseases caused by enteropathogenic organisms using antigens encapsulated within biodegradable-biocompatible microspheres
US5429822A (en) * 1992-03-13 1995-07-04 Cambridge Scientific, Inc. Biodegradable bursting release system
FR2703927B1 (fr) * 1993-04-13 1995-07-13 Coletica Utilisation d'une réaction de transacylation entre un polysaccharide estérifié et une polyamine pour former en milieu aqueux une membrane au moins en surface de particules gélifiées.
JPH09504523A (ja) * 1993-10-22 1997-05-06 ジェネンテク,インコーポレイテッド アジュバントのマイクロカプセル化方法および組成物
CA2172509C (en) * 1993-10-22 2010-08-24 Jeffrey L. Cleland Methods and compositions for microencapsulation of antigens for use as vaccines

Also Published As

Publication number Publication date
JP3841309B2 (ja) 2006-11-01
AU8017494A (en) 1995-05-08
DE69415684D1 (de) 1999-02-11
DK0724433T3 (da) 1999-08-30
CA2172508A1 (en) 1995-04-27
ATE175110T1 (de) 1999-01-15
JPH09504026A (ja) 1997-04-22
CA2172508C (en) 2005-08-23
UY23846A1 (es) 1995-03-28
EP0724433A1 (de) 1996-08-07
WO1995011009A1 (en) 1995-04-27
EP0724433B1 (de) 1998-12-30

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Legal Events

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