WO2012034871A3 - Verfahren zum herstellen von wirkstoff-beads - Google Patents

Verfahren zum herstellen von wirkstoff-beads Download PDF

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Publication number
WO2012034871A3
WO2012034871A3 PCT/EP2011/065186 EP2011065186W WO2012034871A3 WO 2012034871 A3 WO2012034871 A3 WO 2012034871A3 EP 2011065186 W EP2011065186 W EP 2011065186W WO 2012034871 A3 WO2012034871 A3 WO 2012034871A3
Authority
WO
WIPO (PCT)
Prior art keywords
bead
active ingredient
producing
gravity
vacuum
Prior art date
Application number
PCT/EP2011/065186
Other languages
English (en)
French (fr)
Other versions
WO2012034871A2 (de
Inventor
Craig Vincze
Lori Jensen
Mareen Schmökel
Frieder NEUHÄUSSER-WESPY
Carsten Etzold
Original Assignee
Hamilton Bonaduz Ag
Hamilton Company
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 Hamilton Bonaduz Ag, Hamilton Company filed Critical Hamilton Bonaduz Ag
Priority to CN2011800441102A priority Critical patent/CN103209689A/zh
Priority to EP11757229.7A priority patent/EP2616049A2/de
Priority to US13/822,697 priority patent/US20130277872A1/en
Priority to JP2013528594A priority patent/JP2013537207A/ja
Publication of WO2012034871A2 publication Critical patent/WO2012034871A2/de
Publication of WO2012034871A3 publication Critical patent/WO2012034871A3/de

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/02Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of powders
    • 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
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089Processes

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Preparation (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
  • Immobilizing And Processing Of Enzymes And Microorganisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Die vorliegende Erfindung betrifft ein Verfahren zur automatisierten Herstellung von Wirkstoff-Beads (10; 12) mit einem gelartigen Trägermaterial, bevorzugt einem Bio-Polymer, wie etwa Agarose, und mit einem in das Trägermaterial eingebetteten biologisch aktiven Material, wie etwa einem Wirkstoff oder/und einem Wirkstoff erzeugenden Material, umfassend die folgenden Schritte: a) Bereitstellen einer fließfähigen, verfestigbaren Mischung (18), umfassend das Trägermaterial und das biologisch aktive Material, b) Verfestigen eines Kern-Beads (10) durch Einbringen einer vorbestimmten Menge (22) der fließfähigen Mischung (18) in ein Fluidbad (24), vorzugsweise Flüssigkeitsbad, besonders bevorzugt Ölbad, c) Entnehmen des Kern-Beads (10) aus dem Fluidbad (24), wobei zur Durchführung des Schritts c) eine Bead-Kontaktfläche (36; 42) eines Bead-Aufnahmewerkzeugs (34; 38) verwendet wird und Schritt c) hierzu entweder den folgenden Unterschritt ca1) oder den folgenden Unterschritt cb1) umfasst: ca1 ) Herstellen eines Anlageeingriffs zwischen dem Kern-Bead (10) und einer, vorzugsweise konkaven, Bead-Unterdruck-Kontaktfläche (42) eines Bead-Unterdruck-Aufnahmewerkzeugs (38) mittels Unterdruck, oder cb1) Herstellen eines Anlageeingriffs zwischen dem Kern-Bead (10) und einer, vorzugsweise konkaven, Bead-Schwerkraft-Kontaktfläche (36) eines Bead-Schwerkraft-Aufnahmewerkzeugs (34) in dem Fluidbad mittels Schwerkraft.
PCT/EP2011/065186 2010-09-14 2011-09-02 Verfahren zum herstellen von wirkstoff-beads WO2012034871A2 (de)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CN2011800441102A CN103209689A (zh) 2010-09-14 2011-09-02 用于制造活性成分珠粒料的方法
EP11757229.7A EP2616049A2 (de) 2010-09-14 2011-09-02 Verfahren zum herstellen von wirkstoff-beads
US13/822,697 US20130277872A1 (en) 2010-09-14 2011-09-02 Process for the production of active substance beads
JP2013528594A JP2013537207A (ja) 2010-09-14 2011-09-02 活性物質ビーズの製造方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102010040687.2 2010-09-14
DE102010040687A DE102010040687A1 (de) 2010-09-14 2010-09-14 Verfahren zum Herstellen von Wirkstoff-Beads

Publications (2)

Publication Number Publication Date
WO2012034871A2 WO2012034871A2 (de) 2012-03-22
WO2012034871A3 true WO2012034871A3 (de) 2012-09-07

Family

ID=44651711

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2011/065186 WO2012034871A2 (de) 2010-09-14 2011-09-02 Verfahren zum herstellen von wirkstoff-beads

Country Status (6)

Country Link
US (1) US20130277872A1 (de)
EP (1) EP2616049A2 (de)
JP (1) JP2013537207A (de)
CN (1) CN103209689A (de)
DE (1) DE102010040687A1 (de)
WO (1) WO2012034871A2 (de)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HUE034618T2 (en) 2012-01-31 2018-02-28 The Rogosin Inst Inc An improved process for producing macros
US10697972B2 (en) 2016-01-12 2020-06-30 Bioatla, Llc Diagnostics using conditionally active antibodies
EP3403098B1 (de) 2016-01-12 2021-09-22 BioAtla, Inc. Diagnostika mit bedingt aktiven antikörpern
DE102017106867B4 (de) * 2017-03-30 2021-12-02 Hamilton Bonaduz Ag Verfahren zur Herstellung einer Portionseinheit

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5185269A (en) * 1990-02-13 1993-02-09 Source Scientific Systems, Inc. Immunobead aspirator and method of use
USRE38027E1 (en) * 1994-01-13 2003-03-11 The Rogosin Institute Preparation of agarose coated, solid agarose-collagen beads containing secretory cells
US7297331B2 (en) * 1996-04-03 2007-11-20 The Rogosin Institute Beads containing restricted cancer cells producing material suppressing cancer cell proliferation
WO2010099893A2 (de) * 2009-03-06 2010-09-10 Wolfgang Folger Vorrichtungen und verfahren zur herstellung von eisperlen aus einem wässrigen gemisch

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Publication number Priority date Publication date Assignee Title
US4200613A (en) * 1977-06-03 1980-04-29 Ramco Laboratories Inc. Radioimmunoassay apparatus
FI86777C (fi) * 1990-12-31 1992-10-12 Medix Biochemica Ab Oy Foerfarande foer diagnosticering av bristningen av fosterhinnorna samt reagensfoerpackning foer anvaendning daervid
AU3124793A (en) * 1991-10-29 1993-06-07 Clover Consolidated, Limited Crosslinkable polysaccharides, polycations and lipids useful for encapsulation and drug release
US5286495A (en) * 1992-05-11 1994-02-15 University Of Florida Process for microencapsulating cells
USRE39542E1 (en) * 1994-01-13 2007-04-03 The Rogosin Institute Preparation of agarose coated, solid agarose-collagen beads containing secretory cells
US5662840A (en) * 1994-06-10 1997-09-02 Fmc Corporation Process for making gel microbeads
US6558665B1 (en) * 1999-05-18 2003-05-06 Arch Development Corporation Encapsulating particles with coatings that conform to size and shape of the particles
DE19941661B4 (de) * 1999-09-01 2004-06-17 Graffinity Pharmaceuticals Ag Vorrichtung und Verfahren zum Aufnehmen und Plazieren
DE10237125A1 (de) * 2002-08-13 2004-03-11 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Kryokonservierung mit einem gas- oder dampfförmigen Kühlmedium
US20050147595A1 (en) * 2003-09-29 2005-07-07 Dagmar Meissner Bead embedded cells
JP4427411B2 (ja) * 2004-07-28 2010-03-10 日立ソフトウエアエンジニアリング株式会社 ビーズ配列装置及びビーズ配列方法
DE102005018949A1 (de) * 2005-04-18 2006-10-19 Ami-Agrolinz Melamine International Gmbh Harnstoffpartikel, Verfahren zu dessen Herstellung und dessen Verwendung
JP4520359B2 (ja) * 2005-05-13 2010-08-04 日立ソフトウエアエンジニアリング株式会社 粒子捕捉装置、並びに粒子配列方法及び粒子配列装置
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Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5185269A (en) * 1990-02-13 1993-02-09 Source Scientific Systems, Inc. Immunobead aspirator and method of use
USRE38027E1 (en) * 1994-01-13 2003-03-11 The Rogosin Institute Preparation of agarose coated, solid agarose-collagen beads containing secretory cells
US7297331B2 (en) * 1996-04-03 2007-11-20 The Rogosin Institute Beads containing restricted cancer cells producing material suppressing cancer cell proliferation
WO2010099893A2 (de) * 2009-03-06 2010-09-10 Wolfgang Folger Vorrichtungen und verfahren zur herstellung von eisperlen aus einem wässrigen gemisch

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "www.SPÄTZLE.de - Grundrezept", 1 January 2007 (2007-01-01), pages 1 - 3, XP002676399, Retrieved from the Internet <URL:http://www.spaetzle.de/prt/prt_schaben.html> [retrieved on 20120523] *

Also Published As

Publication number Publication date
CN103209689A (zh) 2013-07-17
EP2616049A2 (de) 2013-07-24
JP2013537207A (ja) 2013-09-30
DE102010040687A1 (de) 2012-03-15
WO2012034871A2 (de) 2012-03-22
US20130277872A1 (en) 2013-10-24

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