WO2000024382A3 - Verfahren zur herstellung von festen, sphärischen formen, enthaltend eine biologisch aktive substanz - Google Patents

Verfahren zur herstellung von festen, sphärischen formen, enthaltend eine biologisch aktive substanz Download PDF

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Publication number
WO2000024382A3
WO2000024382A3 PCT/EP1999/007749 EP9907749W WO0024382A3 WO 2000024382 A3 WO2000024382 A3 WO 2000024382A3 EP 9907749 W EP9907749 W EP 9907749W WO 0024382 A3 WO0024382 A3 WO 0024382A3
Authority
WO
WIPO (PCT)
Prior art keywords
active substance
biologically active
materials containing
producing solid
spherical materials
Prior art date
Application number
PCT/EP1999/007749
Other languages
English (en)
French (fr)
Other versions
WO2000024382A2 (de
WO2000024382B1 (de
Inventor
Joerg Breitenbach
Hans Dieter Zettler
Original Assignee
Basf Ag
Joerg Breitenbach
Hans Dieter Zettler
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 Basf Ag, Joerg Breitenbach, Hans Dieter Zettler filed Critical Basf Ag
Publication of WO2000024382A2 publication Critical patent/WO2000024382A2/de
Publication of WO2000024382A3 publication Critical patent/WO2000024382A3/de
Publication of WO2000024382B1 publication Critical patent/WO2000024382B1/de

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29B—PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
    • B29B9/00—Making granules
    • B29B9/12—Making granules characterised by structure or composition
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J3/00—Processes of treating or compounding macromolecular substances
    • C08J3/12—Powdering or granulating
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J3/00—Processes of treating or compounding macromolecular substances
    • C08J3/20—Compounding polymers with additives, e.g. colouring
    • C08J3/201—Pre-melted polymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/06—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of pills, lozenges or dragees
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1658—Proteins, e.g. albumin, gelatin

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Mechanical Engineering (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Manufacturing Of Micro-Capsules (AREA)

Abstract

Verfahren zur Herstellung von festen, sphärischen Formen, enthaltend mindestens eine biologisch aktive Substanz homogen dispergiert in einer Hilfsstoffmatrix, durch Vermischen der biologisch aktiven Substanz mit einem oder mehreren Hilfsstoffen in der Schmelze, Extrusion und Formgebung der Schmelze mittels einer Düse, dadurch gekennzeichnet, dass die biologisch aktive Substanz und Hilfsstoffe enthaltende Schmelze durch Schwingungsanregung der Düse zertropft wird und die Tropfen durch Kontakt mit einer Flüssigkeit gefroren und verfestigt werden.
PCT/EP1999/007749 1998-10-22 1999-10-14 Verfahren zur herstellung von festen, sphärischen formen, enthaltend eine biologisch aktive substanz WO2000024382A2 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE1998148849 DE19848849A1 (de) 1998-10-22 1998-10-22 Verfahren zur Herstellung von festen, sphärischen Formen, enthaltend eine biologisch aktive Substanz
DE19848849.1 1998-10-22

Publications (3)

Publication Number Publication Date
WO2000024382A2 WO2000024382A2 (de) 2000-05-04
WO2000024382A3 true WO2000024382A3 (de) 2000-08-03
WO2000024382B1 WO2000024382B1 (de) 2000-09-14

Family

ID=7885366

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1999/007749 WO2000024382A2 (de) 1998-10-22 1999-10-14 Verfahren zur herstellung von festen, sphärischen formen, enthaltend eine biologisch aktive substanz

Country Status (2)

Country Link
DE (1) DE19848849A1 (de)
WO (1) WO2000024382A2 (de)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4546643B2 (ja) 1997-12-08 2010-09-15 ニコメッド ゲゼルシャフト ミット ベシュレンクテル ハフツング 酸不安定な活性化合物を含有する新規の坐剤形
PT1187601E (pt) 1999-06-07 2005-11-30 Altana Pharma Ag Nova forma de preparacao e a administracao compreendendo um inibidor da bomba de protoes instavel em meio acido
DE10217557A1 (de) * 2002-04-19 2003-11-06 Degussa Bioactives Gmbh Funktionsnahrungsmittel enthaltend eine Phospholipid-haltige stabile Matrix
BRPI0509148B8 (pt) 2004-03-22 2021-05-25 Abbott Products Gmbh composições farmacêuticas orais de produtos contendo lipase, em particular de pancreatina contendo tensoativos, seus usos e respectivos processos de fabricação
JP5140586B2 (ja) 2005-07-29 2013-02-06 アボット プロダクツ ゲゼルシャフト ミット ベシュレンクテル ハフツング 滅菌パンクレアチン粉末の製法
US11266607B2 (en) 2005-08-15 2022-03-08 AbbVie Pharmaceuticals GmbH Process for the manufacture and use of pancreatin micropellet cores
US9198871B2 (en) 2005-08-15 2015-12-01 Abbott Products Gmbh Delayed release pancreatin compositions
AU2007230730B2 (en) 2006-03-24 2013-03-28 Auxilium International Holdings, Inc. Stabilized compositions containing alkaline labile drugs
NZ572206A (en) 2006-03-24 2012-02-24 Auxilium Int Holdings Inc Process for the preparation of a hot-melt extruded laminate
US10072256B2 (en) 2006-05-22 2018-09-11 Abbott Products Gmbh Process for separating and determining the viral load in a pancreatin sample
DE102007007310B4 (de) * 2007-02-07 2012-09-27 Sandvik Materials Technology Deutschland Gmbh Vorrichtung und Verfahren zum Herstellen von Pastillen
ES2393814T3 (es) 2007-04-04 2012-12-28 Sigmoid Pharma Limited Una composición farmacéutica oral
WO2008132707A1 (en) * 2007-04-26 2008-11-06 Sigmoid Pharma Limited Manufacture of multiple minicapsules
DK2471518T3 (en) 2009-05-18 2017-12-04 Sigmoid Pharma Ltd COMPOSITION INCLUDING OIL DROPS
IN2012DN00781A (de) 2009-08-12 2015-06-26 Sigmoid Pharma Ltd
CN101647754B (zh) * 2009-09-17 2011-11-09 河北工业大学 中药滴丸预处理去油装置
MX2013008476A (es) 2011-02-17 2013-08-12 Hoffmann La Roche Proceso para cristalizacion controlada de un ingrediente farmaceutico activo a partir del estado liquido superenfriado por extrusion de fusion en caliente.
GB201212010D0 (en) 2012-07-05 2012-08-22 Sigmoid Pharma Ltd Formulations
GB201319791D0 (en) 2013-11-08 2013-12-25 Sigmoid Pharma Ltd Formulations
EP3881829A1 (de) 2014-11-07 2021-09-22 Sublimity Therapeutics Limited Cyclosporin enthaltende zusammensetzungen
GB201604639D0 (en) 2016-03-18 2016-05-04 Univ London Queen Mary Chlorhexidine crystal forms and uses thereof in medicine
EP3459527B1 (de) 2017-09-20 2022-11-23 Tillotts Pharma Ag Verfahren zur herstellung einer festen dosierungsform mit antikörpern durch nassgranulation, -extrusion und -sphäronisierung

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0438359A1 (de) * 1990-01-19 1991-07-24 Aventis Pharma S.A. Verfahren zur Herstellung kugelförmiger Arzneimittel
WO1994021371A1 (fr) * 1993-03-23 1994-09-29 Laboratoire L. Lafon Procede de preparation de particules renfermant un ingredient actif par extrusion et lyophilisation
WO1997042940A1 (en) * 1996-05-14 1997-11-20 Alkermes Controlled Therapeutics, Inc. Method for fabricating polymer-based controlled-release devices

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0438359A1 (de) * 1990-01-19 1991-07-24 Aventis Pharma S.A. Verfahren zur Herstellung kugelförmiger Arzneimittel
WO1994021371A1 (fr) * 1993-03-23 1994-09-29 Laboratoire L. Lafon Procede de preparation de particules renfermant un ingredient actif par extrusion et lyophilisation
WO1997042940A1 (en) * 1996-05-14 1997-11-20 Alkermes Controlled Therapeutics, Inc. Method for fabricating polymer-based controlled-release devices

Also Published As

Publication number Publication date
WO2000024382A2 (de) 2000-05-04
DE19848849A1 (de) 2000-04-27
WO2000024382B1 (de) 2000-09-14

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