WO2001015664A3 - Procedes de coformulation et leurs produits - Google Patents

Procedes de coformulation et leurs produits Download PDF

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Publication number
WO2001015664A3
WO2001015664A3 PCT/GB2000/003328 GB0003328W WO0115664A3 WO 2001015664 A3 WO2001015664 A3 WO 2001015664A3 GB 0003328 W GB0003328 W GB 0003328W WO 0115664 A3 WO0115664 A3 WO 0115664A3
Authority
WO
WIPO (PCT)
Prior art keywords
coformulation
active
products
methods
amorphous
Prior art date
Application number
PCT/GB2000/003328
Other languages
English (en)
Other versions
WO2001015664A2 (fr
Inventor
Peter York
Simon Anthony Wilkins
Richard Anthony Storey
Stephen Ernest Walker
Ronald Scott Harland
Original Assignee
Bradford Particle Design Plc
Bristol Myers Squibb Co
Peter York
Simon Anthony Wilkins
Richard Anthony Storey
Stephen Ernest Walker
Ronald Scott Harland
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 Bradford Particle Design Plc, Bristol Myers Squibb Co, Peter York, Simon Anthony Wilkins, Richard Anthony Storey, Stephen Ernest Walker, Ronald Scott Harland filed Critical Bradford Particle Design Plc
Priority to MXPA02001803A priority Critical patent/MXPA02001803A/es
Priority to AU68550/00A priority patent/AU783570B2/en
Priority to EP00956682A priority patent/EP1207856A2/fr
Priority to KR1020027002715A priority patent/KR20020047137A/ko
Priority to JP2001519878A priority patent/JP2003508419A/ja
Priority to CA002382556A priority patent/CA2382556A1/fr
Publication of WO2001015664A2 publication Critical patent/WO2001015664A2/fr
Publication of WO2001015664A3 publication Critical patent/WO2001015664A3/fr

Links

Classifications

    • 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
    • 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
    • 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
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61P15/06—Antiabortive agents; Labour repressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D11/00—Solvent extraction
    • B01D11/04—Solvent extraction of solutions which are liquid
    • B01D11/0403—Solvent extraction of solutions which are liquid with a supercritical fluid
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D11/00—Solvent extraction
    • B01D11/04—Solvent extraction of solutions which are liquid
    • B01D11/0403—Solvent extraction of solutions which are liquid with a supercritical fluid
    • B01D11/0407—Solvent extraction of solutions which are liquid with a supercritical fluid the supercritical fluid acting as solvent for the solute
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D11/00—Solvent extraction
    • B01D11/04—Solvent extraction of solutions which are liquid
    • B01D11/0403—Solvent extraction of solutions which are liquid with a supercritical fluid
    • B01D11/0411—Solvent extraction of solutions which are liquid with a supercritical fluid the supercritical fluid acting as solvent for the solvent and as anti-solvent for the solute, e.g. formation of particles from solutions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D11/00—Solvent extraction
    • B01D11/04—Solvent extraction of solutions which are liquid
    • B01D11/0488—Flow sheets

Abstract

L'invention concerne une coformulation d'une substance active (de préférence active au plan pharmaceutique, comme par exemple un inhibiteur enzymatique COX-2) et d'un excipient oligomère ou polymère, contenant au moins 10 % de substance active dont 80 à 100 % est actif. La phase amorphe est stable, par rapport à la/aux phases cristallines, pendant au moins trois mois après sa préparation, lorsqu'elle est stockée entre 0 et 10 °C. L'invention porte également sur des procédés, impliquant de préférence la formation de particules SEDSTM, pour la préparation de ladite coformulation.
PCT/GB2000/003328 1999-08-31 2000-08-31 Procedes de coformulation et leurs produits WO2001015664A2 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
MXPA02001803A MXPA02001803A (es) 1999-08-31 2000-08-31 Metodos de coformulacion y sus productos.
AU68550/00A AU783570B2 (en) 1999-08-31 2000-08-31 Coformulation methods and their products
EP00956682A EP1207856A2 (fr) 1999-08-31 2000-08-31 Procedes de coformulation et leurs produits
KR1020027002715A KR20020047137A (ko) 1999-08-31 2000-08-31 공조제 방법 및 그것의 산물
JP2001519878A JP2003508419A (ja) 1999-08-31 2000-08-31 共配合方法およびそれらの製品
CA002382556A CA2382556A1 (fr) 1999-08-31 2000-08-31 Procedes de coformulation et leurs produits

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9920558.5 1999-08-31
GBGB9920558.5A GB9920558D0 (en) 1999-08-31 1999-08-31 Methods for particle formation and their products

Publications (2)

Publication Number Publication Date
WO2001015664A2 WO2001015664A2 (fr) 2001-03-08
WO2001015664A3 true WO2001015664A3 (fr) 2001-09-20

Family

ID=10860085

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2000/003328 WO2001015664A2 (fr) 1999-08-31 2000-08-31 Procedes de coformulation et leurs produits

Country Status (8)

Country Link
EP (1) EP1207856A2 (fr)
JP (1) JP2003508419A (fr)
KR (1) KR20020047137A (fr)
AU (1) AU783570B2 (fr)
CA (1) CA2382556A1 (fr)
GB (2) GB9920558D0 (fr)
MX (1) MXPA02001803A (fr)
WO (1) WO2001015664A2 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8936813B2 (en) 2001-11-01 2015-01-20 Novartis Ag Spray drying methods and related compositions
US9120031B2 (en) 2000-11-09 2015-09-01 Nektar Therapeutics Compositions of particulate coformulation

Families Citing this family (24)

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Publication number Priority date Publication date Assignee Title
NZ513964A (en) 1999-12-08 2004-01-30 Pharmacia Corp Solid-state form of celecoxib having enhanced bioavailability
CH694686A5 (it) 2000-03-04 2005-06-15 Eco2 Sa Prodotto di micronizzazione di sostanze farmaceutiche.
FR2815540B1 (fr) † 2000-10-19 2005-06-10 Separex Sa Procede de fabrication de tres fines particules constituees d'un principe insere dans une molecule hote
GB0102075D0 (en) 2001-01-26 2001-03-14 Astrazeneca Ab Process
EP1401404B1 (fr) 2001-05-30 2008-04-16 Csir Procede d'encapsulation d'une substance active
US20050260273A1 (en) * 2001-06-07 2005-11-24 Chinea Vanessa I Applicatin of a bioactive agent in a solvent composition to produce a target particle morphology
US20050271737A1 (en) * 2001-06-07 2005-12-08 Chinea Vanessa I Application of a bioactive agent to a substrate
US7767249B2 (en) * 2001-06-07 2010-08-03 Hewlett-Packard Development Company, L.P. Preparation of nanoparticles
ATE444060T1 (de) 2001-06-22 2009-10-15 Pfizer Prod Inc Pharmazeutische zusammensetzungen enthaltend dispersionen aus arzneistoffen und neutralen polymeren
GB0208742D0 (en) 2002-04-17 2002-05-29 Bradford Particle Design Ltd Particulate materials
CA2464308A1 (fr) 2001-10-22 2003-05-01 Dompe S.P.A. Traitement de fluides supercritiques : preparation de microparticules de proteines et leur stabilisation
ES2305434T3 (es) 2002-02-01 2008-11-01 Pfizer Products Inc. Composiciones framaceuticas de dispersiones amorfas de farmacos y materiales que forman microfases lipofilas.
US9339459B2 (en) 2003-04-24 2016-05-17 Nektar Therapeutics Particulate materials
EP1624862B1 (fr) 2003-05-08 2014-12-31 Nektar Therapeutics Materiaux particulaires
MXPA06001417A (es) 2003-08-04 2006-05-15 Pfizer Prod Inc Composiciones farmaceuticas de adsorbatos de farmacos amorfos y materiales que forman microfases lipofilas.
US7507823B2 (en) 2004-05-06 2009-03-24 Bristol-Myers Squibb Company Process of making aripiprazole particles
WO2008070279A2 (fr) 2006-10-11 2008-06-12 Crititech, Inc. Procédé pour précipiter de petites particules de médicament dans des contenants d'utilisation
GB0702402D0 (en) 2007-02-08 2007-03-21 Thar Pharmaceuticals Inc Method of creating crystalline substances
MX2009008582A (es) 2007-02-11 2009-10-30 Map Pharmaceuticals Inc Metodo para la administracion terapeutica de dihidroergotamina para permitir un rapido alivio de la migraña mientras se minimiza el perfil de efectos secundarios.
PL2229233T3 (pl) 2007-12-07 2020-03-31 Xspray Pharma Ab (Publ) Sposób wytwarzania cząstek
GB0812742D0 (en) 2008-07-11 2008-08-20 Critical Pharmaceuticals Ltd Process
MX350838B (es) 2011-02-11 2017-09-18 Grain Proc Corporation * Composicion de sal.
MX371297B (es) * 2012-01-13 2020-01-24 Xspray Microparticles Ab Una composición farmacéutica que comprende nanopartículas híbridas amorfas estables, de al menos un inhibidor de proteína quinasa y al menos un componente estabilizador polimérico y formador de matriz.
EP3181128B1 (fr) * 2012-01-13 2023-03-08 XSpray Pharma AB (publ) Composition pharmaceutique du nilotinib

Citations (11)

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US4404183A (en) * 1979-07-05 1983-09-13 Yamanouchi Pharmaceutical Co., Ltd. Sustained release pharmaceutical composition of solid medical material
WO1992011000A1 (fr) * 1990-12-22 1992-07-09 Schwarz Pharma Ag Procede pour la fabrication de microparticules constituees de polymeres hydrolytiquement degradables et contenant des principes actifs
EP0582169A2 (fr) * 1992-08-05 1994-02-09 Bayer S.p.A. Préparations pharmaceutiques pour l'administration orale des dihydropyridines sous forme de boisson
WO1995001221A1 (fr) * 1993-07-01 1995-01-12 University Of Bradford Procede et appareillage permettant la formation de particules
WO1996031202A1 (fr) * 1995-04-03 1996-10-10 Elan Corporation, Plc Microspheres et nanospheres biodegradables a liberation lente renfermant de la cyclosporine
WO1997031691A1 (fr) * 1996-03-01 1997-09-04 The University Of Kansas Procedes et appareil pour la precipitation et l'enrobage de particules au moyen d'antisolvants quasi-critiques et supercritiques
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WO1992011000A1 (fr) * 1990-12-22 1992-07-09 Schwarz Pharma Ag Procede pour la fabrication de microparticules constituees de polymeres hydrolytiquement degradables et contenant des principes actifs
EP0582169A2 (fr) * 1992-08-05 1994-02-09 Bayer S.p.A. Préparations pharmaceutiques pour l'administration orale des dihydropyridines sous forme de boisson
WO1995001221A1 (fr) * 1993-07-01 1995-01-12 University Of Bradford Procede et appareillage permettant la formation de particules
WO1996031202A1 (fr) * 1995-04-03 1996-10-10 Elan Corporation, Plc Microspheres et nanospheres biodegradables a liberation lente renfermant de la cyclosporine
EP0852140A1 (fr) * 1995-08-11 1998-07-08 Nissan Chemical Industries, Limited Procedes permettant de rendre amorphes des medicaments peu solubles
WO1997031691A1 (fr) * 1996-03-01 1997-09-04 The University Of Kansas Procedes et appareil pour la precipitation et l'enrobage de particules au moyen d'antisolvants quasi-critiques et supercritiques
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WO1998013136A1 (fr) * 1996-09-25 1998-04-02 Mainelab Procede de preparation de microcapsules de matieres actives enrobees par un polymere et nouvelles microcapsules notamment obtenues selon le procede
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9120031B2 (en) 2000-11-09 2015-09-01 Nektar Therapeutics Compositions of particulate coformulation
US8936813B2 (en) 2001-11-01 2015-01-20 Novartis Ag Spray drying methods and related compositions

Also Published As

Publication number Publication date
WO2001015664A2 (fr) 2001-03-08
GB0021227D0 (en) 2000-10-18
KR20020047137A (ko) 2002-06-21
JP2003508419A (ja) 2003-03-04
MXPA02001803A (es) 2004-02-26
AU6855000A (en) 2001-03-26
GB9920558D0 (en) 1999-11-03
GB2355194B (en) 2003-01-08
AU783570B2 (en) 2005-11-10
EP1207856A2 (fr) 2002-05-29
CA2382556A1 (fr) 2001-03-08
GB2355194A (en) 2001-04-18

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