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WO2001015664A3 - Coformulation methods and their products - Google Patents

Coformulation methods and their products 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
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.)
Ceased
Application number
PCT/GB2000/003328
Other languages
French (fr)
Other versions
WO2001015664A2 (en
Inventor
Peter York
Simon Anthony Wilkins
Richard Anthony Storey
Stephen Ernest Walker
Ronald Scott Harland
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.)
Nektar Therapeutics UK Ltd
Bristol Myers Squibb Co
Original Assignee
Bradford Particle Design Ltd
Bristol Myers Squibb Co
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 Ltd, Bristol Myers Squibb Co filed Critical Bradford Particle Design Ltd
Priority to CA002382556A priority Critical patent/CA2382556A1/en
Priority to EP00956682A priority patent/EP1207856A2/en
Priority to KR1020027002715A priority patent/KR20020047137A/en
Priority to MXPA02001803A priority patent/MXPA02001803A/en
Priority to JP2001519878A priority patent/JP2003508419A/en
Priority to AU68550/00A priority patent/AU783570B2/en
Publication of WO2001015664A2 publication Critical patent/WO2001015664A2/en
Publication of WO2001015664A3 publication Critical patent/WO2001015664A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Immunology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Neurology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

A coformulation of an active (preferably pharmaceutically active, for instance a COX-2 enzyme inhibitor) substance and an oligomeric or polymeric excipient, containing at least 10 % of the active, between 80 and 100 % of which is amorphous. The amorphous phase is stable, with respect to the crystalline phase(s), for at least theree months after its preparation when stored at between O and 10 °C. The invention also provides processes, preferably involving SEDSTM particle formation, for preparing such a coformulation.
PCT/GB2000/003328 1999-08-31 2000-08-31 Coformulation methods and their products Ceased WO2001015664A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
CA002382556A CA2382556A1 (en) 1999-08-31 2000-08-31 Coformulation methods and their products
EP00956682A EP1207856A2 (en) 1999-08-31 2000-08-31 Coformulation methods and their products
KR1020027002715A KR20020047137A (en) 1999-08-31 2000-08-31 Coformulation methods and their products
MXPA02001803A MXPA02001803A (en) 1999-08-31 2000-08-31 Coformulation methods and their products.
JP2001519878A JP2003508419A (en) 1999-08-31 2000-08-31 Co-compounding methods and their products
AU68550/00A AU783570B2 (en) 1999-08-31 2000-08-31 Coformulation methods and their products

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 (en) 2001-03-08
WO2001015664A3 true WO2001015664A3 (en) 2001-09-20

Family

ID=10860085

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2000/003328 Ceased WO2001015664A2 (en) 1999-08-31 2000-08-31 Coformulation methods and their products

Country Status (8)

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

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7575761B2 (en) 2000-06-30 2009-08-18 Novartis Pharma Ag Spray drying process control of drying kinetics
US7582284B2 (en) 2002-04-17 2009-09-01 Nektar Therapeutics Particulate materials
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
US9833451B2 (en) 2007-02-11 2017-12-05 Map Pharmaceuticals, Inc. Method of therapeutic administration of DHE to enable rapid relief of migraine while minimizing side effect profile

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2299441T3 (en) 1999-12-08 2008-06-01 Pharmacia Corporation SOLID STATE FORM OF CELECOXIB WITH POWERFUL BIODISPONIBILITY.
CH694686A5 (en) 2000-03-04 2005-06-15 Eco2 Sa Product micronization of pharmaceutical substances.
FR2815540B1 (en) † 2000-10-19 2005-06-10 Separex Sa PROCESS FOR MANUFACTURING VERY FINE PARTICLES COMPRISING A PRINCIPLE INSERTED IN A HOST MOLECULE
GB0102075D0 (en) 2001-01-26 2001-03-14 Astrazeneca Ab Process
WO2003013478A2 (en) 2001-05-30 2003-02-20 Csir Method of encapsulating an active substance
US20050271737A1 (en) * 2001-06-07 2005-12-08 Chinea Vanessa I Application of a bioactive agent to a substrate
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
US7767249B2 (en) * 2001-06-07 2010-08-03 Hewlett-Packard Development Company, L.P. Preparation of nanoparticles
PT1404300E (en) 2001-06-22 2009-11-09 Bend Res Inc Pharmaceutical compositions of dispersions of drugs and neutral polymers
GB0208742D0 (en) 2002-04-17 2002-05-29 Bradford Particle Design Ltd Particulate materials
CA2464308A1 (en) 2001-10-22 2003-05-01 Dompe S.P.A. Supercritical fluids processing: preparation of protein microparticles and their stabilisation
DE60320940D1 (en) 2002-02-01 2008-06-26 Pfizer Prod Inc PHARMACEUTICAL COMPOSITIONS OF AMORPHOUS DISPERSIONS OF ACTIVE SUBSTANCES AND LIPOPHILIC MICROPHASE-BASED MATERIALS
US9339459B2 (en) 2003-04-24 2016-05-17 Nektar Therapeutics Particulate materials
EP1624862B1 (en) 2003-05-08 2014-12-31 Nektar Therapeutics Particulate materials
WO2005011635A2 (en) 2003-08-04 2005-02-10 Pfizer Products Inc. Pharmaceutical compositions of adsorbates of amorphous drugs and lipophilic microphase-forming materials
US7507823B2 (en) 2004-05-06 2009-03-24 Bristol-Myers Squibb Company Process of making aripiprazole particles
EP2077823B1 (en) 2006-10-11 2012-06-27 Crititech, Inc. Method for precipitation of small medicament particles into use containers
GB0702402D0 (en) * 2007-02-08 2007-03-21 Thar Pharmaceuticals Inc Method of creating crystalline substances
US8585943B2 (en) 2007-12-07 2013-11-19 Xspray Microparticles Ab Method and arrangement for the production of particles
GB0812742D0 (en) 2008-07-11 2008-08-20 Critical Pharmaceuticals Ltd Process
MX350838B (en) 2011-02-11 2017-09-18 Grain Proc Corporation * Salt composition.
FI3181122T3 (en) * 2012-01-13 2023-05-31 Xspray Pharma Ab Publ Dasatinib pharmaceutical composition
HRP20210237T1 (en) * 2012-01-13 2021-03-19 Xspray Microparticles Ab PROCESS FOR THE PRODUCTION OF STABLE, AMORPHOUS HYBRID NANOPARTICLES CONTAINING AT LEAST ONE PROTEIN KINASE INHIBITOR AND AT LEAST ONE POLYMER INGREDIENT WHICH STABILIZES AND FORMS A MATRIX

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4404183A (en) * 1979-07-05 1983-09-13 Yamanouchi Pharmaceutical Co., Ltd. Sustained release pharmaceutical composition of solid medical material
WO1992011000A1 (en) * 1990-12-22 1992-07-09 Schwarz Pharma Ag Method of producing microscopic particles made of hydrolytically decomposable polymers and containing active substances
EP0582169A2 (en) * 1992-08-05 1994-02-09 Bayer S.p.A. Pharmaceutical preparations for the oral administration of dihydropyridines in beverage form
WO1995001221A1 (en) * 1993-07-01 1995-01-12 University Of Bradford Method and apparatus for the formation of particles
WO1996031202A1 (en) * 1995-04-03 1996-10-10 Elan Corporation, Plc Controlled release biodegradable micro- and nanospheres containing cyclosporin
WO1997031691A1 (en) * 1996-03-01 1997-09-04 The University Of Kansas Methods and apparatus for particle precipitation and coating using near-critical and supercritical antisolvents
WO1997044028A1 (en) * 1996-05-17 1997-11-27 Merck & Co., Inc. Compositions for a once a day treatment of cyclooxygenase-2 mediated diseases
WO1998013136A1 (en) * 1996-09-25 1998-04-02 Mainelab Method for preparing microcapsules of active substances coated with a polymer and novel microcapsules in particular resulting from the method
EP0852140A1 (en) * 1995-08-11 1998-07-08 Nissan Chemical Industries, Limited Methods for making hardly soluble medicine amorphous
WO1999025322A2 (en) * 1997-11-19 1999-05-27 Eurand International S.P.A. Pharmaceutical compositions having the shape of powders of cross-linked polymers loaded with drugs and related preparation process by supercritical fluids
WO2001003821A1 (en) * 1999-07-07 2001-01-18 Bradford Particle Design Limited Method of particle formation

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US5980942A (en) * 1997-01-23 1999-11-09 Yissum Research Development Company Of The Hebrew University Of Jerusalem Zero-order sustained release matrix tablet formulations of carbamazepine
DE19821951A1 (en) * 1998-05-15 1999-11-18 Basf Ag Orally administered solid or liquid cyclosporin compositions
US6465011B2 (en) * 1999-05-29 2002-10-15 Abbott Laboratories Formulations comprising lipid-regulating agents

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Publication number Priority date Publication date Assignee Title
US4404183A (en) * 1979-07-05 1983-09-13 Yamanouchi Pharmaceutical Co., Ltd. Sustained release pharmaceutical composition of solid medical material
WO1992011000A1 (en) * 1990-12-22 1992-07-09 Schwarz Pharma Ag Method of producing microscopic particles made of hydrolytically decomposable polymers and containing active substances
EP0582169A2 (en) * 1992-08-05 1994-02-09 Bayer S.p.A. Pharmaceutical preparations for the oral administration of dihydropyridines in beverage form
WO1995001221A1 (en) * 1993-07-01 1995-01-12 University Of Bradford Method and apparatus for the formation of particles
WO1996031202A1 (en) * 1995-04-03 1996-10-10 Elan Corporation, Plc Controlled release biodegradable micro- and nanospheres containing cyclosporin
EP0852140A1 (en) * 1995-08-11 1998-07-08 Nissan Chemical Industries, Limited Methods for making hardly soluble medicine amorphous
WO1997031691A1 (en) * 1996-03-01 1997-09-04 The University Of Kansas Methods and apparatus for particle precipitation and coating using near-critical and supercritical antisolvents
WO1997044028A1 (en) * 1996-05-17 1997-11-27 Merck & Co., Inc. Compositions for a once a day treatment of cyclooxygenase-2 mediated diseases
WO1998013136A1 (en) * 1996-09-25 1998-04-02 Mainelab Method for preparing microcapsules of active substances coated with a polymer and novel microcapsules in particular resulting from the method
WO1999025322A2 (en) * 1997-11-19 1999-05-27 Eurand International S.P.A. Pharmaceutical compositions having the shape of powders of cross-linked polymers loaded with drugs and related preparation process by supercritical fluids
WO2001003821A1 (en) * 1999-07-07 2001-01-18 Bradford Particle Design Limited Method of particle formation

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Title
DEBENEDETTI P G ET AL: "APPLICATION OF SUPERCRITICAL FLUIDS FOR THE PRODUCTION OF SUSTAINED DELIVERY DEVICES", JOURNAL OF CONTROLLED RELEASE,NL,ELSEVIER SCIENCE PUBLISHERS B.V. AMSTERDAM, vol. 24, no. 1 / 03, 1 May 1993 (1993-05-01), pages 27 - 44, XP000303918, ISSN: 0168-3659 *
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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7575761B2 (en) 2000-06-30 2009-08-18 Novartis Pharma Ag Spray drying process control of drying kinetics
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
US7582284B2 (en) 2002-04-17 2009-09-01 Nektar Therapeutics Particulate materials
US9833451B2 (en) 2007-02-11 2017-12-05 Map Pharmaceuticals, Inc. Method of therapeutic administration of DHE to enable rapid relief of migraine while minimizing side effect profile

Also Published As

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

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