WO1999047543A3 - Sustained-release composition including amorphous polymer - Google Patents

Sustained-release composition including amorphous polymer Download PDF

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Publication number
WO1999047543A3
WO1999047543A3 PCT/US1999/006198 US9906198W WO9947543A3 WO 1999047543 A3 WO1999047543 A3 WO 1999047543A3 US 9906198 W US9906198 W US 9906198W WO 9947543 A3 WO9947543 A3 WO 9947543A3
Authority
WO
WIPO (PCT)
Prior art keywords
composition
sustained
composition including
release composition
amorphous polymer
Prior art date
Application number
PCT/US1999/006198
Other languages
French (fr)
Other versions
WO1999047543A2 (en
Inventor
Theodore W Randolph
Mark C Manning
Richard F Falk
Original Assignee
Univ Technology Corp
Theodore W Randolph
Mark C Manning
Richard F Falk
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 Univ Technology Corp, Theodore W Randolph, Mark C Manning, Richard F Falk filed Critical Univ Technology Corp
Priority to EP99912785A priority Critical patent/EP1073419A4/en
Priority to JP2000536736A priority patent/JP2002506876A/en
Priority to AU31082/99A priority patent/AU3108299A/en
Priority to CA002324254A priority patent/CA2324254C/en
Publication of WO1999047543A2 publication Critical patent/WO1999047543A2/en
Publication of WO1999047543A3 publication Critical patent/WO1999047543A3/en

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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
    • A61K47/541—Organic ions forming an ion pair complex with the pharmacologically or therapeutically active agent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
    • A61K47/554—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound the modifying agent being a steroid plant sterol, glycyrrhetic acid, enoxolone or bile acid
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Botany (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Provided is a sustained release composition for sustained release of a pharmaceutical substance. The composition includes a biocompatible polymer that is highly amorphous and a pharmaceutical substance in a hydrophobic ion complex with an amphiphilic material. Also provided a compressed antisolvent method for manufacturing the composition, various product forms incorporating the composition and various uses for the composition.
PCT/US1999/006198 1998-03-18 1999-03-18 Sustained-release composition including amorphous polymer WO1999047543A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP99912785A EP1073419A4 (en) 1998-03-18 1999-03-18 Sustained-release composition including amorphous polymer
JP2000536736A JP2002506876A (en) 1998-03-18 1999-03-18 Sustained release composition comprising an amorphous polymer
AU31082/99A AU3108299A (en) 1998-03-18 1999-03-18 Sustained-release composition including amorphous polymer
CA002324254A CA2324254C (en) 1998-03-18 1999-03-18 Sustained-release composition including amorphous polymer

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US7839098P 1998-03-18 1998-03-18
US60/078,390 1998-03-18

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US09403412 A-371-Of-International 2000-03-08
US09/877,330 Continuation US6613358B2 (en) 1998-03-18 2001-06-07 Sustained-release composition including amorphous polymer

Publications (2)

Publication Number Publication Date
WO1999047543A2 WO1999047543A2 (en) 1999-09-23
WO1999047543A3 true WO1999047543A3 (en) 1999-11-04

Family

ID=22143753

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1999/006198 WO1999047543A2 (en) 1998-03-18 1999-03-18 Sustained-release composition including amorphous polymer

Country Status (5)

Country Link
EP (1) EP1073419A4 (en)
JP (1) JP2002506876A (en)
AU (1) AU3108299A (en)
CA (1) CA2324254C (en)
WO (1) WO1999047543A2 (en)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2815540B1 (en) † 2000-10-19 2005-06-10 Separex Sa PROCESS FOR MANUFACTURING VERY FINE PARTICLES COMPRISING A PRINCIPLE INSERTED IN A HOST MOLECULE
US20030108565A1 (en) * 2001-07-10 2003-06-12 Johnson Mark E. Compositions and methods for delivery of proteins and adjuvants encapsulated in microspheres
GB0216780D0 (en) * 2002-07-19 2002-08-28 Bradford Particle Design Ltd Methods of particle formation
EP1452177A1 (en) * 2003-02-27 2004-09-01 Boehringer Ingelheim International GmbH Pharmaceutical formulations comprising sodium laurylsulfate as bitterness masking agent
WO2005055983A2 (en) * 2003-12-09 2005-06-23 Medcrystalforms, Llc Method of preparation of mixed phase co-crystals with active agents
US8399007B2 (en) 2006-12-05 2013-03-19 Landec Corporation Method for formulating a controlled-release pharmaceutical formulation
CA2670749A1 (en) 2006-12-05 2008-06-12 Landec Corporation Drug delivery
US8114883B2 (en) 2007-12-04 2012-02-14 Landec Corporation Polymer formulations for delivery of bioactive materials
CA2714514C (en) * 2008-02-08 2016-08-16 Qps Llc Non-polymeric compositions for controlled drug delivery
JP2016527308A (en) * 2013-08-06 2016-09-08 ドン クック ファーマシューティカル カンパニー リミテッド Entecavir microspheres and pharmaceutical composition for parenteral administration containing the same
WO2016039678A1 (en) * 2014-09-10 2016-03-17 Double Bond Pharmaceuticals Ab Targeted delivery of hydrophilic drugs
US20210186879A1 (en) * 2016-03-07 2021-06-24 Double Bond Pharmaceuticals Ab Targeted delivery of hydrophilic drugs to lung

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4526938A (en) * 1982-04-22 1985-07-02 Imperial Chemical Industries Plc Continuous release formulations
US4582820A (en) * 1982-12-23 1986-04-15 Research Corporation Orally administered biologically active peptides and proteins
US5445832A (en) * 1991-07-22 1995-08-29 Debio Recherche Pharmaceutique S.A. Process for the preparation of microspheres made of a biodegradable polymeric material
US5770559A (en) * 1992-10-14 1998-06-23 The Regents Of The University Of Colorado Solubilization of pharmaceutical substances in an organic solvent and preparation of pharmaceutical powders using the same

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996029998A1 (en) * 1995-03-28 1996-10-03 Fidia Advanced Biopolymers S.R.L. Nanospheres comprising a biocompatible polysaccharide
AU2676397A (en) * 1996-04-18 1997-11-07 University Technology Corporation Methods for treating middle and inner ear disorders

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4526938A (en) * 1982-04-22 1985-07-02 Imperial Chemical Industries Plc Continuous release formulations
US4582820A (en) * 1982-12-23 1986-04-15 Research Corporation Orally administered biologically active peptides and proteins
US5445832A (en) * 1991-07-22 1995-08-29 Debio Recherche Pharmaceutique S.A. Process for the preparation of microspheres made of a biodegradable polymeric material
US5770559A (en) * 1992-10-14 1998-06-23 The Regents Of The University Of Colorado Solubilization of pharmaceutical substances in an organic solvent and preparation of pharmaceutical powders using the same

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP1073419A4 *

Also Published As

Publication number Publication date
CA2324254A1 (en) 1999-09-23
WO1999047543A2 (en) 1999-09-23
JP2002506876A (en) 2002-03-05
AU3108299A (en) 1999-10-11
EP1073419A2 (en) 2001-02-07
EP1073419A4 (en) 2009-03-25
CA2324254C (en) 2005-01-04

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