CA2324254A1 - Sustained-release composition including amorphous polymer - Google Patents

Sustained-release composition including amorphous polymer Download PDF

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Publication number
CA2324254A1
CA2324254A1 CA002324254A CA2324254A CA2324254A1 CA 2324254 A1 CA2324254 A1 CA 2324254A1 CA 002324254 A CA002324254 A CA 002324254A CA 2324254 A CA2324254 A CA 2324254A CA 2324254 A1 CA2324254 A1 CA 2324254A1
Authority
CA
Canada
Prior art keywords
composition
sustained
composition including
release composition
amorphous polymer
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.)
Granted
Application number
CA002324254A
Other languages
French (fr)
Other versions
CA2324254C (en
Inventor
Theodore W. Randolph
Mark C. Manning
Richard F. Falk
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.)
University of Technology Corp
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of CA2324254A1 publication Critical patent/CA2324254A1/en
Application granted granted Critical
Publication of CA2324254C publication Critical patent/CA2324254C/en
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • A61K9/1605—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.
CA002324254A 1998-03-18 1999-03-18 Sustained-release composition including amorphous polymer Expired - Lifetime CA2324254C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US7839098P 1998-03-18 1998-03-18
US60/078,390 1998-03-18
PCT/US1999/006198 WO1999047543A2 (en) 1998-03-18 1999-03-18 Sustained-release composition including amorphous polymer

Publications (2)

Publication Number Publication Date
CA2324254A1 true CA2324254A1 (en) 1999-09-23
CA2324254C CA2324254C (en) 2005-01-04

Family

ID=22143753

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002324254A Expired - Lifetime CA2324254C (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
NZ530315A (en) * 2001-07-10 2007-01-26 Corixa Corp 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
EP1727520A2 (en) 2003-12-09 2006-12-06 Medcrystalforms, Llc Method of preparation of mixed phase co-crystals with active agents
WO2008070118A1 (en) 2006-12-05 2008-06-12 Landec Corporation Drug delivery
US8399007B2 (en) 2006-12-05 2013-03-19 Landec Corporation Method for formulating a controlled-release pharmaceutical formulation
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
BR112016002342A8 (en) * 2013-08-06 2018-01-23 Dong Kook Pharm Co Ltd entecavir microsphere, method for preparation of an entecavir microsphere, and pharmaceutical composition
EP3191138B1 (en) 2014-09-10 2024-05-29 Double Bond Pharmaceutical AB Targeted delivery of hydrophilic drugs
CN109069423A (en) * 2016-03-07 2018-12-21 双键医药品股份公司 Lung's targeted delivery of hydrophilic medicament

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4582820A (en) * 1982-12-23 1986-04-15 Research Corporation Orally administered biologically active peptides and proteins
DE3378250D1 (en) * 1982-04-22 1988-11-24 Ici Plc Continuous release formulations
CH683149A5 (en) * 1991-07-22 1994-01-31 Debio Rech Pharma Sa Process for the preparation of microspheres of a biodegradable polymeric material.
AU5171293A (en) * 1992-10-14 1994-05-09 Regents Of The University Of Colorado, The Ion-pairing of drugs for improved efficacy and delivery
DE69618938T2 (en) * 1995-03-28 2002-10-31 Fidia Advanced Biopolymers, S.R.L. NANOSPHERES WITH A BIO-COMPATIBLE POLYSACCHARIDE
AU2676397A (en) * 1996-04-18 1997-11-07 University Technology Corporation Methods for treating middle and inner ear disorders

Also Published As

Publication number Publication date
JP2002506876A (en) 2002-03-05
WO1999047543A2 (en) 1999-09-23
EP1073419A2 (en) 2001-02-07
EP1073419A4 (en) 2009-03-25
WO1999047543A3 (en) 1999-11-04
CA2324254C (en) 2005-01-04
AU3108299A (en) 1999-10-11

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Effective date: 20190318