JP2009513165A - Plgaマトリックス中に分散された熱不安定性活性成分を含有する皮下インプラントを製造するための可塑剤としてのエタノールの使用 - Google Patents

Plgaマトリックス中に分散された熱不安定性活性成分を含有する皮下インプラントを製造するための可塑剤としてのエタノールの使用 Download PDF

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Publication number
JP2009513165A
JP2009513165A JP2006516183A JP2006516183A JP2009513165A JP 2009513165 A JP2009513165 A JP 2009513165A JP 2006516183 A JP2006516183 A JP 2006516183A JP 2006516183 A JP2006516183 A JP 2006516183A JP 2009513165 A JP2009513165 A JP 2009513165A
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Prior art keywords
plga
weight
ethanol
plasticized
concentration
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JP2006516183A
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English (en)
Japanese (ja)
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JP2009513165A5 (enExample
Inventor
パトリス モーリアク
ピエール マリオン
Original Assignee
メディオラニューム ファーマシューティカルス リミテッド
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Publication of JP2009513165A publication Critical patent/JP2009513165A/ja
Publication of JP2009513165A5 publication Critical patent/JP2009513165A5/ja
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647Polyesters, e.g. poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • A61L31/06Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/141Plasticizers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Materials For Medical Uses (AREA)
  • Medicinal Preparation (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Thermotherapy And Cooling Therapy Devices (AREA)
JP2006516183A 2003-06-26 2004-06-24 Plgaマトリックス中に分散された熱不安定性活性成分を含有する皮下インプラントを製造するための可塑剤としてのエタノールの使用 Pending JP2009513165A (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT001302A ITMI20031302A1 (it) 2003-06-26 2003-06-26 Uso di etanolo come plasticizzante per preparare impianti sottocutanei contenenti principi attivi termolabili dispersi in una matrice di plga.
PCT/EP2004/051226 WO2005000277A1 (en) 2003-06-26 2004-06-24 Use of ethanol as plasticizer for preparing subcutaneous implants containing thermolabile active principles dispersed in a plga matrix

Publications (2)

Publication Number Publication Date
JP2009513165A true JP2009513165A (ja) 2009-04-02
JP2009513165A5 JP2009513165A5 (enExample) 2011-05-06

Family

ID=30131301

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2006516183A Pending JP2009513165A (ja) 2003-06-26 2004-06-24 Plgaマトリックス中に分散された熱不安定性活性成分を含有する皮下インプラントを製造するための可塑剤としてのエタノールの使用

Country Status (17)

Country Link
US (1) US8206621B2 (enExample)
EP (1) EP1638534B1 (enExample)
JP (1) JP2009513165A (enExample)
KR (1) KR101143771B1 (enExample)
CN (1) CN100509060C (enExample)
AT (1) ATE398447T1 (enExample)
AU (1) AU2004251456B2 (enExample)
BR (1) BRPI0411759A (enExample)
CA (1) CA2530117C (enExample)
CY (1) CY1108346T1 (enExample)
DE (1) DE602004014496D1 (enExample)
ES (1) ES2308195T3 (enExample)
IT (1) ITMI20031302A1 (enExample)
MX (1) MXPA05013697A (enExample)
PL (1) PL1638534T3 (enExample)
PT (1) PT1638534E (enExample)
WO (1) WO2005000277A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016530252A (ja) * 2013-08-09 2016-09-29 ロケート・セラピューティクス・リミテッド 組成物および送達系

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7666445B2 (en) 2000-10-20 2010-02-23 The Trustees Of The University Of Pennsylvania Polymer-based surgically implantable haloperidol delivery systems and methods for their production and use
US8221778B2 (en) 2005-01-12 2012-07-17 The Trustees Of The University Of Pennsylvania Drug-containing implants and methods of use thereof
AU2006269927B2 (en) * 2004-01-12 2013-05-16 The Trustees Of The University Of Pennsylvania Drug-containing implants and methods of use thereof
US8329203B2 (en) 2004-01-12 2012-12-11 The Trustees Of The University Of Pennsylvania Drug-containing implants and methods of use thereof
AU2005325213B2 (en) 2004-08-04 2010-10-07 Evonik Operations Gmbh Methods for manufacturing delivery devices and devices thereof
ITMI20061539A1 (it) * 2006-08-02 2008-02-03 Mediolanum Pharmaceuticals Ltd Impianti sottocutanei in grado di rilasciare il principio attivo per un periodo prolungato di tempo
JP5419699B2 (ja) 2006-10-31 2014-02-19 エボニック コーポレイション 球状化されたポリマー粒子
JP5502751B2 (ja) 2007-12-20 2014-05-28 エボニック コーポレイション 低残留溶媒濃度を有する微粒子を調製するためのプロセス
CN102281870B (zh) * 2008-12-10 2015-03-04 安徽中人科技有限责任公司 新型控释组合物
CA2804035A1 (en) * 2010-06-30 2012-01-05 Evonik Degussa Corporation Implant processing methods for thermally labile and other bioactive agents and implants prepared from same
CN103623415B (zh) * 2013-12-04 2015-03-25 北京诺康达医药科技有限公司 一种用于生物多肽制剂的plga与乙醇的复合物
US20170231916A1 (en) * 2014-08-04 2017-08-17 Janssen Sciences Ireland Uc Compacted solid dosage form
GB201702475D0 (en) * 2017-02-15 2017-03-29 Locate Therapeutics Ltd Tissue scaffold and scaffold composition
ES2938608T3 (es) * 2017-09-20 2023-04-13 Tillotts Pharma Ag Método para preparar una forma farmacéutica sólida que comprende anticuerpos mediante granulación en húmedo, extrusión y esferonización

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0549629A (ja) * 1991-08-23 1993-03-02 Konica Corp 医用放射線画像読影装置
US5520923A (en) * 1994-09-19 1996-05-28 Genetics Institute, Inc. Formulations for delivery of osteogenic proteins
JP2002531486A (ja) * 1998-12-10 2002-09-24 メディオラヌム ファルマチェウティチ ソシエタ ペル アチオニ 放出時間が延長された皮下インプラントを製造するのに適したペプチドとポリ乳酸グリコール酸とを含む組成物
JP2005514350A (ja) * 2001-11-14 2005-05-19 アルザ・コーポレーション 注入可能なデポー組成物

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0549629A (ja) * 1991-08-23 1993-03-02 Konica Corp 医用放射線画像読影装置
US5520923A (en) * 1994-09-19 1996-05-28 Genetics Institute, Inc. Formulations for delivery of osteogenic proteins
JP2002531486A (ja) * 1998-12-10 2002-09-24 メディオラヌム ファルマチェウティチ ソシエタ ペル アチオニ 放出時間が延長された皮下インプラントを製造するのに適したペプチドとポリ乳酸グリコール酸とを含む組成物
JP2005514350A (ja) * 2001-11-14 2005-05-19 アルザ・コーポレーション 注入可能なデポー組成物

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016530252A (ja) * 2013-08-09 2016-09-29 ロケート・セラピューティクス・リミテッド 組成物および送達系

Also Published As

Publication number Publication date
PT1638534E (pt) 2008-09-29
KR20060079146A (ko) 2006-07-05
ITMI20031302A1 (it) 2004-12-27
ATE398447T1 (de) 2008-07-15
HK1089954A1 (en) 2006-12-15
ES2308195T3 (es) 2008-12-01
AU2004251456B2 (en) 2009-12-03
MXPA05013697A (es) 2006-05-17
US20060171987A1 (en) 2006-08-03
EP1638534A1 (en) 2006-03-29
PL1638534T3 (pl) 2009-02-27
KR101143771B1 (ko) 2012-05-11
CA2530117C (en) 2012-01-10
WO2005000277A1 (en) 2005-01-06
CY1108346T1 (el) 2014-02-12
ITMI20031302A0 (it) 2003-06-26
EP1638534B1 (en) 2008-06-18
CA2530117A1 (en) 2005-01-06
DE602004014496D1 (de) 2008-07-31
US8206621B2 (en) 2012-06-26
CN1812770A (zh) 2006-08-02
CN100509060C (zh) 2009-07-08
AU2004251456A1 (en) 2005-01-06
BRPI0411759A (pt) 2006-08-08

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