AU2004251456B2 - Use of ethanol as plasticizer for preparing subcutaneous implants containing thermolabile active principles dispersed in a PLGA matrix - Google Patents

Use of ethanol as plasticizer for preparing subcutaneous implants containing thermolabile active principles dispersed in a PLGA matrix Download PDF

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Publication number
AU2004251456B2
AU2004251456B2 AU2004251456A AU2004251456A AU2004251456B2 AU 2004251456 B2 AU2004251456 B2 AU 2004251456B2 AU 2004251456 A AU2004251456 A AU 2004251456A AU 2004251456 A AU2004251456 A AU 2004251456A AU 2004251456 B2 AU2004251456 B2 AU 2004251456B2
Authority
AU
Australia
Prior art keywords
plga
weight
ethanol
plasticized
stage
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
AU2004251456A
Other languages
English (en)
Other versions
AU2004251456A1 (en
Inventor
Pierre Marion
Patrice Mauriac
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.)
Mediolanum Pharmaceuticals Ltd
Original Assignee
Mediolanum Pharmaceuticals Ltd
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 Mediolanum Pharmaceuticals Ltd filed Critical Mediolanum Pharmaceuticals Ltd
Publication of AU2004251456A1 publication Critical patent/AU2004251456A1/en
Application granted granted Critical
Publication of AU2004251456B2 publication Critical patent/AU2004251456B2/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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/16—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
    • A61L—METHODS 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
    • A61L31/00—Materials 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
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L31/00—Materials 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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/141—Plasticizers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L31/00—Materials 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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2300/00—Biologically 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)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
  • Thermotherapy And Cooling Therapy Devices (AREA)
AU2004251456A 2003-06-26 2004-06-24 Use of ethanol as plasticizer for preparing subcutaneous implants containing thermolabile active principles dispersed in a PLGA matrix Ceased AU2004251456B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
ITMI2003A001302 2003-06-26
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
AU2004251456A1 AU2004251456A1 (en) 2005-01-06
AU2004251456B2 true AU2004251456B2 (en) 2009-12-03

Family

ID=30131301

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2004251456A Ceased AU2004251456B2 (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

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)

Families Citing this family (15)

* 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
US8329203B2 (en) 2004-01-12 2012-12-11 The Trustees Of The University Of Pennsylvania Drug-containing implants and methods of use thereof
US8221778B2 (en) 2005-01-12 2012-07-17 The Trustees Of The University Of Pennsylvania Drug-containing implants and methods of use thereof
US8541028B2 (en) 2004-08-04 2013-09-24 Evonik Corporation Methods for manufacturing delivery devices and devices thereof
EP1909689A4 (en) * 2005-07-18 2011-11-16 Univ Pennsylvania PHARMACEUTICAL IMPLANTS AND METHOD OF USE 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
DE602007008125D1 (de) 2006-10-31 2010-09-09 Surmodics Pharmaceuticals Inc Kugelförmige polymer-teilchen
ES2718612T3 (es) 2007-12-20 2019-07-03 Evonik Corp Procedimiento para preparar micropartículas que tienen un bajo volumen de disolvente residual
US9498431B2 (en) * 2008-12-10 2016-11-22 Jianjian Xu Controlled releasing composition
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
GB201314312D0 (en) * 2013-08-09 2013-09-25 Regentec Ltd Composition and delivery system
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
EP3177319A1 (en) * 2014-08-04 2017-06-14 Janssen Sciences Ireland UC Compacted solid dosage form
GB201702475D0 (en) * 2017-02-15 2017-03-29 Locate Therapeutics Ltd Tissue scaffold and scaffold composition
EP3459527B1 (en) * 2017-09-20 2022-11-23 Tillotts Pharma Ag Method for preparing a solid dosage form comprising antibodies by wet granulation, extrusion and spheronization

Family Cites Families (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
IT1304152B1 (it) * 1998-12-10 2001-03-08 Mediolanum Farmaceutici Srl Composizioni comprendenti un peptide ed acido polilattico-glicolicoatte alla preparazione di impianti sottocutanei aventi un prolungato
CN100446809C (zh) 2001-11-14 2008-12-31 阿尔扎有限公司 可注射的长效组合物

Also Published As

Publication number Publication date
PT1638534E (pt) 2008-09-29
EP1638534B1 (en) 2008-06-18
CA2530117C (en) 2012-01-10
MXPA05013697A (es) 2006-05-17
DE602004014496D1 (de) 2008-07-31
KR101143771B1 (ko) 2012-05-11
KR20060079146A (ko) 2006-07-05
WO2005000277A1 (en) 2005-01-06
AU2004251456A1 (en) 2005-01-06
US20060171987A1 (en) 2006-08-03
US8206621B2 (en) 2012-06-26
CY1108346T1 (el) 2014-02-12
EP1638534A1 (en) 2006-03-29
ITMI20031302A0 (it) 2003-06-26
CN1812770A (zh) 2006-08-02
JP2009513165A (ja) 2009-04-02
ES2308195T3 (es) 2008-12-01
PL1638534T3 (pl) 2009-02-27
ITMI20031302A1 (it) 2004-12-27
CA2530117A1 (en) 2005-01-06
CN100509060C (zh) 2009-07-08
BRPI0411759A (pt) 2006-08-08
HK1089954A1 (en) 2006-12-15
ATE398447T1 (de) 2008-07-15

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Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired