WO1996040074A3 - Device for releasing aggregation-stabilized, biologically active agent - Google Patents

Device for releasing aggregation-stabilized, biologically active agent Download PDF

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Publication number
WO1996040074A3
WO1996040074A3 PCT/US1996/008526 US9608526W WO9640074A3 WO 1996040074 A3 WO1996040074 A3 WO 1996040074A3 US 9608526 W US9608526 W US 9608526W WO 9640074 A3 WO9640074 A3 WO 9640074A3
Authority
WO
WIPO (PCT)
Prior art keywords
stabilized
biologically active
active agent
aggregation
releasing
Prior art date
Application number
PCT/US1996/008526
Other languages
French (fr)
Other versions
WO1996040074A2 (en
Inventor
Paul A Burke
Stephen E Zale
Mark A Tracy
Olufunmi Lily Johnson
Howard Bernstein
M Amin Khan
Avram Brickner
Henry Auer
Original Assignee
Alkermes Inc
Paul A Burke
Stephen E Zale
Mark A Tracy
Olufunmi Lily Johnson
Howard Bernstein
M Amin Khan
Avram Brickner
Henry Auer
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
Priority claimed from US08/473,544 external-priority patent/US5654010A/en
Priority claimed from US08/478,502 external-priority patent/US5716644A/en
Priority claimed from US08/483,318 external-priority patent/US5674534A/en
Application filed by Alkermes Inc, Paul A Burke, Stephen E Zale, Mark A Tracy, Olufunmi Lily Johnson, Howard Bernstein, M Amin Khan, Avram Brickner, Henry Auer filed Critical Alkermes Inc
Priority to JP50109797A priority Critical patent/JP2001515457A/en
Priority to AU60341/96A priority patent/AU705968B2/en
Priority to EP96917966A priority patent/EP0831786A2/en
Publication of WO1996040074A2 publication Critical patent/WO1996040074A2/en
Publication of WO1996040074A3 publication Critical patent/WO1996040074A3/en

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1816—Erythropoietin [EPO]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/27—Growth hormone [GH], i.e. somatotropin
    • 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
    • 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
    • A61K9/1611—Inorganic 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
    • A61K9/1605—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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Endocrinology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Nanotechnology (AREA)
  • Biotechnology (AREA)
  • Biophysics (AREA)
  • General Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

A device for the sustained release in vivo of a water soluble, biologically active agent wherein the agent is susceptible to aggregation comprising a drug delivery device and aggregation-stabilized, biologically active agent wherein the aggregation-stabilized agent is disposed within the drug delivery device.
PCT/US1996/008526 1995-06-07 1996-06-04 Device for releasing aggregation-stabilized, biologically active agent WO1996040074A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP50109797A JP2001515457A (en) 1995-06-07 1996-06-04 Aggregation-stabilized bioactive substance release device
AU60341/96A AU705968B2 (en) 1995-06-07 1996-06-04 Device for releasing aggregation-stabilized, biologically active agent
EP96917966A EP0831786A2 (en) 1995-06-07 1996-06-04 Device for releasing aggregation-stabilized, biologically active agent

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
US08/473,544 US5654010A (en) 1992-12-02 1995-06-07 Composition for sustained release of human growth hormone
US08/478,502 US5716644A (en) 1992-06-11 1995-06-07 Composition for sustained release of non-aggregated erythropoietin
US08/483,318 US5674534A (en) 1992-06-11 1995-06-07 Composition for sustained release of non-aggregated erythropoietin
US08/477,725 US5667808A (en) 1992-12-02 1995-06-07 Composition for sustained release of human growth hormone
US52174495A 1995-08-31 1995-08-31
US08/478,502 1995-08-31
US08/483,318 1995-08-31
US08/521,744 1995-08-31
US08/477,725 1995-08-31
US08/473,544 1995-08-31

Publications (2)

Publication Number Publication Date
WO1996040074A2 WO1996040074A2 (en) 1996-12-19
WO1996040074A3 true WO1996040074A3 (en) 1997-02-06

Family

ID=27541710

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1996/008526 WO1996040074A2 (en) 1995-06-07 1996-06-04 Device for releasing aggregation-stabilized, biologically active agent

Country Status (5)

Country Link
EP (1) EP0831786A2 (en)
JP (1) JP2001515457A (en)
AU (1) AU705968B2 (en)
CA (1) CA2223583A1 (en)
WO (1) WO1996040074A2 (en)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6265389B1 (en) 1995-08-31 2001-07-24 Alkermes Controlled Therapeutics, Inc. Microencapsulation and sustained release of oligonucleotides
US6191107B1 (en) 1997-09-26 2001-02-20 Takeda Chemical Industries, Ltd. Complex of human growth hormone and zinc
SE512663C2 (en) 1997-10-23 2000-04-17 Biogram Ab Active substance encapsulation process in a biodegradable polymer
WO2000045847A1 (en) * 1999-02-05 2000-08-10 Alk-Abelló A/S Novel mucosal delivery system
US6451347B1 (en) 1999-03-01 2002-09-17 Alkermes Controlled Therapeutics, Inc. Method for purifying human growth hormone
US6284283B1 (en) 1999-10-21 2001-09-04 Alkermes Controlled Therapeutics, Inc. Method of producing sub-micron particles of biologically active agents and uses thereof
US6465425B1 (en) 2000-02-10 2002-10-15 Alkermes Controlled Therapeutics, Inc. Microencapsulation and sustained release of biologically active acid-stable or free sulfhydryl-containing proteins
AU2002232824A1 (en) † 2000-12-21 2002-07-01 Inhale Therapeutic Systems, Inc. Induced phase transition method for the production of microparticles containing hydrophobic active agents
US8637077B2 (en) 2000-12-28 2014-01-28 Takeda Pharmaceutical Company Limited Sustained-release preparation
JP5160005B2 (en) * 2000-12-28 2013-03-13 武田薬品工業株式会社 Sustained release formulation
US7318931B2 (en) 2001-06-21 2008-01-15 Genentech, Inc. Sustained release formulation
US6818613B2 (en) * 2001-11-07 2004-11-16 Ortho-Mcneil Pharmaceutical, Inc. Aqueous sustained-release formulations of proteins
WO2003066000A2 (en) * 2002-02-08 2003-08-14 Wyeth Formulation comprising bioactive agents and method of using same
GB0812742D0 (en) 2008-07-11 2008-08-20 Critical Pharmaceuticals Ltd Process

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994012158A1 (en) * 1992-12-02 1994-06-09 Alkermes Controlled Therapeutics, Inc. Controlled release growth hormone containing microspheres
WO1995029664A1 (en) * 1994-05-03 1995-11-09 Alkermes Controlled Therapeutics, Inc. Modulated release from biocompatible polymers

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994012158A1 (en) * 1992-12-02 1994-06-09 Alkermes Controlled Therapeutics, Inc. Controlled release growth hormone containing microspheres
WO1995029664A1 (en) * 1994-05-03 1995-11-09 Alkermes Controlled Therapeutics, Inc. Modulated release from biocompatible polymers

Also Published As

Publication number Publication date
AU6034196A (en) 1996-12-30
AU705968B2 (en) 1999-06-03
CA2223583A1 (en) 1996-12-19
WO1996040074A2 (en) 1996-12-19
JP2001515457A (en) 2001-09-18
EP0831786A2 (en) 1998-04-01

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