WO1997035563A3 - Sustained-release preparation and its production - Google Patents

Sustained-release preparation and its production Download PDF

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Publication number
WO1997035563A3
WO1997035563A3 PCT/JP1997/001041 JP9701041W WO9735563A3 WO 1997035563 A3 WO1997035563 A3 WO 1997035563A3 JP 9701041 W JP9701041 W JP 9701041W WO 9735563 A3 WO9735563 A3 WO 9735563A3
Authority
WO
WIPO (PCT)
Prior art keywords
sustained
production
release preparation
dispersing
surfactant
Prior art date
Application number
PCT/JP1997/001041
Other languages
French (fr)
Other versions
WO1997035563A2 (en
Inventor
Shigeyuki Takada
Tomofumi Kurokawa
Susumu Iwasa
Original Assignee
Takeda Chemical Industries Ltd
Shigeyuki Takada
Tomofumi Kurokawa
Susumu Iwasa
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 Takeda Chemical Industries Ltd, Shigeyuki Takada, Tomofumi Kurokawa, Susumu Iwasa filed Critical Takeda Chemical Industries Ltd
Priority to CA002241322A priority Critical patent/CA2241322C/en
Priority to AT97908520T priority patent/ATE227980T1/en
Priority to DK97908520T priority patent/DK0889722T3/en
Priority to US08/849,172 priority patent/US6190702B1/en
Priority to EP97908520A priority patent/EP0889722B1/en
Priority to DE69717263T priority patent/DE69717263T2/en
Priority to AU20432/97A priority patent/AU2043297A/en
Publication of WO1997035563A2 publication Critical patent/WO1997035563A2/en
Publication of WO1997035563A3 publication Critical patent/WO1997035563A3/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
    • A61K9/1629—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
    • 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)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Disclosed is a sustained-release preparation characterized in that it is produced by dispersing in an oil phase a rapidly dried product containing a bioactive polypeptide and a surfactant, and subsequent shaping, and a method of its production.
PCT/JP1997/001041 1996-03-28 1997-03-27 Sustained-release preparation and its production WO1997035563A2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
CA002241322A CA2241322C (en) 1996-03-28 1997-03-27 Sustained-release preparation and its production
AT97908520T ATE227980T1 (en) 1996-03-28 1997-03-27 SUSTAINED RELEASE PREPARATION AND PRODUCTION THEREOF
DK97908520T DK0889722T3 (en) 1996-03-28 1997-03-27 Delayed release preparation and preparation thereof
US08/849,172 US6190702B1 (en) 1996-03-28 1997-03-27 Sustained-released material prepared by dispersing a lyophilized polypeptide in an oil phase
EP97908520A EP0889722B1 (en) 1996-03-28 1997-03-27 Sustained-release preparation and its production
DE69717263T DE69717263T2 (en) 1996-03-28 1997-03-27 PREPARATION WITH DELAYED RELEASE AND THEIR PRODUCTION
AU20432/97A AU2043297A (en) 1996-03-28 1997-03-27 Sustained-release preparation and its production

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP7301696 1996-03-28
JP8/73016 1996-03-28

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US08/849,172 A-371-Of-International US6190702B1 (en) 1996-03-28 1997-03-27 Sustained-released material prepared by dispersing a lyophilized polypeptide in an oil phase
US09/764,052 Division US20010006678A1 (en) 1996-03-28 2001-01-19 Sustained-release material prepared by dispersing a lyophilized polypeptide in an oil phase

Publications (2)

Publication Number Publication Date
WO1997035563A2 WO1997035563A2 (en) 1997-10-02
WO1997035563A3 true WO1997035563A3 (en) 1997-11-20

Family

ID=13506129

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP1997/001041 WO1997035563A2 (en) 1996-03-28 1997-03-27 Sustained-release preparation and its production

Country Status (8)

Country Link
US (2) US6190702B1 (en)
EP (1) EP0889722B1 (en)
AT (1) ATE227980T1 (en)
AU (1) AU2043297A (en)
CA (1) CA2241322C (en)
DE (1) DE69717263T2 (en)
DK (1) DK0889722T3 (en)
WO (1) WO1997035563A2 (en)

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US6270795B1 (en) 1995-11-09 2001-08-07 Microbiological Research Authority Method of making microencapsulated DNA for vaccination and gene therapy
US6287587B2 (en) 1997-07-15 2001-09-11 Takeda Chemical Industries, Ltd. Process for producing sustained-release preparation by in-water drying
HUP0100221A3 (en) 1998-01-16 2002-11-28 Takeda Pharmaceutical Sustained release compositions, process for producing the same and utilization thereof
CA2317039C (en) * 1998-01-21 2009-09-29 Takeda Chemical Industries, Ltd. Lyophilization method for sustained-release preparations
DK1061948T3 (en) 1998-03-20 2003-03-31 Takeda Chemical Industries Ltd Preparation for sustained release of a physiologically active polypeptide and its preparation
GB9810236D0 (en) 1998-05-13 1998-07-08 Microbiological Res Authority Improvements relating to encapsulation of bioactive agents
US7029700B2 (en) 2000-01-14 2006-04-18 Brown University Research Foundation Micronized freeze-dried particles
AU773735B2 (en) * 2000-01-14 2004-06-03 Brown University Research Foundation Micronized freeze-dried particles
WO2001072323A2 (en) 2000-03-24 2001-10-04 Genentech, Inc. Use of insulin for the treatment of cartilagenous disorders
US20080233165A1 (en) * 2000-08-07 2008-09-25 Biolok International, Inc. Time release calcium sulfate and growth factor matrix for bone augmentation
US7488761B2 (en) * 2000-08-07 2009-02-10 Orthogen Llc Polymer containing calcium sulfate particles for bone augmentation
US6824822B2 (en) * 2001-08-31 2004-11-30 Alkermes Controlled Therapeutics Inc. Ii Residual solvent extraction method and microparticles produced thereby
WO2002053136A1 (en) 2000-12-28 2002-07-11 Takeda Chemical Industries, Ltd. Sustained release preparations
JP2002265383A (en) * 2001-03-14 2002-09-18 Mitsubishi Pharma Corp LIQUID PREPARATION FOR INTERFERON-alpha INJECTION
WO2002078673A1 (en) * 2001-03-29 2002-10-10 Takeda Chemical Industries, Ltd. Process for producing fine granulate drug
US20040126900A1 (en) * 2001-04-13 2004-07-01 Barry Stephen E High affinity peptide- containing nanoparticles
US6887897B2 (en) 2001-07-31 2005-05-03 Mission Pharmacal Company Calcium glutarate supplement and phosphorus binder
CN101444476B (en) * 2001-12-26 2011-11-30 武田药品工业株式会社 New microsphere and method for producing the same
EP1551876B1 (en) 2002-10-16 2011-03-16 Purdue Pharma L.P. Antibodies that bind cell-associated ca 125/0722p and methods of use thereof
WO2004035762A2 (en) * 2002-10-17 2004-04-29 Alkermes Controlled Therapeutics, Inc. Ii Microencapsulation and sustained release of biologically active polypeptides
US20060110423A1 (en) * 2004-04-15 2006-05-25 Wright Steven G Polymer-based sustained release device
CN1968700A (en) * 2004-04-15 2007-05-23 阿尔克姆斯有限公司 Polymer-based sustained release device
US7456254B2 (en) * 2004-04-15 2008-11-25 Alkermes, Inc. Polymer-based sustained release device
US20070219131A1 (en) * 2004-04-15 2007-09-20 Ben-Sasson Shmuel A Compositions capable of facilitating penetration across a biological barrier
US8075910B2 (en) * 2004-05-20 2011-12-13 Pbm Pharmaceuticals, Inc. Oral compositions comprising edible oils and vitamins and/or minerals and methods for making oral compositions
US11246913B2 (en) 2005-02-03 2022-02-15 Intarcia Therapeutics, Inc. Suspension formulation comprising an insulinotropic peptide
DE102005017777A1 (en) * 2005-04-13 2006-10-19 Pharmasol Gmbh Preparation of high fine particle suspension comprises dissolving solid in a solvent, freezing, lyophilizing solid matrix, withdrawing solid matrix from solvent and dispersing in an external phase and applying high power on the dispersion
US9248101B2 (en) * 2005-04-13 2016-02-02 Abbvie Deutschland Gmbh & Co Kg Method for the gentle production of ultrafine particle suspensions and ultrafine particles and the use thereof
KR101200728B1 (en) 2006-08-09 2012-11-13 인타르시아 세라퓨틱스 인코포레이티드 Osmotic delivery system and piston assemblies
WO2008118712A1 (en) * 2007-03-22 2008-10-02 Alkermes, Inc. Coacervation process
AU2008244523B2 (en) 2007-04-23 2012-02-16 Intarcia Therapeutics, Inc. Suspension formulations of insulinotropic peptides and uses thereof
US20080317865A1 (en) * 2007-06-20 2008-12-25 Alkermes, Inc. Quench liquids and washing systems for production of microparticles
EP2044934A1 (en) * 2007-10-01 2009-04-08 Institut National De La Sante Et De La Recherche Medicale (Inserm) Dispersion of poloxamer-protein particles, methods of manufacturing and uses thereof
EP2240155B1 (en) 2008-02-13 2012-06-06 Intarcia Therapeutics, Inc Devices, formulations, and methods for delivery of multiple beneficial agents
FI2341905T4 (en) * 2008-09-04 2023-12-04 Amylin Pharmaceuticals Llc Sustained release formulations using non-aqueous carriers
CA2963659C (en) 2008-09-17 2020-06-23 Chiasma Inc. Use of oral octreotride compositions
SI2462246T1 (en) 2009-09-28 2018-01-31 Intarcia Therapeutics, Inc. Rapid establishment and/or termination of substantial steady-state drug delivery
US20120208755A1 (en) 2011-02-16 2012-08-16 Intarcia Therapeutics, Inc. Compositions, Devices and Methods of Use Thereof for the Treatment of Cancers
US9889085B1 (en) 2014-09-30 2018-02-13 Intarcia Therapeutics, Inc. Therapeutic methods for the treatment of diabetes and related conditions for patients with high baseline HbA1c
EP3253401A4 (en) 2015-02-03 2018-11-21 Chiasma Inc. Method of treating diseases
KR20240042548A (en) 2015-06-03 2024-04-02 인타르시아 세라퓨틱스 인코포레이티드 Implant placement and removal systems
MA53353A (en) 2016-05-16 2021-06-09 Intarcia Therapeutics Inc GLUCAGON RECEPTOR SELECTIVE POLYPEPTIDES AND METHODS FOR THEIR USE
USD860451S1 (en) 2016-06-02 2019-09-17 Intarcia Therapeutics, Inc. Implant removal tool
USD840030S1 (en) 2016-06-02 2019-02-05 Intarcia Therapeutics, Inc. Implant placement guide
EP3565580B1 (en) 2017-01-03 2024-03-06 i2o Therapeutics, Inc. Continuous administration of exenatide and co-adminstration of acetaminophen, ethinylestradiol or levonorgestrel
EP4218738A1 (en) 2017-02-24 2023-08-02 The Regents of The University of California Particle-drop structures and methods for making and using the same
US11141457B1 (en) 2020-12-28 2021-10-12 Amryt Endo, Inc. Oral octreotide therapy and contraceptive methods

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4963367A (en) * 1984-04-27 1990-10-16 Medaphore, Inc. Drug delivery compositions and methods
US5288502A (en) * 1991-10-16 1994-02-22 The University Of Texas System Preparation and uses of multi-phase microspheres
EP0633020A1 (en) * 1993-07-05 1995-01-11 Takeda Chemical Industries, Ltd. Method of producing sustained-release preparation
WO1995011009A1 (en) * 1993-10-22 1995-04-27 Genentech, Inc. Method for preparing microspheres comprising a fluidized bed drying step

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US5385738A (en) 1983-10-14 1995-01-31 Sumitomo Pharmaceuticals Company, Ltd. Sustained-release injection
US4774091A (en) 1983-10-14 1988-09-27 Sumitomo Pharmaceuticals Company, Ltd. Long-term sustained-release preparation
US4962091A (en) 1986-05-23 1990-10-09 Syntex (U.S.A.) Inc. Controlled release of macromolecular polypeptides
JP3116311B2 (en) 1990-06-13 2000-12-11 エーザイ株式会社 Manufacturing method of microsphere
NO302481B1 (en) 1990-10-16 1998-03-09 Takeda Chemical Industries Ltd Polymer for an extended release preparation, as well as an extended release preparation
DK0674506T3 (en) 1992-12-02 2001-01-08 Alkermes Inc Controlled release growth hormone-containing microspheres
JP3698721B2 (en) 1993-02-23 2005-09-21 ジェネンテク・インコーポレイテッド Excipient stabilization of polypeptides treated with organic solvents
US6117455A (en) * 1994-09-30 2000-09-12 Takeda Chemical Industries, Ltd. Sustained-release microcapsule of amorphous water-soluble pharmaceutical active agent
TW448055B (en) * 1995-09-04 2001-08-01 Takeda Chemical Industries Ltd Method of production of sustained-release preparation
EP0765660A3 (en) * 1995-09-28 1998-09-23 Takeda Chemical Industries, Ltd. Microcapsules comprising 2-piperazinone-1-acetic acid compounds

Patent Citations (4)

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Publication number Priority date Publication date Assignee Title
US4963367A (en) * 1984-04-27 1990-10-16 Medaphore, Inc. Drug delivery compositions and methods
US5288502A (en) * 1991-10-16 1994-02-22 The University Of Texas System Preparation and uses of multi-phase microspheres
EP0633020A1 (en) * 1993-07-05 1995-01-11 Takeda Chemical Industries, Ltd. Method of producing sustained-release preparation
WO1995011009A1 (en) * 1993-10-22 1995-04-27 Genentech, Inc. Method for preparing microspheres comprising a fluidized bed drying step

Also Published As

Publication number Publication date
CA2241322A1 (en) 1997-10-02
CA2241322C (en) 2009-01-13
DK0889722T3 (en) 2003-02-10
DE69717263T2 (en) 2003-07-24
ATE227980T1 (en) 2002-12-15
AU2043297A (en) 1997-10-17
US20010006678A1 (en) 2001-07-05
WO1997035563A2 (en) 1997-10-02
EP0889722B1 (en) 2002-11-20
US6190702B1 (en) 2001-02-20
DE69717263D1 (en) 2003-01-02
EP0889722A2 (en) 1999-01-13

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