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 AU20432/97A priority Critical patent/AU2043297A/en
Priority to AT97908520T priority patent/ATE227980T1/en
Priority to CA002241322A priority patent/CA2241322C/en
Priority to EP97908520A priority patent/EP0889722B1/en
Priority to US08/849,172 priority patent/US6190702B1/en
Priority to DK97908520T priority patent/DK0889722T3/en
Priority to DE69717263T priority patent/DE69717263T2/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

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
AU20432/97A AU2043297A (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
CA002241322A CA2241322C (en) 1996-03-28 1997-03-27 Sustained-release preparation and its production
EP97908520A EP0889722B1 (en) 1996-03-28 1997-03-27 Sustained-release preparation and its production
US08/849,172 US6190702B1 (en) 1996-03-28 1997-03-27 Sustained-released material prepared by dispersing a lyophilized polypeptide in an oil phase
DK97908520T DK0889722T3 (en) 1996-03-28 1997-03-27 Delayed release preparation and preparation thereof
DE69717263T DE69717263T2 (en) 1996-03-28 1997-03-27 PREPARATION WITH DELAYED RELEASE AND THEIR 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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EP0862419B2 (en) 1995-11-09 2010-11-17 Microbiological Research Authority 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
WO1999036099A1 (en) 1998-01-16 1999-07-22 Takeda Chemical Industries, Ltd. 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
WO1999048519A1 (en) 1998-03-20 1999-09-30 Takeda Chemical Industries, Ltd. Sustained-release preparation of physiologically active polypeptide and production thereof
GB9810236D0 (en) * 1998-05-13 1998-07-08 Microbiological Res Authority Improvements relating to encapsulation of bioactive agents
DE60141680D1 (en) * 2000-01-14 2010-05-12 Univ Brown Res Found PROCESS FOR PRODUCING MICRONIZED FREEZER-DRIED PARTICLES
US7029700B2 (en) 2000-01-14 2006-04-18 Brown University Research Foundation Micronized freeze-dried particles
AU4935701A (en) 2000-03-24 2001-10-08 Genentech Inc Use of insulin for the treatment of cartilagenous disorders
US7488761B2 (en) * 2000-08-07 2009-02-10 Orthogen Llc Polymer containing calcium sulfate particles for bone augmentation
US20080233165A1 (en) * 2000-08-07 2008-09-25 Biolok International, Inc. Time release calcium sulfate and growth factor matrix for bone augmentation
US6824822B2 (en) * 2001-08-31 2004-11-30 Alkermes Controlled Therapeutics Inc. Ii Residual solvent extraction method and microparticles produced thereby
EP1356809A4 (en) * 2000-12-28 2008-05-14 Takeda Pharmaceutical 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
CN1620285A (en) * 2001-12-26 2005-05-25 武田药品工业株式会社 Novel microsphere and method for production thereof
EP2298806A1 (en) 2002-10-16 2011-03-23 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
WO2005110425A1 (en) 2004-04-15 2005-11-24 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
US7456254B2 (en) * 2004-04-15 2008-11-25 Alkermes, Inc. Polymer-based sustained release device
US20060110423A1 (en) * 2004-04-15 2006-05-25 Wright Steven G Polymer-based sustained release device
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
ES2338039T3 (en) * 2005-04-13 2010-05-03 ABBOTT GMBH & CO. KG PROCEDURE FOR THE CAREFUL OBTAINING OF SUPPLIES OF ELEVATE FINE PARTICLES AND ELEVATE FINE PARTICLES, AS WELL AS THE APPLICATION.
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
PL2359808T3 (en) 2006-08-09 2013-10-31 Intarcia Therapeutics Inc Osmotic delivery systems and piston assemblies
EP2131815A4 (en) * 2007-03-22 2012-11-07 Alkermes Inc Coacervation process
MX2009011123A (en) 2007-04-23 2009-11-02 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
LT2341905T (en) * 2008-09-04 2020-09-25 Amylin Pharmaceuticals, Llc Sustained release formulations using non-aqueous carriers
BRPI0918652B1 (en) 2008-09-17 2021-10-19 Chiasma, Inc. PHARMACEUTICAL COMPOSITION INCLUDING A HYDROPHOBIC MEDIUM AND A SOLID FORM WHICH INCLUDES POLYPEPTIDE AND MEDIUM CHAIN FATTY ACID SALT, PRODUCTION PROCESS AND ORAL DOSAGE FORM
NZ598686A (en) 2009-09-28 2014-05-30 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
AU2016270984B2 (en) 2015-06-03 2021-02-25 Intarcia Therapeutics, Inc. Implant placement and removal systems
CN109310743A (en) 2016-05-16 2019-02-05 因塔西亚制药公司 Glucagon receptor selectivity polypeptide and its application method
USD840030S1 (en) 2016-06-02 2019-02-05 Intarcia Therapeutics, Inc. Implant placement guide
USD860451S1 (en) 2016-06-02 2019-09-17 Intarcia Therapeutics, Inc. Implant removal tool
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)

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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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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
ATE195652T1 (en) 1992-12-02 2000-09-15 Alkermes Inc CONTROLLED RELEASE MICROSPHERES CONTAINING GROWTH HORMONE
ATE197550T1 (en) 1993-02-23 2000-12-15 Genentech Inc STABILIZATION OF POLYPEPTIDES TREATED WITH ORGANIC SOLVENTS USING AN EXCIPIENT
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
US6190702B1 (en) 2001-02-20
EP0889722A2 (en) 1999-01-13
US20010006678A1 (en) 2001-07-05
AU2043297A (en) 1997-10-17
CA2241322A1 (en) 1997-10-02
DK0889722T3 (en) 2003-02-10
DE69717263T2 (en) 2003-07-24
DE69717263D1 (en) 2003-01-02
EP0889722B1 (en) 2002-11-20
CA2241322C (en) 2009-01-13
WO1997035563A2 (en) 1997-10-02
ATE227980T1 (en) 2002-12-15

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