CA2241322A1 - Sustained-release preparation and its production - Google Patents

Sustained-release preparation and its production

Info

Publication number
CA2241322A1
CA2241322A1 CA002241322A CA2241322A CA2241322A1 CA 2241322 A1 CA2241322 A1 CA 2241322A1 CA 002241322 A CA002241322 A CA 002241322A CA 2241322 A CA2241322 A CA 2241322A CA 2241322 A1 CA2241322 A1 CA 2241322A1
Authority
CA
Canada
Prior art keywords
sustained
production
release preparation
dispersing
surfactant
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.)
Granted
Application number
CA002241322A
Other languages
French (fr)
Other versions
CA2241322C (en
Inventor
Shigeyuki Takada
Tomofumi Kurokawa
Susumu Iwasa
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.)
Takeda Pharmaceutical Co Ltd
Original Assignee
Takeda Chemical Industries, Ltd.
Shigeyuki Takada
Tomofumi Kurokawa
Susumu Iwasa
Takeda Pharmaceutical Company Limited
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, Takeda Pharmaceutical Company Limited filed Critical Takeda Chemical Industries, Ltd.
Publication of CA2241322A1 publication Critical patent/CA2241322A1/en
Application granted granted Critical
Publication of CA2241322C publication Critical patent/CA2241322C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • 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
    • 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

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.
CA002241322A 1996-03-28 1997-03-27 Sustained-release preparation and its production Expired - Fee Related CA2241322C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP8/73016 1996-03-28
JP7301696 1996-03-28
PCT/JP1997/001041 WO1997035563A2 (en) 1996-03-28 1997-03-27 Sustained-release preparation and its production

Publications (2)

Publication Number Publication Date
CA2241322A1 true CA2241322A1 (en) 1997-10-02
CA2241322C CA2241322C (en) 2009-01-13

Family

ID=13506129

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002241322A Expired - Fee Related CA2241322C (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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EP1048301A4 (en) 1998-01-16 2005-03-09 Takeda Chemical Industries Ltd Sustained release compositions, process for producing the same and utilization thereof
DE69906254T2 (en) * 1998-01-21 2003-11-13 Takeda Chemical Industries Ltd METHOD FOR FREEZING DRYING PREPARATIONS WITH DELAYED DELIVERY OF ACTIVE SUBSTANCE
AU744354B2 (en) 1998-03-20 2002-02-21 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
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
ES2266187T3 (en) 2000-03-24 2007-03-01 Genentech, Inc. USE OF INSULIN FOR THE TREATMENT OF CARTILAGO 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
EP1466596B8 (en) * 2001-12-26 2017-01-11 Takeda Pharmaceutical Company Limited Microsphere and method for production thereof
US7429382B2 (en) 2002-10-16 2008-09-30 Corixa Corporation Antibodies that bind cell-associated CA 125/O772P and methods of use thereof
US7164005B2 (en) * 2002-10-17 2007-01-16 Alkermes, Inc. Microencapsulation and sustained release of biologically active polypeptides
US20070219131A1 (en) * 2004-04-15 2007-09-20 Ben-Sasson Shmuel A Compositions capable of facilitating penetration across a biological barrier
KR101040415B1 (en) * 2004-04-15 2011-06-09 알케르메스,인코포레이티드 Polymer-based sustained release device
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
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
WO2006108637A2 (en) * 2005-04-13 2006-10-19 Abbott Gmbh & Co.Kg Method for carefully producing ultrafine particle suspensions and ultrafine particles and use thereof
ES2422864T3 (en) 2006-08-09 2013-09-16 Intarcia Therapeutics, Inc Osmotic release systems and piston units
JP2010522196A (en) * 2007-03-22 2010-07-01 アルカームズ,インコーポレイテッド Coacervation process
WO2008133908A2 (en) 2007-04-23 2008-11-06 Intarcia Therapeutics, Inc. Suspension formulations of insulinotropic peptides and uses thereof
WO2008157540A1 (en) * 2007-06-20 2008-12-24 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
SG10201703039SA (en) * 2008-09-04 2017-05-30 Amylin Pharmaceuticals Llc Sustained release formulations using non-aqueous carriers
KR101683314B1 (en) 2008-09-17 2016-12-06 키아스마 인코포레이티드 Pharmaceutical compositions and related methods of delivery
WO2011037623A1 (en) 2009-09-28 2011-03-31 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
CN113598842A (en) 2015-06-03 2021-11-05 因塔西亚制药公司 Implant placement and removal system
EP3458084B1 (en) 2016-05-16 2020-04-01 Intarcia Therapeutics, Inc Glucagon-receptor selective polypeptides and methods of use thereof
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
EP3585364B1 (en) 2017-02-24 2021-04-28 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

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US4774091A (en) 1983-10-14 1988-09-27 Sumitomo Pharmaceuticals Company, Ltd. Long-term sustained-release preparation
US5385738A (en) 1983-10-14 1995-01-31 Sumitomo Pharmaceuticals Company, Ltd. Sustained-release injection
US4963367A (en) 1984-04-27 1990-10-16 Medaphore, Inc. Drug delivery compositions and methods
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
NZ240214A (en) * 1990-10-16 1993-02-25 Takeda Chemical Industries Ltd Polymer compositions comprising a polylactic acid and a copolymer of glycolic acid and a hydroxycarboxylic acid; use as carrier for prolonged release pharmaceutical compositions of water soluble drugs
US5288502A (en) 1991-10-16 1994-02-22 The University Of Texas System Preparation and uses of multi-phase microspheres
PT674506E (en) 1992-12-02 2001-01-31 Alkermes Inc MICROSPHERES CONTAINING GROWTH HORMONE WITH CONTROLLED LIBERATION
DK0686045T3 (en) 1993-02-23 2001-03-05 Genentech Inc Stabilization of organic solvent-treated polypeptides with an adjuvant
NZ260909A (en) 1993-07-05 1995-04-27 Takeda Chemical Industries Ltd Production of sustained release preparation by allowing a water-soluble polypeptide to permeate into a biodegradable matrix in an aqueous solution
DE69415684T2 (en) * 1993-10-22 1999-06-10 Genentech Inc METHOD FOR PRODUCING MICROSPHERES WITH A FLUIDIZED LAYER
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

Also Published As

Publication number Publication date
AU2043297A (en) 1997-10-17
WO1997035563A3 (en) 1997-11-20
EP0889722A2 (en) 1999-01-13
WO1997035563A2 (en) 1997-10-02
CA2241322C (en) 2009-01-13
DE69717263D1 (en) 2003-01-02
EP0889722B1 (en) 2002-11-20
DE69717263T2 (en) 2003-07-24
DK0889722T3 (en) 2003-02-10
ATE227980T1 (en) 2002-12-15
US20010006678A1 (en) 2001-07-05
US6190702B1 (en) 2001-02-20

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Legal Events

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EEER Examination request
MKLA Lapsed

Effective date: 20150327