CA2317039A1 - Lyophilization method for sustained-release preparations - Google Patents

Lyophilization method for sustained-release preparations Download PDF

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Publication number
CA2317039A1
CA2317039A1 CA002317039A CA2317039A CA2317039A1 CA 2317039 A1 CA2317039 A1 CA 2317039A1 CA 002317039 A CA002317039 A CA 002317039A CA 2317039 A CA2317039 A CA 2317039A CA 2317039 A1 CA2317039 A1 CA 2317039A1
Authority
CA
Canada
Prior art keywords
sustained
release preparations
release preparation
lyophilization method
freeze
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
CA002317039A
Other languages
French (fr)
Other versions
CA2317039C (en
Inventor
Hisayoshi Shimizu
Muneo Nonomura
Tomomichi Futo
Kei Mukai
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.
Hisayoshi Shimizu
Muneo Nonomura
Tomomichi Futo
Kei Mukai
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., Hisayoshi Shimizu, Muneo Nonomura, Tomomichi Futo, Kei Mukai, Takeda Pharmaceutical Company Limited filed Critical Takeda Chemical Industries, Ltd.
Publication of CA2317039A1 publication Critical patent/CA2317039A1/en
Application granted granted Critical
Publication of CA2317039C publication Critical patent/CA2317039C/en
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing

Abstract

This invention provides a production method for a solid sustained-release preparation, characterized in that a sustained-release preparation (a sustained-release preparation suspension) is freeze-dried in a freeze-drying container whose inner face is partially or totally coated with an ice layer or water-repelling base material.
CA002317039A 1998-01-21 1999-01-20 Lyophilization method for sustained-release preparations Expired - Lifetime CA2317039C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP991198 1998-01-21
JP10/9911 1998-01-21
PCT/JP1999/000175 WO1999037288A1 (en) 1998-01-21 1999-01-20 Lyophilization method for sustained-release preparations

Publications (2)

Publication Number Publication Date
CA2317039A1 true CA2317039A1 (en) 1999-07-29
CA2317039C CA2317039C (en) 2009-09-29

Family

ID=11733300

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002317039A Expired - Lifetime CA2317039C (en) 1998-01-21 1999-01-20 Lyophilization method for sustained-release preparations

Country Status (10)

Country Link
US (2) US20050100604A1 (en)
EP (1) EP1049458B1 (en)
KR (1) KR100595340B1 (en)
CN (1) CN1180768C (en)
AT (1) ATE235231T1 (en)
AU (1) AU1982599A (en)
CA (1) CA2317039C (en)
DE (1) DE69906254T2 (en)
NO (1) NO20003527L (en)
WO (1) WO1999037288A1 (en)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002005787A1 (en) * 2000-07-17 2002-01-24 Takeda Chemical Industries, Ltd. Production method for freeze-dried products
WO2002078673A1 (en) * 2001-03-29 2002-10-10 Takeda Chemical Industries, Ltd. Process for producing fine granulate drug
WO2004000363A1 (en) * 2002-06-25 2003-12-31 Takeda Pharmaceutical Company Limited Process for producing sustained-release composition
EP1870649A1 (en) 2006-06-20 2007-12-26 Octapharma AG Lyophilisation targetting defined residual moisture by limited desorption energy levels
US20100186252A1 (en) * 2009-01-29 2010-07-29 Morimoto-Pharma Co., Ltd. Freeze-drying method and apparatus
CN108571862A (en) * 2017-03-07 2018-09-25 成都青山利康药业有限公司 A kind of freeze-drying stripping means of film
CN111840758A (en) * 2020-07-03 2020-10-30 广州曼翔医药有限公司 Eustachian tube balloon catheter
US11287185B1 (en) 2020-09-09 2022-03-29 Stay Fresh Technology, LLC Freeze drying with constant-pressure and constant-temperature phases

Family Cites Families (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3928566A (en) * 1970-08-14 1975-12-23 Du Pont Lyophilized biological products
JPS60100516A (en) 1983-11-04 1985-06-04 Takeda Chem Ind Ltd Preparation of sustained release microcapsule
ATE61935T1 (en) 1985-02-07 1991-04-15 Takeda Chemical Industries Ltd PROCESS FOR PRODUCTION OF MICROCAPSULES.
JPS6349683A (en) 1986-08-19 1988-03-02 共和真空技術株式会社 Freeze-drying method and device
US4722943A (en) * 1987-03-19 1988-02-02 Pierce & Stevens Corporation Composition and process for drying and expanding microspheres
CA1334379C (en) 1987-11-24 1995-02-14 James William Mcginity Method for preparing a solid sustained release form of a functionally active composition
US4878597A (en) * 1988-03-24 1989-11-07 Haast William E Lyophilization containers
US5044091B1 (en) * 1989-04-18 1997-12-30 Sankyo Co Method of preparing a freeze-dried formulation of a drug
JP2533174Y2 (en) * 1989-04-24 1997-04-23 日東電工株式会社 Adhesive tape for diapers
JP2653255B2 (en) 1990-02-13 1997-09-17 武田薬品工業株式会社 Long-term sustained release microcapsules
DE4004620C1 (en) 1990-02-15 1991-09-05 Du Pont De Nemours (Deutschland) Gmbh, 6380 Bad Homburg, De Photo-structured layer of three=dimensional object prodn. - by using fusible plastisol or organosol contg. unsatd. monomer, photoinitiator and thermally reactive cpd.
JP2551881B2 (en) 1991-06-26 1996-11-06 株式会社大塚製薬工場 Freeze-drying container and method for producing freeze-dried drug in filled container
KR100259989B1 (en) 1991-10-01 2000-08-01 모리다 가쓰라 Prolonged release microparticle preparation and production of the same
ES2110573T3 (en) 1992-08-07 1998-02-16 Takeda Chemical Industries Ltd PRODUCTION OF MICROCAPSULES OF DRUGS SOLUBLE IN WATER.
JP3277342B2 (en) 1992-09-02 2002-04-22 武田薬品工業株式会社 Manufacturing method of sustained release microcapsules
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
US5514670A (en) * 1993-08-13 1996-05-07 Pharmos Corporation Submicron emulsions for delivery of peptides
US5594091A (en) * 1994-02-21 1997-01-14 Takeda Chemical Industries, Ltd. Matrix for sustained-release preparation
US6117455A (en) * 1994-09-30 2000-09-12 Takeda Chemical Industries, Ltd. Sustained-release microcapsule of amorphous water-soluble pharmaceutical active agent
JP3790567B2 (en) 1994-09-30 2006-06-28 武田薬品工業株式会社 Sustained release agent
US6294202B1 (en) 1994-10-06 2001-09-25 Genzyme Corporation Compositions containing polyanionic polysaccharides and hydrophobic bioabsorbable polymers
EP0750913A3 (en) * 1995-06-30 1997-11-05 Takeda Chemical Industries, Ltd. Disaccharide containing freeze-dried preparation for pharmaceutical use
TW448055B (en) 1995-09-04 2001-08-01 Takeda Chemical Industries Ltd Method of production of sustained-release preparation
JPH0995440A (en) 1995-09-29 1997-04-08 Roussel Morishita Kk Sustained release preparation and its production
US5665428A (en) 1995-10-25 1997-09-09 Macromed, Inc. Preparation of peptide containing biodegradable microspheres by melt process
CA2192773C (en) * 1995-12-15 2008-09-23 Hiroaki Okada Production of sustained-release preparation for injection
JP3765338B2 (en) 1995-12-15 2006-04-12 武田薬品工業株式会社 Manufacturing method of sustained-release preparation for injection
AU2043297A (en) * 1996-03-28 1997-10-17 Takeda Chemical Industries Ltd. Sustained-release preparation and its production
US6287587B2 (en) * 1997-07-15 2001-09-11 Takeda Chemical Industries, Ltd. Process for producing sustained-release preparation by in-water drying
JP3639783B2 (en) * 2000-10-30 2005-04-20 共和真空技術株式会社 Freeze-drying method and freeze-drying equipment for food and medicine
JP3653239B2 (en) * 2001-06-14 2005-05-25 共和真空技術株式会社 Freeze-drying equipment for food and medicine

Also Published As

Publication number Publication date
ATE235231T1 (en) 2003-04-15
US20050100604A1 (en) 2005-05-12
CN1180768C (en) 2004-12-22
KR100595340B1 (en) 2006-07-03
DE69906254D1 (en) 2003-04-30
NO20003527L (en) 2000-09-05
US20110070311A1 (en) 2011-03-24
DE69906254T2 (en) 2003-11-13
CA2317039C (en) 2009-09-29
WO1999037288A1 (en) 1999-07-29
EP1049458A1 (en) 2000-11-08
CN1288374A (en) 2001-03-21
KR20010034271A (en) 2001-04-25
US8927016B2 (en) 2015-01-06
AU1982599A (en) 1999-08-09
EP1049458B1 (en) 2003-03-26
NO20003527D0 (en) 2000-07-07

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MKEX Expiry

Effective date: 20190121