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WO2009028598A1 - 徐放性製剤及びその製造方法 - Google Patents

徐放性製剤及びその製造方法 Download PDF

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Publication number
WO2009028598A1
WO2009028598A1 PCT/JP2008/065385 JP2008065385W WO2009028598A1 WO 2009028598 A1 WO2009028598 A1 WO 2009028598A1 JP 2008065385 W JP2008065385 W JP 2008065385W WO 2009028598 A1 WO2009028598 A1 WO 2009028598A1
Authority
WO
WIPO (PCT)
Prior art keywords
preparation
sustained release
production
release preparation
downsizing
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.)
Ceased
Application number
PCT/JP2008/065385
Other languages
English (en)
French (fr)
Inventor
Taro Kanamaru
Shinichiro Tajiri
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.)
Daiichi Sankyo Co Ltd
Original Assignee
Daiichi Sankyo Co Ltd
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 Daiichi Sankyo Co Ltd filed Critical Daiichi Sankyo Co Ltd
Priority to EP08828416.1A priority Critical patent/EP2191848A4/en
Priority to US12/675,350 priority patent/US20100221335A1/en
Priority to JP2009530175A priority patent/JP5545952B2/ja
Publication of WO2009028598A1 publication Critical patent/WO2009028598A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/439—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom the ring forming part of a bridged ring system, e.g. quinuclidine
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

本発明は、高水溶性薬物においても、１日１回投与を可能とする溶出プロファイルを付与可能である徐放性製剤であって、安定な薬物の溶出挙動と、製剤の小型化を兼ね備えた製剤及びその製造方法を提供する。 高水溶性薬物、ゲル形成性高分子及び脂溶性低融点物質を含有する製剤は、１日１回投与が可能な徐放性製剤として使用可能であり、製剤の小型化が可能で、簡便に製造することができ、上記課題を解決した。
PCT/JP2008/065385 2007-08-31 2008-08-28 徐放性製剤及びその製造方法 Ceased WO2009028598A1 (ja)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP08828416.1A EP2191848A4 (en) 2007-08-31 2008-08-28 PREPARATION WITH DELAYED RELEASE AND METHOD OF MANUFACTURING THEREOF
US12/675,350 US20100221335A1 (en) 2007-08-31 2008-08-28 Sustained-release preparation and method for producing the same
JP2009530175A JP5545952B2 (ja) 2007-08-31 2008-08-28 徐放性製剤及びその製造方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2007-226491 2007-08-31
JP2007226491 2007-08-31

Publications (1)

Publication Number Publication Date
WO2009028598A1 true WO2009028598A1 (ja) 2009-03-05

Family

ID=40387312

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2008/065385 Ceased WO2009028598A1 (ja) 2007-08-31 2008-08-28 徐放性製剤及びその製造方法

Country Status (5)

Country Link
US (1) US20100221335A1 (ja)
EP (1) EP2191848A4 (ja)
JP (1) JP5545952B2 (ja)
TW (1) TW200914067A (ja)
WO (1) WO2009028598A1 (ja)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011158870A1 (ja) * 2010-06-16 2011-12-22 帝人ファーマ株式会社 放出制御型の有核錠剤
JP2013010751A (ja) * 2011-05-31 2013-01-17 Sawai Pharmaceutical Co Ltd クロピドグレル含有錠剤及びその製造方法
JP2013018769A (ja) * 2011-06-14 2013-01-31 Taisho Pharmaceutical Co Ltd 生薬含有固形製剤
JP2014501722A (ja) * 2010-11-18 2014-01-23 アドビセンヌ クレブス回路前駆体塩、特にクエン酸塩を含んでなる医薬組成物、及び医薬としてのこれらの使用

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012068076A2 (en) * 2010-11-15 2012-05-24 Dr. Reddy's Laboratories Ltd. Pharmaceutical formulations containing soluble drugs
US10874741B2 (en) 2017-08-28 2020-12-29 Spectrix Therapeutics, LLC Compound to treat Sjogren's syndrome
CN115364063B (zh) * 2021-08-27 2024-03-29 成都硕德药业有限公司 一种枸橼酸钾缓释片及其制备方法

Citations (10)

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US5403593A (en) 1991-03-04 1995-04-04 Sandoz Ltd. Melt granulated compositions for preparing sustained release dosage forms
JPH0920686A (ja) * 1995-07-07 1997-01-21 Teikoku Seiyaku Co Ltd 持続性製剤およびその製法
US5861173A (en) 1995-11-28 1999-01-19 Bayer Aktiengesellschaft Long-lasting release nifedipine preparation
JP2000034224A (ja) 1998-05-11 2000-02-02 Freunt Ind Co Ltd 徐放性錠剤、その添加剤組成物及びそれらの製造方法
JP2001503766A (ja) * 1996-11-12 2001-03-21 フアーマシア・アンド・アツプジヨン・アー・ベー 複数の多孔質セルロースマトリクス（ｐｃｍ）を含むコンパクト部材、その製造および使用方法
JP2001515030A (ja) * 1997-08-15 2001-09-18 フイズ テクノロジーズ リミテッド 水溶性医薬品を含む放出が制御された剤型
US6419954B1 (en) 2000-05-19 2002-07-16 Yamanouchi Pharmaceutical Co., Ltd. Tablets and methods for modified release of hydrophilic and other active agents
US20020160050A1 (en) 1999-09-28 2002-10-31 H. Lundbeck A/S Melt granulated composition and modified release dosage form prepared from said composition
WO2006121941A2 (en) * 2005-05-10 2006-11-16 Novartis Ag Pharmaceutical compositions comprising imatinib and a release retardant
WO2006122022A2 (en) * 2005-05-10 2006-11-16 Novartis Ag Modified release famciclovir pharmaceutical compositions

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JPS6143108A (ja) * 1984-08-03 1986-03-01 Nippon Shinyaku Co Ltd 医薬品製剤及びその製造法
US5585155A (en) * 1995-06-07 1996-12-17 Andersen Corporation Fiber reinforced thermoplastic structural member
SE9604124D0 (sv) * 1996-11-12 1996-11-12 Pharmacia & Upjohn Ab Compact member, method of manufacturing and use thereof
FR2797185B1 (fr) * 1999-08-06 2001-10-26 Galenix Dev Composition pharmaceutique flottante comprenant une phase active et une phase non active
ES2392705T3 (es) * 2000-10-02 2012-12-13 Usv Ltd. Composiciones farmacéuticas de liberación sostenida que contienen metformina y método para su producción
US20030021841A1 (en) * 2001-07-02 2003-01-30 Matharu Amol Singh Pharmaceutical composition
US7959946B2 (en) * 2002-09-20 2011-06-14 Watson Pharmaceuticals, Inc. Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5403593A (en) 1991-03-04 1995-04-04 Sandoz Ltd. Melt granulated compositions for preparing sustained release dosage forms
JPH0920686A (ja) * 1995-07-07 1997-01-21 Teikoku Seiyaku Co Ltd 持続性製剤およびその製法
US5861173A (en) 1995-11-28 1999-01-19 Bayer Aktiengesellschaft Long-lasting release nifedipine preparation
JP2001503766A (ja) * 1996-11-12 2001-03-21 フアーマシア・アンド・アツプジヨン・アー・ベー 複数の多孔質セルロースマトリクス（ｐｃｍ）を含むコンパクト部材、その製造および使用方法
JP2001515030A (ja) * 1997-08-15 2001-09-18 フイズ テクノロジーズ リミテッド 水溶性医薬品を含む放出が制御された剤型
JP2000034224A (ja) 1998-05-11 2000-02-02 Freunt Ind Co Ltd 徐放性錠剤、その添加剤組成物及びそれらの製造方法
US20020160050A1 (en) 1999-09-28 2002-10-31 H. Lundbeck A/S Melt granulated composition and modified release dosage form prepared from said composition
US6419954B1 (en) 2000-05-19 2002-07-16 Yamanouchi Pharmaceutical Co., Ltd. Tablets and methods for modified release of hydrophilic and other active agents
WO2006121941A2 (en) * 2005-05-10 2006-11-16 Novartis Ag Pharmaceutical compositions comprising imatinib and a release retardant
WO2006122022A2 (en) * 2005-05-10 2006-11-16 Novartis Ag Modified release famciclovir pharmaceutical compositions

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
S.T.P. PHARMA SCIENCES, vol. 11, no. 2, 2000, pages 145 - 150

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011158870A1 (ja) * 2010-06-16 2011-12-22 帝人ファーマ株式会社 放出制御型の有核錠剤
JPWO2011158870A1 (ja) * 2010-06-16 2013-08-19 帝人ファーマ株式会社 放出制御型の有核錠剤
US8968779B2 (en) 2010-06-16 2015-03-03 Teijin Pharma Limited Controlled release coat-core tablet
JP2014501722A (ja) * 2010-11-18 2014-01-23 アドビセンヌ クレブス回路前駆体塩、特にクエン酸塩を含んでなる医薬組成物、及び医薬としてのこれらの使用
JP2017061553A (ja) * 2010-11-18 2017-03-30 アドビセンヌ クレブス回路前駆体塩、特にクエン酸塩を含んでなる医薬組成物、及び医薬としてのこれらの使用
US9782352B2 (en) 2010-11-18 2017-10-10 Advicenne Pharmaceutical composition comprising Krebs cycle precursor salt, in particular citrate salt, and use thereof as a medicament
JP2013010751A (ja) * 2011-05-31 2013-01-17 Sawai Pharmaceutical Co Ltd クロピドグレル含有錠剤及びその製造方法
JP2013018769A (ja) * 2011-06-14 2013-01-31 Taisho Pharmaceutical Co Ltd 生薬含有固形製剤

Also Published As

Publication number Publication date
EP2191848A4 (en) 2013-05-15
US20100221335A1 (en) 2010-09-02
TW200914067A (en) 2009-04-01
JPWO2009028598A1 (ja) 2010-12-02
EP2191848A1 (en) 2010-06-02
JP5545952B2 (ja) 2014-07-09

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