WO2009069280A1 - 造粒物の製造法 - Google Patents

造粒物の製造法 Download PDF

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Publication number
WO2009069280A1
WO2009069280A1 PCT/JP2008/003450 JP2008003450W WO2009069280A1 WO 2009069280 A1 WO2009069280 A1 WO 2009069280A1 JP 2008003450 W JP2008003450 W JP 2008003450W WO 2009069280 A1 WO2009069280 A1 WO 2009069280A1
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WO
WIPO (PCT)
Prior art keywords
granulated matter
granulation
granule
tablet
unstable substance
Prior art date
Application number
PCT/JP2008/003450
Other languages
English (en)
French (fr)
Inventor
Hiroshi Sakamoto
Toshiya Taniguchi
Original Assignee
Ohara Pharmaceutical 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 Ohara Pharmaceutical Co., Ltd. filed Critical Ohara Pharmaceutical Co., Ltd.
Priority to JP2009543656A priority Critical patent/JPWO2009069280A1/ja
Priority to EP08855278A priority patent/EP2213305A4/en
Priority to CA2704826A priority patent/CA2704826A1/en
Priority to CN2008801180061A priority patent/CN101878041A/zh
Priority to US12/734,511 priority patent/US20100247737A1/en
Publication of WO2009069280A1 publication Critical patent/WO2009069280A1/ja

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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
    • A61K31/33—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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4433—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with oxygen as a ring hetero atom
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/1682—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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/2027—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

　中性又は酸性領域で化学的に不安定物質について、製剤操作上、簡便かつ安全性の高い方法で、長期に渡り安定性が保持できる造粒物の製造法、及びその方法を利用して製造した錠剤を提供することが望まれていた。 　本発明においては、不安定物質を、水系の安定化処理と造粒操作とを連続的に行う造粒法を提供するとともに、得られた粒子表面に中間層を形成し、次いで腸溶性被覆を行うことにより、胃部で効力を失活することなく腸で吸収される錠剤を提供することができるようになった。
PCT/JP2008/003450 2007-11-27 2008-11-25 造粒物の製造法 WO2009069280A1 (ja)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP2009543656A JPWO2009069280A1 (ja) 2007-11-27 2008-11-25 造粒物の製造法
EP08855278A EP2213305A4 (en) 2007-11-27 2008-11-25 PROCESS FOR PRODUCING A PELLET SUBSTANCE
CA2704826A CA2704826A1 (en) 2007-11-27 2008-11-25 Method for producing granulated preparation
CN2008801180061A CN101878041A (zh) 2007-11-27 2008-11-25 颗粒制剂的制造方法
US12/734,511 US20100247737A1 (en) 2007-11-27 2008-11-25 Method for producing granulated preparation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2007-306466 2007-11-27
JP2007306466 2007-11-27

Publications (1)

Publication Number Publication Date
WO2009069280A1 true WO2009069280A1 (ja) 2009-06-04

Family

ID=40678191

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2008/003450 WO2009069280A1 (ja) 2007-11-27 2008-11-25 造粒物の製造法

Country Status (7)

Country Link
US (1) US20100247737A1 (ja)
EP (1) EP2213305A4 (ja)
JP (2) JPWO2009069280A1 (ja)
KR (1) KR20100097145A (ja)
CN (1) CN101878041A (ja)
CA (1) CA2704826A1 (ja)
WO (1) WO2009069280A1 (ja)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012025683A (ja) * 2010-07-21 2012-02-09 Ohara Yakuhin Kogyo Kk 苦味を有する生理活性物質含有粒子の製造方法
WO2012091039A1 (ja) * 2010-12-27 2012-07-05 富田製薬株式会社 粒子状製剤
JP2013241451A (ja) * 2013-08-05 2013-12-05 Ohara Yakuhin Kogyo Kk 生理活性物質含有粒子の製造方法
JP2014015459A (ja) * 2012-06-15 2014-01-30 Shin Etsu Chem Co Ltd 低置換度ヒドロキシプロピルセルロースを含む複合造粒物の製造方法及び速放性製剤
JP5934835B2 (ja) * 2013-03-08 2016-06-15 富士フイルム株式会社 腸溶性細粒及び医薬組成物
JP7430937B1 (ja) 2022-10-12 2024-02-14 浩 坂本 プレミックス粒子の製造方法

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103120647A (zh) * 2012-01-10 2013-05-29 安徽理工大学 用乳化溶剂扩散法制备奥美拉唑缓释微球的制备方法
JP6443891B2 (ja) * 2014-01-31 2018-12-26 塩野義製薬株式会社 徐放性製剤
KR102227486B1 (ko) * 2017-06-30 2021-03-12 롯데정밀화학 주식회사 프로톤 펌프 저해제를 포함하는 경구용 고형제제 조성물, 이를 포함하는 경구용 고형제제 및 그 제조방법
CN111343974B (zh) * 2017-11-09 2023-06-13 日本脏器制药株式会社 对乙酰氨基酚制剂及其制造方法
KR102494141B1 (ko) * 2019-10-18 2023-02-01 주식회사 대웅테라퓨틱스 프로톤 펌프 저해제 및 탄산수소나트륨을 포함하는 안정한 약제학적 조성물 및 이의 제조방법
CN112137980B (zh) * 2020-10-29 2022-12-06 广州美迪高生物医药科技有限公司 兰索拉唑肠溶片及其制备方法

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS62277322A (ja) * 1986-02-13 1987-12-02 Takeda Chem Ind Ltd 安定化された腸溶性抗潰瘍固形組成物
JPH0768125B2 (ja) 1988-05-18 1995-07-26 エーザイ株式会社 酸不安定化合物の内服用製剤
JPH11508577A (ja) * 1995-07-05 1999-07-27 ビイク グルデン ロンベルク ヒエーミツシエ フアブリーク ゲゼルシヤフト ミツト ベシユレンクテル ハフツング 抗菌活性物質及び徐放性パントプラゾールを含有する経口医薬品
JP2000281564A (ja) * 1998-05-18 2000-10-10 Takeda Chem Ind Ltd 医薬製剤
JP2000355540A (ja) 1998-04-20 2000-12-26 Eisai Co Ltd 安定化したベンズイミダゾール系化合物含有組成物
JP2006131548A (ja) 2004-11-05 2006-05-25 Pauretsuku:Kk 粒子の製造方法
JP2007520529A (ja) * 2004-02-06 2007-07-26 アクティブ バイオテック エイビー キノリン化合物を含有する新規な組成物

Family Cites Families (4)

* Cited by examiner, † Cited by third party
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CA1327010C (en) * 1986-02-13 1994-02-15 Tadashi Makino Stabilized solid pharmaceutical composition containing antiulcer benzimidazole compound and its production
ES2137862B1 (es) * 1997-07-31 2000-09-16 Intexim S A Preparacion farmaceutica oral que comprende un compuesto de actividad antiulcerosa y procedimiento para su obtencion.
EP0998933A1 (de) * 1998-10-09 2000-05-10 Boehringer Mannheim Gmbh Verfahren zur Herstellung von bisphosphonathaltigen pharmazeutischen Zusammensetzungen zur oralen Applikation
CN101982199A (zh) * 2001-11-21 2011-03-02 卫材R&D管理有限公司 含有对酸不稳定的生理活性化合物的制剂组合物及其制法

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS62277322A (ja) * 1986-02-13 1987-12-02 Takeda Chem Ind Ltd 安定化された腸溶性抗潰瘍固形組成物
JPH0768125B2 (ja) 1988-05-18 1995-07-26 エーザイ株式会社 酸不安定化合物の内服用製剤
JPH11508577A (ja) * 1995-07-05 1999-07-27 ビイク グルデン ロンベルク ヒエーミツシエ フアブリーク ゲゼルシヤフト ミツト ベシユレンクテル ハフツング 抗菌活性物質及び徐放性パントプラゾールを含有する経口医薬品
JP2000355540A (ja) 1998-04-20 2000-12-26 Eisai Co Ltd 安定化したベンズイミダゾール系化合物含有組成物
JP2000281564A (ja) * 1998-05-18 2000-10-10 Takeda Chem Ind Ltd 医薬製剤
JP2007520529A (ja) * 2004-02-06 2007-07-26 アクティブ バイオテック エイビー キノリン化合物を含有する新規な組成物
JP2006131548A (ja) 2004-11-05 2006-05-25 Pauretsuku:Kk 粒子の製造方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP2213305A4

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012025683A (ja) * 2010-07-21 2012-02-09 Ohara Yakuhin Kogyo Kk 苦味を有する生理活性物質含有粒子の製造方法
WO2012091039A1 (ja) * 2010-12-27 2012-07-05 富田製薬株式会社 粒子状製剤
JP5585920B2 (ja) * 2010-12-27 2014-09-10 富田製薬株式会社 粒子状製剤
JP2014015459A (ja) * 2012-06-15 2014-01-30 Shin Etsu Chem Co Ltd 低置換度ヒドロキシプロピルセルロースを含む複合造粒物の製造方法及び速放性製剤
JP2016138155A (ja) * 2012-06-15 2016-08-04 信越化学工業株式会社 低置換度ヒドロキシプロピルセルロースを含む複合造粒物及び速放性製剤
JP5934835B2 (ja) * 2013-03-08 2016-06-15 富士フイルム株式会社 腸溶性細粒及び医薬組成物
JP2013241451A (ja) * 2013-08-05 2013-12-05 Ohara Yakuhin Kogyo Kk 生理活性物質含有粒子の製造方法
JP7430937B1 (ja) 2022-10-12 2024-02-14 浩 坂本 プレミックス粒子の製造方法

Also Published As

Publication number Publication date
KR20100097145A (ko) 2010-09-02
CA2704826A1 (en) 2009-06-04
JP5762603B2 (ja) 2015-08-12
JPWO2009069280A1 (ja) 2011-04-07
EP2213305A4 (en) 2010-11-17
CN101878041A (zh) 2010-11-03
US20100247737A1 (en) 2010-09-30
JP2014169344A (ja) 2014-09-18
EP2213305A1 (en) 2010-08-04

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