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WO2008146590A1 - 球形マンニトール結晶粒子 - Google Patents

球形マンニトール結晶粒子 Download PDF

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Publication number
WO2008146590A1
WO2008146590A1 PCT/JP2008/058646 JP2008058646W WO2008146590A1 WO 2008146590 A1 WO2008146590 A1 WO 2008146590A1 JP 2008058646 W JP2008058646 W JP 2008058646W WO 2008146590 A1 WO2008146590 A1 WO 2008146590A1
Authority
WO
WIPO (PCT)
Prior art keywords
crystal particle
tablet
mannitol crystal
spherical mannitol
spherical
Prior art date
Application number
PCT/JP2008/058646
Other languages
English (en)
French (fr)
Inventor
Jin Satomi
Maki Inaba
Original Assignee
Mitsubishi Shoji Foodtech 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 Mitsubishi Shoji Foodtech Co., Ltd. filed Critical Mitsubishi Shoji Foodtech Co., Ltd.
Priority to CA2687794A priority Critical patent/CA2687794C/en
Priority to JP2009516238A priority patent/JP5337027B2/ja
Priority to BRPI0810978-8A priority patent/BRPI0810978B1/pt
Priority to US12/451,667 priority patent/US8883307B2/en
Priority to EP08752529.1A priority patent/EP2168601B1/en
Publication of WO2008146590A1 publication Critical patent/WO2008146590A1/ja

Links

Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/30—Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
    • A23L29/37—Sugar alcohols
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L27/00—Spices; Flavouring agents or condiments; Artificial sweetening agents; Table salts; Dietetic salt substitutes; Preparation or treatment thereof
    • A23L27/30—Artificial sweetening agents
    • A23L27/33—Artificial sweetening agents containing sugars or derivatives
    • A23L27/34—Sugar alcohols
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H3/00—Compounds containing only hydrogen atoms and saccharide radicals having only carbon, hydrogen, and oxygen atoms
    • C07H3/02—Monosaccharides
    • C—CHEMISTRY; METALLURGY
    • C13—SUGAR INDUSTRY
    • C13B—PRODUCTION OF SUCROSE; APPARATUS SPECIALLY ADAPTED THEREFOR
    • C13B30/00—Crystallisation; Crystallising apparatus; Separating crystals from mother liquors ; Evaporating or boiling sugar juice
    • C13B30/02—Crystallisation; Crystallising apparatus
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
    • Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Polymers & Plastics (AREA)
  • Nutrition Science (AREA)
  • Food Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Biotechnology (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Seasonings (AREA)
  • Saccharide Compounds (AREA)

Abstract

【課題】優れた流動性を示し、また極めて真球に近いという立体的形状、さらには球形マンニトール内部に大きな中空部や多くの空隙部を有する、球形マンニトール結晶粒子を提供する。 【解決手段】極めて真球度が高く（アスペクト比が１．０～１．２）、試験法Ａによる吸油率が高く、平均粒子径１５～１６５μｍの粉末のゆるみかさ密度が０．３５～０．６０であり、平均粒子径１５～１６５μｍの粉末の安息角が３０～５０度であって、直接打錠した場合に得られる錠剤の硬度が７～２０ｋｇｆである、噴霧乾燥法により製造された結晶性マンニトール粉末である。
PCT/JP2008/058646 2007-05-28 2008-05-09 球形マンニトール結晶粒子 WO2008146590A1 (ja)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CA2687794A CA2687794C (en) 2007-05-28 2008-05-09 Spherical particle of crystalline mannitol
JP2009516238A JP5337027B2 (ja) 2007-05-28 2008-05-09 球形マンニトール結晶粒子
BRPI0810978-8A BRPI0810978B1 (pt) 2007-05-28 2008-05-09 Partícula esférica de manitol cristalino
US12/451,667 US8883307B2 (en) 2007-05-28 2008-05-09 Spherical particle of crystalline mannitol
EP08752529.1A EP2168601B1 (en) 2007-05-28 2008-05-09 Spherical mannitol crystal particle

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2007140923 2007-05-28
JP2007-140923 2007-05-28

Publications (1)

Publication Number Publication Date
WO2008146590A1 true WO2008146590A1 (ja) 2008-12-04

Family

ID=40074857

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2008/058646 WO2008146590A1 (ja) 2007-05-28 2008-05-09 球形マンニトール結晶粒子

Country Status (6)

Country Link
US (1) US8883307B2 (ja)
EP (1) EP2168601B1 (ja)
JP (1) JP5337027B2 (ja)
BR (1) BRPI0810978B1 (ja)
CA (1) CA2687794C (ja)
WO (1) WO2008146590A1 (ja)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110135927A1 (en) * 2008-08-18 2011-06-09 Mitsubishi Shoji Foodtech Co., Ltd. Excipient for compressed tablets comprising novel spherical mannitol
JP2014080382A (ja) * 2012-10-15 2014-05-08 Mitsubishi Shoji Foodtech Co Ltd 圧縮成形に用いるためのマンニトール賦形剤及びこれを含有する錠剤
WO2015046489A1 (ja) * 2013-09-30 2015-04-02 第一三共株式会社 スプレードライ法を用いたＤ－マンニトールα型結晶の選択的製造方法
JP2015514809A (ja) * 2012-04-25 2015-05-21 エスピーアイ ファーマ，インコーポレイテッド 結晶性マイクロスフェアおよびその同じ物を製造するためのプロセス
JP2017071558A (ja) * 2015-10-05 2017-04-13 三菱商事フードテック株式会社 錠剤の衝撃耐性改善賦形剤
JP2017114791A (ja) * 2015-12-22 2017-06-29 アサヒグループ食品株式会社 錠剤の製造方法、錠剤原料用顆粒の製造方法、及び錠剤原料用顆粒
WO2017199894A1 (ja) * 2016-05-16 2017-11-23 日本製紙株式会社 微小球形粒
JPWO2018131629A1 (ja) * 2017-01-13 2019-11-14 日本製紙株式会社 微小球形粒
JP2019535782A (ja) * 2016-11-28 2019-12-12 ロッテ精密化學株式会社ＬＯＴＴＥＦｉｎｅ Ｃｈｅｍｉｃａｌ Ｃｏ．，Ｌｔｄ． デクスランソプラゾールを含む経口用錠剤組成物、これを含む経口用錠剤およびその製造方法
JP2020510018A (ja) * 2017-03-07 2020-04-02 オリオン コーポレーション 結晶性医薬品の製造

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2519768C2 (ru) * 2008-06-20 2014-06-20 Мерк Патент Гмбх Поддающаяся прямому прессованию и быстро распадающаяся матрица таблетки
WO2010081722A2 (en) * 2009-01-16 2010-07-22 Add Technologies Ltd. Orally disintegrating tablets for the treatment of pain
CN111498874B (zh) * 2020-02-21 2022-10-04 天津大学 一种大粒度碘化铯球晶及其制备方法
CN117503938B (zh) * 2023-11-24 2024-09-13 江苏西典药用辅料有限公司 直压型甘露醇的制备方法

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3145146A (en) * 1961-10-31 1964-08-18 Warner Lambert Pharmaceutical Modified mannitol for pharmaceutical tablets
JPS6185330A (ja) * 1984-10-04 1986-04-30 Fuji Kagaku Kogyo Kk 直打用賦形薬の製造法
WO2001072285A1 (fr) * 2000-03-27 2001-10-04 Kyowa Hakko Kogyo Co., Ltd. Granule facile a prendre
WO2002069934A1 (fr) * 2001-03-06 2002-09-12 Kyowa Hakko Kogyo Co., Ltd. Préparations se délitant rapidement dans la bouche
WO2002070013A1 (fr) * 2001-03-06 2002-09-12 Kyowa Hakko Kogyo Co., Ltd. Utilisation d'une poudre sechee par atomisation contenant un alcool de sucre
JP3447042B2 (ja) * 1997-07-23 2003-09-16 フロイント産業株式会社 単一物質球形粒の製造方法
JP2006028130A (ja) * 2004-07-21 2006-02-02 Toa Eiyo Ltd ピモベンダン経口投与製剤

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4439858A1 (de) * 1994-11-08 1996-05-09 Merck Patent Gmbh Durch Co-Sprühtrocknung erhältliche Polyol-Zusammensetzung
JP3910939B2 (ja) 1997-07-23 2007-04-25 フロイント産業株式会社 単一物質球形粒、それらを用いた食品、医薬及びそれらの製法
JP3491887B2 (ja) 1999-04-28 2004-01-26 フロイント産業株式会社 糖アルコール造粒物集合体の製法
EP1311243A2 (en) * 2000-08-25 2003-05-21 MERCK PATENT GmbH Process for the production and use of powdered mannitol and mannitol-containing compositions
DE10063973A1 (de) * 2000-12-20 2002-06-27 Dhw Deutsche Hydrierwerke Gmbh Verfahren zur Herstellung von kristallinem Mannitol

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3145146A (en) * 1961-10-31 1964-08-18 Warner Lambert Pharmaceutical Modified mannitol for pharmaceutical tablets
JPS6185330A (ja) * 1984-10-04 1986-04-30 Fuji Kagaku Kogyo Kk 直打用賦形薬の製造法
JP3447042B2 (ja) * 1997-07-23 2003-09-16 フロイント産業株式会社 単一物質球形粒の製造方法
WO2001072285A1 (fr) * 2000-03-27 2001-10-04 Kyowa Hakko Kogyo Co., Ltd. Granule facile a prendre
WO2002069934A1 (fr) * 2001-03-06 2002-09-12 Kyowa Hakko Kogyo Co., Ltd. Préparations se délitant rapidement dans la bouche
WO2002070013A1 (fr) * 2001-03-06 2002-09-12 Kyowa Hakko Kogyo Co., Ltd. Utilisation d'une poudre sechee par atomisation contenant un alcool de sucre
JP2006028130A (ja) * 2004-07-21 2006-02-02 Toa Eiyo Ltd ピモベンダン経口投与製剤

Cited By (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8895141B2 (en) * 2008-08-18 2014-11-25 Mitsubishi Shoji Foodtech Co., Ltd. Excipient for compressed tablets comprising novel spherical mannitol
US20110135927A1 (en) * 2008-08-18 2011-06-09 Mitsubishi Shoji Foodtech Co., Ltd. Excipient for compressed tablets comprising novel spherical mannitol
US10245232B2 (en) 2012-04-25 2019-04-02 Spi Pharma, Inc. Crystalline microspheres and the process of manufacturing the same
US12233163B2 (en) 2012-04-25 2025-02-25 Spi Pharma, Inc. Crystalline microspheres and the process of manufacturing the same
JP2015514809A (ja) * 2012-04-25 2015-05-21 エスピーアイ ファーマ，インコーポレイテッド 結晶性マイクロスフェアおよびその同じ物を製造するためのプロセス
US11278496B2 (en) 2012-04-25 2022-03-22 Spi Pharma, Inc. Crystalline microspheres and the process of manufacturing the same
JP2019112438A (ja) * 2012-04-25 2019-07-11 エスピーアイ ファーマ，インコーポレイテッド 結晶性マイクロスフェアおよびその同じ物を製造するためのプロセス
JP2014080382A (ja) * 2012-10-15 2014-05-08 Mitsubishi Shoji Foodtech Co Ltd 圧縮成形に用いるためのマンニトール賦形剤及びこれを含有する錠剤
JPWO2015046489A1 (ja) * 2013-09-30 2017-03-09 第一三共株式会社 スプレードライ法を用いたＤ−マンニトールα型結晶の選択的製造方法
WO2015046489A1 (ja) * 2013-09-30 2015-04-02 第一三共株式会社 スプレードライ法を用いたＤ－マンニトールα型結晶の選択的製造方法
JP2017071558A (ja) * 2015-10-05 2017-04-13 三菱商事フードテック株式会社 錠剤の衝撃耐性改善賦形剤
JP2017114791A (ja) * 2015-12-22 2017-06-29 アサヒグループ食品株式会社 錠剤の製造方法、錠剤原料用顆粒の製造方法、及び錠剤原料用顆粒
KR20190006534A (ko) * 2016-05-16 2019-01-18 닛뽄세이시가부시끼가이샤 미소구형립
WO2017199894A1 (ja) * 2016-05-16 2017-11-23 日本製紙株式会社 微小球形粒
JPWO2017199894A1 (ja) * 2016-05-16 2019-05-09 日本製紙株式会社 微小球形粒
KR102191117B1 (ko) 2016-05-16 2020-12-15 닛뽄세이시가부시끼가이샤 미소구형립
JP2019535782A (ja) * 2016-11-28 2019-12-12 ロッテ精密化學株式会社ＬＯＴＴＥＦｉｎｅ Ｃｈｅｍｉｃａｌ Ｃｏ．，Ｌｔｄ． デクスランソプラゾールを含む経口用錠剤組成物、これを含む経口用錠剤およびその製造方法
JPWO2018131629A1 (ja) * 2017-01-13 2019-11-14 日本製紙株式会社 微小球形粒
JP2020510018A (ja) * 2017-03-07 2020-04-02 オリオン コーポレーション 結晶性医薬品の製造
JP7157071B2 (ja) 2017-03-07 2022-10-19 オリオン コーポレーション 結晶性医薬品の製造

Also Published As

Publication number Publication date
US20100167052A1 (en) 2010-07-01
BRPI0810978B1 (pt) 2021-05-25
EP2168601A4 (en) 2012-06-13
EP2168601A1 (en) 2010-03-31
EP2168601B1 (en) 2013-08-21
JPWO2008146590A1 (ja) 2010-08-19
BRPI0810978A2 (pt) 2015-01-27
CA2687794C (en) 2015-01-27
JP5337027B2 (ja) 2013-11-06
US8883307B2 (en) 2014-11-11
CA2687794A1 (en) 2008-12-04

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