JP7602483B2 - 有効成分顆粒の連続製造のための方法 - Google Patents

有効成分顆粒の連続製造のための方法 Download PDF

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Publication number
JP7602483B2
JP7602483B2 JP2021560711A JP2021560711A JP7602483B2 JP 7602483 B2 JP7602483 B2 JP 7602483B2 JP 2021560711 A JP2021560711 A JP 2021560711A JP 2021560711 A JP2021560711 A JP 2021560711A JP 7602483 B2 JP7602483 B2 JP 7602483B2
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Japan
Prior art keywords
active ingredient
particles
process space
granules
spray composition
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JP2021560711A
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Japanese (ja)
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JP2022528783A (ja
JP2022528783A5 (enExample
Inventor
ノヴァク，ラインハルト
ペリンガー，ノルベルト
グラーヴェ，アネット
ヤコブ，ミハエル
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ADD Advanced Drug Delivery Technologies AG
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ADD Advanced Drug Delivery Technologies AG
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    • 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
    • A61K9/2095—Tabletting processes

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  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • General Preparation And Processing Of Foods (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
JP2021560711A 2019-04-11 2020-04-09 有効成分顆粒の連続製造のための方法 Active JP7602483B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP19168685.6 2019-04-11
EP19168685.6A EP3721871A1 (de) 2019-04-11 2019-04-11 Verfahren zur kontinuierlichen herstellung eines wirkstoffgranulats
PCT/EP2020/060278 WO2020208202A1 (de) 2019-04-11 2020-04-09 Verfahren zur kontinuierlichen herstellung eines wirkstoffgranulats

Publications (3)

Publication Number Publication Date
JP2022528783A JP2022528783A (ja) 2022-06-15
JP2022528783A5 JP2022528783A5 (enExample) 2023-04-14
JP7602483B2 true JP7602483B2 (ja) 2024-12-18

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ID=66105207

Family Applications (1)

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JP2021560711A Active JP7602483B2 (ja) 2019-04-11 2020-04-09 有効成分顆粒の連続製造のための方法

Country Status (13)

Country Link
US (1) US12551443B2 (enExample)
EP (2) EP3721871A1 (enExample)
JP (1) JP7602483B2 (enExample)
CN (2) CN114302711A (enExample)
AU (1) AU2020271280B2 (enExample)
BR (1) BR112021020282A2 (enExample)
CA (1) CA3144742A1 (enExample)
DK (1) DK3952844T3 (enExample)
ES (1) ES3053040T3 (enExample)
IL (1) IL287121B2 (enExample)
PL (1) PL3952844T3 (enExample)
PT (1) PT3952844T (enExample)
WO (1) WO2020208202A1 (enExample)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102024107710A1 (de) * 2024-03-18 2025-09-18 Glatt Gesellschaft Mit Beschränkter Haftung Verfahren zur Herstellung von Tabletten
DE102024107712A1 (de) * 2024-03-18 2025-09-18 Glatt Gesellschaft Mit Beschränkter Haftung Vorrichtung zur Herstellung von Tabletten

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1088357C (zh) 1994-01-14 2002-07-31 埃迪克埃迪法姆药品实验室 5－硝基咪唑衍生物微粒
DE19514187C1 (de) * 1995-04-21 1996-05-15 Degussa Verfahren und Vorrichtung zur Herstellung von Granulaten durch Wirbelschicht-Sprühgranulation
CN1114647C (zh) * 1998-07-21 2003-07-16 范蒂科股份公司 松散的颗粒材料
US6117451A (en) 1998-08-25 2000-09-12 Pharmalogix, Inc. Direct compression metformin hydrochloride tablets
DE10004939C1 (de) 2000-02-05 2001-08-23 Lothar Moerl Steuerbare Gasanströmeinrichtung für Strahlschichtapparate
EP1345968A2 (en) * 2000-12-28 2003-09-24 Altus Biologics Inc. Crystals of whole antibodies and fragments thereof and methods for making and using them
US6667054B2 (en) 2001-12-05 2003-12-23 Bernard Charles Sherman Metformin hydrochloride tablets
KR100592512B1 (ko) * 2002-11-22 2006-07-03 서울약품공업(주) 탐술로신 또는 약제학적으로 허용되는 이의 염을활성성분으로 하는 서방성 배뇨장애 치료제
DE10322062A1 (de) * 2003-05-15 2004-12-02 Glatt Ingenieurtechnik Gmbh Verfahren und Vorrichtung zum Aufbringen von Flüssigkeiten in eine Feststoffströmung eines Strahlschichtapparates
US8231938B2 (en) 2003-06-11 2012-07-31 Glatt Ingenieurtechnik Gmbh Method for production of enzyme granules and enzyme granules produced thus
DE102005037630A1 (de) * 2005-08-09 2007-02-15 Glatt Gmbh Verfahren zur Herstellung von Teilchen aus pharmazeutischen Substanzen, Teilchen aus pharmazeutischen Substanzen sowie deren Verwendung
DE102007012105A1 (de) * 2007-03-13 2008-09-18 Add Advanced Drug Delivery Technologies Ltd. Pellets enthaltend pharmazeutische Substanz, Verfahren zu deren Herstellung und deren Verwendung
EP2735307A1 (de) 2008-12-08 2014-05-28 Ratiopharm GmbH Kompaktiertes Moxifloxacin
WO2010106555A2 (en) 2009-03-17 2010-09-23 Shantilal, Doshi, Bimalkumar Directly compressible pre-granulated cellulose ether polymer and process for preparing the same
JP5922310B2 (ja) * 2013-07-25 2016-05-24 株式会社三和化学研究所 医薬製剤
WO2018034627A1 (en) * 2016-08-18 2018-02-22 İlko Ilaç Sanayi Ve Ticaret Anonim Şirketi Pharmaceutical composition of antidiabetic tablet
EP3721870A1 (de) * 2019-04-11 2020-10-14 ADD Advanced Drug Delivery Technologies, Ltd. Verfahren zur kontinuierlichen herstellung eines wirkstoffgranulats

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
第十八改正日本薬局方 参考情報，p.2524-2527

Also Published As

Publication number Publication date
IL287121B2 (en) 2026-05-01
BR112021020282A2 (pt) 2021-12-14
JP2022528783A (ja) 2022-06-15
WO2020208202A1 (de) 2020-10-15
US12551443B2 (en) 2026-02-17
DK3952844T3 (da) 2025-11-17
EP3952844A1 (de) 2022-02-16
US20220280432A1 (en) 2022-09-08
CA3144742A1 (en) 2020-10-15
ES3053040T3 (en) 2026-01-16
EP3952844B1 (de) 2025-08-27
IL287121A (en) 2022-01-01
CN114302711A (zh) 2022-04-08
AU2020271280A1 (en) 2021-12-09
CN118649138A (zh) 2024-09-17
IL287121B1 (en) 2026-01-01
PT3952844T (pt) 2025-11-21
PL3952844T3 (pl) 2026-01-19
EP3721871A1 (de) 2020-10-14
AU2020271280B2 (en) 2025-07-24

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