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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Prior art keywords
active ingredient
particles
process space
granules
spray composition
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Japanese (ja)
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JP2022528783A (ja
JP2022528783A5 (https=
JPWO2020208202A5 (https=
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 (4)

Publication Number Publication Date
JP2022528783A JP2022528783A (ja) 2022-06-15
JP2022528783A5 JP2022528783A5 (https=) 2023-04-14
JPWO2020208202A5 JPWO2020208202A5 (https=) 2023-04-14
JP7602483B2 true JP7602483B2 (ja) 2024-12-18

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ID=66105207

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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 (https=)
EP (2) EP3721871A1 (https=)
JP (1) JP7602483B2 (https=)
CN (2) CN118649138A (https=)
AU (1) AU2020271280B2 (https=)
BR (1) BR112021020282A2 (https=)
CA (1) CA3144742A1 (https=)
DK (1) DK3952844T3 (https=)
ES (1) ES3053040T3 (https=)
IL (1) IL287121B1 (https=)
PL (1) PL3952844T3 (https=)
PT (1) PT3952844T (https=)
WO (1) WO2020208202A1 (https=)

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
DK0739201T3 (da) 1994-01-14 2000-05-01 Ethypharm Lab Prod Ethiques Mikrogranuler af 5-nitro-imidazolderivater
DE19514187C1 (de) * 1995-04-21 1996-05-15 Degussa Verfahren und Vorrichtung zur Herstellung von Granulaten durch Wirbelschicht-Sprühgranulation
PT1117729E (pt) * 1998-07-21 2004-01-30 Vantico Ag Granulados escoaveis
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
NZ526720A (en) * 2000-12-28 2007-11-30 Altus Pharmaceuticals Inc Crystallisation of whole antibodies or fragments thereof, on a large scale and a process allowing an alternative route for delivery of therapeutic antibodies
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
ES2374191T3 (es) 2003-06-11 2012-02-14 Glatt Ingenieurtechnik Gmbh Procedimiento de preparación de granulados de enzimas y granulados de enzimas así obtenidos.
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
WO2010066385A1 (de) 2008-12-08 2010-06-17 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
IL287121A (en) 2022-01-01
JP2022528783A (ja) 2022-06-15
DK3952844T3 (da) 2025-11-17
WO2020208202A1 (de) 2020-10-15
CN118649138A (zh) 2024-09-17
AU2020271280B2 (en) 2025-07-24
IL287121B1 (en) 2026-01-01
ES3053040T3 (en) 2026-01-16
US20220280432A1 (en) 2022-09-08
PT3952844T (pt) 2025-11-21
EP3952844B1 (de) 2025-08-27
CN114302711A (zh) 2022-04-08
CA3144742A1 (en) 2020-10-15
PL3952844T3 (pl) 2026-01-19
EP3952844A1 (de) 2022-02-16
BR112021020282A2 (pt) 2021-12-14
US12551443B2 (en) 2026-02-17
EP3721871A1 (de) 2020-10-14
AU2020271280A1 (en) 2021-12-09

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