CN114302711A - 连续制造有效成分颗粒的方法 - Google Patents

连续制造有效成分颗粒的方法 Download PDF

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Publication number
CN114302711A
CN114302711A CN202080042899.7A CN202080042899A CN114302711A CN 114302711 A CN114302711 A CN 114302711A CN 202080042899 A CN202080042899 A CN 202080042899A CN 114302711 A CN114302711 A CN 114302711A
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CN
China
Prior art keywords
active ingredient
particles
liquid
spray
solid particles
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.)
Pending
Application number
CN202080042899.7A
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English (en)
Chinese (zh)
Inventor
R·诺瓦克
N·波林杰
A·格拉维
M·雅各布
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Ed Advanced Drug Delivery Technology Co ltd
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Ed Advanced Drug Delivery Technology Co ltd
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Publication date
Application filed by Ed Advanced Drug Delivery Technology Co ltd filed Critical Ed Advanced Drug Delivery Technology Co ltd
Priority to CN202410708653.9A priority Critical patent/CN118649138A/zh
Publication of CN114302711A publication Critical patent/CN114302711A/zh
Pending 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
    • 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
    • A61K9/14—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
    • A61K9/20—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)
CN202080042899.7A 2019-04-11 2020-04-09 连续制造有效成分颗粒的方法 Pending CN114302711A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202410708653.9A CN118649138A (zh) 2019-04-11 2020-04-09 连续制造有效成分颗粒的方法

Applications Claiming Priority (3)

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN202410708653.9A Division CN118649138A (zh) 2019-04-11 2020-04-09 连续制造有效成分颗粒的方法

Publications (1)

Publication Number Publication Date
CN114302711A true CN114302711A (zh) 2022-04-08

Family

ID=66105207

Family Applications (2)

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CN202080042899.7A Pending CN114302711A (zh) 2019-04-11 2020-04-09 连续制造有效成分颗粒的方法
CN202410708653.9A Pending CN118649138A (zh) 2019-04-11 2020-04-09 连续制造有效成分颗粒的方法

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CN202410708653.9A Pending CN118649138A (zh) 2019-04-11 2020-04-09 连续制造有效成分颗粒的方法

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US (1) US12551443B2 (https=)
EP (2) EP3721871A1 (https=)
JP (1) JP7602483B2 (https=)
CN (2) CN114302711A (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
DE102024107712A1 (de) * 2024-03-18 2025-09-18 Glatt Gesellschaft Mit Beschränkter Haftung Vorrichtung zur Herstellung von Tabletten
DE102024107710A1 (de) * 2024-03-18 2025-09-18 Glatt Gesellschaft Mit Beschränkter Haftung Verfahren zur Herstellung von Tabletten

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6159252A (en) * 1995-04-21 2000-12-12 Degussa-Hus Aktiengesellschaft Process and device for producing granulates by fluidized bed spray granulation
CN1310737A (zh) * 1998-07-21 2001-08-29 范蒂科股份公司 松散的颗粒材料
WO2004047811A1 (en) * 2002-11-22 2004-06-10 Centurion, Inc. Controlled release formulation of tamsulosin or pharmaceutically acceptable salts thereof for treatment of the signs and symptoms of benign prostatic hyperplasia
CN1705508A (zh) * 2003-05-15 2005-12-07 格拉特工程技术有限公司 将液体加入到一个喷射层装置的固体流中的方法和设备
US20100080849A1 (en) * 2007-03-13 2010-04-01 Add Advanced Drug Delivery Technologies Ltd. Pellets containing a pharmaceutical substance, method for the production thereof and use of the same
US20100152486A1 (en) * 2005-08-09 2010-06-17 Michael Jacob Method for Production of Particles of Pharmaceutical Substances and the Use Thereof
WO2015012365A1 (ja) * 2013-07-25 2015-01-29 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

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2152212C1 (ru) 1994-01-14 2000-07-10 Лаборатуар Де Продюи Этик Этифарм Лекарственная форма производных 5-нитроимидазола
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
KR20030074693A (ko) * 2000-12-28 2003-09-19 알투스 바이올로직스 인코포레이티드 전항체 및 이의 단편의 결정과 이의 제조 및 사용 방법
US6667054B2 (en) 2001-12-05 2003-12-23 Bernard Charles Sherman Metformin hydrochloride tablets
CA2528637C (en) 2003-06-11 2012-10-23 Glatt Ingenieurtechnik Gmbh Method for production of enzyme granules and enzyme granules produced thus
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
EP3721870A1 (de) * 2019-04-11 2020-10-14 ADD Advanced Drug Delivery Technologies, Ltd. Verfahren zur kontinuierlichen herstellung eines wirkstoffgranulats

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6159252A (en) * 1995-04-21 2000-12-12 Degussa-Hus Aktiengesellschaft Process and device for producing granulates by fluidized bed spray granulation
CN1310737A (zh) * 1998-07-21 2001-08-29 范蒂科股份公司 松散的颗粒材料
WO2004047811A1 (en) * 2002-11-22 2004-06-10 Centurion, Inc. Controlled release formulation of tamsulosin or pharmaceutically acceptable salts thereof for treatment of the signs and symptoms of benign prostatic hyperplasia
CN1705508A (zh) * 2003-05-15 2005-12-07 格拉特工程技术有限公司 将液体加入到一个喷射层装置的固体流中的方法和设备
US20100152486A1 (en) * 2005-08-09 2010-06-17 Michael Jacob Method for Production of Particles of Pharmaceutical Substances and the Use Thereof
US20100080849A1 (en) * 2007-03-13 2010-04-01 Add Advanced Drug Delivery Technologies Ltd. Pellets containing a pharmaceutical substance, method for the production thereof and use of the same
WO2015012365A1 (ja) * 2013-07-25 2015-01-29 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

Non-Patent Citations (7)

* Cited by examiner, † Cited by third party
Title
CHRISTOPH NEUGEBAUER ET AL: "Influence of Thermal Conditions on Particle Properties in Fluidized Bed Layering Granulation", 《PROCESSES》 *
CHRISTOPH NEUGEBAUER ET AL: "Influence of Thermal Conditions on Particle Properties in Fluidized Bed Layering Granulation", 《PROCESSES》, vol. 6, no. 235, 22 November 2018 (2018-11-22), pages 1 - 17 *
STEFAN HEINRICH ET AL: "Analysis of the start-up process in continuous fuidized bed spray granulation by population balance modelling", 《CHEMICAL ENGINEERING SCIENCE》 *
STEFAN HEINRICH ET AL: "Analysis of the start-up process in continuous fuidized bed spray granulation by population balance modelling", 《CHEMICAL ENGINEERING SCIENCE》, vol. 57, 31 December 2002 (2002-12-31), pages 4369 - 4390, XP004390381, DOI: 10.1016/S0009-2509(02)00352-4 *
冯怡主编: "《中药固体制剂技术理论与实践》", 31 March 2017, 中国中医药出版社, pages: 22 - 26 *
王月茹: "制粒工艺对 盐酸二甲双胍片可压性的影响", 《中国医药工业杂志》 *
王月茹: "制粒工艺对 盐酸二甲双胍片可压性的影响", 《中国医药工业杂志》, vol. 48, no. 7, 31 December 2017 (2017-12-31), pages 1042 - 1047 *

Also Published As

Publication number Publication date
PL3952844T3 (pl) 2026-01-19
IL287121A (en) 2022-01-01
EP3952844A1 (de) 2022-02-16
US12551443B2 (en) 2026-02-17
DK3952844T3 (da) 2025-11-17
CN118649138A (zh) 2024-09-17
BR112021020282A2 (pt) 2021-12-14
ES3053040T3 (en) 2026-01-16
CA3144742A1 (en) 2020-10-15
AU2020271280A1 (en) 2021-12-09
WO2020208202A1 (de) 2020-10-15
AU2020271280B2 (en) 2025-07-24
EP3952844B1 (de) 2025-08-27
US20220280432A1 (en) 2022-09-08
EP3721871A1 (de) 2020-10-14
JP7602483B2 (ja) 2024-12-18
JP2022528783A (ja) 2022-06-15
IL287121B1 (en) 2026-01-01
PT3952844T (pt) 2025-11-21

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