CA3144742A1 - Method for the continuous production of an active ingredient granulate - Google Patents

Method for the continuous production of an active ingredient granulate Download PDF

Info

Publication number
CA3144742A1
CA3144742A1 CA3144742A CA3144742A CA3144742A1 CA 3144742 A1 CA3144742 A1 CA 3144742A1 CA 3144742 A CA3144742 A CA 3144742A CA 3144742 A CA3144742 A CA 3144742A CA 3144742 A1 CA3144742 A1 CA 3144742A1
Authority
CA
Canada
Prior art keywords
active ingredient
particles
granulate
process space
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
CA3144742A
Other languages
English (en)
French (fr)
Inventor
Reinhard Nowak
Norbert Pollinger
Annette Grave
Michael Jacob
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ADD Advanced Drug Delivery Technologies AG
Original Assignee
ADD Advanced Drug Delivery Technologies AG
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 ADD Advanced Drug Delivery Technologies AG filed Critical ADD Advanced Drug Delivery Technologies AG
Publication of CA3144742A1 publication Critical patent/CA3144742A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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

Landscapes

  • 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)
CA3144742A 2019-04-11 2020-04-09 Method for the continuous production of an active ingredient granulate Pending CA3144742A1 (en)

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 (1)

Publication Number Publication Date
CA3144742A1 true CA3144742A1 (en) 2020-10-15

Family

ID=66105207

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3144742A Pending CA3144742A1 (en) 2019-04-11 2020-04-09 Method for the continuous production of an active ingredient granulate

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

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
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
JP7602483B2 (ja) 2024-12-18
PT3952844T (pt) 2025-11-21
PL3952844T3 (pl) 2026-01-19
EP3721871A1 (de) 2020-10-14
AU2020271280B2 (en) 2025-07-24

Similar Documents

Publication Publication Date Title
US9050254B2 (en) Method for production of particles of pharmaceutical substances and the use thereof
US20220323361A1 (en) Process for continuous production of an active ingredient granulate
BRPI0718761A2 (pt) "método para produzir grândulos a partir de um pó, massa de granulado, processo para preparar um tablete, tablete, aparelho para granulação a seco, dispositivo de fracionamento, e, uso de um aparelho ou dispositivo."
US12551443B2 (en) Method for continuously producing an active ingredient granulate
CN116782888A (zh) 药物组合物
US20100080849A1 (en) Pellets containing a pharmaceutical substance, method for the production thereof and use of the same
WO2009135951A2 (en) Process for preparing a tablet comprising metformin
JP4092587B2 (ja) 二軸混練機を用いた乾式コーティング
US20140163109A1 (en) Taste-masked ibupropen granules
JP2022540994A (ja) 実質的に水性環境中に溶解性のカンナビノイド顆粒を製造するための方法および装置
Georgieva et al. Taste masking of enalapril maleate by the precipitation method
JP2006160730A (ja) 低融点薬物含有粉粒体及びその製造方法
Rashid Centrifugal granulating process for preparing drug-layered pellets based on microcrystalline cellulose beads

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20240402

D15 Examination report completed

Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D15-D126 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXAMINER'S REPORT

Effective date: 20250326

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 5TH ANNIV.) - STANDARD

Year of fee payment: 5

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20250327

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT DETERMINED COMPLIANT

Effective date: 20250327

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20250327

T11 Administrative time limit extension requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-T10-T11-T100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXTENSION OF TIME FOR TAKING ACTION REQUEST RECEIVED

Effective date: 20250716

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT RECEIVED - RESPONSE TO EXAMINER'S REQUISITION

Effective date: 20250926

T13 Administrative time limit extension granted

Free format text: ST27 STATUS EVENT CODE: A-2-2-T10-T13-T101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXTENSION OF TIME FOR TAKING ACTION REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20251121

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20251121

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 6TH ANNIV.) - STANDARD

Year of fee payment: 6

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20260330

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20260330

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20260423

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT DETERMINED COMPLIANT

Effective date: 20260505

P13 Application amended

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P13-X000 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: APPLICATION AMENDED

Effective date: 20260505