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EP4251162A4 - Procédé de fabrication amélioré pour les formulations comprenant une forme h de solvate de butanol de hbr de vortioxétine - Google Patents

Procédé de fabrication amélioré pour les formulations comprenant une forme h de solvate de butanol de hbr de vortioxétine Download PDF

Info

Publication number
EP4251162A4
EP4251162A4 EP20963799.0A EP20963799A EP4251162A4 EP 4251162 A4 EP4251162 A4 EP 4251162A4 EP 20963799 A EP20963799 A EP 20963799A EP 4251162 A4 EP4251162 A4 EP 4251162A4
Authority
EP
European Patent Office
Prior art keywords
manufacturing process
formulations containing
solvate form
improved manufacturing
butanol solvate
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
EP20963799.0A
Other languages
German (de)
English (en)
Other versions
EP4251162A1 (fr
Inventor
Erol KIRESEPI
Ersin Yildirim
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.)
Santa Farma Ilac Sanayi AS
Original Assignee
Santa Farma Ilac Sanayi AS
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 Santa Farma Ilac Sanayi AS filed Critical Santa Farma Ilac Sanayi AS
Publication of EP4251162A1 publication Critical patent/EP4251162A1/fr
Publication of EP4251162A4 publication Critical patent/EP4251162A4/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Neurology (AREA)
  • Biophysics (AREA)
  • Psychiatry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
EP20963799.0A 2020-11-27 2020-11-27 Procédé de fabrication amélioré pour les formulations comprenant une forme h de solvate de butanol de hbr de vortioxétine Pending EP4251162A4 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/TR2020/051190 WO2022115057A1 (fr) 2020-11-27 2020-11-27 Procédé de fabrication amélioré pour les formulations comprenant une forme h de solvate de butanol de hbr de vortioxétine

Publications (2)

Publication Number Publication Date
EP4251162A1 EP4251162A1 (fr) 2023-10-04
EP4251162A4 true EP4251162A4 (fr) 2024-08-14

Family

ID=81754740

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20963799.0A Pending EP4251162A4 (fr) 2020-11-27 2020-11-27 Procédé de fabrication amélioré pour les formulations comprenant une forme h de solvate de butanol de hbr de vortioxétine

Country Status (2)

Country Link
EP (1) EP4251162A4 (fr)
WO (1) WO2022115057A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2897943A1 (fr) * 2012-09-19 2015-07-29 Sandoz AG Nouvelle forme cristalline de bromhydrate de vortioxétine
CN105367515A (zh) * 2015-05-08 2016-03-02 北京北陆药业股份有限公司 一种氢溴酸沃替西汀α晶型的制备方法
US20170333424A1 (en) * 2014-10-24 2017-11-23 Hexal Ag Amorphous Vortioxetine Hydrobromide

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160200698A1 (en) * 2013-09-12 2016-07-14 Hangzhou Pushai Pharmaceutical Technology Co., Ltd Vortioxetine salt and crystal thereof, their preparation method, pharmaceutical compositions and usage
WO2017041680A1 (fr) * 2015-09-07 2017-03-16 常州方楠医药技术有限公司 Composition pharmaceutique à base de vortioxétine ou d'un sel de celle-ci, et son procédé de préparation
CN105193763B (zh) * 2015-09-18 2018-04-20 康普药业股份有限公司 一种氢溴酸沃替西汀片及其制备方法
CN107789327B (zh) * 2016-09-07 2020-06-02 成都康弘药业集团股份有限公司 一种含有氢溴酸沃赛汀的药物组合物及其制备方法
US20180273499A1 (en) * 2017-03-17 2018-09-27 Teva Pharmaceuticals International Gmbh Salts and solid state forms of vortioxetine

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2897943A1 (fr) * 2012-09-19 2015-07-29 Sandoz AG Nouvelle forme cristalline de bromhydrate de vortioxétine
US20170333424A1 (en) * 2014-10-24 2017-11-23 Hexal Ag Amorphous Vortioxetine Hydrobromide
CN105367515A (zh) * 2015-05-08 2016-03-02 北京北陆药业股份有限公司 一种氢溴酸沃替西汀α晶型的制备方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2022115057A1 *

Also Published As

Publication number Publication date
WO2022115057A1 (fr) 2022-06-02
EP4251162A1 (fr) 2023-10-04

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DAV Request for validation of the european patent (deleted)
DAX Request for extension of the european patent (deleted)
A4 Supplementary search report drawn up and despatched

Effective date: 20240712

RIC1 Information provided on ipc code assigned before grant

Ipc: A61K 9/20 20060101ALI20240708BHEP

Ipc: A61P 25/24 20060101ALI20240708BHEP

Ipc: A61K 9/28 20060101ALI20240708BHEP

Ipc: A61K 31/495 20060101AFI20240708BHEP