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EP4213815A4 - Long-term stable anagrelid capsule composition - Google Patents

Long-term stable anagrelid capsule composition Download PDF

Info

Publication number
EP4213815A4
EP4213815A4 EP20954278.6A EP20954278A EP4213815A4 EP 4213815 A4 EP4213815 A4 EP 4213815A4 EP 20954278 A EP20954278 A EP 20954278A EP 4213815 A4 EP4213815 A4 EP 4213815A4
Authority
EP
European Patent Office
Prior art keywords
anagrelid
long
term stable
capsule composition
capsule
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
EP20954278.6A
Other languages
German (de)
French (fr)
Other versions
EP4213815A1 (en
Inventor
Hatice Öncel
Onur Pinarbasli
Feristah BILGIN
Bahar KÖKSEL ÖZGEN
Asuman AYBEY DOGANAY
Nagehan Sarraçoglu
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.)
Ilko Ilac Sanayi ve Ticaret AS
Original Assignee
Ilko Ilac Sanayi ve Ticaret 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 Ilko Ilac Sanayi ve Ticaret AS filed Critical Ilko Ilac Sanayi ve Ticaret AS
Publication of EP4213815A1 publication Critical patent/EP4213815A1/en
Publication of EP4213815A4 publication Critical patent/EP4213815A4/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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP20954278.6A 2020-09-18 2020-09-18 Long-term stable anagrelid capsule composition Pending EP4213815A4 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/TR2020/050858 WO2022060309A1 (en) 2020-09-18 2020-09-18 Long-term stable anagrelid capsule composition

Publications (2)

Publication Number Publication Date
EP4213815A1 EP4213815A1 (en) 2023-07-26
EP4213815A4 true EP4213815A4 (en) 2023-09-06

Family

ID=80776970

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20954278.6A Pending EP4213815A4 (en) 2020-09-18 2020-09-18 Long-term stable anagrelid capsule composition

Country Status (2)

Country Link
EP (1) EP4213815A4 (en)
WO (1) WO2022060309A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115381791B (en) * 2022-09-21 2023-06-16 迪沙药业集团有限公司 Flunarizine hydrochloride pharmaceutical composition

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2915526A1 (en) * 2014-03-07 2015-09-09 Galenicum Health S.L. Pharmaceutical compositions comprising anagrelide
WO2016198166A1 (en) * 2015-06-10 2016-12-15 Disphar International B.V. Improved pharmaceutical formulation

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AT10562U3 (en) * 2008-12-05 2010-01-15 Aop Orphan Pharmaceuticals Ag A NEW COMPOSITION FOR TREATING AN ESSENCIAL THROMBOCYTEMIA
US10022377B2 (en) * 2015-12-02 2018-07-17 Cipla Limited Method of treating hypertension

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2915526A1 (en) * 2014-03-07 2015-09-09 Galenicum Health S.L. Pharmaceutical compositions comprising anagrelide
WO2016198166A1 (en) * 2015-06-10 2016-12-15 Disphar International B.V. Improved pharmaceutical formulation

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
SHIRE PHARMACEUTICAL CONTRACTS LTD.,: "Xagrid", SUMMARY OF PRODUCT CHARACTERISTICS, 1 January 2011 (2011-01-01), UK, pages 1 - 26, XP055265822, Retrieved from the Internet <URL:https://web.archive.org/web/20160312132101/http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000480/WC500056557.pdf> [retrieved on 20160415] *

Also Published As

Publication number Publication date
EP4213815A1 (en) 2023-07-26
WO2022060309A1 (en) 2022-03-24

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Legal Events

Date Code Title Description
STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE

PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE

17P Request for examination filed

Effective date: 20230313

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

A4 Supplementary search report drawn up and despatched

Effective date: 20230807

RIC1 Information provided on ipc code assigned before grant

Ipc: A61K 9/16 20060101ALI20230801BHEP

Ipc: A61K 31/7016 20060101ALI20230801BHEP

Ipc: A61K 31/519 20060101ALI20230801BHEP

Ipc: A61K 9/48 20060101AFI20230801BHEP

DAV Request for validation of the european patent (deleted)
DAX Request for extension of the european patent (deleted)