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WO2016167729A1 - Comprimés dispersibles contenant du déférasirox - Google Patents

Comprimés dispersibles contenant du déférasirox Download PDF

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Publication number
WO2016167729A1
WO2016167729A1 PCT/TR2015/000154 TR2015000154W WO2016167729A1 WO 2016167729 A1 WO2016167729 A1 WO 2016167729A1 TR 2015000154 W TR2015000154 W TR 2015000154W WO 2016167729 A1 WO2016167729 A1 WO 2016167729A1
Authority
WO
WIPO (PCT)
Prior art keywords
deferasirox
dispersible tablet
weight
tablet according
dispersible
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.)
Ceased
Application number
PCT/TR2015/000154
Other languages
English (en)
Inventor
Yusuf Toktamış ÖĞÜN
Mehmet AĞCAYAZI
Hatice CANBAĞI
Fatma ÖZTÜRK
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to PCT/TR2015/000154 priority Critical patent/WO2016167729A1/fr
Publication of WO2016167729A1 publication Critical patent/WO2016167729A1/fr
Anticipated expiration legal-status Critical
Ceased 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4196—1,2,4-Triazoles
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets

Definitions

  • PCT application WO2007/045445 (Novartis AG) is related to dispersible tablet dosage form comprising deferasirox 42% to 65% by weight and specific amounts of tablet excipients. Equivalent EP 1940360 was deemed to be withdrawn.
  • the dispersible tablet formulation comprises excipients in ratios given below:
  • At least one surfactant 0.5% to 1.5% by weight
  • the lubricant may be selected among talc, magnesium stearate, PEG 6000, sodium chloride, silicon dioxide, stearic acid, sodium stearyl fumarate and/or a combination thereof.
  • binder may be selected among polyvinylpyrrolidone, polyethyleneglycol, hydroxypropyl cellulose.
  • Step II Granulation of at least one filler and deferasirox with the granulation solution of Step I (Step II)
  • Step III • Mixing of granules obtained in Step II with at least one pharmaceutically available excipient in order to obtain a mixture
  • Test formulations are produced with the process below.
  • Granules are dried in fluidized bed drier or drying oven.
  • Crospovidone, sodium chloride present in the outer phase are mixed by adding aerosol 200.
  • test formulations and reference products have shown similar dissolution results and since more than 85% of them have dissolved in the dissolution medium (pH 6.8 phosphate buffer comprising 0.5% Tween 20), they are accepted as compatible without the requirement of f 2 calculation according to CPMP/QWP/EWP/ 1401/98.
  • dissolution medium pH 6.8 phosphate buffer comprising 0.5% Tween 20
  • the results obtained above in line with the 500 mg tablet, also the 250 mg and 125 mg dispersible tablet formulations were studied and results similar to the ones obtained with high dosage products were obtained.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne une formulation de comprimé dispersible comprenant 42 à 50 % en poids de déférasirox ou un sel pharmaceutiquement acceptable de celui-ci, rapporté au poids total du comprimé et au moins un agent délitant dont la dureté de comprimé se situe entre 20 et 200N et l'indice de friabilité est inférieur à 0,6 %.
PCT/TR2015/000154 2015-04-16 2015-04-16 Comprimés dispersibles contenant du déférasirox Ceased WO2016167729A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/TR2015/000154 WO2016167729A1 (fr) 2015-04-16 2015-04-16 Comprimés dispersibles contenant du déférasirox

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/TR2015/000154 WO2016167729A1 (fr) 2015-04-16 2015-04-16 Comprimés dispersibles contenant du déférasirox

Publications (1)

Publication Number Publication Date
WO2016167729A1 true WO2016167729A1 (fr) 2016-10-20

Family

ID=53277018

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/TR2015/000154 Ceased WO2016167729A1 (fr) 2015-04-16 2015-04-16 Comprimés dispersibles contenant du déférasirox

Country Status (1)

Country Link
WO (1) WO2016167729A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019151967A3 (fr) * 2017-12-29 2019-10-17 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Formulations de comprimés dispersibles dans l'eau comprenant du déférasirox

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997049395A1 (fr) 1996-06-25 1997-12-31 Novartis-Erfindungen Verwaltungsgesellschaft M.B.H. 3,5-diphenyl-1,2,4-triazoles substitues et leur utilisation comme chelateurs de metaux pharmaceutiques
WO2004035026A1 (fr) 2002-10-15 2004-04-29 Novartis Ag Comprimes solubles de deferasirox
WO2005097062A1 (fr) 2004-04-08 2005-10-20 Novartis Ag Deferasirox en comprimes delitables
WO2007045445A1 (fr) 2005-10-19 2007-04-26 Novartis Ag Comprimes dispersibles contenant du deferasirox
EP2062572A1 (fr) * 2007-11-19 2009-05-27 Teva Pharmaceutical Industries Ltd. Compositions pharmaceutiques
WO2009106824A2 (fr) * 2008-02-25 2009-09-03 Cipla Limited Formulations pharmaceutiques
WO2012003987A1 (fr) * 2010-07-08 2012-01-12 Ratiopharm Gmbh Forme posologique orale de déférasirox
WO2014136079A1 (fr) * 2013-03-08 2014-09-12 Novartis Ag Formulations orales de déférasirox

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997049395A1 (fr) 1996-06-25 1997-12-31 Novartis-Erfindungen Verwaltungsgesellschaft M.B.H. 3,5-diphenyl-1,2,4-triazoles substitues et leur utilisation comme chelateurs de metaux pharmaceutiques
WO2004035026A1 (fr) 2002-10-15 2004-04-29 Novartis Ag Comprimes solubles de deferasirox
EP1556013B1 (fr) 2002-10-15 2009-05-13 Novartis AG Comprimes solubles de deferasirox
WO2005097062A1 (fr) 2004-04-08 2005-10-20 Novartis Ag Deferasirox en comprimes delitables
EP1734924A1 (fr) 2004-04-08 2006-12-27 Novartis AG Deferasirox en comprimes delitables
WO2007045445A1 (fr) 2005-10-19 2007-04-26 Novartis Ag Comprimes dispersibles contenant du deferasirox
EP1940360A1 (fr) 2005-10-19 2008-07-09 Novartis AG Comprimes dispersibles contenant du deferasirox
EP2062572A1 (fr) * 2007-11-19 2009-05-27 Teva Pharmaceutical Industries Ltd. Compositions pharmaceutiques
WO2009067557A1 (fr) 2007-11-19 2009-05-28 Teva Pharmaceutical Industries Ltd. Compositions pharmaceutiques de déférasirox
WO2009106824A2 (fr) * 2008-02-25 2009-09-03 Cipla Limited Formulations pharmaceutiques
WO2012003987A1 (fr) * 2010-07-08 2012-01-12 Ratiopharm Gmbh Forme posologique orale de déférasirox
WO2014136079A1 (fr) * 2013-03-08 2014-09-12 Novartis Ag Formulations orales de déférasirox

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019151967A3 (fr) * 2017-12-29 2019-10-17 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Formulations de comprimés dispersibles dans l'eau comprenant du déférasirox

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