ECSP15042897A - Formulaciones orales de deferasirox - Google Patents

Formulaciones orales de deferasirox

Info

Publication number
ECSP15042897A
ECSP15042897A ECIEPI201542897A ECPI201542897A ECSP15042897A EC SP15042897 A ECSP15042897 A EC SP15042897A EC IEPI201542897 A ECIEPI201542897 A EC IEPI201542897A EC PI201542897 A ECPI201542897 A EC PI201542897A EC SP15042897 A ECSP15042897 A EC SP15042897A
Authority
EC
Ecuador
Prior art keywords
deferasirox
tablet
exposure
present
tablets
Prior art date
Application number
ECIEPI201542897A
Other languages
English (en)
Spanish (es)
Inventor
Jia-Ai Zhang
Indrajit Ghosh
Original Assignee
Novartis 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=50288212&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ECSP15042897(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of ECSP15042897A publication Critical patent/ECSP15042897A/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/12Ketones
    • A61K31/122Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • A61K31/125Camphor; Nuclear substituted derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic 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
    • A61K31/41961,2,4-Triazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/148Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with compounds of unknown constitution, e.g. material from plants or animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893Tablet coating processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/12Drugs for disorders of the metabolism for electrolyte homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00General protective or antinoxious agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00General protective or antinoxious agents
    • A61P39/04Chelating agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Toxicology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Obesity (AREA)
  • Zoology (AREA)
  • Botany (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
ECIEPI201542897A 2013-03-08 2015-10-08 Formulaciones orales de deferasirox ECSP15042897A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361774893P 2013-03-08 2013-03-08
US201361824435P 2013-05-17 2013-05-17

Publications (1)

Publication Number Publication Date
ECSP15042897A true ECSP15042897A (es) 2019-03-29

Family

ID=50288212

Family Applications (1)

Application Number Title Priority Date Filing Date
ECIEPI201542897A ECSP15042897A (es) 2013-03-08 2015-10-08 Formulaciones orales de deferasirox

Country Status (41)

Country Link
US (4) US9283209B2 (enExample)
EP (2) EP3124018B2 (enExample)
JP (3) JP6434429B2 (enExample)
KR (2) KR101925671B1 (enExample)
CN (1) CN105025886B (enExample)
AP (1) AP2015008668A0 (enExample)
AU (2) AU2014224198B2 (enExample)
BR (1) BR112015021254A2 (enExample)
CA (1) CA2890465A1 (enExample)
CL (1) CL2015002495A1 (enExample)
CR (1) CR20150467A (enExample)
CU (1) CU24348B1 (enExample)
CY (2) CY1120021T1 (enExample)
DK (2) DK3124018T3 (enExample)
DO (1) DOP2015000220A (enExample)
EA (1) EA031719B1 (enExample)
EC (1) ECSP15042897A (enExample)
ES (2) ES2708955T5 (enExample)
HR (2) HRP20190173T1 (enExample)
HU (2) HUE036921T2 (enExample)
IL (1) IL240797B (enExample)
JO (1) JO3570B1 (enExample)
LT (2) LT2964202T (enExample)
ME (1) ME03297B (enExample)
MX (1) MX361055B (enExample)
MY (1) MY170303A (enExample)
NI (1) NI201500126A (enExample)
NZ (1) NZ711179A (enExample)
PE (1) PE20151600A1 (enExample)
PH (1) PH12015501981A1 (enExample)
PL (2) PL3124018T3 (enExample)
PT (2) PT2964202T (enExample)
RS (2) RS58317B1 (enExample)
SA (1) SA515360425B1 (enExample)
SG (2) SG10201807204YA (enExample)
SI (2) SI2964202T1 (enExample)
TN (1) TN2015000393A1 (enExample)
TW (2) TWI686215B (enExample)
UY (1) UY35367A (enExample)
WO (1) WO2014136079A1 (enExample)
ZA (1) ZA201506060B (enExample)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2708955T5 (es) 2013-03-08 2023-11-10 Novartis Ag Formulaciones orales de deferasirox
US9866684B2 (en) * 2015-02-16 2018-01-09 Microsoft Technology Licensing, Llc Process for real-time data exchange between users on a phone call
WO2016167729A1 (en) * 2015-04-16 2016-10-20 Öğün Yusuf Toktamiş Dispersible tablets comprising deferasirox
WO2016205658A1 (en) 2015-06-17 2016-12-22 Dispersol Technologies, Llc Improved formulations of deferasirox and methods of making the same
EP3429562A1 (en) 2016-03-17 2019-01-23 Lupin Limited Compositions of deferasirox
CA2937365C (en) 2016-03-29 2018-09-18 F. Hoffmann-La Roche Ag Granulate formulation of 5-methyl-1-phenyl-2-(1h)-pyridone and method of making the same
CA3029543C (en) * 2016-07-05 2021-11-23 Jubilant Generics Limited Immediate release pharmaceutical composition of iron chelating agents
EP3518904A1 (en) 2016-09-30 2019-08-07 Synthon B.V. Pharmaceutical composition comprising deferasirox
CZ2017255A3 (cs) 2017-05-04 2018-11-14 Zentiva, K.S. Filmem potažené tablety Deferasiroxu
TR201707764A2 (tr) * 2017-05-29 2018-12-21 Biofarma Ilac Sanayi Ve Ticaret Anonim Sirketi Deferasiroksun bölünebilir tablet formları.
WO2019108156A1 (en) * 2017-11-28 2019-06-06 Biofarma Ilac Sanayi Ve Ticaret A.S. A scored tablet formulation comprising deferasirox in a film tablet form
KR20200113116A (ko) 2019-03-22 2020-10-06 주식회사 한국팜비오 데페라시록스를 포함하는 필름코팅정제
EP3854385A1 (en) * 2020-01-27 2021-07-28 ROS Therapeutics ApS Methotrexate dosage form
EP4052698A1 (en) * 2021-03-05 2022-09-07 Sanovel Ilac Sanayi Ve Ticaret A.S. Film coated tablet comprising deferasirox
CN115154428B (zh) * 2022-09-06 2023-01-10 上海奥科达医药科技股份有限公司 一种地拉罗司药物组合物及其制备方法
WO2025242589A1 (en) 2024-05-21 2025-11-27 Chiesi Farmaceutici S.P.A. Pharmaceutical dosage forms for deferiprone and deferasirox combined therapy

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY129541A (en) * 1996-06-25 2007-04-30 Novartis Ag Substituded 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators
GB0223978D0 (en) 2002-10-15 2002-11-20 Novartis Ag Organic compound
KR20070022243A (ko) * 2004-04-08 2007-02-26 노파르티스 아게 데페라시록스 분산성 정제
GB0408078D0 (en) * 2004-04-08 2004-05-12 Novartis Ag Organic compounds
BRPI0617715A2 (pt) * 2005-10-19 2011-08-02 Novartis Ag comprimidos dispersìveis compreendendo deferasirox
EP2062572A1 (en) * 2007-11-19 2009-05-27 Teva Pharmaceutical Industries Ltd. Pharmaceutical compositions
WO2009106824A2 (en) 2008-02-25 2009-09-03 Cipla Limited Pharmaceutical formulations
WO2009130604A2 (en) 2008-04-21 2009-10-29 Actavis Group Ptc Ehf Solid state forms of deferasirox salts and process for the preparation thereof
WO2010035282A1 (en) 2008-09-24 2010-04-01 Matrix Laboratories Limited Pharmaceutical compositions comprising deferasirox
WO2010143006A1 (en) * 2009-06-10 2010-12-16 Carlo Ghisalberti Orally bioavailable iron chelators in the treatment of an inflammatory bowel disease
WO2012003987A1 (en) * 2010-07-08 2012-01-12 Ratiopharm Gmbh Oral dosage form of deferasirox
BR112013007276A2 (pt) 2010-10-01 2016-06-14 Cipla Ltd composição farmacêutica, processo para preparar uma composição farmacêutica, uso da coposição farmacêutica e método para tratar sobrecarga crônica de ferro
ES2708955T5 (es) 2013-03-08 2023-11-10 Novartis Ag Formulaciones orales de deferasirox
EP3429562A1 (en) 2016-03-17 2019-01-23 Lupin Limited Compositions of deferasirox

Also Published As

Publication number Publication date
CY1121315T1 (el) 2020-05-29
HUE041224T2 (hu) 2019-05-28
AU2014224198A1 (en) 2015-09-10
HRP20180387T1 (hr) 2018-04-20
NI201500126A (es) 2015-11-18
PT2964202T (pt) 2019-02-06
CY1120021T1 (el) 2018-12-12
KR20170045391A (ko) 2017-04-26
AU2017203897B2 (en) 2019-02-14
CN105025886B (zh) 2019-01-15
PE20151600A1 (es) 2015-11-26
IL240797B (en) 2022-01-01
CL2015002495A1 (es) 2016-03-04
SG11201506491RA (en) 2015-09-29
ES2663135T3 (es) 2018-04-11
TN2015000393A1 (en) 2017-01-03
EA031719B1 (ru) 2019-02-28
AP2015008668A0 (en) 2015-08-31
AU2014224198B2 (en) 2017-06-15
SG10201807204YA (en) 2018-09-27
PL3124018T3 (pl) 2018-05-30
PH12015501981B1 (en) 2016-01-11
ES2708955T3 (es) 2019-04-12
SI2964202T1 (sl) 2019-02-28
DK3124018T3 (en) 2018-03-26
ME03297B (me) 2019-07-20
RS56890B1 (sr) 2018-04-30
NZ711179A (en) 2018-07-27
EA201591665A1 (ru) 2015-12-30
JP2020180123A (ja) 2020-11-05
JP2016510068A (ja) 2016-04-04
US20160220493A1 (en) 2016-08-04
UY35367A (es) 2014-10-31
MX2015011962A (es) 2016-07-07
US20150017241A1 (en) 2015-01-15
CN105025886A (zh) 2015-11-04
EP3124018B1 (en) 2017-12-20
DK2964202T3 (en) 2019-02-25
SA515360425B1 (ar) 2018-01-21
PL2964202T3 (pl) 2019-04-30
PH12015501981A1 (en) 2016-01-11
CU24348B1 (es) 2018-05-08
US9283209B2 (en) 2016-03-15
BR112015021254A2 (pt) 2017-07-18
IL240797A0 (en) 2015-10-29
TW201442742A (zh) 2014-11-16
US20170290811A1 (en) 2017-10-12
TWI686215B (zh) 2020-03-01
JP6434429B2 (ja) 2018-12-05
MY170303A (en) 2019-07-17
EP3124018B2 (en) 2024-04-24
EP2964202B1 (en) 2018-10-31
AU2017203897A1 (en) 2017-06-29
JO3570B1 (ar) 2020-07-05
MX361055B (es) 2018-11-26
HUE036921T2 (hu) 2018-08-28
KR20150126900A (ko) 2015-11-13
TW201838623A (zh) 2018-11-01
WO2014136079A1 (en) 2014-09-12
EP2964202A1 (en) 2016-01-13
ZA201506060B (en) 2016-12-21
PT3124018T (pt) 2018-03-22
EP2964202B2 (en) 2023-05-31
LT3124018T (lt) 2018-03-12
EP3124018A1 (en) 2017-02-01
CA2890465A1 (en) 2014-09-12
DOP2015000220A (es) 2015-11-30
LT2964202T (lt) 2019-02-11
HK1212242A1 (en) 2016-06-10
JP2018162255A (ja) 2018-10-18
KR101925671B1 (ko) 2019-02-27
RS58317B1 (sr) 2019-03-29
HRP20190173T1 (hr) 2019-03-22
SI3124018T1 (en) 2018-04-30
CR20150467A (es) 2015-10-27
US20180221285A1 (en) 2018-08-09
ES2708955T5 (es) 2023-11-10
ES2663135T5 (en) 2024-12-16
JP6739470B2 (ja) 2020-08-12
TWI625136B (zh) 2018-06-01
CU20150110A7 (es) 2016-04-25

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