HRP20180387T1 - Oralne formulacije deferasiroksa - Google Patents

Oralne formulacije deferasiroksa Download PDF

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Publication number
HRP20180387T1
HRP20180387T1 HRP20180387TT HRP20180387T HRP20180387T1 HR P20180387 T1 HRP20180387 T1 HR P20180387T1 HR P20180387T T HRP20180387T T HR P20180387TT HR P20180387 T HRP20180387 T HR P20180387T HR P20180387 T1 HRP20180387 T1 HR P20180387T1
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HR
Croatia
Prior art keywords
tablet
deferasirox
film
oral administration
administration according
Prior art date
Application number
HRP20180387TT
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English (en)
Inventor
Indrajit Ghosh
Jia-Ai Zhang
Original Assignee
Novartis Ag
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Application filed by Novartis Ag filed Critical Novartis Ag
Publication of HRP20180387T1 publication Critical patent/HRP20180387T1/hr

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    • 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

Claims (9)

1. Filmom obložena tableta za oralnu primjenu, naznačena time, da ona obuhvaća deferasiroks ili njegovu farmaceutski prihvatljivu sol, koji/koja je prisutan/prisutna u količini od 45 do 60 masenih postotaka na osnovi ukupne mase tablete, te time, da tableta sadrži 90 mg, 180 mg ili 360 mg deferasiroksa ili njegove farmaceutski prihvatljive soli, pri čemu tableta nadalje obuhvaća sljedeće: (i) najmanje jedno punilo u ukupnoj količini od 10 do 40 masenih postotaka na osnovi ukupne mase tablete, gdje to punilo je mikrokristalna celuloza; (ii) najmanje jedan dezintegrator u ukupnoj količini od jednoga do 10 masenih postotaka na osnovi ukupne mase tablete, gdje taj dezintegrator je unakrsno povezani polivinilpirolidon (krospovidon); (iii) najmanje jedno vezivo u ukupnoj količini od jednoga do 5 masenih postotaka na osnovi ukupne mase tablete, gdje to vezivo je polivinilpirolidon (PVP); (iv) prema potrebi, najmanje jedan tenzid u ukupnoj količini od 0,0 do dva masena postotka na osnovi ukupne mase tablete, gdje taj tenzid je poloksamer; (v) najmanje jedno klizno sredstvo u ukupnoj količini od 0,1 do jednog masenog postotka na osnovi ukupne mase tablete, gdje to klizno sredstvo je koloidni silicijev dioksid; (vi) najmanje jedan lubrikant u ukupnoj količini od manje od 0,1 do dva masena postotka na osnovi ukupne mase tablete, gdje taj lubrikant je magnezijev stearat; i (vii) obloga.
2. Filmom obložena tableta za oralnu primjenu prema zahtjevu 1, naznačena time, da tableta obuhvaća 90 mg deferasiroksa ili njegove farmaceutski prihvatljive soli.
3. Filmom obložena tableta za oralnu primjenu prema zahtjevu 1, naznačena time, da tableta obuhvaća 180 mg deferasiroksa ili njegove farmaceutski prihvatljive soli.
4. Filmom obložena tableta za oralnu primjenu prema zahtjevu 1, naznačena time, da tableta obuhvaća 360 mg deferasiroksa ili njegove farmaceutski prihvatljive soli.
5. Filmom obložena tableta za oralnu primjenu prema bilo kojem od prethodnih zahtjeva, naznačena time, da tableta pokazuje vrijeme dezintegracije u trajanju od 5-10 minuta kada se mjeri standardnim USP testom dezintegracije.
6. Filmom obložena tableta za oralnu primjenu prema zahtjevu 1, naznačena time, da se ona sastoji od: 90 mg deferasiroksa; 53,61 mg mikrokristalne celuloze; 3,65 mg polivinilpirolidona; 11,34 mg krospovidona; 0,16 mg poloksamera 188; 0,81 mg koloidnog silicijevog dioksida; 2,43 mg magnezijevog stearata; i 4,86 mg obloge.
7. Filmom obložena tableta za oralnu primjenu prema zahtjevu 1, naznačena time, da se ona sastoji od: 180 mg deferasiroksa; 107,23 mg mikrokristalne celuloze; 7,29 mg polivinilpirolidona; 22,68 mg krospovidona; 0,32 mg poloksamera 188; 1,62 mg koloidnog silicijevog dioksida; 4,86 mg magnezijevog stearata; i 9,72 mg obloge.
8. Filmom obložena tableta za oralnu primjenu prema zahtjevu 1, naznačena time, da se ona sastoji od: 360 mg deferasiroksa; 215,45 mg mikrokristalne celuloze; 14,58 mg polivinilpirolidona; 45,36 mg krospovidona; 0,65 mg poloksamera 188; 3,24 mg koloidnog silicijevog dioksida; 9,72 mg magnezijevog stearata; i 19,44 mg obloge.
9. Filmom obložena tableta za oralnu primjenu prema zahtjevu 1, naznačena time, da ona obuhvaća sljedeće: [image]
HRP20180387TT 2013-03-08 2018-03-06 Oralne formulacije deferasiroksa HRP20180387T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361774893P 2013-03-08 2013-03-08
US201361824435P 2013-05-17 2013-05-17
EP16188627.0A EP3124018B2 (en) 2013-03-08 2014-03-06 Oral formulations of deferasirox

Publications (1)

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HRP20180387T1 true HRP20180387T1 (hr) 2018-04-20

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HRP20180387TT HRP20180387T1 (hr) 2013-03-08 2018-03-06 Oralne formulacije deferasiroksa
HRP20190173TT HRP20190173T1 (hr) 2013-03-08 2019-01-25 Oralne formulacije deferasiroksa

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HRP20190173TT HRP20190173T1 (hr) 2013-03-08 2019-01-25 Oralne formulacije deferasiroksa

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US (4) US9283209B2 (hr)
EP (2) EP3124018B2 (hr)
JP (3) JP6434429B2 (hr)
KR (2) KR20170045391A (hr)
CN (1) CN105025886B (hr)
AP (1) AP2015008668A0 (hr)
AU (2) AU2014224198B2 (hr)
BR (1) BR112015021254A2 (hr)
CA (1) CA2890465A1 (hr)
CL (1) CL2015002495A1 (hr)
CR (1) CR20150467A (hr)
CU (1) CU24348B1 (hr)
CY (2) CY1120021T1 (hr)
DK (2) DK3124018T3 (hr)
DO (1) DOP2015000220A (hr)
EA (1) EA031719B1 (hr)
EC (1) ECSP15042897A (hr)
ES (2) ES2708955T5 (hr)
HK (1) HK1212242A1 (hr)
HR (2) HRP20180387T1 (hr)
HU (2) HUE041224T2 (hr)
IL (1) IL240797B (hr)
JO (1) JO3570B1 (hr)
LT (2) LT3124018T (hr)
ME (1) ME03297B (hr)
MX (1) MX361055B (hr)
MY (1) MY170303A (hr)
NI (1) NI201500126A (hr)
NZ (1) NZ711179A (hr)
PE (1) PE20151600A1 (hr)
PH (1) PH12015501981A1 (hr)
PL (2) PL3124018T3 (hr)
PT (2) PT3124018T (hr)
RS (2) RS58317B1 (hr)
SA (1) SA515360425B1 (hr)
SG (2) SG10201807204YA (hr)
SI (2) SI2964202T1 (hr)
TN (1) TN2015000393A1 (hr)
TW (2) TWI625136B (hr)
UY (1) UY35367A (hr)
WO (1) WO2014136079A1 (hr)
ZA (1) ZA201506060B (hr)

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TR201707764A2 (tr) * 2017-05-29 2018-12-21 Biofarma Ilac Sanayi Ve Ticaret Anonim Sirketi Deferasiroksun bölünebilir tablet formları.
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KR20200113116A (ko) 2019-03-22 2020-10-06 주식회사 한국팜비오 데페라시록스를 포함하는 필름코팅정제
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

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WO2017158559A1 (en) 2016-03-17 2017-09-21 Lupin Limited Compositions of deferasirox

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CU20150110A7 (es) 2016-04-25
SI2964202T1 (sl) 2019-02-28
TWI625136B (zh) 2018-06-01
NZ711179A (en) 2018-07-27
HK1212242A1 (en) 2016-06-10
TW201838623A (zh) 2018-11-01
EP3124018A1 (en) 2017-02-01
AP2015008668A0 (en) 2015-08-31
KR20150126900A (ko) 2015-11-13
CR20150467A (es) 2015-10-27
DK2964202T3 (en) 2019-02-25
IL240797A0 (en) 2015-10-29
ME03297B (me) 2019-07-20
JP2020180123A (ja) 2020-11-05
US20160220493A1 (en) 2016-08-04
BR112015021254A2 (pt) 2017-07-18
JP6739470B2 (ja) 2020-08-12
CY1120021T1 (el) 2018-12-12
CY1121315T1 (el) 2020-05-29
PT2964202T (pt) 2019-02-06
HUE036921T2 (hu) 2018-08-28
CU24348B1 (es) 2018-05-08
EP3124018B1 (en) 2017-12-20
EA201591665A1 (ru) 2015-12-30
EP2964202B2 (en) 2023-05-31
TWI686215B (zh) 2020-03-01
JP6434429B2 (ja) 2018-12-05
SG10201807204YA (en) 2018-09-27
LT2964202T (lt) 2019-02-11
AU2014224198A1 (en) 2015-09-10
US9283209B2 (en) 2016-03-15
IL240797B (en) 2022-01-01
RS56890B1 (sr) 2018-04-30
WO2014136079A1 (en) 2014-09-12
SI3124018T1 (en) 2018-04-30
CN105025886A (zh) 2015-11-04
AU2014224198B2 (en) 2017-06-15
UY35367A (es) 2014-10-31
ECSP15042897A (es) 2019-03-29
NI201500126A (es) 2015-11-18
KR20170045391A (ko) 2017-04-26
PH12015501981B1 (en) 2016-01-11
EP2964202B1 (en) 2018-10-31
EP3124018B2 (en) 2024-04-24
ES2708955T5 (es) 2023-11-10
US20180221285A1 (en) 2018-08-09
HRP20190173T1 (hr) 2019-03-22
CA2890465A1 (en) 2014-09-12
US20150017241A1 (en) 2015-01-15
KR101925671B1 (ko) 2019-02-27
PE20151600A1 (es) 2015-11-26
PL3124018T3 (pl) 2018-05-30
US20170290811A1 (en) 2017-10-12
ES2708955T3 (es) 2019-04-12
JP2018162255A (ja) 2018-10-18
DOP2015000220A (es) 2015-11-30
LT3124018T (lt) 2018-03-12
ES2663135T3 (es) 2018-04-11
PH12015501981A1 (en) 2016-01-11
EA031719B1 (ru) 2019-02-28
MY170303A (en) 2019-07-17
JO3570B1 (ar) 2020-07-05
EP2964202A1 (en) 2016-01-13
TN2015000393A1 (en) 2017-01-03
MX361055B (es) 2018-11-26
PL2964202T3 (pl) 2019-04-30
ZA201506060B (en) 2016-12-21
SA515360425B1 (ar) 2018-01-21
MX2015011962A (es) 2016-07-07
AU2017203897B2 (en) 2019-02-14
PT3124018T (pt) 2018-03-22
AU2017203897A1 (en) 2017-06-29
CL2015002495A1 (es) 2016-03-04
SG11201506491RA (en) 2015-09-29
HUE041224T2 (hu) 2019-05-28
DK3124018T3 (en) 2018-03-26
JP2016510068A (ja) 2016-04-04
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TW201442742A (zh) 2014-11-16
RS58317B1 (sr) 2019-03-29

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