ECSP15042897A - Formulaciones orales de deferasirox - Google Patents
Formulaciones orales de deferasiroxInfo
- 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
Links
Classifications
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- 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
- A61K31/12—Ketones
- A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
- A61K31/125—Camphor; Nuclear substituted derivatives thereof
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/141—Intimate 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
- A61K9/148—Intimate 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
-
- 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
-
- 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
- A61K9/2027—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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- 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
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- 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
-
- 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
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2886—Dragees; 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
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2893—Tablet coating processes
-
- 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
- A61K9/50—Microcapsules 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
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules 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
- A61K9/5089—Processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P39/00—General protective or antinoxious agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P39/00—General protective or antinoxious agents
- A61P39/04—Chelating agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
Abstract
Un aspecto de la presente invención proporciona una tableta para el tratamiento de enfermedades que causan un exceso de metal, tal como hierro, en un cuerpo humano o animal, o enfermedades causadas por un exceso de metal en un humano que comprende Exjade® TM (deferasirox) de la fórmula I : o una sal farmacéutica aceptable del mismo presente en una cantidad entre 45% y 60% por peso con base en el peso total del comprimido, dicho comprimido tiene una liberación 5 reducida bajo condiciones gástricas y liberación rápida a pH casi neutro o a pH neutro. Típicamente, un fármaco que muestre disolución más rápida tendrá un nivel de exposición mucho mayor cuando se prueba humanos. Sorprendentemente, en el caso actual, las tabletas de Exjade TM (deferasirox) formuladas por tener liberación más lenta mostraron mucho mayor biodisponibilidad y sin efectos en los alimentos cuando se 10 comparan con tabletas dispersables comerciales, que tienen una tasa de disolución más rápida, pero que exhiben significativamente niveles de exposición más bajos. Las características de los comprimidos y sachets tragables (ingeribles, administrables por vía oral), tales como su tiempo de desintegración y disolución son necesarias únicamente para llegar a los niveles de exposición previstos. 15 Otro aspecto de la presente invención proporciona un comprimido recubierto que comprende (a) deferasirox o una sal farmaceuticamente aceptable del mismo, y (b) al menos un excipiente farmaceuticamente aceptable adecuado
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 (42)
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JO3570B1 (ar) | 2013-03-08 | 2020-07-05 | Novartis Ag | صيغ للإعطاء بالفم من ديفيرازيروكس |
| 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 |
| EP3310354A4 (en) | 2015-06-17 | 2018-12-12 | Dispersol Technologies, LLC | Improved formulations of deferasirox and methods of making the same |
| WO2017158559A1 (en) | 2016-03-17 | 2017-09-21 | 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 |
| EP3481390A4 (en) * | 2016-07-05 | 2020-03-04 | Jubilant Generics Limited | PHARMACEUTICAL COMPOSITION WITH IMMEDIATE RELEASE OF IRON CHELATE IMAGERS |
| WO2018059922A1 (en) | 2016-09-30 | 2018-04-05 | 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 |
| 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 |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TW533205B (en) | 1996-06-25 | 2003-05-21 | Novartis Ag | Substituted 3,5-diphenyl-l,2,4-triazoles and their pharmaceutical composition |
| GB0223978D0 (en) * | 2002-10-15 | 2002-11-20 | Novartis Ag | Organic compound |
| GB0408078D0 (en) * | 2004-04-08 | 2004-05-12 | Novartis Ag | Organic compounds |
| KR20070022243A (ko) * | 2004-04-08 | 2007-02-26 | 노파르티스 아게 | 데페라시록스 분산성 정제 |
| WO2007045445A1 (en) * | 2005-10-19 | 2007-04-26 | Novartis Ag | Dispersible tablets comprising deferasirox |
| US20090142395A1 (en) * | 2007-11-19 | 2009-06-04 | Uri Zadok | Deferasirox pharmaceutical compositions |
| WO2009106824A2 (en) | 2008-02-25 | 2009-09-03 | Cipla Limited | Pharmaceutical formulations |
| US20110097413A1 (en) | 2008-04-21 | 2011-04-28 | 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 |
| US8703203B2 (en) * | 2010-07-08 | 2014-04-22 | Ratiopharm Gmbh | Oral dosage form of deferasirox |
| RU2589842C2 (ru) * | 2010-10-01 | 2016-07-10 | Сипла Лимитед | Фармацевтическая композиция |
| JO3570B1 (ar) | 2013-03-08 | 2020-07-05 | Novartis Ag | صيغ للإعطاء بالفم من ديفيرازيروكس |
| WO2017158559A1 (en) | 2016-03-17 | 2017-09-21 | Lupin Limited | Compositions of deferasirox |
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2014
- 2014-03-06 JO JOP/2014/0075A patent/JO3570B1/ar active
- 2014-03-06 MX MX2015011962A patent/MX361055B/es active IP Right Grant
- 2014-03-06 EA EA201591665A patent/EA031719B1/ru not_active IP Right Cessation
- 2014-03-06 ES ES14710654T patent/ES2708955T5/es active Active
- 2014-03-06 LT LTEP16188627.0T patent/LT3124018T/lt unknown
- 2014-03-06 AP AP2015008668A patent/AP2015008668A0/xx unknown
- 2014-03-06 PL PL16188627T patent/PL3124018T3/pl unknown
- 2014-03-06 SI SI201431064T patent/SI2964202T1/sl unknown
- 2014-03-06 KR KR1020177010591A patent/KR20170045391A/ko not_active Application Discontinuation
- 2014-03-06 TW TW103107731A patent/TWI625136B/zh active
- 2014-03-06 SG SG10201807204YA patent/SG10201807204YA/en unknown
- 2014-03-06 SG SG11201506491RA patent/SG11201506491RA/en unknown
- 2014-03-06 EP EP16188627.0A patent/EP3124018B2/en active Active
- 2014-03-06 US US14/198,872 patent/US9283209B2/en active Active
- 2014-03-06 KR KR1020157027470A patent/KR101925671B1/ko active IP Right Grant
- 2014-03-06 WO PCT/IB2014/059494 patent/WO2014136079A1/en active Application Filing
- 2014-03-06 AU AU2014224198A patent/AU2014224198B2/en active Active
- 2014-03-06 CN CN201480012815.XA patent/CN105025886B/zh active Active
- 2014-03-06 UY UY0001035367A patent/UY35367A/es not_active Application Discontinuation
- 2014-03-06 PE PE2015001870A patent/PE20151600A1/es unknown
- 2014-03-06 PT PT161886270T patent/PT3124018T/pt unknown
- 2014-03-06 SI SI201430621T patent/SI3124018T1/en unknown
- 2014-03-06 CA CA2890465A patent/CA2890465A1/en not_active Abandoned
- 2014-03-06 PL PL14710654T patent/PL2964202T3/pl unknown
- 2014-03-06 RS RS20190142A patent/RS58317B1/sr unknown
- 2014-03-06 DK DK16188627.0T patent/DK3124018T3/en active
- 2014-03-06 TW TW107112193A patent/TWI686215B/zh active
- 2014-03-06 MY MYPI2015702695A patent/MY170303A/en unknown
- 2014-03-06 EP EP14710654.6A patent/EP2964202B2/en active Active
- 2014-03-06 NZ NZ711179A patent/NZ711179A/en unknown
- 2014-03-06 ES ES16188627.0T patent/ES2663135T3/es active Active
- 2014-03-06 LT LTEP14710654.6T patent/LT2964202T/lt unknown
- 2014-03-06 CU CUP2015000110A patent/CU24348B1/es unknown
- 2014-03-06 RS RS20180167A patent/RS56890B1/sr unknown
- 2014-03-06 DK DK14710654.6T patent/DK2964202T3/en active
- 2014-03-06 ME MEP-2019-30A patent/ME03297B/me unknown
- 2014-03-06 PT PT14710654T patent/PT2964202T/pt unknown
- 2014-03-06 JP JP2015560837A patent/JP6434429B2/ja active Active
- 2014-03-06 HU HUE14710654A patent/HUE041224T2/hu unknown
- 2014-03-06 HU HUE16188627A patent/HUE036921T2/hu unknown
- 2014-03-06 BR BR112015021254A patent/BR112015021254A2/pt not_active IP Right Cessation
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2015
- 2015-05-12 SA SA515360425A patent/SA515360425B1/ar unknown
- 2015-08-20 ZA ZA2015/06060A patent/ZA201506060B/en unknown
- 2015-08-24 IL IL240797A patent/IL240797B/en unknown
- 2015-09-04 TN TN2015000393A patent/TN2015000393A1/en unknown
- 2015-09-07 NI NI201500126A patent/NI201500126A/es unknown
- 2015-09-07 CL CL2015002495A patent/CL2015002495A1/es unknown
- 2015-09-07 PH PH12015501981A patent/PH12015501981A1/en unknown
- 2015-09-08 CR CR20150467A patent/CR20150467A/es unknown
- 2015-09-08 DO DO2015000220A patent/DOP2015000220A/es unknown
- 2015-10-08 EC ECIEPI201542897A patent/ECSP15042897A/es unknown
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2016
- 2016-01-13 HK HK16100339.2A patent/HK1212242A1/xx active IP Right Maintenance
- 2016-02-05 US US15/017,084 patent/US20160220493A1/en not_active Abandoned
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2017
- 2017-06-08 AU AU2017203897A patent/AU2017203897B2/en active Active
- 2017-06-16 US US15/625,863 patent/US20170290811A1/en not_active Abandoned
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2018
- 2018-03-06 HR HRP20180387TT patent/HRP20180387T1/hr unknown
- 2018-03-12 CY CY20181100302T patent/CY1120021T1/el unknown
- 2018-03-23 US US15/934,595 patent/US20180221285A1/en not_active Abandoned
- 2018-05-24 JP JP2018099612A patent/JP6739470B2/ja active Active
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2019
- 2019-01-25 HR HRP20190173TT patent/HRP20190173T1/hr unknown
- 2019-01-31 CY CY20191100143T patent/CY1121315T1/el unknown
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2020
- 2020-06-08 JP JP2020099402A patent/JP2020180123A/ja active Pending
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