WO2010035282A1 - Compositions pharmaceutiques comprenant du deferasirox - Google Patents

Compositions pharmaceutiques comprenant du deferasirox Download PDF

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Publication number
WO2010035282A1
WO2010035282A1 PCT/IN2009/000518 IN2009000518W WO2010035282A1 WO 2010035282 A1 WO2010035282 A1 WO 2010035282A1 IN 2009000518 W IN2009000518 W IN 2009000518W WO 2010035282 A1 WO2010035282 A1 WO 2010035282A1
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WO
WIPO (PCT)
Prior art keywords
deferasirox
tablet
pharmaceutical composition
oral pharmaceutical
total weight
Prior art date
Application number
PCT/IN2009/000518
Other languages
English (en)
Inventor
Nikunj Ladani
Ajay K. Mendiratta
Uday Kumar Singh
Boopalan Swaminathan
Satishkumar Jain
Manoj Kumar Pananchukunnath
Rajesh Gupta
Indu Bhushan
Original Assignee
Matrix Laboratories Limited
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Publication date
Application filed by Matrix Laboratories Limited filed Critical Matrix Laboratories Limited
Publication of WO2010035282A1 publication Critical patent/WO2010035282A1/fr

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Classifications

    • 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
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/2009—Inorganic 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Definitions

  • the invention is related to oral pharmaceutical compositions comprising deferasirox or its pharmaceutically acceptable salts, polymorphic forms, and mixtures thereof.
  • the invention relates to oral pharmaceutical composition
  • oral pharmaceutical composition comprising deferasirox or its pharmaceutically acceptable salts, polymorphic forms and mixtures thereof, in the form of a dispersible tablet wherein the active ingredient has a mean particle size less than about lOO ⁇ m and is present in an amount greater than 66% by weight based on total weight of the tablet.
  • EXJ ADETM dispersible tablet
  • Deferasirox is highly water-insoluble. It is highly lipid-soluble, and is observed to possess good permeability. According to the Bio-pharmaceutics Classification System, it is classified as Class II drug, implying that it is a poorly soluble, and highly permeable drug. Though deferasirox is highly water-insoluble, whatever limited solubility it has, that too shows high pH-dependent solubility. Though it is practically insoluble in lower pH; however, even at a pH of 6.8, it still remains practically insoluble, until the buffer strength is altered to get optimal dissolution profile.
  • the recommended dosage strength of deferasirox is on the higher side in order to have clinical benefit. Due to its high dosage strength, the overall tablet weight and its volume including its dimension make it inconvenient to administer, in order to provide a pharmacologically active daily dosage amount of deferasirox. Hence there is a need for an oral dosage form having a high drug content which would be convenient for patient administration, as well as from manufacturing point of view. Further, high drug content dosage forms require less amount of inactive ingredients, which makes the dosage form less expensive to manufacture and moreover the dosage form becomes relatively smaller in size which would thereby be easier to swallow, especially for children and geriatric patients.
  • WO/2004/035026 discloses a dispersible tablet of deferasirox wherein the active ingredient is present in an amount of from 5% to 40% by weight based on total weight of the tablet.
  • WO/2005/097062 discloses a dispersible tablet of deferasirox wherein the active ingredient is present in an amount of from 42% to 65% by weight based on total weight of the tablet.
  • WO/2007/045445 discloses a dispersible tablet of deferasirox or a pharmaceutically acceptable salt thereof present in an amount of from 42% to 65% by weight based on total weight of the tablet and at least one pharmaceutically acceptable excipient suitable for the preparation of dispersible tablets and to process for making said dispersible tablet.
  • WO/2008/065123 discloses crystalline forms of deferasirox and its amorphous form, processes for its preparation thereof, compositions containing same, wherein the active ingredient is preferably in polymorphic fo ⁇ n designated as "Form B".
  • WO/2009/067557 discloses a process of preparing deferasirox formulations having sufficiently high dissolution rate and good bioavailability wherein said process comprises co- milling deferasirox with at least two pharmaceutically acceptable excipients in the absence of any solvent.
  • compositions of deferasirox or its pharmaceutically acceptable salts, polymorphic forms, and mixtures thereof, in the form of a dispersible tablet can be prepared, wherein the active ingredient is present in an amount greater than 66% by weight based on total weight of the tablet and having a mean particle size less than about lOO ⁇ m; thus allowing an oral dosage form with a high drug load, which would be convenient to administer, manufacture and would also be cost-effective and further having a acceptable dissolution and absorption profile.
  • the invention relates to oral pharmaceutical compositions comprising deferasirox or its pharmaceutically acceptable salts, polymorphic forms, and mixtures thereof, process of preparing such compositions and their uses.
  • the invention relates to oral pharmaceutical composition
  • oral pharmaceutical composition comprising deferasirox or its pharmaceutically acceptable salts, polymorphic forms and mixtures thereof, in the form of a dispersible tablet wherein the active ingredient has a mean particle size less than about lOO ⁇ m and is present in an amount greater than 66% by weight based on total weight of the tablet.
  • An aspect of the invention provides for a dispersible tablet comprising deferasirox or its pharmaceutically acceptable salts, polymorphic forms and mixtures thereof.
  • An aspect of the invention provides for deferasirox compositions in the form of dispersible tablet wherein the mean particle size of deferasirox is less than about 100 ⁇ m.
  • An aspect of the invention provides for deferasirox compositions in the form of dispersible tablet wherein the active ingredient is present in an amount greater than 66% by weight based on total weight of the tablet.
  • An aspect of the invention provides for deferasirox compositions wherein the active ingredient is primarily present in polymorphic form designated as "Form A”.
  • An aspect of the invention provides for the process of preparing deferasirox compositions in the form of dispersible tablet wherein the mean particle size of deferasirox is less than about 100 ⁇ m.
  • An aspect of the invention provides for the process of preparing deferasirox compositions in the form of dispersible tablet wherein the active ingredient is present in an amount greater than 66% by weight based on total weight of the tablet.
  • An aspect of the invention provides for the process of preparing deferasirox compositions in the form of dispersible tablet wherein the active ingredient has a mean particle size less than about lOO ⁇ m and is present in an amount greater than 66% by weight based on total weight of the tablet.
  • compositions of deferasirox wherein the in vitro dissolution release profile matches with the commercially available EXJADETM.
  • the invention relates to oral pharmaceutical compositions comprising deferasirox or its pharmaceutically acceptable salts, polymorphic forms, and mixtures thereof, process of preparing such compositions and their uses.
  • An embodiment of the invention provides for a dispersible tablet comprising deferasirox or its pharmaceutically acceptable salts, polymorphic forms and mixtures thereof.
  • An another embodiment of the invention provides for a dispersible tablet comprising deferasirox or its pharmaceutically acceptable salts, polymorphic forms and mixtures thereof, in the form of a dispersible tablet wherein the active ingredient has a mean particle size less than about lOO ⁇ m and is present in an amount greater than 66% by weight based on total weight of the tablet. .
  • An another embodiment of the invention provides for the process of preparing deferasirox compositions in the form of dispersible tablet wherein the active ingredient has a mean particle size less than about lOO ⁇ m and is present in an amount greater than 66% by weight based on total weight of the tablet.
  • active or “active ingredient” or “drug” or “drug substance” or “pharmacologically active agent” or “active substance” may be used interchangeably and synonymously for 4-[3, 5-Bis(2-hydroxyphenyl)-lH-l,2,4-triazol-l-yi]- benzoic acid or deferasirox or its pharmaceutically acceptable salts, polymorphic forms and mixtures thereof.
  • dispenser tablet refers to a tablet which normally disperses in aqueous phase, e.g. in water, with or without external agitation.
  • particles refers to individual particle of deferasirox or particles of deferasirox or deferasirox compositions.
  • mean particle size refers to the distribution of deferasirox particles wherein about 50 volume percent of all particles measured have a particle size less than the defined mean particle size value and about 50 volume percent of all measurable particles measured have a particle size greater than the defined mean particle size value.
  • D 50 and D 90 represent the median or the 50 th percentile and the 90 th percentile of the particle size distribution, respectively as measured by volume.
  • Dg 0 refers to the size in microns below which 90 percent of the particles reside, on a volume basis.
  • D 50 refers to the size in microns below which 50 percent of the particles reside, on a volume basis.
  • composition comprising deferasirox in the form of dispersible tablet, wherein the mean particle size of deferasirox is less than about lOO ⁇ m.
  • composition of deferasirox in the form of dispersible tablet wherein the mean particle size of deferasirox is about 0.1 ⁇ m to about 50 ⁇ m. More preferably, in some embodiments, there are provided pharmaceutical compositions of deferasirox in the form of dispersible tablet, wherein deferasirox has a mean particle size of about 0.5 ⁇ m to about 25 ⁇ m and still more preferably some embodiments provide deferasirox compositions having a mean particle size of deferasirox from about 1 ⁇ m to about lO ⁇ m.
  • compositions of deferasirox in the form of dispersible tablet wherein the active ingredient has a D 90 of about 50 ⁇ m or less. More preferably, in some embodiments, there are provided pharmaceutical compositions of deferasirox wherein the active ingredient has a D 90 of about 25 ⁇ m or less and still more preferably, some embodiments provide deferasirox compositions, wherein the active ingredient has a D 90 of about lO ⁇ m or less.
  • compositions of deferasirox in the form of dispersible tablet wherein the active ingredient has a D 50 of about 25 ⁇ m or less. More preferably, in some embodiments, there are provided pharmaceutical compositions of deferasirox wherein the active ingredient has a D 50 of about lO ⁇ m or less and still more preferably, some embodiments provide deferasirox compositions, wherein the active ingredient has a D 50 of about 5 ⁇ m or less. According to the invention, there are provided pharmaceutical compositions of deferasirox in the form of dispersible tablet, wherein the active ingredient has a mean particle size of about 50 ⁇ m or less.
  • compositions of deferasirox wherein the active ingredient has a mean particle size of about 25 ⁇ m and still more preferably, some embodiments provide deferasirox compositions, wherein the active ingredient has a mean particle size of about lO ⁇ m or less.
  • the desired particle size range material is obtained directly from a synthesis process or alternatively any known particle size reduction processes can be used, such as but not limited to sifting, milling, micronization, fluid energy milling, ball milling and the like.
  • Particle size can be determined, for example, by laser light scattering using a particle size analyzer, such as the proprietary MastersizerTM apparatus available from Malvern Instruments Ltd.
  • compositions comprising deferasirox may be in the form of encapsulated free flowing powders or granules; compressed solid dosage forms such as tablets, including chewable or dispersible or mouth dissolving, as well as the conventional tablets; pellets or beads or spheres or cores filled into sachets or capsules; syrups, suspensions or dispersions; elixirs, lyophilized powders and the like.
  • compressed solid dosage forms such as tablets, including chewable or dispersible or mouth dissolving, as well as the conventional tablets
  • pellets or beads or spheres or cores filled into sachets or capsules syrups, suspensions or dispersions
  • elixirs lyophilized powders and the like.
  • pharmaceutical compositions of deferasirox in the form of dispersible tablets are the most preferred.
  • compositions of deferasirox in the form of dispersible tablet wherein the active ingredient is present in an amount greater than about 66% by weight based on total weight of the tablet.
  • pharmaceutical compositions of deferasirox in the form of dispersible tablet which comprises active ingredient in an amount ranging from about 66%- 86% by weight based on the total weight of the tablet.
  • pharmaceutical compositions of deferasirox in the form of dispersible tablet which comprises active ingredient in an amount ranging from about 68%- 85% by weight based on total weight of the tablet.
  • weight of the orally administrable dispersible tablet comprising from about 125-500mg of active ingredient ranges from 150 to 765mg; and preferably between about 155 to 750mg.
  • the active ingredient according to the invention may be present in free acid form or in pharmaceutically acceptable salts. More preferably, the active ingredient is present in the free acid form.
  • the active ingredient may further be present in various polymorphic forms and mixtures thereof as disclosed in the prior art. More preferably, active ingredient is present in the polymorphic form designated as "Form A", having X-ray diffraction pattern with a peak at an angle of refraction 2 theta (?) of 10.0°, 10.5°, 14.1°, 16.6°, 23.1°, 25.1°, 25.7°, 26.2° ⁇ 0.2°.
  • the active ingredient according to invention is primarily present in the polymorphic form designated as "Form A", wherein the percentage of "Form A” is more than 80% by weight of solid deferasirox.
  • the remainder of solid deferasirox i.e., 20% or less of the total weight of active ingredient may be, e.g., other crystalline forms or amorphous form or a mixture of crystalline and amorphous forms.
  • the composition contains at least 90% of crystalline "Form A" of deferasirox with respect to total weight of the solid active ingredient in the composition.
  • the composition may contain at least 95% of crystalline "Form A" with respect to total weight of solid deferasirox in the composition.
  • One or more pharmaceutically acceptable excipients used according to the invention includes without any limitations, those that are conventionally used, for e.g. fillers/diluents, disintegrants, binders, surfactants, glidants, lubricants, and optionally outer coating ingredients.
  • Suitable fillers/diluents may include, but are not limited to lactose, microcrystalline cellulose, silicified microcrystalline cellulose, dicalcium phosphate, sugar alcohols, dextrates, dextrin, calcium carbonate, calcium sulfate, dibasic calcium phosphate dihydrate, tribasic calcium phosphate, magnesium carbonate, magnesium oxide, starch, pregelatinized starch, and the like.
  • Suitable disintegrants according to the invention may include, but are not limited to cross- linked polypyrollidone commercially available as CrospovidoneTM & PolyplasdoneTM, sodium starch glycolate, maize starch, salts of carboxy methyl cellulose, microcrystalline cellulose, alginic acid, sodium alginate, guar gum, low-substituted hydroxypropyl cellulose and the like.
  • Suitable binders according to the invention may include, but are not limited to starches, hydroxypropyl cellulose, hydroxyethyl cellulose, hypromellose, polyvinylpyrrolidone, gelatin, and the like.
  • Suitable surfactants according to the invention may include, but are not limited to sodium lauryl sulfate, quaternary ammonium salts, polysorbates, sorbitan esters, poloxamer, betaines, higher fatty alcohols such as cetyl alcohol and oleyl alcohol and the like.
  • Suitable glidants and lubricants according to the invention may include, but are not limited to silica, colloidal silica, magnesium trisilicate, talc, stearates, behenates, fumarates, hydrogenated castor oil, and the like.
  • the tablets according to the invention are prepared by granulation techniques such as dry granulation or wet granulation.
  • the ingredients are blended in dry form, made denser by slugging or compaction and reduced to granules by grinding or milling, using suitable equipments.
  • the ground particles or granules are then compressed into tablet form in conventional manner using lubricants, glidants, etc., which can take any of the conventional shapes, e.g., round, elongated, oval, etc.
  • a tablet press fitted with suitably sized punches and dies is used to form the tablet.
  • wet granulation technique can also be used.
  • the dry active ingredient, other diluents are blended, for example, in a planetary mixer or a rapid mixer granulator.
  • the powders are wetted with a granulating liquid like water, isopropyl alcohol or acetone or dichloromethane and other hydro-alcoholic solvents such as isopropyl alcohol-water mixture.
  • Binders may be included in the granulating liquid.
  • the moist mass is granulated, e.g., by forcing through a screen of suitable mesh size, dried, and, if desired, the particles further reduced in size. Granulates obtained are then compressed in conventional manner, using lubricants, glidants, etc., as required.
  • the process may involve direct compression, wherein the ingredients are blended or homogeneously mixed in dry form, optionally sized through suitable sieves and directly compressed into tablet form in convention manner, using lubricants, glidants, etc., as required.
  • the process involves combination of wet granulation and direct compression wherein the granules prepared by wet granulation are further blended with extra- granular inactive ingredients, lubricated and compressed to form the tablet.
  • the dispersible tablet can optionally be coated with an aesthetic outer coat comprising polymers such as cellulose derivatives such as one which is commercially available as OpadryTM.
  • compositions according of the invention can be used for the treatment of chronic iron overload due to blood transfusions.
  • composition A. Composition:
  • step no. 1 Material of step no. 1 was granulated using the solution of step no. 2 to get granules.
  • step no. 3 Granules of step no. 3 were dried in drier.
  • step no. 4 Dried granules of step no. 4 were sized using suitable mesh.
  • Microcrystalline cellulose was passed through suitable mesh and blended with sized granules of step no. 5.
  • Magnesium stearate was sifted through suitable mesh.
  • step no. 6 and step no. 7 were blended together.
  • Blend of step no. 8 was compressed using suitable tooling.
  • composition A. Composition:
  • step no. 1 Granulate the material of step no. 1 using the binder solution of step no. 2.
  • step no. 3 Dry the material of step no. 3 in drier.
  • step no. 4 Material of step no. 4 is passed through suitable mesh.
  • Microcrystalline cellulose is sifted through suitable mesh and mixed with material of step no. 5.
  • Magnesium stearate is sifted through suitable mesh.
  • step no. 6 Blend the material of step no. 6 and step no. 7.
  • composition A. Composition:
  • step no. 1 Material of step no. 1 was granulated using the solution of step no. 2.
  • step no. 3 Granules of step no. 3 were dried in drier.
  • step no. 4 Dried granules of step no. 4 were sized using suitable mesh.
  • Microcrystalline cellulose was passed through suitable mesh and blended with sized granules of step no. 5.
  • Magnesium stearate was sifted through suitable mesh.
  • step no. 6 and step no. 7 were blended together.
  • Blend of step no. 8 was compressed using suitable tooling.
  • composition A. Composition:
  • step no. 1 Granulate the material of step no. 1 using the solution of step no 2.
  • step no. 3 Dry the material of step no. 3 in drier.
  • step no. 4 Material of step no. 4 is passed through suitable mesh.
  • Microcrystalline cellulose is sifted through suitable mesh and mixed with material of step no. 5.
  • Magnesium stearate is sifted through suitable mesh.
  • step no. 6 Blend the material of step no. 6 and step no. 7.
  • composition A. Composition:
  • Deferasirox, crospovidone (part 1), colloidal silicon dioxide (part 1), and sodium lauryl sulphate are mixed and passed through suitable mesh.
  • step no. 1 Material of step no. 1 was dry granulated to yield the granules.
  • Crospovidone (part 2), and colloidal silicon dioxide (part 2) was sifted through suitable mesh.
  • Magnesium stearate was sifted through suitable mesh.
  • step no. 4 and step no. 5 was blended together.
  • composition A. Composition:
  • step no. 1 Granulate the material of step no. 1 using the solution of step no 2.
  • step no. 3 Dry the material of step no. 3 in drier.
  • step no. 4 Material of step no. 4 is passed through suitable mesh.
  • Microcrystalline cellulose, crospovidone and colloidal silicon dioxide is sifted through suitable mesh and mixed with material of step no. 5.
  • Magnesium stearate/sodium lauryl sulfate (Stear-o-wetTM) is sifted through suitable mesh.
  • step no. 6 Blend the material of step no. 6 and step no. 7.
  • Disintegration time 110 seconds Dissolution Study
  • compositions comprising deferasirox were tested in vitro for drug release and was compared with the commercially available EXJ ADETM.

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Abstract

L'invention concerne une composition pharmaceutique orale comprenant du déférasirox ou des sels pharmaceutiquement acceptables, des formules polymorphes et des mélanges de ceux-ci. L'ingrédient actif a une granulométrie moyenne inférieure à environ 100ƒÊm et est présent en dose  supérieure à 66% en poids sur la base du poids total du comprimé. L'invention concerne également un procédé de préparation desdites compositions pharmaceutiques orales et à leurs utilisations associées.
PCT/IN2009/000518 2008-09-24 2009-09-23 Compositions pharmaceutiques comprenant du deferasirox WO2010035282A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IN2330/CHE/2008 2008-09-24
IN2330CH2008 2008-09-24
IN905CH2009 2009-04-20
IN905/CHE/2009 2009-04-20

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WO2010035282A1 true WO2010035282A1 (fr) 2010-04-01

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WO2012042224A2 (fr) 2010-10-01 2012-04-05 Cipla Limited Composition pharmaceutique
CN103735519A (zh) * 2014-01-10 2014-04-23 无锡万全医药技术有限公司 一种地拉罗司颗粒剂及其制备方法
WO2014072673A1 (fr) 2012-11-12 2014-05-15 Cipla Limited Composition pharmaceutique à dose fixe à base de déférasirox et de déféripone
WO2014109350A1 (fr) * 2013-01-10 2014-07-17 コニカミノルタ株式会社 Composition de résine, composé triazole, film optique, plaque de polarisation, lentille optique, plaque de polarisation circulaire et dispositif d'affichage d'image
WO2014181108A1 (fr) 2013-05-10 2014-11-13 Cipla Limited Composition pharmaceutique à faible dosage
EP2946771A1 (fr) * 2014-05-20 2015-11-25 Sanovel Ilac Sanayi ve Ticaret A.S. Formulation de comprimé dispersible dans l'eau comprenant du déférasirox
EP2987482A1 (fr) 2014-08-22 2016-02-24 Santa Farma Ilaç Sanayi A.S. Composition pharmaceutique soluble et dispersible contenant du déférasirox
WO2016114624A3 (fr) * 2015-01-16 2016-09-09 대원제약주식회사 Suspension contenant du déférasirox
EP3095443A1 (fr) * 2015-05-21 2016-11-23 Abdi Ibrahim Ilac Sanayi ve Ticaret A.S. Composition pharmaceutique contenant du déférasirox
WO2017022997A1 (fr) * 2015-07-31 2017-02-09 건일제약 주식회사 Poudre contenant du déférasirox et procédé de préparation correspondant
EP3124018B1 (fr) 2013-03-08 2017-12-20 Novartis Ag Formulations orales de déférasirox
WO2018059922A1 (fr) 2016-09-30 2018-04-05 Synthon B.V. Composition pharmaceutique comprenant du deferasirox
WO2018208242A1 (fr) 2017-05-10 2018-11-15 İlko Ilaç Sanayi Ve Ticaret Anonim Şirketi Formulation de comprimé de déférasirox pour composition de suspension orale présentant une capacité de traitement améliorée
US10188637B2 (en) 2016-03-29 2019-01-29 Hoffmann-La Roche Inc. Granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone and method of making the same
GR1009592B (el) * 2018-07-03 2019-09-11 Φαρματεν Α.Β.Ε.Ε. Φαρμακευτικο σκευασμα που περιλαμβανει εναν χηλικο παραγοντα συμπλεκτικο του σιδηρου και μεθοδος για την παρασκευη αυτου
CN115154428A (zh) * 2022-09-06 2022-10-11 上海奥科达生物医药科技有限公司 一种地拉罗司药物组合物及其制备方法

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Cited By (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012042224A2 (fr) 2010-10-01 2012-04-05 Cipla Limited Composition pharmaceutique
WO2012042224A3 (fr) * 2010-10-01 2012-08-09 Cipla Limited Composition pharmaceutique
CN103209687A (zh) * 2010-10-01 2013-07-17 希普拉有限公司 包含地拉罗司的药物组合物
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