WO2012087255A2 - Formulations pharmaceutiques - Google Patents

Formulations pharmaceutiques Download PDF

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Publication number
WO2012087255A2
WO2012087255A2 PCT/TR2011/000274 TR2011000274W WO2012087255A2 WO 2012087255 A2 WO2012087255 A2 WO 2012087255A2 TR 2011000274 W TR2011000274 W TR 2011000274W WO 2012087255 A2 WO2012087255 A2 WO 2012087255A2
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical formulation
formulation according
formulations
pharmaceutically acceptable
imatinib
Prior art date
Application number
PCT/TR2011/000274
Other languages
English (en)
Other versions
WO2012087255A3 (fr
Inventor
Mahmut Bilgic
Original Assignee
Mahmut Bilgic
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 Mahmut Bilgic filed Critical Mahmut Bilgic
Publication of WO2012087255A2 publication Critical patent/WO2012087255A2/fr
Publication of WO2012087255A3 publication Critical patent/WO2012087255A3/fr

Links

Classifications

    • 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
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • 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
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • 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
    • 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
    • A61K9/205Polysaccharides, 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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

Definitions

  • the present invention relates to imatinib formulations comprising a pharmaceutically acceptable disintegrant in the range of 0.1% to 5% by weight and at least one other excipient.
  • Imatinib mesylate which is the methane sulfonic acid addition salt of imatinib, is available on the market under the trade name Glivec by Novartis AG.
  • Free base and pharmaceutically acceptable salts of imatinib are disclosed in the European patent numbered EP 0564409.
  • Imatinib which is a tyrosine kinase inhibitor is effective on BCR-ABL enzyme. Therefore, this compound is indicated for chronic myelogenous leukemia and acute lymphoblastic leukemia. In addition, it is known to inhibit trance membrane receptor KIT and PDGF receptors (Merck Index, 14 th Edition, no: 4902, page 851).
  • the active agent is marketed in 100 and 400 mg tablet and 100 mg capsule forms.
  • the prior art indicates various problems about the active agent and pharmaceutical formulations and dosage forms comprising it.
  • the patent numbered EP 1501485 describes dosage forms comprising high amounts of active agent in order to ensure therapeutic dose in leukemia treatment.
  • using high amounts of active agent in the formulations comprising imatinib also affects the physical characteristics of the dosage form obtained.
  • the patent numbered WO 03/090720 discloses that this problem is solved with dosage forms produced by wet granulation method.
  • wet granulation method is not a good choice for an active agent like imatinib which is highly prone to absorb moisture. In the dosage form produced by wet granulation method, it is not predictable for how long the active agent can remain stabile without absorbing moisture.
  • having content uniformity means to comprise equal amount of active agent in unit dosage form. Ensuring content uniformity is a pretty significant parameter for efficiency of the treatment.
  • dose of an active agent which is required to be contained in a capsule or a tablet in order to provide therapeutic effect is closely related to flow characteristics of the formulation comprising said active agent.
  • the inventor has found that sufficient flow characteristics and content uniformity can be ensured by using a disintegrant in the range of 0.1% to 5% by weight in the formulations comprising imatinib as active agent.
  • the present invention relates to pharmaceutical formulations comprising imatinib as active agent.
  • the pharmaceutical formulations of the present invention comprise at least 80%, preferably in the range of 80% to 99%, more preferably in the range of 80% to 98% of imatinib by weight.
  • imatinib refers to pharmaceutically acceptable salts, enantiomers, racemates, solvates, hydrates, different polymorphic forms, amorphous and crystalline forms or combinations thereof.
  • a characteristic feature of the pharmaceutical formulations of the present invention is that imatinib comprised in said formulations is mesylate salt of imatinib.
  • mesylate salt of imatinib comprised in said formulations is in alpha or beta crystalline form, more preferably in alpha crystalline form.
  • a characteristic feature of the pharmaceutical formulations of the present invention comprising imatinib as active agent is that said formulations comprise a pharmaceutically acceptable disintegrant in the range of 0.1% to 5% by weight and at least one other excipient in addition to the active agent.
  • a characteristic feature of the pharmaceutical formulations of the present invention comprising imatinib as active agent is that said formulations comprise a pharmaceutically acceptable disintegrant in the range of 0.1% to 3% by weight and at least one other excipient in addition to the active agent.
  • a characteristic feature of the pharmaceutical formulations of the present invention comprising imatinib as active agent is that said formulations comprise a pharmaceutically acceptable disintegrant in the range of 0.1% to 2% by weight and at least one other excipient in addition to the active agent.
  • a characteristic feature of the pharmaceutical formulations of the present invention comprising imatinib as active agent is that said formulations comprise a pharmaceutically acceptable disintegrant in the range of 0.1% to 1.75% by weight and at least one other excipient in addition to the active agent.
  • Excipients that can be used in the pharmaceutical formulations of the present invention can be selected from a group comprising binders, viscosity enhancing components, filling agents, drying agents, surfactants, stabilizing agents, lubricants, diluents, glidants, wetting agents, coating agents designed to provide various release characteristics, pH regulators, effervescent acids, effervescent bases, gelling agents, flavouring agents, sweeteners, emulsifying agents, anti-foam agents, protecting agents, solvents or solvent mixtures, coloring agents and complexing agents or combinations thereof.
  • a characteristic feature of the pharmaceutical formulations of the present invention comprising a pharmaceutically acceptable disintegrant in the range of 0.1% to 5% by weight in addition to imatinib as active agent is that said formulations comprise at least one other excipient selected from the group comprising lubricants, glidants, diluents, binders or combinations thereof.
  • a characteristic feature of the pharmaceutical formulations of the present invention comprising a pharmaceutically acceptable disintegrant in the range of 0.1% to 5% by weight and at least one other excipient in addition to imatinib as active agent is that the average particle size (d 50 ) of the disintegrant comprised in the formulations is finer than 100 ⁇ , preferably finer than 80 ⁇ , more preferably finer than 60 ⁇ , even more preferably in the range of 1 ⁇ to 60 ⁇ .
  • average particle size refers to volumetric average particle diameter and it is briefly displayed as d 50 .
  • d 50 refers that half of said substance by volume has a particle size above the value specified by d 50 and the other half has a particle size below the value specified by d 50.
  • d 50 particle size can be measured by one of the conventional measuring devices, for instance by a device which measures particle distribution by laser diffraction (for instance Malvern Mastersizer etc.).
  • the disintegrants that can be used in the formulations of the present invention can be selected from a group comprising carboxymethyl cellulose, carboxymethyl cellulose calcium, carboxymethyl cellulose sodium, croscarmellose sodium, crospovidone, hydroxypropyl cellulose, microcrystalline cellulose, methyl cellulose, chitosan, starch, sodium starch glycolate or combinations thereof.
  • the disintegrant preferred in the formulations of the present invention is crospovidone.
  • the binders that can be used in the formulations of the present invention can be selected from a group comprising potato, wheat or corn starch; microcrystalline cellulose (Avicel®, Filtrak®, Heweten® or Pharmacel®), hydroxypropyl cellulose, hydroxyethyl cellulose; hydroxypropyl methyl cellulose (hydroxypropyl methyl cellulose- Type 2910 USP, hypromellose) and polyvinylpyrrolidone (for instance, Povidone® K30(BASF)), lactose, guar gum, pectin, gelatine, sodium alginate or combinations thereof.
  • microcrystalline cellulose Avicel®, Filtrak®, Heweten® or Pharmacel®
  • hydroxypropyl cellulose hydroxyethyl cellulose
  • hydroxypropyl methyl cellulose hydroxypropyl methyl cellulose- Type 2910 USP, hypromellose
  • polyvinylpyrrolidone for instance, Povidone® K30(BASF)
  • the lubricants that can be used in the formulations of the present invention can be selected from a group comprising metallic stearates (such as magnesium stearate, calcium stearate, aluminum stearate), fatty acid esters (such as sodium stearyl fumarate), fatty acids (such as stearic acid), fatty alcohols, glyceryl behenate, mineral oil, paraffins, hydrogenated vegetable oil, leucine, polyethylene glycols (PEG), metallic lauryl sulphates (such as sodium lauryl sulphate, magnesium lauryl sulphate), sodium chloride, sodium benzoate, sodium acetate, talc, siliconized talc and/or hydrates thereof or combinations thereof.
  • metallic stearates such as magnesium stearate, calcium stearate, aluminum stearate
  • fatty acid esters such as sodium stearyl fumarate
  • fatty acids such as stearic acid
  • fatty alcohols glyceryl behenate
  • the glidants that can be used in the formulations of the present invention can be selected from a group comprising silica, talc, colloidal silicone dioxide (Aerosil® 200, Syloid®, Cab-OSil®), magnesium trisilicate, cellulose powder, magnesium stearate and corn starch or combinations thereof.
  • the pharmaceutical formulations of the present invention which comprise a pharmaceutically acceptable disintegrant in the range of 0.1% to 5% by weight in addition to imatinib as active agent are in powder form.
  • the powder formulations of the present invention comprising a pharmaceutically acceptable disintegrant in the range of 0.1% to 5% by weight in addition to imatinib as active agent can be prepared in the form of any solid oral forms comprising tablet; layered tablet (for instance bilayer tablet); capsule; enterically coated or modified release tablets; controlled release tablet; prolonged release tablet; delayed release tablet; slow or fast release tablet; fast soluble tablet; effervescent tablet; fast soluble powder mixture; water soluble powder; pellet; mini tablet; micro tablet; granule capsule; pellet capsule; mini tablet capsule; micro tablet capsule or dry powder mixture for syrup preparation; dragee; orodispersible tablet; film tablet or combinations thereof.
  • the powder formulations of the present invention comprising a pharmaceutically acceptable disintegrant in the range of 0.1% to 5% by weight in addition to imatinib as active agent
  • the capsule of the present invention can be made of a substance selected from the group comprising gelatine, chitosan, starch and/or starch derivatives, cellulose and/or cellulose derivatives or synthetic polymers.
  • the capsule is made of telescoping cap and body parts.
  • cap and body parts can be made of the same or different materials.
  • the capsule material can be selected from a group comprising hydroxypropyl cellulose, hydroxypropyl methyl cellulose, methyl cellulose, hydroxy methyl cellulose, hydroxy ethyl cellulose or combinations thereof in the case that the capsule is made of cellulose or derivatives thereof.
  • the capsule material can be selected from a group comprising polyethylene polyester, polyethylene terephthalate, polycarbonate or polypropylene or combinations thereof in the case that the capsule is made of synthetic polymer.
  • polyethylene glycol of various molecular weights sorbitol, glycerol, propylene glycol, titanium dioxide, polyethylene oxide-polypropylene oxide block copolymers and/or other polyalcohols and polyethers
  • the capsule material is gelatine.
  • the capsule preferred is gelatine capsule and said capsule can be in any shape and color.
  • powder formulations of the present invention are prepared in tablet dosage form
  • said tablet dosage form can be coated with protective coating, enteric coating, film coating and/or coatings designed to provide various release characteristics (fast release, slow release, controlled release).
  • the film coating materials that can be used in scope of the invention can be selected from a group comprising cellulose derivatives such as hydroxypropyl cellulose, hydroxypropyl methyl cellulose hydroxyl ethyl cellulose, methyl hydroxyl ethyl cellulose and sodium carboxymethyl cellulose; iron oxides; titanium oxide; polyvinyl alcohols such as polyethylene glycol; synthetic polymers such as polyvinyl acetal diethyl aminoacetate, aminoalkyl methacrylate copolymers and polyvinylpyrrolidone; and polysaccharides such as pullulan or combinations thereof.
  • cellulose derivatives such as hydroxypropyl cellulose, hydroxypropyl methyl cellulose hydroxyl ethyl cellulose, methyl hydroxyl ethyl cellulose and sodium carboxymethyl cellulose
  • iron oxides titanium oxide
  • polyvinyl alcohols such as polyethylene glycol
  • synthetic polymers such as polyvinyl acetal diethyl aminoacetate, aminoal
  • the enteric coating materials that can be used in scope of the present invention can be selected from a group comprising cellulose derivatives such as hydroxypropyl methyl cellulose phthalate, hydroxypropyl methyl cellulose acetate succinate, carboxymethyl ethyl cellulose, cellulose acetate phthalate; acrylic acid derivatives such as methacrylic acid copolymer L, methacrylic acid copolymer LD and methacrylic acid copolymer S; and natural substances such as shellac or combinations thereof.
  • Effective dose amount required to be taken daily can vary according to factors such as patient's age, personal conditions, phase of the disease, mode of administration. For instance, daily imatinib dose amount required for adults varies in the range of 400 mg to 800 mg.
  • the amount of active agent in oral dosage form is in the range of 50 mg to 800 mg, preferably in the range of 100 mg to 600 mg, more preferably in the range of 100 mg to 400 mg in the case that the active agent is imatinib free base in another embodiment of the present invention.
  • the active agent is a pharmaceutically acceptable derivative of imatinib
  • these substances are used in an equivalent amount to imatinib in the range of 50 mg to 800 mg, preferably in the range of 100 mg to 600 mg, more preferably in the range of 100 mg to 400 mg.
  • the amount of imatinib comprised in the pharmaceutical formulations corresponds to imatinib free base in the range of 50 mg to 800 mg, preferably in the range of 100 mg to 600 mg, more preferably in the range of 100 mg to 400 mg.
  • the oral dosage form comprising an effective amount of alpha crystalline form of imatinib mesylate can be administered separately, sequentially and simultaneously with oral dosage forms comprising active agents belonging to groups such as rapamycin, cyclosporine, ascomycin, corticosteroid, cyclophosphamide, azathioprine, methotrexate, brequinar, leflunomide, mizoribine, mycophenolic acid and/or mycophenolate mofetil.
  • active agents belonging to groups such as rapamycin, cyclosporine, ascomycin, corticosteroid, cyclophosphamide, azathioprine, methotrexate, brequinar, leflunomide, mizoribine, mycophenolic acid and/or mycophenolate mofetil.
  • the pharmaceutical capsule formulations of the present invention comprising a pharmaceutically acceptable disintegrant in the range of 0.1% to 5% by weight and at least one other excipient in addition to imatinib as active agent are preferably produced by dry blending method.
  • the pharmaceutical capsule formulations of the present invention comprising a pharmaceutically acceptable disintegrant in the range of 0.1% to 5% by weight and at least one other excipient in addition to imatinib as active agent are used in the treatment of diseases of acute lymphocytic leukemia, gastrointestinal stromal tumors (GIST), hypereosinophilic syndrome, chronic myelogenous leukemia (CML), myelodysplastic syndrome and systemic mastocytosis.
  • GIST gastrointestinal stromal tumors
  • CML chronic myelogenous leukemia
  • myelodysplastic syndrome myelodysplastic syndrome and systemic mastocytosis.
  • imatinib mesylate and the other excipients are mixed homogenously.
  • the mixture is preferably presented as filled into hard gelatine capsules which are made of titanium dioxide and gelatine.
  • imatinib mesylate and the other excipients are mixed homogenously.
  • the mixture is compressed in tablet form and coated with film coating.

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

Abstract

La présente invention concerne des formulations d'imatinib renfermant un désintégrant pharmaceutiquement acceptable dans une proportion comprise entre 0,1 % et 5 % en poids et au moins un autre excipient.
PCT/TR2011/000274 2010-12-20 2011-12-19 Formulations pharmaceutiques WO2012087255A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2010/10618A TR201010618A2 (tr) 2010-12-20 2010-12-20 İmatinib içeren bir oral dozaj formu ve bu oral dozaj formunun üretimi
TR2010/10618 2010-12-20

Publications (2)

Publication Number Publication Date
WO2012087255A2 true WO2012087255A2 (fr) 2012-06-28
WO2012087255A3 WO2012087255A3 (fr) 2012-08-16

Family

ID=45529174

Family Applications (3)

Application Number Title Priority Date Filing Date
PCT/TR2011/000276 WO2012087257A2 (fr) 2010-12-20 2011-12-19 Forme galénique orale contenant de l'imatinib et production de ladite forme galénique orale
PCT/TR2011/000275 WO2012087256A2 (fr) 2010-12-20 2011-12-19 Formulations de capsules pharmaceutiques
PCT/TR2011/000274 WO2012087255A2 (fr) 2010-12-20 2011-12-19 Formulations pharmaceutiques

Family Applications Before (2)

Application Number Title Priority Date Filing Date
PCT/TR2011/000276 WO2012087257A2 (fr) 2010-12-20 2011-12-19 Forme galénique orale contenant de l'imatinib et production de ladite forme galénique orale
PCT/TR2011/000275 WO2012087256A2 (fr) 2010-12-20 2011-12-19 Formulations de capsules pharmaceutiques

Country Status (2)

Country Link
TR (1) TR201010618A2 (fr)
WO (3) WO2012087257A2 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2497464A3 (fr) * 2011-03-09 2012-09-19 Adamed SP. Z O.O. Composition pharmaceutique de l'imatinibe methanesulphonate et son procédé de fabrication
WO2014081172A1 (fr) * 2012-11-22 2014-05-30 에스케이케미칼 (주) Préparation d'imatinib super-délitante effervescente et procédé de production de celle-ci
WO2014139836A1 (fr) * 2013-03-15 2014-09-18 Pharmaceutical Oriented Services Ltd Compositions pharmaceutiques à base d'imatinib
EP2803352A1 (fr) * 2013-05-14 2014-11-19 Hetero Research Foundation Compositions d'imatinib
US20160143850A1 (en) * 2013-07-09 2016-05-26 Shilpa Medicare Limited Oral Pharmaceutical Compositions Comprising Imatinib Mesylate
WO2019229648A1 (fr) * 2018-05-28 2019-12-05 Shivalik Rasayan Limited Compositions orales de mésylate d'imatinib

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI608849B (zh) * 2014-06-16 2017-12-21 國邑藥品科技股份有限公司 可調控釋放度之高載藥量之醫藥組合物及其製備方法
EP3257499A1 (fr) 2016-06-17 2017-12-20 Vipharm S.A. Procédé pour la préparation de capsules de méthanesulfonate d'imatinib

Citations (5)

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Publication number Priority date Publication date Assignee Title
EP0564409A1 (fr) 1992-04-03 1993-10-06 Ciba-Geigy Ag Dérivés de pyrimidine et procédé pour leur préparation
WO1999003854A1 (fr) 1997-07-18 1999-01-28 Novartis Ag Modification de la forme cristalline d'un derive n-phenyl-2-pyrimidineamine, procede de preparation et d'utilisation de ce dernier
WO2003090720A1 (fr) 2002-04-23 2003-11-06 Novartis Ag Comprime a forte charge en substance medicamenteuse
WO2004074502A2 (fr) 2003-02-18 2004-09-02 Cipla Ltd Procede de preparation d’imatinibe et produit ainsi prepare
EP1857454A1 (fr) 2006-05-15 2007-11-21 Chemagis Ltd. Base cristalline d'imatinib et son procédé de fabrication

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ITMI992711A1 (it) * 1999-12-27 2001-06-27 Novartis Ag Composti organici
MY148074A (en) * 2005-05-10 2013-02-28 Novartis Ag Pharmaceutical compositions comprising imatinib and a release retardant
ES2341996T3 (es) * 2005-06-03 2010-06-30 Elan Pharma International Limited Formulaciones de mesilato de imatinib en forma de manoparticulas.
ES2334933T3 (es) * 2005-08-15 2010-03-17 Siegfried Generics International Ag Comprimido recubierto o granulado que contiene una piridilpirimidina.
US20090324718A1 (en) * 2006-09-01 2009-12-31 Ilan Zalit Imatinib compositions
WO2009042809A1 (fr) * 2007-09-25 2009-04-02 Teva Pharmaceutical Industries Ltd. Compositions d'imatinib stables

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Publication number Priority date Publication date Assignee Title
EP0564409A1 (fr) 1992-04-03 1993-10-06 Ciba-Geigy Ag Dérivés de pyrimidine et procédé pour leur préparation
WO1999003854A1 (fr) 1997-07-18 1999-01-28 Novartis Ag Modification de la forme cristalline d'un derive n-phenyl-2-pyrimidineamine, procede de preparation et d'utilisation de ce dernier
WO2003090720A1 (fr) 2002-04-23 2003-11-06 Novartis Ag Comprime a forte charge en substance medicamenteuse
EP1501485A1 (fr) 2002-04-23 2005-02-02 Novartis AG Comprime a forte charge en substance medicamenteuse
WO2004074502A2 (fr) 2003-02-18 2004-09-02 Cipla Ltd Procede de preparation d’imatinibe et produit ainsi prepare
EP1857454A1 (fr) 2006-05-15 2007-11-21 Chemagis Ltd. Base cristalline d'imatinib et son procédé de fabrication

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Title
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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2497464A3 (fr) * 2011-03-09 2012-09-19 Adamed SP. Z O.O. Composition pharmaceutique de l'imatinibe methanesulphonate et son procédé de fabrication
WO2014081172A1 (fr) * 2012-11-22 2014-05-30 에스케이케미칼 (주) Préparation d'imatinib super-délitante effervescente et procédé de production de celle-ci
WO2014139836A1 (fr) * 2013-03-15 2014-09-18 Pharmaceutical Oriented Services Ltd Compositions pharmaceutiques à base d'imatinib
EP2803352A1 (fr) * 2013-05-14 2014-11-19 Hetero Research Foundation Compositions d'imatinib
US20160143850A1 (en) * 2013-07-09 2016-05-26 Shilpa Medicare Limited Oral Pharmaceutical Compositions Comprising Imatinib Mesylate
EP3019159A4 (fr) * 2013-07-09 2017-01-18 Shilpa Medicare Limited Compositions pharmaceutiques orales comprenant du mésylate d'imatinib
WO2019229648A1 (fr) * 2018-05-28 2019-12-05 Shivalik Rasayan Limited Compositions orales de mésylate d'imatinib

Also Published As

Publication number Publication date
WO2012087255A3 (fr) 2012-08-16
WO2012087256A3 (fr) 2012-09-27
WO2012087256A2 (fr) 2012-06-28
WO2012087257A2 (fr) 2012-06-28
WO2012087257A3 (fr) 2012-09-27
TR201010618A2 (tr) 2012-07-23

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