EP2968175A1 - Compositions pharmaceutiques à base d'imatinib - Google Patents

Compositions pharmaceutiques à base d'imatinib

Info

Publication number
EP2968175A1
EP2968175A1 EP14727714.9A EP14727714A EP2968175A1 EP 2968175 A1 EP2968175 A1 EP 2968175A1 EP 14727714 A EP14727714 A EP 14727714A EP 2968175 A1 EP2968175 A1 EP 2968175A1
Authority
EP
European Patent Office
Prior art keywords
imatinib
dosage form
tablet
present
pharmaceutically acceptable
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP14727714.9A
Other languages
German (de)
English (en)
Inventor
Charalambos PATTIHIS
Antje NORDMANN
Panagiotis PANAGOPOULOS
Konstantinos-Emmanouil PANITSAS
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Remedica Ltd
Pharmaceutical Oriented Services Ltd
Original Assignee
Remedica Ltd
Pharmaceutical Oriented Services Ltd
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 Remedica Ltd, Pharmaceutical Oriented Services Ltd filed Critical Remedica Ltd
Publication of EP2968175A1 publication Critical patent/EP2968175A1/fr
Withdrawn legal-status Critical Current

Links

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
    • A61K31/495—Heterocyclic 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Definitions

  • the present invention is concerned with tablet and capsule compositions of imatinib, or a pharmaceutically acceptable salt thereof, and processes of preparing the same.
  • Imatinib is chemically designated as 4-[(4-methyl-l-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3- pyridinyl)-2-pyrimidinyl] amino]-phenyl] benzamide, and can be represented by the chemical structure of formula (I)
  • Imatinib is a protein tyrosine kinase inhibitor, especially useful in the treatment of various types of cancer.
  • the approved indications and patient groups for imatinib include adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment; adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis; adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy; adult patients with relapsed or refractory Ph+ ALL as monotherapy; adult patients with myelodysplastic / myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements; adult patients with advanced hypereosinophilic syndrome (HES) and
  • Basic pharmaceutically active therapeutic compounds such as imatinib
  • imatinib are commonly formulated into pharmaceutical preparations as an acid addition salt form, particularly as a crystalline acid addition salt.
  • imatinib is marketed in many countries as its monomethanesulfonate salt (imatinib mesylate) under the trademarks GLIVEC or GLEEVEC.
  • imatinib mesylate monomethanesulfonate salt
  • GLEEVEC Two crystal forms of imatinib mesylate are described in WO 99/03854.
  • the crystal form designated as the beta form is described as having physical properties that make it advantageous for the manufacture of solid oral pharmaceutical dosage forms, such as tablet and capsule dosage forms.
  • WO 03/090720 discloses tablets comprising imatinib mesylate which are prepared by means of wet granulation, and wherein imatinib, or a pharmaceutically acceptable salt thereof, is present in an amount of from about 30 to 80% (based on the free base) in weight based on the total weight of the tablet.
  • WO 03/090720 explains that the inventors thereof encountered difficulties in the production of imatinib tablets due to high friability values and poor abrasion resistance. Further, the flexibility in the quantity of excipients, e.g. disintegrants, was found to be limited due to the high drug load of the product according to WO 03/090720.
  • a solid oral dosage form comprising imatinib, or a pharmaceutically acceptable salt thereof, together with one or more pharmaceutically acceptable excipients, said solid oral dosage form comprising said imatinib in an amount of greater than about 80% based on the weight of imatinib free base compared to the total weight of said solid oral dosage form.
  • a solid dosage form according to the present invention comprises said imatinib in an amount of at least about 96%, or more preferably at least about 97%, or more preferably at least about 98%, or more preferably at least about 99%, or even up to 100%, either based on the weight of the free base of imatinib when imatinib is present as the free base, or based on the weight of a pharmaceutically acceptable salt of imatinib when imatinib is present as a pharmaceutically acceptable salt, compared to the total weight of said solid oral dosage form.
  • a solid oral dosage form according to the present invention can comprise either a tablet or a capsule, wherein preferred excipients for use therein, and associated formulation methods, are substantially as hereinafter described. Accordingly, in a first preferred embodiment of the present invention there is provided a tablet comprising imatinib, or a pharmaceutically acceptable salt thereof, together with one or more pharmaceutical ly acceptable excipients, said tablet comprising said imatinib in an amount of at least about 96%, either based on the weight of the free base of imatinib when imatinib is present as the free base, or based on the weight of a pharmaceutically acceptable salt of imatinib when imatinib is present as a pharmaceutically acceptable salt, compared to the total weight of said tablet.
  • a capsule comprising imatinib, or a pharmaceutically acceptable salt thereof, together with one or more pharmaceutically acceptable excipients, said capsule comprising said imatinib in an amount of at least about 96%, either based on the weight of the free base of imatinib when imatinib is present as the free base, or based on the weight of a pharmaceutically acceptable salt of imatinib when imatinib is present as a pharmaceutically acceptable salt, compared to the total weight of said capsule.
  • the one or more excipients as used in a solid oral dosage form according to the present invention preferably include pharmaceutically acceptable excipients, such as fillers, binders, disintegrants, glidants, lubricants and the like.
  • Suitable fillers for inclusion in solid oral dosage forms according to the present invention include sugars, sugar alcohols and polymeric glycosides.
  • sugars are sucrose, glucose and lactose as the monohydrate or in anhydrous form.
  • sugar alcohols include mannitol, xylitol and sorbitol.
  • polymeric glycosides are maltodextrin, microcrystalline cellulose and starches of different origins.
  • a filler is included in an oral dosage form according to the present invention when imatinib is present as imatinib free base.
  • a solid dosage form according to the present invention can be essentially free from any excipient that functions in said dosage form as a filler, which typically facilitates the high drug loading of a dosage form according to the present invention.
  • Suitable binders for inclusion in solid oral dosage forms according to the present invention so as to ensure the required mechanical strength include wet and / or dry binders depending on the formulation process employed.
  • Typical binders include polymers, such as polyvinylpyrrolidone, and cellulose derivatives, such as hydroxypropyl cellulose and microcrystalline cellulose (which as indicated above can also function as a filler).
  • a preferred wet binder comprises hydroxypropyl cellulose and a preferred dry binder comprises microcrystalline cellulose.
  • the amount of binder present can vary depending on the formulation process employed. Typically, however, a binder is present in an amount of less than about 2%, or in an amount of less than about 1%, based on the weight thereof compared to the total weight of the solid oral dosage form.
  • the binder can be included either in dry state (mixed with imatinib before granulation), or can be dissolved or suspended in a granulation liquid. In certain embodiments and depending on the formulation process employed, then the dry binder might be employed in an extra-granular phase.
  • hydroxypropyl cellulose is dispersed in a suitable solvent, such as water, and mixed with imatinib or a pharmaceutically acceptable salt thereof, typically imatinib mesylate as hereinafter discussed.
  • a solid dosage form according to the present invention can be essentially free from any excipient that functions in said dosage form as a binder, which typically facilitates the high drug loading of a dosage form according to the present invention.
  • Suitable disintegrants for inclusion in solid oral dosage forms according to the present invention are crospovidone and croscarmellose, such as croscarmellose sodium, starches and modified starches, e.g. maize starch, in pregelatinized form or as sodium glycolate, and hydroxypropyl cellulose with a low degree of substitution (L-HPC).
  • a preferred disintegrant is sodium starch glycolate (suitably present in an extra-granular phase as hereinafter described).
  • a disintegrant is present in an amount of less than about 2%, or in an amount of less than about 1%, based on the weight thereof compared to the total weight of the solid oral dosage form.
  • a solid dosage form according to the present invention can be essentially free from any excipient that functions in said dosage form as a disintegrant, which again typically facilitates the high drug loading of a dosage form according to the present invention.
  • glidants include colloidal silicon dioxide, calcium silicates and talcum.
  • Colloidal silicon dioxide is preferred and typically a glidant is present in an amount of less than about 0.5%, based on the weight thereof compared to the total weight of the solid oral dosage form .
  • a glidant is present in an extra-granular phase of a solid oral dosage form according to the present invention.
  • Preferred lubricants include stearic acid or salts thereof, with a particularly preferred lubricant comprising magnesium stearate.
  • lubricant is present in an amount of less than about 1%, such as about 0.8%, about 0.6% or about 0.4%, based on the weight thereof compared to the total weight of the solid oral dosage form.
  • Lubricant can be present in an amount of about 0.6%.
  • a lubricant is present at least in an extra-granular phase of a solid oral dosage form according to the present invention.
  • an oral dosage form according to the present invention can comprise, or be prepared from, granules comprising imatinib, or a pharmaceutically acceptable salt thereof, together with one or more lubricants. Such granules are then typically mixed with one or more glidants, and / or one or more lubricants, prior to formulation into final dosage form.
  • a solid oral dosage form comprises a tablet substantially as hereinbefore described
  • the tablet can be coated or un-coated.
  • the tablet comprises a film coated tablet.
  • film coated tablet means a tablet core provided with a film coating, including suitable coating excipients together with other auxiliaries, such as plasticizers, colorants and the like.
  • core denotes both the intra- and extra-granular phase as compressed together in a typical tabletting process
  • total weight of a tablet in the context of the present invention is meant the weight of a tablet being the intra- and extra-granular phases and a coating thereon (if any).
  • Total weight in the context of a capsule in the context of the present invention is meant the weight of the intra- and extra-granular phases and a coating thereon (if any), which are to be included in an appropriate capsule shell.
  • imatinib as present in a solid oral dosage form according to the present invention is present as the mesylate salt, and furthermore it is still further preferred that imatinib mesylate is present as crystalline form alpha as characterized in WO 99/03854.
  • a process of preparing a solid oral dosage form comprising imatinib, or a pharmaceutically acceptable salt thereof, together with one or more pharmaceutically acceptable excipients, said process comprising contacting said imatinib with said one or more pharmaceutically acceptable excipients, so as to provide a solid oral dosage form comprising said imatinib in an amount of greater than about 80% based on the weight of imatinib free base compared to the total weight of said solid oral dosage form.
  • the above process can comprise a dry or wet granulation process, or direct compression.
  • the process comprises initially forming an intra-granular phase comprising imatinib, or a pharmaceutically acceptable salt thereof, together with one or more excipients, by dry granulation or wet granulation (such as wet mixing or spray granulating), blending with one or more excipients of an extra-granular phase, and compressing the resulting mixture to form a tablet, and optionally and if required providing a film coating on the compressed tablet.
  • the process may involve slugging.
  • imatinib or a pharmaceutically acceptable salt thereof is mixed with one or more suitable lubricants, such as magnesium stearate, the resulting mixture is granulated, followed by mixing with one or more glidants and / or a second portion of one or more suitable lubricants.
  • suitable lubricants such as magnesium stearate
  • any suitable granulation liquid can be used, such as water, ethanol, isopropanol, or mixtures thereof.
  • the process can typically comprise a direct compression process wherein imatinib (which can be compacted) is blended with excipients, the blend is compressed and where required provided with a film coating.
  • the excipients can typically consist essentially of a glidant and a lubricant, with a preferred glidant being colloidal silicon dioxide and a preferred lubricant being magnesium stearate.
  • a direct compression technique can suitably facilitate particularly high drug loading of the imatinib, either as the free base or a pharmaceutically acceptable salt, preferably in an amount of at least about 97%, either based on the weight of the free base of imatinib when imatinib is present as the free base, or based on the weight of a pharmaceutically acceptable salt of imatinib when imatinib is present as a pharmaceutically acceptable salt, compared to the total weight of the tablet.
  • a coating typically a film coating
  • the process comprises initially forming an intra-granular phase comprising imatinib, or a pharmaceutically acceptable salt thereof, together with one or more excipients, by a dry or wet granulation process, blending with one or more excipients of an extra-granular phase, and filling the resulting mixture into an appropriately sized capsule.
  • a film coated tablet comprising imatinib, or a pharmaceutically acceptable salt thereof, together with one or more pharmaceutically acceptable excipients, said tablet comprising said imatinib in an amount of at least about 97%, either based on the weight of the free base of imatinib when imatinib is present as the free base, or based on the weight of a pharmaceutically acceptable salt of imatinib when imatinib is present as a pharmaceutically acceptable salt, compared to the total weight of said tablet, together with at least one glidant and at least one lubricant.
  • the imatinib is present in an amount of at least about 97.5%, either based on the weight of the free base of imatinib when imatinib is present as the free base, or based on the weight of a pharmaceutically acceptable salt of imatinib when imatinib is present as a pharmaceutically acceptable salt, compared to the total weight of said tablet.
  • the imatinib is present as imatinib mesylate.
  • the glidant comprises colloidal silicon dioxide.
  • the lubricant comprises magnesium stearate.
  • the tablet is essentially free from any excipient that functions in the tablet as a filler.
  • the tablet is essentially free from any excipient that functions in the tablet as a binder.
  • the tablet is essentially free from any excipient that functions in the tablet as a disintegrant.
  • the tablet is prepared by direct compression.
  • a film coated tablet comprising a core and a film coating on the core, wherein said core consists essentially of imatinib, or a pharmaceutically acceptable salt thereof (in particular mesylate), a glidant and a lubricant, wherein said imatinib is present in an amount of at least about 97%, either based on the weight of the free base of imatinib when imatinib is present as the free base, or based on the weight of a pharmaceutically acceptable salt of imatinib when imatinib is present as a pharmaceutically acceptable salt, compared to the total weight of said tablet, wherein said tablet is prepared by direct compression.
  • this tablet can be prepared by a process comprising blending said imatinib with excipients that consist of a glidant and a lubricant (in other words, no other excipient being present for this blending step), subjecting the resulting blend to direct compression to form a tablet core, and providing a film coating on the thus compressed tablet core, wherein said imatinib is present in the tablet in an amount of at least about 97%, either based on the weight of the free base of imatinib when imatinib is present as the free base, or based on the weight of a pharmaceutically acceptable salt of imatinib when imatinib is present as a pharmaceutically acceptable salt, compared to the total weight of the tablet.
  • the glidant is preferably silicon dioxide and the lubricant is preferably magnesium stearate.
  • a film coated tablet comprising imatinib, or a pharmaceutically acceptable salt thereof, together with one or more pharmaceutically acceptable excipients, said tablet comprising said imatinib in an amount of at least about 96%, either based on the weight of the free base of imatinib when imatinib is present as the free base, or based on the weight of a pharmaceutically acceptable salt of imatinib when imatinib is present as a pharmaceutically acceptable salt, compared to the total weight of said tablet, together with at least one lubricant, at least one binder and at least one disintegrant.
  • the imatinib is present as imatinib mesylate.
  • the lubricant comprises magnesium stearate.
  • the binder comprises hydroxypropyl cellulose.
  • the disintegrant comprises sodium starch glycolate.
  • the tablet is essentially free from any excipient that functions in the tablet as a filler.
  • the tablet is prepared by a wet granulation process.
  • a film coated tablet comprising imatinib, or a pharmaceutically acceptable salt thereof, together with one or more pharmaceutically acceptable excipients, said tablet comprising said imatinib in an amount of at least about 96%, either based on the weight of the free base of imatinib when imatinib is present as the free base, or based on the weight of a pharmaceutically acceptable salt of imatinib when imatinib is present as a pharmaceutically acceptable salt, compared to the total weight of said tablet, together with at least one glidant and at least one lubricant.
  • the imatinib is present as imatinib mesylate.
  • the glidant comprises colloidal silicon dioxide.
  • the lubricant comprises magnesium stearate.
  • the tablet is essentially free from any excipient that functions in the tablet as a filler.
  • the tablet is essentially free from any excipient that functions in the tablet as a binder.
  • the tablet is essentially free from any excipient that functions in the tablet as a disintegrant.
  • the tablet is prepared by a dry granulation process.
  • compositions according to the present invention as described herein can be used in the treatment of conditions that can be alleviated by the administration of a protein tyrosine kinase inhibitor, such as imatinib or a pharmaceutically acceptable salt thereof, such as imatinib mesylate.
  • a protein tyrosine kinase inhibitor such as imatinib or a pharmaceutically acceptable salt thereof, such as imatinib mesylate.
  • compositions according to the present invention as described herein are useful in the treatment of various types of cancer and especially for the treatment of the approved indications for imatinib substantially as hereinbefore described.
  • Hydroxypropyl cellulose was dispersed in water. Imatinib mesylate was wetted with the hydroxypropyl cellulose / water dispersion and mixed until granules were formed. The granules were dried in a tray-drying oven and passed through an appropriate sieve. The dried and sieved granules were mixed with the sodium starch glycolate and magnesium stearate. The mixture was compressed into tablets and the tablets were coated.
  • Imatinib mesylate was compacted with half the total amount of magnesium stearate. The resulting flakes were passed through an appropriate sieve. The resulting granules were mixed with colloidal silicon dioxide and the remaining magnesium stearate. The mixture was compressed into tablets and the tablets were coated.

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

Abstract

La présente invention concerne une forme galénique solide administrée par voie orale contenant de l'imatinib ou un sel pharmaceutiquement acceptable de celui-ci, ainsi qu'un ou plusieurs excipients pharmaceutiquement acceptables, ladite forme galénique solide administrée par voie orale contenant de l'imatinib en quantité supérieure à environ 80 % par rapport au poids de la base libre d'imatinib par comparaison au poids total de ladite forme galénique solide administrée par voie orale.
EP14727714.9A 2013-03-15 2014-03-04 Compositions pharmaceutiques à base d'imatinib Withdrawn EP2968175A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB201304699A GB201304699D0 (en) 2013-03-15 2013-03-15 Pharmaceutical compositions
PCT/EP2014/054173 WO2014139836A1 (fr) 2013-03-15 2014-03-04 Compositions pharmaceutiques à base d'imatinib

Publications (1)

Publication Number Publication Date
EP2968175A1 true EP2968175A1 (fr) 2016-01-20

Family

ID=48226404

Family Applications (1)

Application Number Title Priority Date Filing Date
EP14727714.9A Withdrawn EP2968175A1 (fr) 2013-03-15 2014-03-04 Compositions pharmaceutiques à base d'imatinib

Country Status (3)

Country Link
EP (1) EP2968175A1 (fr)
GB (1) GB201304699D0 (fr)
WO (1) WO2014139836A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2937365C (fr) 2016-03-29 2018-09-18 F. Hoffmann-La Roche Ag Formulation en granules de 5-methyl-1-phenyl-2-(1h)-pyridone et methode de fabrication associee

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CO4940418A1 (es) 1997-07-18 2000-07-24 Novartis Ag Modificacion de cristal de un derivado de n-fenil-2- pirimidinamina, procesos para su fabricacion y su uso
GB0209265D0 (en) 2002-04-23 2002-06-05 Novartis Ag Organic compounds
CA2789307A1 (fr) * 2010-03-29 2011-10-06 Hetero Research Foundation Composition pharmaceutique stable d'imatinib
EA029416B1 (ru) * 2010-06-21 2018-03-30 Заклады Фармацеутицне Польфарма Са Таблетка, содержащая иматиниб или его фармацевтически приемлемую соль, и способ ее получения
TR201010618A2 (tr) * 2010-12-20 2012-07-23 Bi̇lgi̇ç Mahmut İmatinib içeren bir oral dozaj formu ve bu oral dozaj formunun üretimi
WO2013008253A2 (fr) * 2011-07-11 2013-01-17 Dr. Reddys Laboratories Limited Formulations d'imatinib

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
None *
See also references of WO2014139836A1 *

Also Published As

Publication number Publication date
WO2014139836A1 (fr) 2014-09-18
GB201304699D0 (en) 2013-05-01

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