NZ623844A - Immediate release 4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-n-[5-(4-methyl- 1h-imidazol-1-yl)-3-(trifluoromethyl)phenyl] benzamide formulation - Google Patents

Immediate release 4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-n-[5-(4-methyl- 1h-imidazol-1-yl)-3-(trifluoromethyl)phenyl] benzamide formulation

Info

Publication number
NZ623844A
NZ623844A NZ623844A NZ62384412A NZ623844A NZ 623844 A NZ623844 A NZ 623844A NZ 623844 A NZ623844 A NZ 623844A NZ 62384412 A NZ62384412 A NZ 62384412A NZ 623844 A NZ623844 A NZ 623844A
Authority
NZ
New Zealand
Prior art keywords
methyl
imidazol
pyridinyl
pyrimidinyl
trifluoromethyl
Prior art date
Application number
NZ623844A
Other versions
NZ623844B2 (en
Inventor
Upkar Bhardwaj
Mangesh Sadashiv Bordawekar
Ann Reese Comfort
Ping Li
Shoufeng Li
Alexey Makarov
Original Assignee
Novartis Ag
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 Novartis Ag filed Critical Novartis Ag
Publication of NZ623844A publication Critical patent/NZ623844A/en
Publication of NZ623844B2 publication Critical patent/NZ623844B2/en

Links

Classifications

    • 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
    • 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
    • A61K9/2095—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
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Plural Heterocyclic Compounds (AREA)

Abstract

Provided is a solid dosage form in the form of a film coated tablet that comprises: (i) a core comprising 4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl] benzamide (nilotinib) or a pharmaceutically acceptable salt thereof and excipients; and (ii) at least one polymeric coating over the core, wherein the polymeric coating comprises hydroxypropylmethyl cellulose, and the coating is 7-13% of the dosage form. Also provided is a method for preparing a solid dosage form comprising amorphous 4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino-N-[5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl] benzamide or a pharmaceutically acceptable salt thereof comprising the steps of: (i) roller compacting a core comprising 4-Methyl-3-[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl] benzamide or a pharmaceutically acceptable salt thereof and excipients; and (ii) coating said core with at least one polymer.
NZ623844A 2011-11-14 2012-11-12 Immediate release 4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-n-[5-(4-methyl- 1h-imidazol-1-yl)-3-(trifluoromethyl)phenyl] benzamide formulation NZ623844B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161559281P 2011-11-14 2011-11-14
US61/559,281 2011-11-14
PCT/US2012/064610 WO2013074432A1 (en) 2011-11-14 2012-11-12 Immediate release 4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-n-[5-(4-methyl- 1h-imidazol-1-yl)-3-(trifluoromethyl)phenyl] benzamide formulation

Publications (2)

Publication Number Publication Date
NZ623844A true NZ623844A (en) 2016-09-30
NZ623844B2 NZ623844B2 (en) 2017-01-05

Family

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Also Published As

Publication number Publication date
EP2779995A1 (en) 2014-09-24
SG11201401476TA (en) 2014-10-30
SG10201707768RA (en) 2017-10-30
AU2012339829A1 (en) 2014-05-29
TWI574690B (en) 2017-03-21
CN103930094A (en) 2014-07-16
GT201400094A (en) 2017-09-28
BR112014011518A2 (en) 2017-05-16
AR088844A1 (en) 2014-07-10
MA35636B1 (en) 2014-11-01
IN2014DN03416A (en) 2015-06-26
JP2014533283A (en) 2014-12-11
CO6960546A2 (en) 2014-05-30
MX2014005874A (en) 2014-06-23
TN2014000177A1 (en) 2015-09-30
HK1197025A1 (en) 2015-01-02
IL232480A0 (en) 2014-06-30
JP6275645B2 (en) 2018-02-07
EA201490960A1 (en) 2014-08-29
ZA201402756B (en) 2015-04-29
KR20140093230A (en) 2014-07-25
AU2012339829B2 (en) 2016-05-12
TW201325594A (en) 2013-07-01
CA2855503A1 (en) 2013-05-23
WO2013074432A1 (en) 2013-05-23
PE20141337A1 (en) 2014-10-16
CL2014001247A1 (en) 2014-10-17

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Legal Events

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PSEA Patent sealed
RENW Renewal (renewal fees accepted)

Free format text: PATENT RENEWED FOR 3 YEARS UNTIL 12 NOV 2019 BY BALDWINS INTELLECTUAL PROPERTY

Effective date: 20170105

LAPS Patent lapsed