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PH12014501062B1 - Immediate release 4-methyl-3-[[4-(3-pyridinyl )-2-pyrimidinyl ]amino]-n-[5-(4-methyl-1h-1midazol-1yl)-3-(trifluoromethyl)phenyl]benzamide formulation - Google Patents

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

Info

Publication number
PH12014501062B1
PH12014501062B1 PH1/2014/501062A PH12014501062A PH12014501062B1 PH 12014501062 B1 PH12014501062 B1 PH 12014501062B1 PH 12014501062 A PH12014501062 A PH 12014501062A PH 12014501062 B1 PH12014501062 B1 PH 12014501062B1
Authority
PH
Philippines
Prior art keywords
methyl
pyridinyl
pyrimidinyl
trifluoromethyl
phenyl
Prior art date
Application number
PH1/2014/501062A
Other versions
PH12014501062A1 (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 PH12014501062A1 publication Critical patent/PH12014501062A1/en
Publication of PH12014501062B1 publication Critical patent/PH12014501062B1/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

A solid dosage form of nilotinib is disclosed 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 or a pharmaceutically acceptable salt thereof and excipients; and (ii) at least one polymer, said polymer coating said core, wherein disintegration of said solid dosage form is delayed.
PH1/2014/501062A 2011-11-14 2012-11-12 Immediate release 4-methyl-3-[[4-(3-pyridinyl )-2-pyrimidinyl ]amino]-n-[5-(4-methyl-1h-1midazol-1yl)-3-(trifluoromethyl)phenyl]benzamide formulation PH12014501062B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161559281P 2011-11-14 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
PH12014501062A1 PH12014501062A1 (en) 2014-06-23
PH12014501062B1 true PH12014501062B1 (en) 2018-04-20

Family

ID=47324402

Family Applications (1)

Application Number Title Priority Date Filing Date
PH1/2014/501062A PH12014501062B1 (en) 2011-11-14 2012-11-12 Immediate release 4-methyl-3-[[4-(3-pyridinyl )-2-pyrimidinyl ]amino]-n-[5-(4-methyl-1h-1midazol-1yl)-3-(trifluoromethyl)phenyl]benzamide formulation

Country Status (23)

Country Link
EP (1) EP2779995A1 (en)
JP (1) JP6275645B2 (en)
KR (1) KR20140093230A (en)
CN (1) CN103930094A (en)
AR (1) AR088844A1 (en)
BR (1) BR112014011518A2 (en)
CA (1) CA2855503A1 (en)
CL (1) CL2014001247A1 (en)
CO (1) CO6960546A2 (en)
EA (1) EA201490960A1 (en)
GT (1) GT201400094A (en)
HK (1) HK1197025A1 (en)
IL (1) IL232480A0 (en)
IN (1) IN2014DN03416A (en)
MA (1) MA35636B1 (en)
MX (1) MX2014005874A (en)
PE (1) PE20141337A1 (en)
PH (1) PH12014501062B1 (en)
SG (2) SG10201707768RA (en)
TN (1) TN2014000177A1 (en)
TW (1) TWI574690B (en)
WO (1) WO2013074432A1 (en)
ZA (1) ZA201402756B (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2792360A1 (en) 2013-04-18 2014-10-22 IP Gesellschaft für Management mbH (1aR,12bS)-8-cyclohexyl-11-fluoro-N-((1-methylcyclopropyl)sulfonyl)-1a-((3-methyl-3,8-diazabicyclo[3.2.1]oct-8-yl)carbonyl)-1,1a,2,2b-tetrahydrocyclopropa[d]indolo[2,1-a][2]benzazepine-5-carboxamide for use in treating HCV
CZ2017821A3 (en) 2017-12-20 2019-07-03 Zentiva, K.S. Dosing of crystalline nilotinib
JP7378279B2 (en) * 2019-11-18 2023-11-13 日本化薬株式会社 Pharmaceutical tablet containing nilotinib as an active ingredient and method for producing the same
JP7489849B2 (en) * 2020-07-20 2024-05-24 日本化薬株式会社 Nilotinib tablets
JP7776274B2 (en) * 2021-07-19 2025-11-26 日本化薬株式会社 Nilotinib tablets and their manufacturing method
JP7776275B2 (en) * 2021-07-26 2025-11-26 日本化薬株式会社 Nilotinib tablets and their manufacturing method

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0215676D0 (en) * 2002-07-05 2002-08-14 Novartis Ag Organic compounds
GT200600315A (en) 2005-07-20 2007-03-19 CRYSTAL FORMS OF 4-METHYL-N- [3- (4-METHYL-IMIDAZOL-1-ILO) -5-TRIFLUOROMETILO-PHENYL] -3- (4-PYRIDINA-3-ILO-PIRIMIDINA-2-ILOAMINO) -BENZAMIDA
GT200600316A (en) 2005-07-20 2007-04-02 SALTS OF 4-METHYL-N- (3- (4-METHYL-IMIDAZOL-1-ILO) -5-TRIFLUOROMETILO-PHENYL) -3- (4-PIRIDINA-3-ILO-PIRIMIDINA-2-ILOAMINO) - BENZAMIDA.
EP1923053A1 (en) * 2006-09-27 2008-05-21 Novartis AG Pharmaceutical compositions comprising nilotinib or its salt
US20100136097A1 (en) * 2008-12-02 2010-06-03 Searete Llc, A Limited Liability Corporation Of The State Of Delaware Systems for modulating inflammation
WO2012164578A1 (en) * 2011-06-02 2012-12-06 Hetero Research Foundation Compositions and methods for preparing immediate release formulations of nilotinib

Also Published As

Publication number Publication date
GT201400094A (en) 2017-09-28
AU2012339829B2 (en) 2016-05-12
JP2014533283A (en) 2014-12-11
AR088844A1 (en) 2014-07-10
EP2779995A1 (en) 2014-09-24
CA2855503A1 (en) 2013-05-23
NZ623844A (en) 2016-09-30
KR20140093230A (en) 2014-07-25
PH12014501062A1 (en) 2014-06-23
MA35636B1 (en) 2014-11-01
WO2013074432A1 (en) 2013-05-23
CN103930094A (en) 2014-07-16
PE20141337A1 (en) 2014-10-16
CO6960546A2 (en) 2014-05-30
JP6275645B2 (en) 2018-02-07
MX2014005874A (en) 2014-06-23
TN2014000177A1 (en) 2015-09-30
ZA201402756B (en) 2015-04-29
TWI574690B (en) 2017-03-21
AU2012339829A1 (en) 2014-05-29
EA201490960A1 (en) 2014-08-29
SG10201707768RA (en) 2017-10-30
IL232480A0 (en) 2014-06-30
HK1197025A1 (en) 2015-01-02
TW201325594A (en) 2013-07-01
CL2014001247A1 (en) 2014-10-17
SG11201401476TA (en) 2014-10-30
BR112014011518A2 (en) 2017-05-16
IN2014DN03416A (en) 2015-06-26

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