CA2930055C - Pharmaceutical dosage forms comprising protein kinase inhibitor - Google Patents

Pharmaceutical dosage forms comprising protein kinase inhibitor Download PDF

Info

Publication number
CA2930055C
CA2930055C CA2930055A CA2930055A CA2930055C CA 2930055 C CA2930055 C CA 2930055C CA 2930055 A CA2930055 A CA 2930055A CA 2930055 A CA2930055 A CA 2930055A CA 2930055 C CA2930055 C CA 2930055C
Authority
CA
Canada
Prior art keywords
capsule
weight
blend
pharmaceutical
pharmaceutical blend
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.)
Active
Application number
CA2930055A
Other languages
English (en)
French (fr)
Other versions
CA2930055A1 (en
Inventor
Suzie RIBEIRO
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.)
Novartis AG
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 CA2930055A1 publication Critical patent/CA2930055A1/en
Application granted granted Critical
Publication of CA2930055C publication Critical patent/CA2930055C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K9/48Preparations 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
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic 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
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • 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
    • 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
    • A61K9/4833Encapsulating processes; Filling of capsules
    • 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
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CA2930055A 2013-12-13 2014-12-11 Pharmaceutical dosage forms comprising protein kinase inhibitor Active CA2930055C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361915606P 2013-12-13 2013-12-13
US61/915,606 2013-12-13
PCT/IB2014/066820 WO2015087283A1 (en) 2013-12-13 2014-12-11 Pharmaceutical dosage forms

Publications (2)

Publication Number Publication Date
CA2930055A1 CA2930055A1 (en) 2015-06-18
CA2930055C true CA2930055C (en) 2023-07-04

Family

ID=52146563

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2930055A Active CA2930055C (en) 2013-12-13 2014-12-11 Pharmaceutical dosage forms comprising protein kinase inhibitor

Country Status (33)

Country Link
US (3) US10278969B2 (https=)
EP (2) EP3597179B1 (https=)
JP (2) JP6522619B2 (https=)
KR (1) KR102349893B1 (https=)
CN (2) CN116942629A (https=)
AR (1) AR098716A1 (https=)
AU (1) AU2014362999B2 (https=)
CA (1) CA2930055C (https=)
CL (1) CL2016001436A1 (https=)
CY (1) CY1122063T1 (https=)
DK (1) DK3079667T3 (https=)
EA (1) EA036288B1 (https=)
EC (1) ECSP16060194A (https=)
ES (1) ES2745983T3 (https=)
HR (1) HRP20191691T1 (https=)
HU (1) HUE045156T2 (https=)
IL (1) IL245705B (https=)
LT (1) LT3079667T (https=)
MA (1) MA39175A1 (https=)
MX (1) MX2016007652A (https=)
MY (1) MY194303A (https=)
NZ (2) NZ719865A (https=)
PE (1) PE20160851A1 (https=)
PH (1) PH12016501039B1 (https=)
PL (1) PL3079667T3 (https=)
PT (1) PT3079667T (https=)
RS (1) RS59270B1 (https=)
SG (1) SG10202104627UA (https=)
SI (1) SI3079667T1 (https=)
TN (1) TN2016000207A1 (https=)
TW (2) TWI721938B (https=)
WO (1) WO2015087283A1 (https=)
ZA (1) ZA201603064B (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ719865A (en) 2013-12-13 2022-07-29 Novartis Ag A pharmaceutical dosage form produced from the wet granulation of 3-(2,6-dichloro-3,5- dimethoxy-phenyl)-1-{ 6-[4-(4-ethyl-piperazin-1-yl)-phenylamino]-pyrimidin-4-yl} -1-methylurea
MA41611A (fr) * 2015-02-23 2018-01-02 Omthera Pharmaceuticals Inc Préparations en milli-capsules comprenant des acides gras polyinsaturés libres
EP3675827A1 (en) 2017-08-30 2020-07-08 Acadia Pharmaceuticals Inc. Formulations of pimavanserin
CA3202267A1 (en) * 2020-12-18 2022-06-23 Riccardo Panicucci Methods of treating achondroplasia
WO2022194941A1 (en) * 2021-03-17 2022-09-22 Actelion Pharmaceuticals Ltd Pharmaceutical dosage system

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0512324D0 (en) 2005-06-16 2005-07-27 Novartis Ag Organic compounds
NZ591443A (en) 2005-09-22 2013-04-26 Intermune Inc Granule formation of pirfenidone and pharmaceutically acceptable excipients
BRPI0620408B8 (pt) 2005-12-21 2021-05-25 Novartis Ag derivados de pirimidinil aril uréia sendo inibidores de fgf, seus usos, e preparação farmacêutica
FR2910813B1 (fr) * 2006-12-28 2009-02-06 Sanofi Aventis Sa Nouvelle utilisation therapeutique pour le traitement des leucemies
AR079257A1 (es) * 2009-12-07 2012-01-04 Novartis Ag Formas cristalinas de 3-(2,6-dicloro-3-5-dimetoxi-fenil)-1-{6-[4-(4-etil-piperazin-1-il)-fenil-amino]-pirimidin-4-il}-1-metil-urea y sales de las mismas
RU2014103250A (ru) 2011-07-01 2015-08-10 Новартис Аг Комбинированная терапия
EP3019491A4 (en) 2013-07-09 2016-12-21 Dana Farber Cancer Inst Inc KINASEHEMMER FOR THE TREATMENT OF DISEASES
NZ719865A (en) 2013-12-13 2022-07-29 Novartis Ag A pharmaceutical dosage form produced from the wet granulation of 3-(2,6-dichloro-3,5- dimethoxy-phenyl)-1-{ 6-[4-(4-ethyl-piperazin-1-yl)-phenylamino]-pyrimidin-4-yl} -1-methylurea
ES2771926T3 (es) 2014-09-13 2020-07-07 Novartis Ag Terapias de combinación
EP3273959A1 (en) 2015-03-25 2018-01-31 Novartis Ag Pharmaceutical combinations
US10702527B2 (en) 2015-06-12 2020-07-07 Dana-Farber Cancer Institute, Inc. Combination therapy of transcription inhibitors and kinase inhibitors

Also Published As

Publication number Publication date
EP3597179B1 (en) 2024-04-03
KR102349893B1 (ko) 2022-01-10
IL245705A0 (en) 2016-07-31
PL3079667T3 (pl) 2020-02-28
PE20160851A1 (es) 2016-09-14
US20200054632A1 (en) 2020-02-20
JP6804585B2 (ja) 2020-12-23
LT3079667T (lt) 2019-09-10
IL245705B (en) 2021-05-31
PH12016501039A1 (en) 2016-07-04
US11160804B2 (en) 2021-11-02
KR20160096093A (ko) 2016-08-12
AU2014362999A1 (en) 2016-05-26
EA036288B1 (ru) 2020-10-22
JP2017502941A (ja) 2017-01-26
ZA201603064B (en) 2017-07-26
CY1122063T1 (el) 2020-11-25
US10278969B2 (en) 2019-05-07
PT3079667T (pt) 2019-10-10
TN2016000207A1 (en) 2017-10-06
SI3079667T1 (sl) 2019-10-30
NZ719865A (en) 2022-07-29
NZ760002A (en) 2022-07-29
US20220265651A1 (en) 2022-08-25
EP3079667B1 (en) 2019-06-26
HUE045156T2 (hu) 2019-12-30
CA2930055A1 (en) 2015-06-18
US20170007602A1 (en) 2017-01-12
MY194303A (en) 2022-11-27
TW202128137A (zh) 2021-08-01
SG10202104627UA (en) 2021-06-29
CN116942629A (zh) 2023-10-27
PH12016501039B1 (en) 2024-01-19
EP3597179A1 (en) 2020-01-22
CL2016001436A1 (es) 2017-02-10
HRP20191691T1 (hr) 2019-12-27
TWI800759B (zh) 2023-05-01
ES2745983T3 (es) 2020-03-04
WO2015087283A1 (en) 2015-06-18
AU2014362999B2 (en) 2017-10-12
TW201605494A (zh) 2016-02-16
HK1223833A1 (en) 2017-08-11
JP2019142927A (ja) 2019-08-29
JP6522619B2 (ja) 2019-05-29
RS59270B1 (sr) 2019-10-31
EA201691231A1 (ru) 2016-10-31
MA39175A1 (fr) 2017-10-31
MX2016007652A (es) 2016-10-13
TWI721938B (zh) 2021-03-21
CN105813635A (zh) 2016-07-27
EP3079667A1 (en) 2016-10-19
AR098716A1 (es) 2016-06-08
ECSP16060194A (es) 2019-07-31
DK3079667T3 (da) 2019-09-09

Similar Documents

Publication Publication Date Title
US11160804B2 (en) Pharmaceutical dosage forms
TWI453203B (zh) 包含bibw2992之新固體醫藥調配劑
JP6144713B2 (ja) 新たな医薬組成物
JP5775464B2 (ja) 非晶質cddo−meを含有する遅延放出性経口投薬組成物
HK40021638A (en) Pharmaceutical dosage forms
HK40021638B (en) Pharmaceutical dosage forms
HK1223833B (en) Pharmaceutical dosage forms
EP4419086A1 (en) Pharmaceutical compositions
BR112016013281B1 (pt) Mistura farmacêutica e cápsula para administração oral
JP2011241181A (ja) クエチアピンフマル酸塩含有経口用錠剤

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20191202

MPN Maintenance fee for patent paid

Free format text: FEE DESCRIPTION TEXT: MF (PATENT, 10TH ANNIV.) - STANDARD

Year of fee payment: 10

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20241206

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT DETERMINED COMPLIANT

Effective date: 20241206