HRP20190181T4 - Farmaceutski dozni oblik za trenutno oslobađanje jednog derivata indolinona - Google Patents

Farmaceutski dozni oblik za trenutno oslobađanje jednog derivata indolinona Download PDF

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Publication number
HRP20190181T4
HRP20190181T4 HRP20190181TT HRP20190181T HRP20190181T4 HR P20190181 T4 HRP20190181 T4 HR P20190181T4 HR P20190181T T HRP20190181T T HR P20190181TT HR P20190181 T HRP20190181 T HR P20190181T HR P20190181 T4 HRP20190181 T4 HR P20190181T4
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Croatia
Prior art keywords
dosage form
pharmaceutical dosage
active substance
form according
mass percent
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HRP20190181TT
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English (en)
Inventor
Roman Messerschmid
Peter Lach
Torsten Sokoliess
Peter Stopfer
Dirk Trommeshauser
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Boehringer Ingelheim International Gmbh
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Application filed by Boehringer Ingelheim International Gmbh filed Critical Boehringer Ingelheim International Gmbh
Publication of HRP20190181T1 publication Critical patent/HRP20190181T1/hr
Publication of HRP20190181T4 publication Critical patent/HRP20190181T4/hr

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    • 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
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • 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
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404Indoles, e.g. pindolol
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/10Dispersions; Emulsions
    • 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
    • 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
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • 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
    • A61P37/00Drugs for immunological or allergic disorders
    • 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
    • GPHYSICS
    • G09EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09BEDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B19/00Teaching not covered by other main groups of this subclass

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Business, Economics & Management (AREA)
  • Physics & Mathematics (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Educational Technology (AREA)
  • Dispersion Chemistry (AREA)
  • Immunology (AREA)
  • Educational Administration (AREA)
  • Physical Education & Sports Medicine (AREA)
  • General Physics & Mathematics (AREA)
  • Theoretical Computer Science (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Entrepreneurship & Innovation (AREA)
  • Pathology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Claims (10)

1. Farmaceutski oblik za doziranje djelatne tvari 3-Z-[1-(4-(N-((4-metil-piperazin-1-il)-metilkarbonil)-N-metil-amino)-anilino)-1-fenil-metilen]-6-metoksikarbonil-2-indolinon-monoetilsulfonata, naznačen time, da on dostavlja profil trenutnog oslobađanja u kojem se ne manje od 70% (Q65%) djelatne tvari otapa u vremenu od 60 minuta in vitro pod sljedećim uvjetima in vitro otapanja u skladu s Europskom Farmakopejom 6.2: uređaj 2 (lopatice), medij za otapanje s 0,1 M HCl (pH 1) i brzina miješanja od 50 do 150 rpm, na temperaturi od 37°C, te time, da obuhvaća viskoznu lipidnu suspenzijsku formulaciju od 10 do 50 masenih postotaka djelatne tvari u 10 do 70 masenih postotaka triglicerida srednjeg lanca, 1 do 30 masenih postotaka teških masti i 0,1 do 10 masenih postotaka lecitina, na temelju ukupne mase viskozne lipidne suspenzijske formulacije.
2. Farmaceutski oblik za doziranje prema patentnom zahtjevu 1, naznačen time, da obuhvaća vrijednosti raspona za doziranje između 25 i 300 mg djelatne tvari.
3. Farmaceutski oblik za doziranje prema patentnom zahtjevu 1, naznačen time, da obuhvaća 10 do 70 masenih postotaka triglicerida srednjeg lanca, 10 do 30 masenih postotaka teških masti i 0,25 do 2,5 masenih postotaka lecitina.
4. Farmaceutski oblik za doziranje prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da je oblik za doziranje prikladan za oralnu isporuku.
5. Farmaceutski oblik za doziranje prema patentnom zahtjevu 4, naznačen time, da je u obliku mekane želatinske kapsule koja sadrži 50 mg djelatne tvari, ekvivalenta slobodne baze, odabrane od sljedećih sastava A, B i C: [image]
6. Farmaceutski oblik za doziranje prema patentnom zahtjevu 4, naznačen time, da je u obliku mekane želatinske kapsule koja sadrži 75 mg djelatne tvari, ekvivalenta slobodne baze, odabrane od sljedećih sastava A, B i C: [image]
7. Farmaceutski oblik za doziranje prema patentnom zahtjevu 4, naznačen time, da je u obliku mekane želatinske kapsule koja sadrži 100 mg djelatne tvari, ekvivalenta slobodne baze, odabrane od sljedećih sastava A, B i C: [image]
8. Farmaceutski oblik za doziranje prema patentnom zahtjevu 4, naznačen time, da je u obliku mekane želatinske kapsule koja sadrži 125 mg djelatne tvari, ekvivalenta slobodne baze, odabrane od sljedećih sastava A, B i C: [image]
9. Farmaceutski oblik za doziranje prema patentnom zahtjevu 4, naznačen time, da je u obliku mekane želatinske kapsule koja sadrži 150 mg djelatne tvari, ekvivalenta slobodne baze, odabrane od sljedećih sastava A, B i C: [image]
10. Farmaceutski oblik za doziranje prema patentnom zahtjevu 4, naznačen time, da je u obliku mekane želatinske kapsule koja sadrži 200 mg djelatne tvari, ekvivalenta slobodne baze, odabrane od sljedećih sastava A, B i C: [image]
HRP20190181TT 2008-06-06 2009-06-04 Farmaceutski dozni oblik za trenutno oslobađanje jednog derivata indolinona HRP20190181T4 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP08157750 2008-06-06
PCT/EP2009/056895 WO2009147220A1 (en) 2008-06-06 2009-06-04 Pharmaceutical dosage form for immediate release of an indolinone derivative
EP09757601.1A EP2313087B2 (en) 2008-06-06 2009-06-04 Pharmaceutical dosage form for immediate release of an indolinone derivative

Publications (2)

Publication Number Publication Date
HRP20190181T1 HRP20190181T1 (hr) 2019-03-22
HRP20190181T4 true HRP20190181T4 (hr) 2024-07-05

Family

ID=41017080

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20190181TT HRP20190181T4 (hr) 2008-06-06 2009-06-04 Farmaceutski dozni oblik za trenutno oslobađanje jednog derivata indolinona

Country Status (35)

Country Link
US (3) US20110190318A1 (hr)
EP (1) EP2313087B2 (hr)
JP (2) JP5583119B2 (hr)
KR (1) KR20110022586A (hr)
CN (1) CN102056599A (hr)
AR (1) AR072060A1 (hr)
AU (1) AU2009254556B2 (hr)
BR (1) BRPI0913235A2 (hr)
CA (1) CA2726648A1 (hr)
CL (1) CL2010001362A1 (hr)
CO (1) CO6280468A2 (hr)
CY (1) CY1121272T1 (hr)
DK (1) DK2313087T4 (hr)
EA (1) EA201001857A1 (hr)
EC (1) ECSP10010717A (hr)
ES (1) ES2711913T5 (hr)
FI (1) FI2313087T4 (hr)
HR (1) HRP20190181T4 (hr)
HU (1) HUE042524T2 (hr)
IL (1) IL209055A0 (hr)
LT (1) LT2313087T (hr)
MA (1) MA32386B1 (hr)
MX (1) MX338001B (hr)
PE (1) PE20100050A1 (hr)
PL (1) PL2313087T5 (hr)
PT (1) PT2313087T (hr)
RS (1) RS58280B2 (hr)
SG (1) SG191607A1 (hr)
SI (1) SI2313087T2 (hr)
TR (1) TR201901579T4 (hr)
TW (1) TW201002692A (hr)
UA (1) UA107560C2 (hr)
UY (1) UY31876A (hr)
WO (1) WO2009147220A1 (hr)
ZA (1) ZA201007972B (hr)

Families Citing this family (13)

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US20040077604A1 (en) * 2001-12-19 2004-04-22 Lenard Lichtenberger Method and compositions employing formulations of lecithin oils and nsaids for protecting the gastrointestinal tract and providingenhanced therapeutic activity
PT2299987T (pt) 2008-06-06 2018-05-21 Boehringer Ingelheim Int Forma de dosagem farmacêutica em cápsula compreendendo uma formulação de suspensão de um derivado de indolinona
CA2883807A1 (en) 2012-09-28 2014-04-03 Boehringer Ingelheim International Gmbh Pharmaceutical combinations comprising dual angiopoietin-2 / dll4 binders and anti-vegf-r agents
US20140350022A1 (en) 2013-05-10 2014-11-27 Boehringer Ingelheim International Gmbh Efficacious treatment of NSCLC and predictive clinical marker of the responsiveness of a tumour to a treatment
TWI642768B (zh) 2013-06-04 2018-12-01 蒙諾蘇爾有限公司 水溶性膜之密封溶液、相關方法及相關物品
US20150044288A1 (en) 2013-07-31 2015-02-12 Windward Pharma, Inc. Aerosol tyrosine kinase inhibitor compounds and uses thereof
US20200069679A1 (en) 2016-12-12 2020-03-05 Boehringer Ingelheim International Gmbh Nintedanib for use in methods for the treatment of interstitial lung diseases by coadministration with oladaterol
CN110573161A (zh) * 2017-03-28 2019-12-13 勃林格殷格翰国际有限公司 用于治疗肌营养不良的方法的尼达尼布
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PL3761980T3 (pl) 2018-03-07 2024-06-10 Pliant Therapeutics, Inc. Związki aminokwasowe i sposoby zastosowania
US20230135671A1 (en) 2020-04-01 2023-05-04 Boehringer Ingelheim International Gmbh Use of biomarkers in the treatment of fibrotic conditions
EP4098246A1 (en) 2021-05-31 2022-12-07 Lotus Pharmaceutical Co., Ltd. Formulation of nintedanib
WO2024037982A1 (en) 2022-08-16 2024-02-22 Boehringer Ingelheim International Gmbh Pharmaceutical formulations of nintedanib for intraocular use

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PT2299987T (pt) * 2008-06-06 2018-05-21 Boehringer Ingelheim Int Forma de dosagem farmacêutica em cápsula compreendendo uma formulação de suspensão de um derivado de indolinona
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CL2010001362A1 (es) 2011-05-13
CA2726648A1 (en) 2009-12-10
JP5583119B2 (ja) 2014-09-03
DK2313087T4 (da) 2024-01-15
IL209055A0 (en) 2011-01-31
RS58280B1 (sr) 2019-03-29
MX2010013092A (es) 2011-02-25
PE20100050A1 (es) 2010-01-29
UY31876A (es) 2010-01-29
SI2313087T1 (sl) 2019-03-29
PT2313087T (pt) 2019-02-15
ES2711913T5 (es) 2024-06-24
EA201001857A1 (ru) 2011-06-30
CY1121272T1 (el) 2020-05-29
JP2014098045A (ja) 2014-05-29
ZA201007972B (en) 2011-07-27
EP2313087A1 (en) 2011-04-27
US20130203773A1 (en) 2013-08-08
PL2313087T3 (pl) 2019-05-31
AU2009254556B2 (en) 2015-08-20
AU2009254556A1 (en) 2009-12-10
MX338001B (es) 2016-03-30
HRP20190181T1 (hr) 2019-03-22
US20140163040A1 (en) 2014-06-12
BRPI0913235A2 (pt) 2016-01-19
SG191607A1 (en) 2013-07-31
ES2711913T3 (es) 2019-05-08
HUE042524T2 (hu) 2019-07-29
LT2313087T (lt) 2019-02-25
WO2009147220A1 (en) 2009-12-10
UA107560C2 (uk) 2015-01-26
PL2313087T5 (pl) 2024-03-04
KR20110022586A (ko) 2011-03-07
ECSP10010717A (es) 2011-02-28
MA32386B1 (fr) 2011-06-01
EP2313087B1 (en) 2018-11-21
FI2313087T4 (fi) 2023-12-28
SI2313087T2 (sl) 2024-03-29
CO6280468A2 (es) 2011-05-20
US20110190318A1 (en) 2011-08-04
JP2011522010A (ja) 2011-07-28
DK2313087T3 (en) 2019-02-18
RS58280B2 (sr) 2024-02-29
AR072060A1 (es) 2010-08-04
TW201002692A (en) 2010-01-16
CN102056599A (zh) 2011-05-11
TR201901579T4 (tr) 2019-02-21
EP2313087B2 (en) 2023-11-22
JP5992937B2 (ja) 2016-09-14

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