HRP20140355T1 - Farmaceutska formulacija - Google Patents

Farmaceutska formulacija Download PDF

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Publication number
HRP20140355T1
HRP20140355T1 HRP20140355AT HRP20140355T HRP20140355T1 HR P20140355 T1 HRP20140355 T1 HR P20140355T1 HR P20140355A T HRP20140355A T HR P20140355AT HR P20140355 T HRP20140355 T HR P20140355T HR P20140355 T1 HRP20140355 T1 HR P20140355T1
Authority
HR
Croatia
Prior art keywords
surfactant
weight
mixture
ethanol
range
Prior art date
Application number
HRP20140355AT
Other languages
English (en)
Inventor
Jean-Pierre Burnouf
Tsiala Benard
Original Assignee
Sanofi
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 Sanofi filed Critical Sanofi
Publication of HRP20140355T1 publication Critical patent/HRP20140355T1/hr

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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
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)

Claims (16)

1. Farmaceutska formulacija, naznačena time što sadrži spoj formule (I): [image] , u obliku baze, ili u obliku soli farmaceutski prihvatljive kiseline, solubilizirane u smjesi: • etanola i • surfaktanta koji sadrži smjesu polietoksiliranog mono- i diestera 12-hidroksistearinske kiseline, čije su odgovarajuće formule: [image] , gdje je n cijeli broj, u rasponu od 15 do 16, u smjesi surfaktant/etanol čiji je težinski omjer u rasponu od 25/75 do 80/20.
2. Farmaceutska formulacija u skladu s patentnim zahtjevom 1, naznačena time što je surfaktant surfaktantni makrogol 15-hidroksistearat.
3. Farmaceutska formulacija u skladu s patentnim zahtjevom 1 ili 2, naznačena time što smjesa surfaktant/etanol čiji je težinski omjer u rasponu od 73/27 do 77/23.
4. Formulacija u skladu s patentnim zahtjevom 2, naznačena time što surfaktant čini od 35 do 55%, težinski, mono- i diestera, te od 30 do 40%, težinski, polietilen-glikola H(OCH2CH2)n-OH.
5. Formulacija u skladu s patentnim zahtjevom 4, naznačena time što surfaktant kao glavne komponente sadrži od 35 do 55%, težinski, mono- i diestera, te od 30 do 40%, težinski, polietilen-glikola H(OCH2CH2)n-OH, kao i druge spojeve kao dopunu do 100%.
6. Formulacija u skladu s patentnim zahtjevom 1 ili 2, naznačena time što surfaktant čini od 10 do 20%, težinski, monoestera, od 25 do 35%, težinski, diestera, te od 30 do 40%, težinski, polietilen-glikola H(OCH2CH2)n-OH, kao i druge spojeve kao dopunu do 100%.
7. Farmaceutska formulacija u skladu s patentnim zahtjevom 1 do 6, naznačena time što je omjer surfaktant/etanol u rasponu od 73/27 do 77/23, a koncentracija spoja formule (I) je u rasponu od 5 do 25 mg/ml.
8. Farmaceutska formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačena time što je namijenjena za razrjeđivanje kojim se dobiva perfuzijska otopina.
9. Postupak priprave farmaceutske formulacije u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što se sastoji u sljedećim koracima: – grijanja surfaktanta dok ne postane tekuć; – dodavanja etanola; – hlađenja smjese surfaktant/etanol do temperature okoliša; – dodavanja spoja formule (I) u ohlađenu smjesu; – steriliziranja gotove smjese.
10. Postupak u skladu s patentnim zahtjevom 9, naznačen time što se smjesu sterilizira filtriranjem.
11. Perfuzijska otopina, naznačena time što sadrži spoj formule (I): [image] , u obliku baze, ili u obliku soli farmaceutski prihvatljive kiseline, dobivene razrjeđivanjem 1 volumena farmaceutske otopine u skladu s patentnim zahtjevom 1 do 8 u 20 do 500 volumena izotonične otopine.
12. Perfuzijska otopina, naznačena time što sadrži spoj formule (I): [image] , u obliku baze, ili u obliku soli farmaceutski prihvatljive kiseline, u rasponu koncentracija od 0,01 do 1,2 mg/ml, surfaktant u skladu s bilo kojim od patentnih zahtjeva 1 do 7 u rasponu koncentracija od 0,48 do 37 mg/ml, te etanol u rasponu koncentracija od 0,35 do 35 mg/ml, razrijeđen u izotoničnoj otopini.
13. Perfuzijska otopina u skladu s patentnim zahtjevom 11 ili 12, naznačena time što je namijenjena primjeni na čovjeku.
14. Postupak priprave perfuzijske otopine, naznačen time što se sastoji u razrjeđivanju 1 volumena farmaceutske otopine u skladu s patentnim zahtjevom 1 do 8 u 20 do 500 volumena izotonične otopine.
15. Boca, naznačena time što sadrži farmaceutsku otopinu u skladu s bilo kojim od patentnih zahtjeva 1 do 8.
16. Vreća za polaganu infuziju, naznačena time što sadrži perfuzijsku otopinu u skladu s patentnim zahtjevom 11 do 13.
HRP20140355AT 2009-07-30 2014-04-14 Farmaceutska formulacija HRP20140355T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0903742A FR2948568B1 (fr) 2009-07-30 2009-07-30 Formulation pharmaceutique
PCT/FR2010/051611 WO2011012816A2 (fr) 2009-07-30 2010-07-29 Formulation pharmaceutique

Publications (1)

Publication Number Publication Date
HRP20140355T1 true HRP20140355T1 (hr) 2014-06-20

Family

ID=41570922

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20140355AT HRP20140355T1 (hr) 2009-07-30 2014-04-14 Farmaceutska formulacija

Country Status (40)

Country Link
US (1) US20120202831A1 (hr)
EP (1) EP2459221B1 (hr)
JP (1) JP5658754B2 (hr)
KR (1) KR20120052943A (hr)
CN (1) CN102470176B (hr)
AR (1) AR077338A1 (hr)
AU (1) AU2010277406B2 (hr)
BR (1) BR112012002105A2 (hr)
CA (1) CA2769477A1 (hr)
CL (1) CL2012000231A1 (hr)
CO (1) CO6491065A2 (hr)
CR (1) CR20120047A (hr)
CY (1) CY1115043T1 (hr)
DK (1) DK2459221T3 (hr)
DO (1) DOP2012000011A (hr)
EA (1) EA021059B1 (hr)
ES (1) ES2458419T3 (hr)
FR (1) FR2948568B1 (hr)
HK (1) HK1169960A1 (hr)
HN (1) HN2012000182A (hr)
HR (1) HRP20140355T1 (hr)
IL (1) IL217762A0 (hr)
MA (1) MA33462B1 (hr)
MX (1) MX2012001386A (hr)
MY (1) MY183312A (hr)
NI (1) NI201200017A (hr)
NZ (1) NZ597963A (hr)
PE (1) PE20120619A1 (hr)
PL (1) PL2459221T3 (hr)
PT (1) PT2459221E (hr)
RS (1) RS53266B (hr)
SG (1) SG177754A1 (hr)
SI (1) SI2459221T1 (hr)
SM (1) SMT201400069B (hr)
TN (1) TN2011000659A1 (hr)
TW (1) TWI478921B (hr)
UA (1) UA105229C2 (hr)
UY (1) UY32816A (hr)
WO (1) WO2011012816A2 (hr)
ZA (1) ZA201200719B (hr)

Families Citing this family (20)

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WO2012088266A2 (en) 2010-12-22 2012-06-28 Incyte Corporation Substituted imidazopyridazines and benzimidazoles as inhibitors of fgfr3
ME02651B (me) 2012-06-13 2017-06-20 Incyte Holdings Corp Substituisana triciklična jedinjenja kao inhibitori fgfr
US9388185B2 (en) 2012-08-10 2016-07-12 Incyte Holdings Corporation Substituted pyrrolo[2,3-b]pyrazines as FGFR inhibitors
US9266892B2 (en) 2012-12-19 2016-02-23 Incyte Holdings Corporation Fused pyrazoles as FGFR inhibitors
CA2909207C (en) 2013-04-19 2021-11-02 Incyte Corporation Bicyclic heterocycles as fgfr inhibitors
US10851105B2 (en) 2014-10-22 2020-12-01 Incyte Corporation Bicyclic heterocycles as FGFR4 inhibitors
WO2016134294A1 (en) 2015-02-20 2016-08-25 Incyte Corporation Bicyclic heterocycles as fgfr4 inhibitors
CR20170390A (es) 2015-02-20 2017-10-23 Incyte Holdings Corp Heterociclos biciclicos como inhibidores de fgfr
MA41551A (fr) 2015-02-20 2017-12-26 Incyte Corp Hétérocycles bicycliques utilisés en tant qu'inhibiteurs de fgfr4
AR111960A1 (es) 2017-05-26 2019-09-04 Incyte Corp Formas cristalinas de un inhibidor de fgfr y procesos para su preparación
WO2019213544A2 (en) 2018-05-04 2019-11-07 Incyte Corporation Solid forms of an fgfr inhibitor and processes for preparing the same
BR112020022373A2 (pt) 2018-05-04 2021-02-02 Incyte Corporation sais de um inibidor de fgfr
WO2020185532A1 (en) 2019-03-08 2020-09-17 Incyte Corporation Methods of treating cancer with an fgfr inhibitor
US11591329B2 (en) 2019-07-09 2023-02-28 Incyte Corporation Bicyclic heterocycles as FGFR inhibitors
JOP20220083A1 (ar) 2019-10-14 2023-01-30 Incyte Corp حلقات غير متجانسة ثنائية الحلقة كمثبطات لـ fgfr
US11566028B2 (en) 2019-10-16 2023-01-31 Incyte Corporation Bicyclic heterocycles as FGFR inhibitors
JP2023505258A (ja) 2019-12-04 2023-02-08 インサイト・コーポレイション Fgfr阻害剤としての三環式複素環
BR112022010664A2 (pt) 2019-12-04 2022-08-16 Incyte Corp Derivados de um inibidor de fgfr
WO2021146424A1 (en) 2020-01-15 2021-07-22 Incyte Corporation Bicyclic heterocycles as fgfr inhibitors
TW202313611A (zh) 2021-06-09 2023-04-01 美商英塞特公司 作為fgfr抑制劑之三環雜環

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DE2911241A1 (de) 1979-03-22 1980-10-02 Basf Ag Alkoxylierte fettsaeuren, verfahren zu deren herstellung und ihre anwendung als loesungsvermittler
HU201567B (en) * 1988-07-21 1990-11-28 Gyogyszerkutato Intezet Process for production of intravenous medical compositions containing cyclosphorin
WO1996011007A1 (en) * 1994-10-05 1996-04-18 Glaxo Wellcome Inc. Parenteral pharmaceutical compositions containing gf120918a
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Also Published As

Publication number Publication date
CA2769477A1 (fr) 2011-02-03
WO2011012816A2 (fr) 2011-02-03
EA201270216A1 (ru) 2012-06-29
HK1169960A1 (en) 2013-02-15
TW201120036A (en) 2011-06-16
AU2010277406A1 (en) 2012-02-23
MA33462B1 (fr) 2012-07-03
PL2459221T3 (pl) 2014-06-30
CL2012000231A1 (es) 2012-09-14
TWI478921B (zh) 2015-04-01
IL217762A0 (en) 2012-03-29
HN2012000182A (es) 2014-11-10
ES2458419T3 (es) 2014-05-05
CO6491065A2 (es) 2012-07-31
KR20120052943A (ko) 2012-05-24
TN2011000659A1 (fr) 2013-05-24
EP2459221A2 (fr) 2012-06-06
DK2459221T3 (da) 2014-04-22
SMT201400069B (it) 2014-07-07
BR112012002105A2 (pt) 2019-09-24
FR2948568A1 (fr) 2011-02-04
CN102470176A (zh) 2012-05-23
UY32816A (es) 2011-02-28
EP2459221B1 (fr) 2014-01-22
EA021059B1 (ru) 2015-03-31
JP2013500321A (ja) 2013-01-07
JP5658754B2 (ja) 2015-01-28
NI201200017A (es) 2012-05-24
FR2948568B1 (fr) 2012-08-24
UA105229C2 (uk) 2014-04-25
AU2010277406B2 (en) 2015-11-12
PE20120619A1 (es) 2012-05-29
RS53266B (en) 2014-08-29
CR20120047A (es) 2012-06-01
DOP2012000011A (es) 2012-02-29
MY183312A (en) 2021-02-18
NZ597963A (en) 2014-02-28
CN102470176B (zh) 2015-07-29
SG177754A1 (en) 2012-03-29
WO2011012816A3 (fr) 2011-12-22
SI2459221T1 (sl) 2014-05-30
US20120202831A1 (en) 2012-08-09
ZA201200719B (en) 2013-05-29
CY1115043T1 (el) 2016-12-14
PT2459221E (pt) 2014-04-30
AR077338A1 (es) 2011-08-17
MX2012001386A (es) 2012-06-01

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