HRP20191369T1 - Farmaceutski pripravak koji sadrži antivirusni derivat dihidrokvinazolina - Google Patents
Farmaceutski pripravak koji sadrži antivirusni derivat dihidrokvinazolina Download PDFInfo
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- HRP20191369T1 HRP20191369T1 HRP20191369T HRP20191369T1 HR P20191369 T1 HRP20191369 T1 HR P20191369T1 HR P20191369 T HRP20191369 T HR P20191369T HR P20191369 T1 HRP20191369 T1 HR P20191369T1
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- dihydroquinazolin
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- 239000000825 pharmaceutical preparation Substances 0.000 title claims 26
- NTURVSFTOYPGON-UHFFFAOYSA-N Dihydroquinazoline Chemical class C1=CC=C2C=NCNC2=C1 NTURVSFTOYPGON-UHFFFAOYSA-N 0.000 title 1
- 239000000243 solution Substances 0.000 claims 18
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 15
- 150000003839 salts Chemical class 0.000 claims 14
- 239000012453 solvate Chemical class 0.000 claims 14
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 9
- 229920000858 Cyclodextrin Polymers 0.000 claims 9
- 238000002360 preparation method Methods 0.000 claims 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 7
- FWYSMLBETOMXAG-UHFFFAOYSA-N 2-[8-fluoro-2-[4-(3-methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5-(trifluoromethyl)phenyl]-4h-quinazolin-4-yl]acetic acid Chemical compound COC1=CC=CC(N2CCN(CC2)C=2N(C(CC(O)=O)C3=CC=CC(F)=C3N=2)C=2C(=CC=C(C=2)C(F)(F)F)OC)=C1 FWYSMLBETOMXAG-UHFFFAOYSA-N 0.000 claims 6
- 238000000034 method Methods 0.000 claims 5
- 238000004519 manufacturing process Methods 0.000 claims 4
- 125000001997 phenyl group Chemical group [H]C1=C([H])C([H])=C(*)C([H])=C1[H] 0.000 claims 4
- 125000004194 piperazin-1-yl group Chemical group [H]N1C([H])([H])C([H])([H])N(*)C([H])([H])C1([H])[H] 0.000 claims 4
- 239000000872 buffer Substances 0.000 claims 3
- 238000001914 filtration Methods 0.000 claims 3
- 238000010438 heat treatment Methods 0.000 claims 3
- 239000000546 pharmaceutical excipient Substances 0.000 claims 3
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims 3
- 239000007787 solid Substances 0.000 claims 3
- 230000001954 sterilising effect Effects 0.000 claims 3
- 238000004659 sterilization and disinfection Methods 0.000 claims 3
- 239000000126 substance Substances 0.000 claims 3
- 239000000725 suspension Substances 0.000 claims 3
- 238000011282 treatment Methods 0.000 claims 3
- 239000001116 FEMA 4028 Substances 0.000 claims 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 2
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical group OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims 2
- 229960004853 betadex Drugs 0.000 claims 2
- 238000004090 dissolution Methods 0.000 claims 2
- 238000004108 freeze drying Methods 0.000 claims 2
- 238000011321 prophylaxis Methods 0.000 claims 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 1
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 1
- 206010011831 Cytomegalovirus infection Diseases 0.000 claims 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 1
- 241000700586 Herpesviridae Species 0.000 claims 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 1
- 239000007983 Tris buffer Substances 0.000 claims 1
- 208000036142 Viral infection Diseases 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 claims 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 1
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims 1
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims 1
- 239000007979 citrate buffer Substances 0.000 claims 1
- 229940097362 cyclodextrins Drugs 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 239000008103 glucose Substances 0.000 claims 1
- 125000002791 glucosyl group Chemical group C1([C@H](O)[C@@H](O)[C@H](O)[C@H](O1)CO)* 0.000 claims 1
- 208000015181 infectious disease Diseases 0.000 claims 1
- 238000001990 intravenous administration Methods 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 239000008363 phosphate buffer Substances 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- 239000000600 sorbitol Substances 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
- 125000004964 sulfoalkyl group Chemical group 0.000 claims 1
- 230000009385 viral infection Effects 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
-
- 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
- A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- 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
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
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- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/20—Antivirals for DNA viruses
- A61P31/22—Antivirals for DNA viruses for herpes viruses
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D239/00—Heterocyclic compounds containing 1,3-diazine or hydrogenated 1,3-diazine rings
- C07D239/70—Heterocyclic compounds containing 1,3-diazine or hydrogenated 1,3-diazine rings condensed with carbocyclic rings or ring systems
- C07D239/72—Quinazolines; Hydrogenated quinazolines
- C07D239/78—Quinazolines; Hydrogenated quinazolines with hetero atoms directly attached in position 2
- C07D239/84—Nitrogen atoms
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Claims (20)
1. Farmaceutski pripravak za intravenoznu primjenu, koji sadrži sljedeće, poimence:
a) {8-fluoro-2-[4-(3-metoksifenil)piperazin-1-il]-3-[2-metoksi-5-(trifluorometil)fenil]-3,4-dihidrokvinazolin-4-il}octenu kiselinu ili njenu sol, solvat ili solvat soli.
b) pomoćnu tvar odabranu od ciklodekstrina i
c) vodu.
2. Farmaceutski pripravak prema zahtjevu 1, koji dalje sadrži barem jedan pufer, odabran od fosfatnih pufera, Tris pufera i citratnih pufera.
3. Farmaceutski pripravak prema zahtjevu 1 ili 2, koji dalje sadrži barem jedan šećer.
4. Farmaceutski pripravak prema zahtjevu 3, pri čemu je šećer odabran od skupine koja se sastoji od glukoze, sukroze, laktoze, maltoze, trehaloze, sorbitola i manitola.
5. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 4, naznačen time što su {8-fluoro-2-[4-(3-metoksifenil)piperazin-1-il]-3-[2-metoksi-5-(trifluorometil)fenil]-3,4-dihidrokvinazolin-4-il} octena kiselina ili njena sol, solvat ili solvat soli prisutni u količini koja odgovara 1 do 100 mg čistog aktivnog sastojka po ml pripravka.
6. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 5, naznačen time što pripravak ima pH u rasponu od 7,5 do 8,5.
7. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 6, naznačen time što je barem jedna pomoćna tvar prisutna u količini od 1 do 5 ekvivalenata u odnosu na sadržaj {8-fluoro-2-[4-(3-metoksifenil)piperazin-1-il]-3-[2-metoksi-5-(trifluorometil)fenil]-3,4-dihidrokvinazolin-4-il}octene kiseline.
8. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 7, naznačen time što je barem jedna pomoćna tvar prisutna u količini od 2 do 5 ekvivalenata u odnosu na sadržaj {8-fluoro-2-[4-(3-metoksifenil)piperazin-1-il]-3-[2-metoksi-5-(trifluorometil)fenil]-3,4-dihidrokvinazolin-4-il}octene kiseline.
9. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 6, naznačen time što je pomoćna tvar odabrana od β-ciklodekstrina i modificiranih β-ciklodekstrina, posebice hidroksialkil-β-ciklodekstrina, alkil-hidroksialkil-β-ciklodekstrina i sulfoalkil ciklodekstrina.
10. Farmaceutski pripravak prema zahtjevu 9, naznačen time što spomenuti pripravak, u odnosu na sadržaj {8-fluoro-2-[4-(3-metoksifenil)piperazin-1-il]-3-[2-metoksi-5-(trifluorometil)fenil]-3,4-dihidrokvinazolin-4-il}octene kiseline, sadrži 1 do 10 ekvivalenata ciklodekstrina kao i 0 do 2,0 ekvivalenta NaOH.
11. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 6 ili prema zahtjevima 9 ili 10, naznačen time što 100 ml spomenutog pripravka sadrži sljedeće:
a) 0,5 – 2,5 g {8-fluoro-2-[4-(3-metoksifenil)piperazin-1-il]-3-[2-metoksi-5-(trifluorometil)fenil]-3,4-dihidrokvinazolin-4-il} octene kiseline ili njene soli, solvata ili solvata soli,
b) 10,0 – 30,0 g HP-β-ciklodekstrina,
c) 0,0 - 350 mg, posebice 100 - 125 mg NaOH, i
d) vodu,
pri čemu spomenuti pripravak ima pH u rasponu od 7,5 do 8,5.
12. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 6 ili prema zahtjevima 9 do 11, naznačen time što 100 ml spomenutog pripravka sadrži sljedeće:
a) poželjno 1,0 – 2,0 g {8-fluoro-2-[4-(3-metoksifenil)piperazin-1-il]-3-[2-metoksi-5-(trifluorometil)fenil]-3,4-dihidrokvinazolin-4-il} octene kiseline ili njene soli, solvata ili solvata soli,
b) poželjno 12,5g – 22,5 g HP-β-ciklodekstrina,
c) poželjno 75 - 225 mg, posebice 100 - 125 mg NaOH, i
d) vodu,
pri čemu spomenuti pripravak ima pH u rasponu od 7,5 do 8,5.
13. Kruti farmaceutski pripravak proizveden liofilizacijom farmaceutskog pripravka prema bilo kojem od zahtjeva 1 do 12.
14. Postupak proizvodnje farmaceutskog pripravka prema bilo kojem od zahtjeva 1 do 8, koristeći sljedeće korake, poimence:
A) rastapanje barem jedne pomoćne tvari u vodi,
B) dodavanje {8-fluoro-2-[4-(3-metoksifenil)piperazin-1-il]-3-[2-metoksi-5-(trifluorometil)fenil]-3,4-dihidrokvinazolin-4-il} octene kiseline ili njene soli, solvata ili solvata soli u otopinu dobivenu u koraku A),
C) ako je potrebno, dodavanje barem jednog šećera i/ili barem jednog pufera,
D) prilagođavanje pH na željenu vrijednost kako bi se dobio farmaceutski pripravak, i
E) sterilno filtriranje otopine dobivene u koraku D) i punjenje u odgovarajuće spremnike.
F) ako je potrebno, izvođenje posljednje sterilizacije otopine dobivene u koraku E) grijanjem.
15. Postupak proizvodnje farmaceutskog pripravka prema bilo kojem od zahtjeva 1 do 8, koristeći sljedeće korake, poimence:
I.) rastapanje barem jedne pomoćne tvari u dijelu vode,
II.) dodavanje {8-fluoro-2-[4-(3-metoksifenil)piperazin-1-il]-3-[2-metoksi-5-(trifluorometil)fenil]-3,4-dihidrokvinazolin-4-il} octene kiseline ili njene soli, solvata ili solvata soli u otopinu dobivenu u koraku I.),
III.) ako je potrebno, prilagođavanje pH otopine dobivene u koraku II.) na željenu vrijednost kako bi se dobila prva otopina,
IV.) rastapanje barem jednog šećera i/ili pufera u dijelu vode,
V.) ako je potrebno, prilagođavanje pH otopine dobivene u koraku IV.) na željenu vrijednost kako bi se dobila druga otopina,
VI.) miješanje prve i druge otopine kako bi se dobio farmaceutski pripravak, i
VII.) sterilno filtriranje otopine dobivene u koraku VI.) i punjenje u odgovarajuće spremnike.
VIII.) ako je potrebno, izvođenje posljednje sterilizacije otopine dobivene u koraku VII.) grijanjem.
16. Postupak proizvodnje farmaceutskog pripravka prema bilo kojem od zahtjeva 1 do 6 ili 9 do 12 koristeći sljedeće korake, poimence:
a.) dodavanje 8-fluoro-2-[4-(3-metoksifenil)piperazin-1-il]-3-[2-metoksi-5-(trifluorometil)fenil]-3,4-dihidrokvinazolin-4-il} octene kiseline ili njene soli, solvata ili solvata soli u vodenu otopinu NaOH, poželjno u vodenu 0,1 M NaOH otopinu kako bi se proizvela otopina ili suspenzija,
b.) dodavanje vode u otopinu ili suspenziju dobivenu u koraku a.),
c.) dodavanje ciklodekstrina i NaCl u otopinu ili suspenziju dobivenu u koraku b.),
d.) sterilno filtriranje otopine dobivene u koraku c.) i punjenje u odgovarajuće spremnike.
e.) ako je potrebno, izvođenje posljednje sterilizacije otopine dobivene u koraku d.) grijanjem.
17. Postupak proizvodnje krutog farmaceutskog pripravka prema zahtjevu 13, koji sadrži proizvodnju farmaceutskog pripravka prema postupku prema bilo kojem od zahtjeva 14 do 16, praćen korakom liofilizacije dobivenog farmaceutskog pripravka kako bi se dobio kruti farmaceutski pripravak.
18. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 13 za uporabu u postupku liječenja i/ili profilakse bolesti.
19. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 13 za uporabu u liječenju i/ili profilaksi virusnih infekcija.
20. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 13 za uporabu u liječenju HCMV infekcija ili infekcija drugim članom skupine herpes viridae.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
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| DE102012101680A DE102012101680A1 (de) | 2012-02-29 | 2012-02-29 | Pharmazeutische Zubereitung enthaltend ein antiviral wirksames Dihydrochinazolinderivat |
| EP13707000.9A EP2819648B1 (de) | 2012-02-29 | 2013-02-28 | Pharmazeutische zubereitung enthaltend ein antiviral wirksames dihydrochinazolinderivat |
| PCT/EP2013/054114 WO2013127970A1 (de) | 2012-02-29 | 2013-02-28 | Pharmazeutische zubereitung enthaltend ein antiviral wirksames dihydrochinazolinderivat |
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| HRP20191369T1 true HRP20191369T1 (hr) | 2019-11-01 |
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| HRP20240197TT HRP20240197T1 (hr) | 2012-02-29 | 2013-02-28 | Farmaceutski pripravak koji sadrži protuvirusni derivat dihidrokinazolina koji ima konfiguraciju s na položaju 4 |
| HRP20191369 HRP20191369T1 (hr) | 2012-02-29 | 2019-07-30 | Farmaceutski pripravak koji sadrži antivirusni derivat dihidrokvinazolina |
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| HRP20240197TT HRP20240197T1 (hr) | 2012-02-29 | 2013-02-28 | Farmaceutski pripravak koji sadrži protuvirusni derivat dihidrokinazolina koji ima konfiguraciju s na položaju 4 |
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Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
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| DE10319612A1 (de) * | 2003-05-02 | 2004-11-18 | Bayer Healthcare Ag | Substituierte Dihydrochinazoline |
| SG11201510426PA (en) * | 2013-06-19 | 2016-01-28 | Aicuris Anti Infective Cures Gmbh | Amorphous letermovir and solid pharmaceutical formulations thereof for oral administration |
| EP3463064B1 (en) | 2016-06-03 | 2021-11-03 | Atreya Innovations Private Limited | A device for the detection and reliable capturing of the pulse characteristics |
| WO2018165048A1 (en) | 2017-03-06 | 2018-09-13 | VenatoRx Pharmaceuticals, Inc. | Solid forms and combination compositions comprising a beta-lactamase inhibitor and uses thereof |
| UY39099A (es) * | 2020-02-27 | 2021-08-31 | Aic246 Gmbh & Co Kg | 2-[(4s)-8-fluoro-2-[4-(3-metoxifenil)piperazin-1-il]-3-[2-metoxi-5-(trifluorometil)fenil]-4h-quinazolin-4-il] acetato de sodio y composiciones farmacéuticas del mismo |
| UY39095A (es) * | 2020-02-27 | 2021-09-30 | Aic246 Gmbh & Co Kg | Composiciones farmacéuticas que comprenden acetato de 2- [(4s)-8-fluoro-2-[4-(3-metoxifenil)piperazin-1-il]-3-[2-metoxi-5- (trifluorometil)fenil]-4h-quinazolin-4-il] e iones de sodio |
| CN114539085B (zh) * | 2020-11-26 | 2023-10-20 | 山东诚创蓝海医药科技有限公司 | 一种脲基衍生物的制备 |
| CN115403528A (zh) * | 2021-05-27 | 2022-11-29 | 南京正大天晴制药有限公司 | 无定形3,4-二氢喹唑啉衍生物的制备方法 |
| CN113880776B (zh) * | 2021-11-16 | 2023-06-16 | 山东诚创蓝海医药科技有限公司 | 一种莱特莫韦中间体的制备方法 |
| AR128035A1 (es) | 2021-12-21 | 2024-03-20 | Aic246 Ag & Co Kg | Composiciones farmacéuticas que comprenden acetato de 2-[(4s)-8-fluoro-2-[4-(3-metoxifenil)piperazin-1-il]-3-[2-metoxi-5-(trifluorometil)fenil]-4h-quinazolin-4-il] e iones de potasio |
| CN115322157B (zh) * | 2022-06-02 | 2023-12-05 | 浙江车头制药股份有限公司 | 来特莫韦中间体化合物及其制备方法和应用 |
| CN115677539B (zh) * | 2022-11-01 | 2023-10-24 | 南京工业大学 | 一种温和条件下钴催化脲基导向芳烃的高选择性单烯基化的方法 |
Family Cites Families (12)
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| CA1242699A (en) * | 1985-02-01 | 1988-10-04 | Bristol-Myers Company | Cefbuperazone and derivatives thereof |
| CA1284994C (en) * | 1985-08-05 | 1991-06-18 | Murray Arthur Kaplan | Cephalosporin salts and injectable compositions |
| JP3552240B2 (ja) * | 1993-02-23 | 2004-08-11 | 第一製薬株式会社 | 高濃度ｔｃｆ製剤 |
| JPH11209277A (ja) * | 1998-01-19 | 1999-08-03 | Yoshitomi Pharmaceut Ind Ltd | 医薬組成物 |
| IT1304190B1 (it) * | 1998-12-18 | 2001-03-08 | Euphar Group Srl | Clatrati di deidroepiandrosterone e relative composizionifarmaceutiche |
| PL200804B1 (pl) * | 1999-03-17 | 2009-02-27 | Astrazeneca Ab | Pochodne amidowe, sposoby ich wytwarzania, ich kompozycje farmaceutyczne oraz ich zastosowanie |
| AU2000249111A1 (en) * | 2000-05-30 | 2001-12-11 | Dr. Reddy's Research Foundation | New pharmaceutical composition and the process for its preparation |
| DE10319612A1 (de) * | 2003-05-02 | 2004-11-18 | Bayer Healthcare Ag | Substituierte Dihydrochinazoline |
| WO2005051922A1 (en) * | 2003-11-25 | 2005-06-09 | Chiron Corporation | Quinazolinone compounds as anticancer agents |
| WO2006086464A2 (en) | 2005-02-10 | 2006-08-17 | Bristol-Myers Squibb Company | Dihydroquinazolinones as 5ht modulators |
| DE102005027517A1 (de) | 2005-06-15 | 2006-12-21 | Bayer Healthcare Ag | Verfahren zur Herstellung von Dihydrochinazolinen |
| US8743287B2 (en) * | 2009-07-24 | 2014-06-03 | Broadcom Corporation | Method and system for mitigating motion trail artifacts and improving low contrast contours in temporal filtering based noise reduction |
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