HRP20211686T1 - Formulacije intravenozne otopine sa posakonazolom, stabilizirane supstituiranim beta-ciklodekstrinom - Google Patents
Formulacije intravenozne otopine sa posakonazolom, stabilizirane supstituiranim beta-ciklodekstrinom Download PDFInfo
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- HRP20211686T1 HRP20211686T1 HRP20211686TT HRP20211686T HRP20211686T1 HR P20211686 T1 HRP20211686 T1 HR P20211686T1 HR P20211686T T HRP20211686T T HR P20211686TT HR P20211686 T HRP20211686 T HR P20211686T HR P20211686 T1 HRP20211686 T1 HR P20211686T1
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- pharmaceutical composition
- posaconazole
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- cyclodextrin
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- RAGOYPUPXAKGKH-XAKZXMRKSA-N posaconazole Chemical compound O=C1N([C@H]([C@H](C)O)CC)N=CN1C1=CC=C(N2CCN(CC2)C=2C=CC(OC[C@H]3C[C@@](CN4N=CN=C4)(OC3)C=3C(=CC(F)=CC=3)F)=CC=2)C=C1 RAGOYPUPXAKGKH-XAKZXMRKSA-N 0.000 title claims 8
- 229960001589 posaconazole Drugs 0.000 title claims 8
- 239000000203 mixture Substances 0.000 title claims 7
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical class 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 title claims 2
- 238000001990 intravenous administration Methods 0.000 title claims 2
- 229920000858 Cyclodextrin Polymers 0.000 title 1
- 239000001116 FEMA 4028 Substances 0.000 title 1
- 235000011175 beta-cyclodextrine Nutrition 0.000 title 1
- 229960004853 betadex Drugs 0.000 title 1
- 238000009472 formulation Methods 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 9
- 241001465754 Metazoa Species 0.000 claims 6
- 238000001802 infusion Methods 0.000 claims 4
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims 3
- 208000015181 infectious disease Diseases 0.000 claims 3
- 230000002265 prevention Effects 0.000 claims 3
- 229940097346 sulfobutylether-beta-cyclodextrin Drugs 0.000 claims 3
- 229940121375 antifungal agent Drugs 0.000 claims 2
- 239000007864 aqueous solution Substances 0.000 claims 2
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 claims 2
- 239000003085 diluting agent Substances 0.000 claims 2
- 239000012458 free base Substances 0.000 claims 2
- 239000004615 ingredient Substances 0.000 claims 2
- FRPZMMHWLSIFAZ-UHFFFAOYSA-N 10-undecenoic acid Chemical compound OC(=O)CCCCCCCCC=C FRPZMMHWLSIFAZ-UHFFFAOYSA-N 0.000 claims 1
- 239000005711 Benzoic acid Substances 0.000 claims 1
- IIUZTXTZRGLYTI-UHFFFAOYSA-N Dihydrogriseofulvin Natural products COC1CC(=O)CC(C)C11C(=O)C(C(OC)=CC(OC)=C2Cl)=C2O1 IIUZTXTZRGLYTI-UHFFFAOYSA-N 0.000 claims 1
- 108010049047 Echinocandins Proteins 0.000 claims 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Chemical compound OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 1
- UXWOXTQWVMFRSE-UHFFFAOYSA-N Griseoviridin Natural products O=C1OC(C)CC=C(C(NCC=CC=CC(O)CC(O)C2)=O)SCC1NC(=O)C1=COC2=N1 UXWOXTQWVMFRSE-UHFFFAOYSA-N 0.000 claims 1
- CTETYYAZBPJBHE-UHFFFAOYSA-N Haloprogin Chemical compound ClC1=CC(Cl)=C(OCC#CI)C=C1Cl CTETYYAZBPJBHE-UHFFFAOYSA-N 0.000 claims 1
- DDUHZTYCFQRHIY-UHFFFAOYSA-N Negwer: 6874 Natural products COC1=CC(=O)CC(C)C11C(=O)C(C(OC)=CC(OC)=C2Cl)=C2O1 DDUHZTYCFQRHIY-UHFFFAOYSA-N 0.000 claims 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 claims 1
- -1 allylamines Chemical class 0.000 claims 1
- 230000000844 anti-bacterial effect Effects 0.000 claims 1
- 230000003474 anti-emetic effect Effects 0.000 claims 1
- 239000002111 antiemetic agent Substances 0.000 claims 1
- 229940125683 antiemetic agent Drugs 0.000 claims 1
- 239000003443 antiviral agent Substances 0.000 claims 1
- 229940121357 antivirals Drugs 0.000 claims 1
- 150000003851 azoles Chemical class 0.000 claims 1
- 229960004365 benzoic acid Drugs 0.000 claims 1
- 235000010233 benzoic acid Nutrition 0.000 claims 1
- KHAVLLBUVKBTBG-UHFFFAOYSA-N caproleic acid Natural products OC(=O)CCCCCCCC=C KHAVLLBUVKBTBG-UHFFFAOYSA-N 0.000 claims 1
- 239000002738 chelating agent Substances 0.000 claims 1
- SCKYRAXSEDYPSA-UHFFFAOYSA-N ciclopirox Chemical compound ON1C(=O)C=C(C)C=C1C1CCCCC1 SCKYRAXSEDYPSA-UHFFFAOYSA-N 0.000 claims 1
- 229960003749 ciclopirox Drugs 0.000 claims 1
- XRECTZIEBJDKEO-UHFFFAOYSA-N flucytosine Chemical compound NC1=NC(=O)NC=C1F XRECTZIEBJDKEO-UHFFFAOYSA-N 0.000 claims 1
- 229960004413 flucytosine Drugs 0.000 claims 1
- DDUHZTYCFQRHIY-RBHXEPJQSA-N griseofulvin Chemical compound COC1=CC(=O)C[C@@H](C)[C@@]11C(=O)C(C(OC)=CC(OC)=C2Cl)=C2O1 DDUHZTYCFQRHIY-RBHXEPJQSA-N 0.000 claims 1
- 229960002867 griseofulvin Drugs 0.000 claims 1
- 229960001906 haloprogin Drugs 0.000 claims 1
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 claims 1
- 150000004291 polyenes Chemical class 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 150000003431 steroids Chemical class 0.000 claims 1
- FUSNMLFNXJSCDI-UHFFFAOYSA-N tolnaftate Chemical compound C=1C=C2C=CC=CC2=CC=1OC(=S)N(C)C1=CC=CC(C)=C1 FUSNMLFNXJSCDI-UHFFFAOYSA-N 0.000 claims 1
- 229960004880 tolnaftate Drugs 0.000 claims 1
- 229960002703 undecylenic acid Drugs 0.000 claims 1
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Claims (11)
1. Farmaceutska kompozicija za intravensku primjenu koja sadrži:
posakonazol ili njegovu farmaceutski prihvatljivu sol;
modificirani β-ciklodekstrin koji sadrži sulfobutiletar-β-ciklodekstrin i
kelatni agens koji sadrži EDTA
u vodenoj otopini, pri čemu je koncentracija navedenog posakonazola između oko 14 i oko 22 mg/ml, na bazi posakonazola u vidu slobodne baze, koncentracija navedenog sulfobutiletar-β-ciklodekstrina je između oko 350 i oko 450 mg/mL, i koncentracija navedenog EDTA je između oko 0.1 i oko 0.3 mg/mL i
pri čemu se vodena otopina zakiseli do pH vrijednosti od između oko 2.3 i oko 3.0.
2. Kompozicija prema patentnom zahtjevu 1, naznačena time što je koncentracija posakonazola oko 18mg/mL, na bazi posakonazola u vidu slobodne baze, koncentracija navedenog sulfobutiletar-β-ciklodekstrina oko 400mg/mL, i koncentracija navedenog EDTA oko 0.2mg/mL.
3. Farmaceutska kompozicija prema patentnom zahtjevu 2 koja sadrži komponente i količine svake od komponenti, kako slijedi:
[image]
4. Farmaceutska kompozicija prema patentnom zahtjevu 1, za uporabu u liječenju ili u prevenciji infekcije kod životinje.
5. Farmaceutska kompozicija prema patentnom zahtjevu 1, za uporabu u liječenju ili u prevenciji infekcije kod životinje, naznačena time što se navedena kompozicija primjenjuje kod navedene životinje u količini koja je dovoljna za isporučivanje doze od 100 mg do 400 mg posakonazola svakih 12 do 24 sata.
6. Farmaceutska kompozicija prema patentnom zahtjevu 1, za uporabu u liječenju ili u prevenciji infekcije kod životinje, naznačena time što se navedena kompozicija primjenjuje kod navedene životinje u količini koja je dovoljna za isporučivanje navedenoj životinji doze od oko 200 mg posakonazola.
7. Farmaceutska kompozicija za uporabu prema patentnom zahtjevu 5, naznačena time što se navedena primjena događa jednom dnevno.
8. Farmaceutska kompozicija za uporabu prema patentnom zahtjevu 5, naznačena time što se navedena primjena događa dva puta dnevno.
9. Farmaceutska kompozicija za uporabu prema patentnom zahtjevu 4, koja dodatno obuhvaća primjenu drugog aktivnog sastojka izabranog od jednog ili više sastojaka iz grupe koja se sastoji od antimikotika, antibakterijskih sastojaka, antivirotika, steroida, nesteroidnih anti-upalnih lijekova, kemoterapeutika i anti-emetika.
10. Farmaceutska kompozicija za uporabu prema patentnom zahtjevu 4, naznačena time što su navedeni antimikotici odabrani iz grupe koja se sastoji od azola, ehinokandina, alilamina, poliena, flucitozina, benzojeve kiseline, ciklopiroksa, 1,3-dihidro-5-fluoro-1-hidroksi-2, 1-benzoksaborata, tolnaftata, undeciklenske kiseline, grizeofulvina i haloprogina.
11. Komplet koji sadrži:
malu, lomljivu posudu;
vrećicu za infuziju;
i kompoziciju prema patentnom zahtjevu 1,
pri čemu navedena posuda sadrži kompoziciju prema patentnom zahtjevu 1,
i navedena vrećica za infuziju sadrži razblaživač odabran iz grupe koja se sastoji od normalne fiziološke otopine i 5% otopine dekstroze,
i pri čemu je navedena mala, lomljiva posuda smještena direktno unutar vrećice za infuziju pogodno, kako bi se omogućilo da se navedena kompozicija razblaži tako što se navedena mala, lomljiva posuda prelomi direktno unutar razblaživača u navedenoj vrećici za infuziju.
Applications Claiming Priority (2)
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US35970110P | 2010-06-29 | 2010-06-29 | |
EP18171672.1A EP3391890B1 (en) | 2010-06-29 | 2011-06-24 | Posaconazole intravenous solution formulations stabilized by substituted beta-cyclodextrin |
Publications (1)
Publication Number | Publication Date |
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HRP20211686T1 true HRP20211686T1 (hr) | 2022-03-04 |
Family
ID=45441500
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HRP20211686TT HRP20211686T1 (hr) | 2010-06-29 | 2011-06-24 | Formulacije intravenozne otopine sa posakonazolom, stabilizirane supstituiranim beta-ciklodekstrinom |
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US (2) | US9023790B2 (hr) |
EP (3) | EP3391890B1 (hr) |
JP (1) | JP6008849B2 (hr) |
KR (1) | KR101834024B1 (hr) |
CN (2) | CN107049935A (hr) |
AU (1) | AU2011276680B2 (hr) |
BR (1) | BR112012033077B8 (hr) |
CA (1) | CA2802929C (hr) |
CY (1) | CY1124690T1 (hr) |
DK (1) | DK3391890T3 (hr) |
ES (1) | ES2893444T3 (hr) |
HR (1) | HRP20211686T1 (hr) |
HU (1) | HUE056581T2 (hr) |
LT (1) | LT3391890T (hr) |
MX (2) | MX338685B (hr) |
PL (1) | PL3391890T3 (hr) |
PT (1) | PT3391890T (hr) |
RS (1) | RS62583B1 (hr) |
SI (1) | SI3391890T1 (hr) |
WO (1) | WO2012005973A1 (hr) |
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US20090175810A1 (en) | 2008-01-03 | 2009-07-09 | Gareth Winckle | Compositions and methods for treating diseases of the nail |
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JP6008849B2 (ja) | 2010-06-29 | 2016-10-19 | メルク・シャープ・エンド・ドーム・コーポレイション | 置換β−シクロデキストリンにより安定化されたポサコナゾール静脈注射用溶液製剤 |
US8039494B1 (en) | 2010-07-08 | 2011-10-18 | Dow Pharmaceutical Sciences, Inc. | Compositions and methods for treating diseases of the nail |
PL3702374T3 (pl) | 2012-02-15 | 2022-11-21 | Cydex Pharmaceuticals, Inc. | Sposób wytwarzania pochodnych cyklodekstryny |
CA2924748C (en) | 2013-10-03 | 2019-09-03 | Dow Pharmaceutical Sciences, Inc. | Stabilized efinaconazole formulations |
CN104546724A (zh) * | 2013-10-12 | 2015-04-29 | 博瑞生物医药技术(苏州)有限公司 | 一种抗真菌药的固体分散体 |
CN112999223A (zh) | 2013-11-22 | 2021-06-22 | 博世健康爱尔兰有限公司 | 抗感染的方法、组合物和装置 |
CN105879041A (zh) * | 2014-11-14 | 2016-08-24 | 北京赛林泰医药技术有限公司 | 一种泊沙康唑口服液及其制备方法 |
EA201791100A1 (ru) * | 2014-11-19 | 2017-11-30 | Гуфик Байосайенсиз Лимитед | Способ получения парентерального состава на основе анидулафунгина |
CN104473871B (zh) * | 2014-11-28 | 2017-03-08 | 济南康和医药科技有限公司 | 一种泊沙康唑脂肪乳注射液及其制备方法 |
CN106265534A (zh) * | 2015-05-25 | 2017-01-04 | 江苏正大丰海制药有限公司 | 一种泊沙康唑冻干粉针剂的制备方法 |
CN106511262A (zh) * | 2015-09-11 | 2017-03-22 | 上海美悦生物科技发展有限公司 | 一种泊沙康唑口服溶液剂及其制备方法 |
CN107033186B (zh) | 2016-02-04 | 2020-06-09 | 武汉朗来科技发展有限公司 | 泊沙康唑衍生物、其药物组合物和用途 |
CN110022857A (zh) | 2016-11-18 | 2019-07-16 | 艾库里斯抗感染治疗有限公司 | 基于改性环糊精和酸化剂的脒取代β-内酰胺化合物的新制剂、其制备及作为抗微生物药物组合物的用途 |
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JP6008849B2 (ja) | 2010-06-29 | 2016-10-19 | メルク・シャープ・エンド・ドーム・コーポレイション | 置換β−シクロデキストリンにより安定化されたポサコナゾール静脈注射用溶液製剤 |
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- 2011-06-24 HU HUE18171672A patent/HUE056581T2/hu unknown
- 2011-06-24 HR HRP20211686TT patent/HRP20211686T1/hr unknown
- 2011-06-24 RS RS20211325A patent/RS62583B1/sr unknown
- 2011-06-24 CN CN201710169203.7A patent/CN107049935A/zh active Pending
- 2011-06-24 EP EP18171672.1A patent/EP3391890B1/en active Active
- 2011-06-24 CA CA2802929A patent/CA2802929C/en active Active
- 2011-06-24 KR KR1020127034087A patent/KR101834024B1/ko active IP Right Grant
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- 2011-06-24 US US13/704,145 patent/US9023790B2/en active Active
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- 2011-06-24 EP EP11804061.7A patent/EP2588116A4/en not_active Withdrawn
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