HRP20170376T1 - Postupak za izradu tekućeg pripravka koji se primjenjuje na kožu u obliku pjene i pripravka koji se može primijeniti lokalno - Google Patents
Postupak za izradu tekućeg pripravka koji se primjenjuje na kožu u obliku pjene i pripravka koji se može primijeniti lokalno Download PDFInfo
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- HRP20170376T1 HRP20170376T1 HRP20170376TT HRP20170376T HRP20170376T1 HR P20170376 T1 HRP20170376 T1 HR P20170376T1 HR P20170376T T HRP20170376T T HR P20170376TT HR P20170376 T HRP20170376 T HR P20170376T HR P20170376 T1 HRP20170376 T1 HR P20170376T1
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Claims (36)
1. Postupak za izradu tekućeg farmaceutskog pripravka koji se primjenjuje u obliku pjene na kožu, pri čemu pjenasti tekući pripravak sadržava barem jedno otapalo, barem jedan farmaceutski aktivan sastojak i barem jedno sredstvo za pjenjenje na bazi fosfolipida, naznačen time, da
a) fosfolipidno sredstvo za pjenjenje je sredstvo za pjenjenje koje je izolirano iz soje i sadržava fosfatidilkolin u koncentraciji između 50 % i 95 % težinskog udjela, pri čemu navedeni fosfatidilkolin ima kiselinski broj od najviše 10, peroksidni broj od najviše 10 i koncentraciju ulja od najviše 6 % težinskog udjela, u odnosu na suhu masu fosfatidilkolina, a
b) volumen pjene i stabilnost pjene određuju se SITA postupkom mjerenja kao što je opisano u navedenim primjerima, pri čemu se pjena izrađuje bez upotrebe pogonskog plina i pri čemu se upotrebom SITA postupkom mjerenja 250 ml tekućeg sastava zapjeni uz brzinu rotora 2000 okretaja u minuti tijekom pet ciklusa rotora od kojih svaki traje 20 sekundi, a stanka je 15 sekundi između svakog ciklusa rotora i pri čemu se volumen pjene mjeri svakih 50 sekundi pomoću detektora u obliku igle u vremenskom razdoblju od 35 minuta i da
c) omjer u tekućem sastavu barem jednog sredstva za pjenjenje, barem jednog otapala i barem jednog farmaceutski aktivnog sastojka mijenja se tako dugo u odnosu na njihovu kemijsku prirodu i/ili koncentraciju sve dok pjena dobivena SITA postupkom mjerenja ne dobije sljedeće karakteristike
d) gustoća pjene između 0,05 g/ml i 0,8 g/ml,
e) volumen pjene između 450 i 1400 ml i
f) stabilnost pjene kojom pjena nakon vremena zadržavanja do pet minuta još uvijek ima barem 50 % volumena pjene koja je izvorno prisutna odmah nakon stvaranja pjene.
2. Postupak u skladu s patentnim zahtjevom 1, naznačen time, da se pjena stvorio metode mjerenja SITA ima volumen pjene između 600 ml i 1200 ml.
3. Postupak u skladu s patentnim zahtjevom 1 ili 2, naznačen time, da pjena nastala SITA postupkom mjerenja ima takvu stabilnost pjene da pjena, nakon vremena zadržavanja do deset minuta, još uvijek ima između 55 % i 100 % volumena pjene koja je izvorno prisutna odmah nakon stvaranja pjene.
4. Postupak u skladu s patentnim zahtjevom 3, naznačen time, da pjena, nakon vremena zadržavanja do deset minuta, još uvijek ima volumen pjene najmanje između 85 % i 99 % volumena pjene koja je izvorno prisutna odmah nakon stvaranja pjene.
5. Postupak u skladu s jednim od prethodnih patentnih zahtjeva, naznačen time, da je pokazana korelacija između pjene naznačene SITA postupkom mjerenja i farmaceutskih svojstava.
6. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time, da je aplikator pjene odabran za mehaničko pjenjenje u tekućem pripravku, da se pjena stvara iz tekućeg pripravka odabranim aplikatorom pjene i da je pokazana korelacija između svojstava, osobito farmaceutskih svojstava pjene stvorene aplikatorom pjene i volumena pjene i/ili stabilnosti pjene kao što je određeno SITA postupkom mjerenja.
7. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time, da je tako stvorena pjena dobivena iz tekućeg pripravka kojem je gustoća pjene između 0,15 g / ml i 0,4 g / ml u skladu sa SITA postupkom mjerenja.
8. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time, da je otapalo za proizvodnju tekućeg pripravka odabrano iz skupine koju čine voda, barem jedan alkohol, osobito barem jedan monovalentni do trovalentni alkohol, barem jedan polialkohol te smjese prethodno navedenih otapala.
9. Postupak u skladu s jednim od prethodnih patentnih zahtjeva, naznačen time, da se za proizvodnju tekućeg pripravka, nadalje koriste sredstva za tvorbu kompleksa, pufer, sredstvo za zgušnjavanje, antioksidans i/ili stabilizator.
10. Pripravak pogodan za topikalnu primjenu koji sadržava barem jedan sistemski i/ili lokalno djelujući farmaceutski aktivan sastojak, pri čemu pripravak, osim farmaceutski aktivnog sastojka sadržava barem jedno otapalo i barem jedno fosfolipidno sredstvo za pjenjenje i ima takvu tekuću konzistenciju da tvori pjenu kada se primjenjuje, naznačen time, da
a) fosfolipidno sredstvo za pjenjenje jest fosfolipidno sredstvo za pjenjenje koje je izolirano iz soje i sadržava fosfatidilkolin u koncentraciji između 50 % i 95 % težinskog udjela, pri čemu navedeni fosfatidilkolin ima kiselinski broj od najviše 10, peroksidni broj od najviše 10 i koncentraciju ulja od najviše 6 % težinskog udjela u odnosu na suhu masu fosfatidilkolina, a
b) barem jednog fosfolipidno sredstvo za pjenjenje, barem jedno otapalo i barem jedan aktivni sastojak usklađeni su jedan s drugim na takav način da se pripravak može mehanički pjeniti bez dodatnog pogonskog plina, te da je pjena izrađena na način da ima
c) gustoću pjene između 0, 05 g/ml i 0,8 g/ml,
d) volumen pjene između 450 i 1400 ml, te
e) stabilnost pjene kojom pjena, nakon vremena zadržavanja do pet minuta, još uvijek ima barem 50 % volumena pjene koja je izvorno prisutna odmah nakon stvaranja pjene, pri čemu se volumen pjene kao i stabilnost pjene određuju SITA postupkom mjerenja kao što je opisano u primjerima i pri čemu se, korištenjem SITA postupkom mjerenja 250 ml tekućeg pripravka pjeni pri brzini rotora 2000 okretaja u minuti tijekom pet ciklusa rotora od kojih svaki ima trajanje od 20 sekundi i pauzu od 15 sekundi između svakog ciklusa rotora i pri čemu je volumen pjene izmjeren svakih 50 sekundi pomoću detektora u obliku igle tijekom perioda od 35 minuta.
11. Pripravak u skladu s patentnim zahtjevom 10, naznačen time, da pjena proizvedena SITA postupkom mjerenja ima volumen pjene između 600 ml i 1200 ml.
12. Pripravak u skladu s patentnim zahtjevom 10 ili 11, naznačen time, da pjena proizvedena SITA postupkom mjerenja ima takvu stabilnost pjene da pjena, nakon vremena zadržavanja do deset minuta, još uvijek ima volumen pjene barem između 55 % i 100 % volumena pjene koja je izvorno prisutna odmah nakon stvaranja pjene.
13. Pripravak u skladu s patentnim zahtjevom 12, naznačen time, da pjena, nakon vremena zadržavanja do deset minuta, još uvijek ima barem volumen pjene između 85 % i 99 % volumena pjene koja je izvorno prisutna odmah nakon stvaranja pjene.
14. Pripravak u skladu s patentnim zahtjevom 10, naznačen time, da pjena proizvedena SITA postupkom mjerenja pomoću pripravka ima gustoću pjene između 0,15 g/ml i 0,4 g/ml.
15. Pripravak u skladu s jednim od patentnih zahtjeva 10 do 14, naznačen time, da pripravak sadržava vodu kao otapalo, barem jedan alkohol, osobito barem jedan monovalentni na trovalentni alkohol i/ili barem jedan polialkohol.
16. Pripravak u skladu s jednim od patentnih zahtjeva 10 do 15, naznačen time, da barem jedan aktivni sastojak jest aktivni sastojak za primjenu kod ljudi ili životinja i odabran je iz skupine koja sadržava lokalne anestetike, sredstva protiv alergije, dermatike, aktivne sastojke protiv infekcija gripe i prehlade, aktivnih tvari za liječenje neuropatija, aktivne tvari za liječenje poremećaja cirkulacije, kemoterapijska sredstva, kinin, antimikotike, antibiotike, talidomid, serotonin, eikozanoid, analgetike, sredstva protiv grčeva, nesteroidne antireumatike, leukotriene, leukotrien inhibitore, androgene, antiandrogene, kortikoide, antagoniste receptora opijata, tvari za inhibiciju zgrušavanja krvi, inhibitore agregacije trombocita, antagoniste histamina, regulatorne i enzimski djelujuće peptide i proteine, nukleinske kiseline (jednostruke i dvostruke DNK, s jednom ili dvije RNA, snRNA DNA oligonukleotide, RNK oligonukleotide) i oligopeptide, antipruritike, antidiabetike, prostaglandine, inhibitore sinteze prostaglandina, antivirusne ili virostatične tvari, tvari s antimikrobnim djelovanjem, aktivne tvari protiv priona, imunosupresive, hormone, aktivne tvari za liječenje bradavica ili rana, posebice kroničnih rana, vitamine, biljne ekstrakte ili esencije biljnih ekstrakata, psihofarmake, aktivne tvari koje utječu na spavanje, analeptike, anestetike, mišićne relaksante, antiepileptike, antiparkinsonike, antiemetike, antiparazitike, ganglijski aktivne sastojke, simpatički aktivne sastojke, parasimpatički aktivne sastojke, antibakterijski djelujuće lijekove, antagoniste kalcija, kardiovaskularna sredstva, antiastmatike, antitusike, ekspektorante, hepatike, diuretike, koleretike, dezinficijense, elemente u tragovima, protuupalna sredstava, citostatike, antimetabolite, antagoniste hormona, imunomodulatore te derivate i soli spomenutih aktivnih sastojaka.
17. Pripravak u skladu s patentnim zahtjevom 16, naznačen time, da je barem jedno analgetsko sredstvo sadržano u pripravku u koncentraciji između 0,1 % i 20 % težinskog udjela, poželjno u koncentraciji između 2 % i 10 % težinskog udjela.
18. Pripravak u skladu s jednim od patentnih zahtjeva 16 ili 17, naznačen time, da je u pripravku sadržano barem jedno antimikozno sredstvo u koncentraciji između 0,01 % i 10 % težinskog udjela, poželjno u koncentracijama između 0,2 % i 5 % težinskog udjela.
19. Pripravak u skladu s jednim od patentnih zahtjeva 16 do 18, naznačen time, da pripravak ima barem jedan kortikoidni aktivni sastojak u koncentraciji između 0,001 % i 3 % težinskog udjela, poželjno između 0,1 % i 0,8 % težinskog udjela.
20. Pripravak u skladu s jednim od patentnih zahtjeva 16 do 19, naznačen time, da pripravak ima barem jedan lokalni anestetik u koncentraciji između 3 % i 15 % težinskog udjela, osobito od 6 % do 12 % težinskog udjela.
21. Pripravak u skladu s jednim od patentnih zahtjeva 10 do 20, naznačen time, da pripravak sadržava barem jedan imunomodulator u koncentraciji između 0,03 % i 0,1 % težinskog udjela.
22. Pripravak u skladu s patentnim zahtjevom 10, naznačen time, da je u fosfolipidnom sredstvu za pjenjenje sadržano najviše 15 % težinskog udjela lizo-fosfatidil kolina, najviše 10 % težinskog udjela fosfatidne kiseline i najviše 10 % težinskog udjela fosfatidil etanolamina.
23. Pripravak u skladu s jednim od patentnih zahtjeva 10 do 22, naznačen time, da pripravak sadržava fosfolipidni agens za pjenjenje u koncentraciji između 2 % i 25 % težinskog udjela, poželjno u koncentraciji između 4 % i 15 % težinskog udjela.
24. Pripravak u skladu s patentnim zahtjevom 15, naznačen time, da pripravak sadržava kao alkohol propilen glikol u koncentraciji između 2% i 25% težinskog udjela, poželjno u koncentraciji između 5% i 15% težinskog udjela.
25. Uporaba tekućeg pripravka u skladu s jednim od patentnih zahtjeva 10 do 24, koji se lokalno aplicira na kožu toplokrvnog sisavca i pjeni se bez upotrebe potisnog plina za pripravu lijeka za liječenje atopijskog ekcema ili neurodermatitisa, naznačena time, da lijek sadržava imunomodulator takrolimusa u koncentraciji između 0,03 % i 0,1 % težinskog udjela.
26. Uporaba tekućeg pripravka u skladu s jednim od patentnih zahtjeva 10 do 24, koji se lokalno aplicira na kožu toplokrvnog sisavca i pjeni se bez upotrebe potisnog plina i koristi se za pripravu lijeka za liječenje upalnih bolesti ili svrbeža kože, psorijaze, dermatitisa, neurodermatitisa ili psorijaze, naznačena time, da lijek sadržava glukokortikoid, poželjno betametazon, deksametazon, predinkarbat fuorat i/ili klobetazon butirat u koncentraciji između 0,01 % i 0,4 % težinskog udjela.
27. Uporaba tekućeg pripravka u skladu s jednim od patentnih zahtjeva 10 do 24, koji se lokalno aplicira na kožu toplokrvnog sisavca i pjeni se bez upotrebe potisnog plina i koristi se za proizvodnju lijeka za liječenje bolova, upale, reumatske bolesti ili akutnih trauma, naznačena time, da lijek sadržava analgetik, po mogućnosti diklofenak, ketoprofen i/ili ibuprofen u koncentraciji između 0,1 % i 20 % težinskog udjela, poželjno 2 % i 10 % težinskog udjela.
28. Uporaba tekućeg pripravka u skladu s jednim od patentnih zahtjeva 10 do 24, koji se lokalno aplicira na kožu toplokrvnog sisavca i pjeni se bez upotrebe potisnog plina i koristi se za proizvodnju lijeka za liječenje gljivičnih infekcija, naznačena time, da lijek sadržava antimikotik, poželjno bifonazol i/ili terbinafin, u koncentraciji između 0,5 % i 10 % težinskog udjela.
29. Uporaba tekućeg pripravka u skladu s jednim od patentnih zahtjeva 10 do 24, koji se lokalno aplicira na kožu toplokrvnog sisavca i pjeni se bez upotrebe potisnog plina te se koristi za proizvodnju lijeka za liječenje infekcija uzrokovanih Gram pozitivnim mikrobima, anaerobnim mikrobima i mikoplazmama, posebice za tretman akni, naznačena time, da lijek sadržava antibiotik, poželjno eritromicin, u koncentraciji između 2 % i 4 % težinskog udjela.
30. Uporaba tekućeg pripravka u skladu s jednim od patentnih zahtjeva 10 do 24, koji se lokalno aplicira na kožu toplokrvnog sisavca i pjeni se bez upotrebe potisnog plina i koristi se za proizvodnju lijeka za liječenje svrbeža kože, naznačena time, da lijek sadržava lokalni anestetik ponajprije benzokain i/ili lidokain, u koncentraciji između 1 % i 20 % težinskog udjela, poželjno je između 2 % i 10 % težinskog udjela.
31. Uporaba tekućeg pripravka u skladu s jednim od patentnih zahtjeva 10 do 24, koji se lokalno aplicira na kožu toplokrvnog sisavca i pjeni se bez upotrebe potisnog plina i koristi se za proizvodnju lijeka za liječenje psorijaze, naznačena time, da lijek sadržava aktivni sastojak kalcipotriol u koncentraciji između 0,005 % i 0,05 % težinskog udjela.
32. Uporaba tekućeg pripravka u skladu s jednim od patentnih zahtjeva 10 do 24, koji se lokalno aplicira na kožu toplokrvnog sisavca i pjeni se bez upotrebe potisnog plina i koristi se za proizvodnju lijeka za liječenje akni, naročito akne komedonika i akne papulopustuloza, naznačena time, da lijek sadržava aktivni sastojak tretinoin u koncentraciji između 0,05 % i 0,1 % težinskog udjela.
33. Uporaba tekućeg pripravka u skladu s jednim od patentnih zahtjeva 10 do 24, koji se lokalno aplicira na kožu toplokrvnog sisavca i pjeni se bez upotrebe potisnog plina i koristi se za proizvodnju lijeka za liječenje gubitka kose, naznačena time, da lijek sadržava aktivni sastojak minoksidil u koncentraciji između 3 % i 6 % težinskog udjela.
34. Uporaba tekućeg pripravka u skladu s jednim od patentnih zahtjeva 10 do 24, koji se lokalno aplicira na kožu toplokrvnog sisavca i pjeni se bez upotrebe potisnog plina i koristi se za proizvodnju lijeka za antiseptičko liječenje površinskih rana, naznačena time, da lijek sadržava aktivni sastojak dekspantenol u koncentraciji između 0,03 % i 1 % težinskog udjela.
35. Uporaba tekućeg pripravka u skladu s jednim od patentnih zahtjeva 10 do 24, koji se lokalno aplicira na kožu toplokrvnog sisavca i pjeni se bez upotrebe potisnog plina te se koristi za proizvodnju lijeka za liječenje herpesa i nuspojava koje prate herpes, naznačena time, da lijek sadržava aktivni sastojak aciklovir u koncentraciji između 3 % i 7 %, težinskog udjela.
36. Uporaba tekućeg pripravka u skladu s jednim od patentnih zahtjeva 10 do 24, koji se lokalno aplicira na kožu toplokrvnog sisavca i pjeni se bez upotrebe potisnog plina i koristi se za proizvodnju lijeka za liječenje blage do srednje teške psorijaze vlasišta, naznačena time, da lijek sadržava aktivni sastojak salicilnu kiselinu u koncentraciji između 8 % i 12 % težinskog udjela.
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-
2010
- 2010-07-16 US US13/143,740 patent/US20110269704A1/en not_active Abandoned
- 2010-07-16 CA CA 2752849 patent/CA2752849C/en active Active
- 2010-07-16 PL PL10757384T patent/PL2387391T3/pl unknown
- 2010-07-16 JP JP2012520903A patent/JP2013500239A/ja active Pending
- 2010-07-16 EP EP10757384.2A patent/EP2387391B1/de active Active
- 2010-07-16 DE DE102010027315A patent/DE102010027315A1/de not_active Ceased
- 2010-07-16 MX MX2011008660A patent/MX2011008660A/es unknown
- 2010-07-16 PT PT107573842T patent/PT2387391T/pt unknown
- 2010-07-16 ES ES10757384.2T patent/ES2622097T3/es active Active
- 2010-07-16 BR BRPI1006790A patent/BRPI1006790B8/pt not_active IP Right Cessation
- 2010-07-16 RU RU2011134420/15A patent/RU2532027C2/ru active
- 2010-07-16 SI SI201031425A patent/SI2387391T1/sl unknown
- 2010-07-16 WO PCT/DE2010/000818 patent/WO2011009436A2/de active Application Filing
- 2010-07-19 US US12/838,737 patent/US9005626B2/en active Active
-
2015
- 2015-02-27 US US14/633,929 patent/US9693956B2/en active Active
-
2017
- 2017-03-07 HR HRP20170376TT patent/HRP20170376T1/hr unknown
- 2017-05-31 US US15/609,581 patent/US20180104185A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
PT2387391T (pt) | 2017-04-20 |
ES2622097T3 (es) | 2017-07-05 |
JP2013500239A (ja) | 2013-01-07 |
PL2387391T3 (pl) | 2017-09-29 |
EP2387391A2 (de) | 2011-11-23 |
US20180104185A1 (en) | 2018-04-19 |
SI2387391T1 (sl) | 2017-04-26 |
WO2011009436A3 (de) | 2011-09-15 |
US20110269704A1 (en) | 2011-11-03 |
US20160022579A1 (en) | 2016-01-28 |
BRPI1006790B8 (pt) | 2021-05-25 |
MX2011008660A (es) | 2011-09-22 |
BRPI1006790A2 (pt) | 2017-05-02 |
WO2011009436A2 (de) | 2011-01-27 |
US20110059117A1 (en) | 2011-03-10 |
RU2011134420A (ru) | 2013-02-27 |
RU2532027C2 (ru) | 2014-10-27 |
US9005626B2 (en) | 2015-04-14 |
US9693956B2 (en) | 2017-07-04 |
WO2011009436A9 (de) | 2011-03-31 |
EP2387391B1 (de) | 2017-01-11 |
CA2752849C (en) | 2014-07-08 |
BRPI1006790B1 (pt) | 2020-10-20 |
CA2752849A1 (en) | 2011-01-27 |
DE102010027315A1 (de) | 2011-01-27 |
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