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HRP20200181T1 - Homogena vodena otopina hitozana pogodna za injekcije čiji je ph blizak fiziološkim ph - Google Patents

Homogena vodena otopina hitozana pogodna za injekcije čiji je ph blizak fiziološkim ph Download PDF

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Publication number
HRP20200181T1
HRP20200181T1 HRP20200181TT HRP20200181T HRP20200181T1 HR P20200181 T1 HRP20200181 T1 HR P20200181T1 HR P20200181T T HRP20200181T T HR P20200181TT HR P20200181 T HRP20200181 T HR P20200181T HR P20200181 T1 HRP20200181 T1 HR P20200181T1
Authority
HR
Croatia
Prior art keywords
aqueous solution
chitosan
acid
solution
weight
Prior art date
Application number
HRP20200181TT
Other languages
English (en)
Inventor
Alexandre GUERRY
Frédéric BERTAINA
Original Assignee
Bioxis Pharmaceuticals
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Filing date
Publication date
Application filed by Bioxis Pharmaceuticals filed Critical Bioxis Pharmaceuticals
Publication of HRP20200181T1 publication Critical patent/HRP20200181T1/hr

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Claims (19)

1. Homogena vodena otopina hitozana pogodna za injekcije, koja sadrži, u fiziološki prihvatljivom mediju, između 0.1 i 4.5%, težinski, hitozana sa stupnjem acetiranja manjim od 20% i težinski prosječnom molekulskom masom između 100,000 i 1,500,000 g/mol, gdje navedena otopina ima pH veći od ili jednak 6.2, a po mogućnosti između 6.2 i 7.2, gdje navedena otopina ne sadrži hitozan sa stupnjem acetiranja veći od 20%, gdje je navedena otopina tekuća i homogena na temperaturi okoliša.
2. Vodena otopina u skladu s prethodnim patentnim zahtjevom, naznačena time što hitozan ima stupanj acetiranja manji od 19%, po mogućnosti manji od 17%, poželjnije manji od ili jednak 15%, a najpoželjnije manji od 10%.
3. Vodena otopina u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što sadrži između 1 i 3.5%, težinski, hitozana, osobito između 2 i 3.5%, težinski, hitozana, u odnosu na ukupnu težinu vodene otopine.
4. Vodena otopina u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što hitozan ima težinski prosječnu molekulsku masu između 200,000 i 1,000,000 g/mol, poželjnije između 250,000 i 800,000 g/mol, a još poželjnije između 300,000 i 600,000 g/mol.
5. Vodena otopina u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što ima pH između 6.25 i 7.1, po mogućnosti između 6.3 i 7.0.
6. Vodena otopina u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što je se može pripraviti postupkom koji se sastoji od sljedećih koraka: – otapanja hitozana u vodi dodavanjem kiseline, poput slabe kiseline, kako bi se dobila homogena vodena otopina hitozana koja sadrži, u fiziološki prihvatljivom mediju, između 0.1 i 4.5 %, težinski, hitozana sa stupnjem acetiranja manjim od 20% i težinski prosječnom molekulskom masom između 100,000 i 1 500,000 g/mol, gdje navedena otopina ima pH manji od 6.2, gdje se navedenu kiselinu po mogućnosti bira iz skupine koju čine octena kiselina, glikolna kiselina, mliječna kiselina, glutaminska kiselina, te njihove smjese, i – naknadnog podešavanja pH dijalizom, po mogućnosti na temperaturi okoliša, kako bi se dobila vodena otopina čiji je pH veći od ili jednak 6.2, po mogućnosti između 6.2 i 7.2, a po mogućnosti između 6.25 i 7.1.
7. Vodena otopina u skladu s patentnim zahtjevom 3, naznačena time što se, u koraku otapanja, kiselinu dodaje strogo u količini potrebnoj za otapanje hitozana.
8. Vodena otopina u skladu s bilo kojim od patentnih zahtjeva 3 ili 4, naznačena time što je se dijalizira prema puferskoj otopini čiji je pH veći od 6.2, po mogućnosti između 6.2 i 7.2, po mogućnosti između 6.25 i 7.1.
9. Vodena otopina u skladu s bilo kojim od patentnih zahtjeva 3 do 5, naznačena time što je puferska otopina fosfatno puferirana fiziološka otopina koja sadrži "kiselu" sol NaH2PO4, "bazičnu" sol Na2HPO4 i NaCl.
10. Vodena otopina u skladu s bilo kojim od patentnih zahtjeva 3 do 6, naznačena time što je dijaliza dinamična, gdje se osobito upotrebljavaju sljedeći koraci: i. priprava, u prvom spremniku A, prve otopine, koja sadrži slabu kiselinu, koju se navodi kao "otopinu slabe kiseline", ii. priprava, u drugom spremniku B, druge otopine koja sadrži konjugiranu bazu ili bazu jaču od konjugirane baze slabe kiseline upotrijebljenu u "otopini slabe kiseline", iii. cirkuliranje "otopine slabe kiseline" kroz jedan ili više džepova za dijalizu koji čine membranu za dijalizu koja omeđuje vodenu otopinu hitozana koja sadrži, u fiziološki prihvatljivom mediju, između 0.1 i 4.5 %, težinski, hitozana sa stupnjem acetiranja manjim od 20% i težinski prosječnom molekulskom masom između 100,000 i 1,500,000 g/mol, gdje navedena otopina ima pH manji od 6.2, iv. uvođenje navedene "otopine slabe kiseline" prikupljene na kraju dijalize u koraku iii) u drugi spremnik B, čime se pripravak iz navedenog drugog spremnika B modificira u smjesu "baza + ε slaba kiselina", gdje ε predstavlja vrlo malu količinu, v. uvođenje smjese "baza + ε slaba kiselina" iz spremnika B u spremnik A kako bi se dobila smjesa "slaba kiselina + ε baza" u navedenom spremniku A, vi. ponavljanje koraka iii, iv, i v dok se ne uspostavi kiselinsko-bazna ravnoteža u spremnicima A i B, čime se dobije, u svakom spremniku, puferska otopina s određenim pH.
11. Vodena otopina u skladu s patentnim zahtjevom 7, naznačena time što je slaba kiselina upotrijebljena u spremniku A smjesa dihidrogenfosfata (H2PO4–) i NaCl, a baza upotrijebljena u spremniku B je hidrogenfosfat (HPO42–).
12. Vodena otopina u skladu s bilo kojim od patentnih zahtjeva 3 do 8, naznačena time što je membrana za dijalizu načinjena od regeneriranog celuloznog polimera (prirodne celuloze transformirane nizom kemijskih i fizičkih postupaka) ili celuloznog estera (primjerice celuloznog acetata) s pragom isključenja između 5 kDa i 30 kDa.
13. Pripravak koji sadrži vodenu otopinu u skladu s bilo kojim od prethodnih patentnih zahtjeva, te izborno spoj ili prihvatljivu pomoćnu tvar.
14. Pripravak u skladu s patentnim zahtjevom 13 koji sadrži najmanje jedan aktivni spoj poput analgetskog spoja, lokalni anestetik, poput lidokaina, mepivakaina, bupivakaina ili ropivakaina, angiogeni spoj, cjepivo, hormon, ili čak aktivni spoj, poput čimbenika rasta ili bioaktivnog oligosaharida, primjerice oligosaharidnu hijaluronsku kiselinu, ili oligosaharidni hitozan sa stupnjem polimerizacije manjim od 20, ili čak nukleinsku kiselinu, protein ili sredstvo protiv raka.
15. Pripravak u skladu s patentnim zahtjevom 13 ili 14, naznačen time što se formulira za primjenu ili se upotrebljava intradermalnom ili supkutanom, intramuskularnom, intraartikularnom ili intraokularnom injekcijom, te općenitije u tvrdo ili meko tkivo tijela, primjerice organe (probavni sustav ili urogenitalni sustav) ili masna tkiva, sluznice, desni, hrskavicu ili kosti.
16. Pripravak u skladu s bilo kojim od patentnih zahtjeva 13 do 15, namijenjen upotrebi u obnovi ili rekonstrukciji tkiva, osobito u stvaranju ili zamjeni bioloških tkiva, primjerice u obliku usadaka, ili u ispunjavanju bioloških tkiva, primjerice ispunjavanju kožnih udubljenja, injekcija u koštanu hrskavicu ili u zglobove.
17. Pripravak u skladu s bilo kojim od patentnih zahtjeva 13 do 15, namijenjen upotrebi kao dermatološki ili kozmetički pripravak, ili namijenjen upotrebi kao medicinska naprava, po mogućnosti kao bioresorbabilni usadak.
18. Pripravak u skladu s patentnim zahtjevom 17, namijenjen upotrebi u kirurgiji, medicini ili estetskoj kirurgiji, u urologiji, reumatologiji, oftalmologiji, odontologiji, ortopediji ili angiologiji.
19. Pripravak u skladu s patentnim zahtjevom 17, namijenjen upotrebi kao vektor za aktivne tvari, primjerice kao vehikulum za cjepiva, sredstva protiv raka ili hormone.
HRP20200181TT 2015-04-23 2016-04-22 Homogena vodena otopina hitozana pogodna za injekcije čiji je ph blizak fiziološkim ph HRP20200181T1 (hr)

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FR1553644A FR3035327B1 (fr) 2015-04-23 2015-04-23 Solution aqueuse homogene de chitosane ou derive de chitosane injectable presentant un ph proche du ph physiologique
EP16721203.4A EP3285781B1 (fr) 2015-04-23 2016-04-22 Solution aqueuse homogene de chitosane injectable presentant un ph proche du ph physiologique
PCT/FR2016/050953 WO2016170284A1 (fr) 2015-04-23 2016-04-22 Solution aqueuse homogene de chitosane injectable presentant un ph proche du ph physiologique

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