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HRP20231453T1 - Postupak za morseliranje i/ili usmjeravanje farmaceutski aktivnih sastojaka na sinovijalno tkivo - Google Patents

Postupak za morseliranje i/ili usmjeravanje farmaceutski aktivnih sastojaka na sinovijalno tkivo Download PDF

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HRP20231453T1
HRP20231453T1 HRP20231453TT HRP20231453T HRP20231453T1 HR P20231453 T1 HRP20231453 T1 HR P20231453T1 HR P20231453T T HRP20231453T T HR P20231453TT HR P20231453 T HRP20231453 T HR P20231453T HR P20231453 T1 HRP20231453 T1 HR P20231453T1
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biodegradable
drug delivery
preparation
joint
use according
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HRP20231453TT
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Georges Gaudriault
Sylvestre Grizot
Mark Hurtig
Matthew Shive
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Medincell S.A.
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    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
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    • A61K31/33—Heterocyclic compounds
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    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
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    • A61K31/415—1,2-Diazoles
    • A61K31/4152—1,2-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. antipyrine, phenylbutazone, sulfinpyrazone
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    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
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    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
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    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/5415—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
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    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/618—Salicylic acid; Derivatives thereof having the carboxyl group in position 1 esterified, e.g. salsalate
    • A61K31/621—Salicylic acid; Derivatives thereof having the carboxyl group in position 1 esterified, e.g. salsalate having the hydroxy group in position 2 esterified, e.g. benorylate
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Claims (22)

1. Biorazgradivi pripravak za isporuku lijeka za upotrebu u liječenju najmanje jednog zgloba pacijenta, naznačen time što pripravak sadrži: (a) biorazgradivi triblok kopolimer koji ima formulu: PLAv-PEGw-PLAx pri čemu su v i x broj ponavljajućih jedinica u rasponu od 24 do 682 i w je broj ponavljajućih jedinica u rasponu od 4 do 273 i v=x ili v≠x; (b) biorazgradivi diblok kopolimer koji ima formulu: mPEGy-PLAz pri čemu su y i z broj ponavljajućih jedinica sa y u rasponu od 3 do 45 i z u rasponu od 7 do 327, pri čemu je omjer biorazgradivog triblok kopolimera (a) i biorazgradivog diblok kopolimera (b) 3:2 do 1:19 u navedenom biorazgradivom pripravku lijeka i (c) najmanje jedan farmaceutski aktivan sastojak; i pri čemu upotreba uključuje davanje navedenog biorazgradivog pripravka za isporuku lijeka u najmanje jedan zglob pacijenta, tako da je sadržan unutar artikulirajuće čahure zgloba, a upotreba nadalje uključuje morseliranje pripravka za isporuku lijeka.
2. Biorazgradivi pripravak za isporuku lijeka prema zahtjevu 1 za upotrebu prema zahtjevu 1, naznačen time što tijekom upotrebe navedeni biorazgradivi pripravak za isporuku lijeka: (i) uzima se štrcaljkom za davanje i ubrizgava u navedeni zglob ili se ručno oblikuje u čvrsti bolus izlaganjem formulacije vodenoj tekućini i ručno se stavlja u zglob; i/ili (ii) podvrgnut je mehaničkom naprezanju, naročito mehaničkom naprezanju uzrokovanom unutarnjim strukturama zglobova, artikulacijom, opterećenjem i/ili pritiskom sinovijalnog tkiva; i/ili (iii) lomi se u komadiće, pri čemu se navedeni komadići poželjno lome na sve manje i manje komadiće.
3. Biorazgradivi pripravak za isporuku lijeka prema zahtjevu 1 ili 2 za upotrebu prema zahtjevu 1 ili 2, naznačen time što je navedeni najmanje jedan farmaceutski aktivan sastojak prisutan u navedenom pripravku u količini od 1% do 85% tež.%/tež.%.
4. Biorazgradivi pripravak za isporuku lijeka prema bilo kojem od zahtjeva 1 do 3 za upotrebu prema bilo kojem od zahtjeva 1 do 3, naznačen time što lanac polietilen glikola u tribloku i dibloku ima raspon od 300 Da do 12 kDa, naročito je lanac polietilen glikola u tribloku ili dibloku 2 kDa.
5. Biorazgradivi pripravak za isporuku lijeka prema bilo kojem od zahtjeva 1 do 4 za upotrebu prema bilo kojem od zahtjeva 1 do 4, naznačen time što je molarni omjer polimliječne ponovljene jedinice prema etilen oksidu 1,6 do 7,2 u tribloku i 1,9 do 4,8 u dibloku.
6. Biorazgradivi pripravak za isporuku lijeka prema bilo kojem od zahtjeva 1 do 5 za upotrebu prema bilo kojem od zahtjeva 1 do 5, naznačen time što je stupanj polimerizacije u tribloku 72 do 324 i stupanj polimerizacije u dibloku je 85,5 do 216.
7. Biorazgradivi pripravak za isporuku lijeka prema bilo kojem od zahtjeva 1 do 6 za upotrebu prema bilo kojem od zahtjeva 1 do 6, naznačen time što je triblok prisutan u količini od 6% do 24% (tež.%/tež.%) i diblok je prisutan u količini od 12% do 40% (tež.%/tež.%).
8. Postupak formuliranja biorazgradivog pripravka za isporuku lijeka prema bilo kojem od zahtjeva 1 do 7, (i) pri čemu formulacija navedenog biorazgradivog pripravka lijeka uključuje miješanje triblok kopolimera s diblok kopolimerom u biokompatibilnom organskom otapalu da se dobije smjesa triblok kopolimera i diblok kopolimera, pri čemu se navedeno otapalo poželjno isparava, i (ii) izborno pri čemu navedeni postupak nadalje uključuje dodavanje u navedenu mješavinu triblok kopolimera i diblok kopolimera (i) najmanje jednog farmaceutski aktivnog sastojka, i pri čemu su navedena mješavina triblok kopolimera i diblok kopolimera i navedeni najmanje jedan farmaceutski aktivan sastojak poželjno dalje izloženi vodenoj tekućini kako bi se dobio čvrsti bolus.
9. Biorazgradivi pripravak za isporuku lijeka prema bilo kojem od zahtjeva 1 do 7 za upotrebu prema bilo kojem od zahtjeva 1 do 7, naznačen time što se najmanje jedan farmaceutski aktivan sastojak može primijeniti na post-kirurške primjene koje su potpune ili djelomične zamjene koljena, potpune ili djelomične zamjene kuka, potpune ili djelomične zamjene gležnja, operacije zglobova, artroskopske ili otvorene operacije zglobova, mikrofrakture, implantacija autolognih kondrocita, osteoartikularni sustav prijenosa, mozaikoplastika, debridment i lavaža, popravak ligamenata, popravak tetiva, popravak rotatorne manšete, operacija meniskusa, jednokompartmentalna zamjena koljena, sinovektomija ili ne kirurške primjene intra-zglobnih injekcija za upalne bolesti ili bol u zglobovima.
10. Biorazgradivi pripravak za isporuku lijeka prema bilo kojem od zahtjeva 1 do 7 ili zahtjevu 9 za upotrebu prema bilo kojem od zahtjeva 1 do 7 ili zahtjevu 9, naznačen time što navedena primjena navedenom pacijentu iznosi 0,1 do 6 ml za koljeno, 0,1 do 6 ml za kuk, 0,1 do 4 ml za gležanj, 0,1 do 6 ml za rame i 0,1 do 2 ml za lakat.
11. Biorazgradivi pripravak za isporuku lijeka koji sadrži najmanje jedan farmaceutski aktivan sastojak koja sadrži: (a) biorazgradivi triblok kopolimer koji ima formulu: PLAv-PEGw-PLAx pri čemu su v i x broj ponavljajućih jedinica u rasponu od 24 do 682 i w je broj ponavljajućih jedinica u rasponu od 4 do 273 i v=x ili v≠x; (b) biorazgradivi diblok kopolimer koji ima formulu: mPEGy-PLAz pri čemu su y i z broj ponavljajućih jedinica sa y u rasponu od 3 do 45 i z u rasponu od 7 do 327, i pri čemu je omjer biorazgradivog triblok kopolimera (a) i biorazgradivog diblok kopolimera (b) 3:2 do 1:19 u navedenom biorazgradivom pripravku lijeka; i (c) najmanje jedan farmaceutski aktivan sastojak za morseliranje navedenog biorazgradivog pripravka za isporuku lijeka; pri čemu se navedeni biorazgradivi pripravak za isporuku lijeka nalazi unutar zglobne kapsule zgloba radi morseliranja.
12. Biorazgradivi pripravak za isporuku lijeka za upotrebu u postupku ciljanja najmanje jednog farmaceutski aktivnog sastojka na najmanje jedan zglob, poželjno na sinovijalno tkivo, navedeni postupak uključuje davanje sisavcu ili životinji kojoj je potrebno takvo liječenje biorazgradivog pripravka za isporuku lijeka koji sadrži: (a) biorazgradivi triblok kopolimer koji ima formulu: PLAv-PEGw-PLAx pri čemu su v i x broj ponavljajućih jedinica u rasponu od 24 do 682 i w je broj ponavljajućih jedinica u rasponu od 4 do 273 i v=x ili v≠x; (b) biorazgradivi diblok kopolimer koji ima formulu: mPEGy-PLAz pri čemu su y i z broj ponavljajućih jedinica sa y u rasponu od 3 do 45 i z u rasponu od 7 do 327, pri čemu je omjer biorazgradivog triblok kopolimera (a) i biorazgradivog diblok kopolimera (b) je 3:2 do 1:19 u navedenom biorazgradivom pripravku lijeka; i (c) najmanje jedan farmaceutski aktivan sastojak.
13. Biorazgradivi pripravak za isporuku lijeka prema zahtjevu 12 za upotrebu prema zahtjevu 12, naznačen time što (i) triblok kopolimer je prisutan u količini od 2,0% do 45% (tež.%/tež.%) ukupnog pripravka i diblok kopolimer je prisutan u količini od 8,0% do 50% (tež.%/tež.%) ukupnog pripravka; i/ili (ii) aktivni sastojak je prisutan u količini od 1% do 20% (tež.%/tež.%) ukupnog pripravka; i/ili (iii) ukupni sadržaj polimera je u rasponu od 20% do 50% (tež.%/tež.%) ukupnog pripravka i najmanje jedan farmaceutski aktivni sastojak je prisutan u količini od 10% do 20% (tež.%/tež.%) ukupnog pripravka.
14. Biorazgradivi pripravak za isporuku lijeka prema zahtjevu 12 ili 13 za upotrebu prema zahtjevu 12 ili zahtjevu 13, naznačen time što je navedeni pripravak tekućina koja se može ubrizgati u najmanje jedan zglob ili su male čvrste čestice koje se mogu ubrizgati u najmanje jedan zglob ili su štapićasti implantati ili prostorne formulacije.
15. Biorazgradivi pripravak za isporuku lijeka prema bilo kojem od zahtjeva 12 do 14 za upotrebu prema bilo kojem od zahtjeva 12 do 14, naznačen time što je veličina lanca polietilen glikola u rasponu od 200 Da do 12 kDa ili 194 Da do 12 kDa i veličina na krajevima zatvorenog lanca polietilen glikola je u rasponu od 100 Da do 2 kDa ili 164 Da do 2 kDa.
16. Biorazgradivi pripravak za isporuku lijeka prema bilo kojem od zahtjeva 12 do 15 za upotrebu prema bilo kojem od zahtjeva 12 do 15, naznačen time što nadalje sadrži farmaceutski prihvatljiv nosač.
17. Biorazgradivi pripravak za isporuku lijeka prema bilo kojem od zahtjeva 12 do 16 za upotrebu prema bilo kojem od zahtjeva 12 do 16, naznačen time što je molarni omjer mliječne kiseline i etilen oksida u pripravku između 0,5 do 3,5 ili 0,5 do 22,3 za triblok kopolimer i između 2 do 6 ili 0,8 do 13 za diblok kopolimer.
18. Biorazgradivi pripravak za isporuku lijeka prema bilo kojem od zahtjeva 12 do 17 za upotrebu prema bilo kojem od zahtjeva 12 do 17, naznačen time što je najmanje jedan zglob sinovijalno tkivo i pri čemu je molarni omjer mliječne kiseline i etilen oksida u pripravku između 0,5 do 22,3 za triblok kopolimer i između 0,8 do 13 za diblok kopolimer.
19. Biorazgradivi pripravak za isporuku lijeka prema bilo kojem od zahtjeva 12 do 18 za upotrebu prema bilo kojem od zahtjeva 12 do 18, naznačen time što je najmanje jedan zglob sinovijalni zglob, a navedeni sinovijalni zglob je zglob koljena, zglob gležnja, zglob lakta, zglob nadlaktične kosti, zglob lakatne kosti, obrtni zglobovi, kuglasti zglobovi, pregibni zglobovi, zglobovi ramena, zglobovi lopatice, zglobovi nogu, zglobovi fibule, sedlasti zglobovi, zglobovi zapešća, zglobovi prstiju i zglobovi tibije.
20. Biorazgradivi pripravak za isporuku lijeka prema bilo kojem od zahtjeva 12 do 19 za upotrebu prema bilo kojem od zahtjeva 12 do 19, naznačen time što se navedeni farmaceutski aktivan sastojak može primijeniti na post-kirurške primjene kao što su operacije zglobova, mozaikoplastika, mikrofrakture, autologna implantacija kondrocita, osteoartikularni sustav prijenosa, popravak ligamenata i tetiva, popravak ligamenata i tetiva ili jednokompartmentalna zamjena koljena, potpune ili djelomične zamjene koljena, potpune ili djelomične zamjene kuka, potpune ili djelomične zamjene gležnja, artroskopske ili otvorene operacije zglobova, debridment i lavaža, popravak rotatorne manšete, sinovektomija ili ne kirurške primjene intra-zglobnih injekcija za upalne bolesti ili bol u zglobovima.
21. Biorazgradivi pripravak za isporuku lijeka prema bilo kojem od zahtjeva 12 do 20 za upotrebu prema bilo kojem od zahtjeva 12 do 20, naznačen time što je navedeni najmanje jedan farmaceutski aktivan sastojak peptidni lijek, proteinski lijek, sredstvo za desenzibilizaciju, antigen, ne steroidno protuupalno sredstvo, protuupalni lijek, anestetik, antioksidativno sredstvo, antiinfektivno sredstvo, kemoterapijsko sredstvo, antinociceptivno sredstvo, DMOAD, anabolička sredstva, anti-katabolička sredstva, regulacijska sredstva za autofagiju, sredstva za gubitak kosti posredovana anti-osteoklastima, nutraceutička sredstva, analgetici, biološki lijekovi i njihove smjese.
22. Biorazgradivi pripravak za isporuku lijeka prema zahtjevu 21 za upotrebu prema zahtjevu 21, naznačen time što je navedeno ne steroidno protuupalno sredstvo etofenamat, celekoksib, aprikoksib, rofekoksib, nabumeton, benorilat, etorikoksib, ampiroksikam, aminofemazon, valdekoksib, acetominofen, bufeksamak, nimesulid, parekoksib, mefenaminska kiselina, deksibuprofen, ibuprofen, flurbiprofen, aspirin, deksketoprofen, diklofenak, diflunisal, etodolak, fenoprofen, firokoksib, indometacin, ketoprofen, ketorolac, lornoksikam, loksoprofen, lumirakoksib, meklofenaminska kiselina, meloksikam, naproksen, nimaloks, oksaporozin, piroksikam, salsalat, sulindak, tenoksikam, tolfenamska kiselina, ropivikain i njihove smjese.
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