HRP20230800T1 - Očni usadak koji sadrži inhibitor tirozin kinaze - Google Patents
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- HRP20230800T1 HRP20230800T1 HRP20230800TT HRP20230800T HRP20230800T1 HR P20230800 T1 HRP20230800 T1 HR P20230800T1 HR P20230800T T HRP20230800T T HR P20230800TT HR P20230800 T HRP20230800 T HR P20230800T HR P20230800 T1 HRP20230800 T1 HR P20230800T1
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- axitinib
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- 239000007943 implant Substances 0.000 title claims 53
- 229940121358 tyrosine kinase inhibitor Drugs 0.000 title 1
- 239000005483 tyrosine kinase inhibitor Substances 0.000 title 1
- 150000004917 tyrosine kinase inhibitor derivatives Chemical class 0.000 title 1
- 238000013268 sustained release Methods 0.000 claims 17
- 239000012730 sustained-release form Substances 0.000 claims 17
- 239000002202 Polyethylene glycol Substances 0.000 claims 15
- RITAVMQDGBJQJZ-FMIVXFBMSA-N axitinib Chemical compound CNC(=O)C1=CC=CC=C1SC1=CC=C(C(\C=C\C=2N=CC=CC=2)=NN2)C2=C1 RITAVMQDGBJQJZ-FMIVXFBMSA-N 0.000 claims 15
- 229960003005 axitinib Drugs 0.000 claims 15
- 229920001223 polyethylene glycol Polymers 0.000 claims 15
- 239000000017 hydrogel Substances 0.000 claims 14
- 238000013265 extended release Methods 0.000 claims 9
- 206010064930 age-related macular degeneration Diseases 0.000 claims 6
- 208000002780 macular degeneration Diseases 0.000 claims 5
- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 claims 4
- 238000000034 method Methods 0.000 claims 4
- 239000002245 particle Substances 0.000 claims 4
- 239000002953 phosphate buffered saline Substances 0.000 claims 4
- 238000002347 injection Methods 0.000 claims 3
- 239000007924 injection Substances 0.000 claims 3
- 238000001035 drying Methods 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 230000000269 nucleophilic effect Effects 0.000 claims 2
- 239000002243 precursor Substances 0.000 claims 2
- 230000002035 prolonged effect Effects 0.000 claims 2
- 201000006165 Kuhnt-Junius degeneration Diseases 0.000 claims 1
- 208000017442 Retinal disease Diseases 0.000 claims 1
- 208000000208 Wet Macular Degeneration Diseases 0.000 claims 1
- 230000033115 angiogenesis Effects 0.000 claims 1
- 230000000845 anti-microbial effect Effects 0.000 claims 1
- 230000036760 body temperature Effects 0.000 claims 1
- 239000008366 buffered solution Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000003431 cross linking reagent Substances 0.000 claims 1
- 239000000499 gel Substances 0.000 claims 1
- 238000001879 gelation Methods 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 239000000463 material Substances 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 238000012014 optical coherence tomography Methods 0.000 claims 1
- 230000004962 physiological condition Effects 0.000 claims 1
- 229920000642 polymer Polymers 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 239000007787 solid Substances 0.000 claims 1
- 239000000243 solution Substances 0.000 claims 1
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
- A61K9/0051—Ocular inserts, ocular implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
- A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
-
- 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
- A61K31/435—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
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
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- 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
- A61K31/435—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
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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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
- A61K9/0012—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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
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- Proteomics, Peptides & Aminoacids (AREA)
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Claims (32)
1. Biorazgradivi očni usadak s produljenim otpuštanjem koji sadrži hidrogel i 150 µg +25% i -20% do 800 µg +25% i -20% aksitiniba, hidrogel sadrži polimernu mrežu koja sadrži jedinice polietilen glikola (PEG), pri čemu su čestice aksitiniba raspršene unutar hidrogela, i pri čemu je usadak cilindričan i u suhom stanju ima promjer od 0,1 mm do 0,5 mm i duljinu manju od 17 mm.
2. Biorazgradivi očni usadak s produljenim otpuštanjem prema zahtjevu 1, naznačen time što usadak sadrži aksitinib u količini od 480 µg +25% i -20% do 750 µg +25% i -20%, ili 320 µg +25% i -20% do 500 µg +25% i -20%, ili 160 µg +25% i -20% do 250 µg +25% i -20%.
3. Biorazgradivi očni usadak s produljenim otpuštanjem prema zahtjevu 2, naznačen time što usadak sadrži aksitinib u količini od 200 µg +/-10%, 400 µg +/-10%, ili 600 µg +/-10%.
4. Biorazgradivi očni usadak s produljenim otpuštanjem prema bilo kojem od prethodnih zahtjeva, naznačen time što usadak u suhom stanju ima ukupnu težinu od 0,2 mg do 1,5 mg, poželjno ukupnu težinu od 0,75 mg do 1,25 mg.
5. Biorazgradivi očni usadak s produljenim otpuštanjem prema bilo kojem od prethodnih zahtjeva, naznačen time što je usadak cilindričan i u svom hidratiziranom stanju (nakon 24 sata u fosfatno puferiranoj fiziološkoj otopini pri pH 7,2 na 37 °C) ima duljinu jednaku ili manju od 10 mm i promjer jednak ili manji od 0,8 mm.
6. Biorazgradivi očni usadak s produljenim otpuštanjem prema bilo kojem od prethodnih zahtjeva, naznačen time što usadak je usadak cilindričan i ima omjer promjera u hidratiziranom stanju prema promjeru u suhom stanju manji od 5, poželjno manji od 2,25, i/ ili ima omjer duljine u suhom stanju prema duljini u hidratiziranom stanju veći od 0,7, poželjno veći od 0,8.
7. Biorazgradivi očni usadak s produljenim otpuštanjem prema bilo kojem od prethodnih zahtjeva, naznačen time što usadak osigurava otpuštanje aksitiniba prosječnom brzinom od 0,25 µg do 2,5 µg dnevno, poželjno od 0,25 µg do 1,5 µg dnevno, poželjnije od 0,3 µg do 0,5 µg dnevno, u fosfatnoj puferiranoj fiziološkoj otopini pri pH od 7,2 i 37 °C tijekom razdoblja od 30 dana u simuliranim fiziološkim uvjetima bez potonuća.
8. Biorazgradivi očni usadak s produljenim otpuštanjem prema bilo kojem od prethodnih zahtjeva, naznačen time što je usadak intravitrealni usadak.
9. Biorazgradivi očni usadak s produljenim otpuštanjem prema bilo kojem od prethodnih zahtjeva, naznačen time što usadak osigurava otpuštanje aksitiniba u razdoblju od najmanje 3 mjeseca nakon primjene, najmanje 6 mjeseci nakon primjene, najmanje 9 mjeseci nakon primjene, ili najmanje 12 mjeseci nakon primjene.
10. Biorazgradivi očni usadak s produljenim otpuštanjem prema zahtjevu 9, naznačen time što usadak osigurava oslobađanje aksitiniba u razdoblju od 6 do 9 mjeseci nakon primjene.
11. Biorazgradivi očni usadak s produljenim otpuštanjem prema bilo kojem od prethodnih zahtjeva, naznačen time što hidrogel sadrži PEG jedinice s više krakova koje su iste ili različite i koje imaju brojčanu prosječnu molekularnu težinu od 10.000 do 60.000 Daltona, poželjno 20.000 Daltona.
12. Biorazgradivi očni usadak s produljenim otpuštanjem prema zahtjevu 11, naznačen time što hidrogel sadrži umrežene PEG jedinice, a umrežene veze između PEG jedinica uključuju skupinu predstavljenu sljedećom formulom
[image]
pri čemu m je cijeli broj od 0 do 10.
13. Biorazgradivi očni usadak s produljenim otpuštanjem prema zahtjevu 12, naznačen time što m je 6.
14. Biorazgradivi očni usadak s produljenim otpuštanjem prema bilo kojem od zahtjeva 11 do 13, naznačen time što PEG jedinice sadrže 4-krake i/ili 8-krake PEG jedinice.
15. Biorazgradivi očni usadak s produljenim otpuštanjem prema bilo kojem od prethodnih zahtjeva, naznačen time što čestice aksitiniba imaju veličinu čestica d90 manju od 30 µm kako je određeno laserskom difrakcijom.
16. Biorazgradivi očni usadak s produljenim otpuštanjem prema bilo kojem od prethodnih zahtjeva, naznačen time što usadak ne sadrži ili uglavnom ne sadrži antimikrobne konzervanse.
17. Biorazgradivi očni usadak s produljenim otpuštanjem prema bilo kojem od prethodnih zahtjeva, naznačen time što usadak u suhom stanju sadrži od 500 µg do 800 µg aksitiniba po mm3.
18. Biorazgradivi očni usadak s produljenim otpuštanjem prema bilo kojem od prethodnih zahtjeva, naznačen time što usadak u suhom stanju sadrži od 60% do 75% težinskih aksitiniba i od 21% do 31% težinskih PEG jedinica, ili sadrži od 45% do 55% težinskih aksitiniba i od 37% do 47% težinskih PEG jedinica (suhi pripravak).
19. Biorazgradivi očni usadak s produljenim otpuštanjem prema zahtjevu 1, naznačen time što je usadak intravitrealni usadak i sadrži od 480 µg do 750 µg aksitiniba, cilindričan je i u suhom stanju ima duljinu manju ili jednaku 10 mm i promjer od 0,3 mm do 0,4 mm, te u hidratiziranom stanju (nakon 24 sata u fosfatno puferiranoj fiziološkoj otopini pri pH 7,2 na 37 °C) ima duljinu od 6 mm do 10,5 mm i promjer od 0,6 mm do 0,8 mm, te pri čemu hidrogel sadrži umrežene 4a20k i 8a20k PEG jedinice, pri čemu poprečne veze između PEG jedinica uključuju skupinu predstavljenu sljedećom formulom
[image]
pri čemu m je 6.
20. Biorazgradivi očni usadak s produljenim otpuštanjem prema zahtjevu 1, naznačen time što je usadak intravitrealni usadak i sadrži od 160 µg do 250 µg aksitiniba, cilindričan je i u suhom stanju ima duljinu manju od 17 mm i promjer od 0,2 mm do oko 0,3 mm, a u svojem hidratiziranom stanju (nakon 24 sata u fosfatnoj puferiranoj fiziološkoj otopini pri pH 7,2 na 37 °C) ima duljinu od 6,5 mm do 8 mm i promjer od 0,7 mm do 0,8 mm, i pri čemu hidrogel sadrži umrežene 4a20k i 8a20k PEG jedinice, pri čemu poprečne veze između PEG jedinica uključuju skupinu predstavljenu sljedećom formulom
[image]
pri čemu m je 6.
21. Biorazgradivi očni usadak s produljenim otpuštanjem prema bilo kojem od prethodnih zahtjeva, naznačen time što je za upotrebu za liječenje neovaskularne makularne degeneracije povezane sa starenjem (AMD) kod pacijenta kojem je to potrebno.
22. Biorazgradivi očni usadak s produljenim otpuštanjem prema zahtjevu 21, naznačen time što je za upotrebu za liječenje AMD tijekom perioda liječenja od najmanje 3 mjeseca, ili najmanje 6 mjeseci, ili najmanje 9 mjeseci, ili najmanje 12 mjeseci.
23. Biorazgradivi očni usadak s produljenim otpuštanjem prema zahtjevu 22, naznačen time što je period liječenja 6 do 9 mjeseci.
24. Biorazgradivi očni usadak s produljenim otpuštanjem za upotrebu za liječenje AMD prema zahtjevu 23, naznačen time što je usadak intravitrealni usadak, pri čemu je doza primijenjena po oku jednom tijekom perioda liječenja od 150 µg do 1800 µg, poželjno od 150 µg do 1200 µg, poželjnije od 480 µg do 750 µg aksitiniba i sadržana je u jednom ili više usadaka koji se daju istovremeno.
25. Biorazgradivi očni usadak s produljenim otpuštanjem za upotrebu za liječenje AMD prema bilo kojem od zahtjeva 21 do 24, naznačen time što se istovremeno ili u kombinaciji s tretmanom usadkom pacijentu daje anti-VEGF sredstvo.
26. Biorazgradivi očni usadak s produljenim otpuštanjem za upotrebu za liječenje AMD prema bilo kojem od zahtjeva 21 do 25, naznačen time što je liječenje učinkovito u smanjenju, uglavnom održavanju ili sprječavanju klinički značajnog povećanja debljine središnjeg podpolja mjereno optičkom koherentnom tomografijom kod pacijenta čija je debljina središnjeg podpolja povišena zbog bolesti mrežnice koja uključuje angiogenezu.
27. Postupak proizvodnje biorazgradivog očnog usadka s produljenim otpuštanjem prema bilo kojem od zahtjeva 1 do 20, naznačen time što postupak sadrži korake formiranja hidrogela miješanjem i reakcijom PEG prekursora koji sadrži elektrofilnu skupinu s više krakova s nukleofilnom skupinom koja sadrži PEG prekursor s više krakova ili drugog sredstva za umrežavanje koje sadrži nukleofilnu skupinu u puferiranoj otopini u prisutnosti čestica aksitiniba, omogućavajući smjesi da želira kako bi nastao hidrogel, te sušenje hidrogela.
28. Postupak prema zahtjevu 27, naznačen time što se sastoji od lijevanja smjese u cijev prije potpunog želiranja hidrogela kako bi nastala nit hidrogela, te postupak dalje uključuje istezanje niti hidrogela u uzdužnom smjeru prije ili nakon sušenja hidrogela (mokro istezanje ili suho istezanje), poželjno s faktorom istezanja od 1 do 4,5.
29. Komplet naznačen time što sadrži jedan ili više biorazgradivih očnih usadaka s produženim otpuštanjem prema bilo kojem od zahtjeva 1 do 20 i jednu ili više igala za injekciju.
30. Komplet prema zahtjevu 29, naznačen time što je svaki usadak umetnut u iglu koja ima veličinu od 22 do 30.
31. Komplet prema zahtjevu 29 ili 30, naznačen time što je lumen svake igle zatvoren materijalom koji je čvrst na sobnoj temperaturi i mekan ili tekuć na tjelesnoj temperaturi.
32. Komplet prema bilo kojem od zahtjeva 29 do 31, naznačen time što dalje sadrži uređaj za injektiranje, pri čemu svaka igla je ili nije unaprijed spojena na uređaj za injektiranje.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202062994391P | 2020-03-25 | 2020-03-25 | |
| PCT/US2020/029827 WO2020219890A1 (en) | 2019-04-25 | 2020-04-24 | Ocular hydrogel tyrosine kinase inhibitor implants |
| US202063106276P | 2020-10-27 | 2020-10-27 | |
| US202163148463P | 2021-02-11 | 2021-02-11 | |
| EP21164737.5A EP3884929B1 (en) | 2020-03-25 | 2021-03-24 | Ocular implant containing a tyrosine kinase inhibitor |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20230800T1 true HRP20230800T1 (hr) | 2023-10-27 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20230800TT HRP20230800T1 (hr) | 2020-03-25 | 2021-03-24 | Očni usadak koji sadrži inhibitor tirozin kinaze |
Country Status (20)
| Country | Link |
|---|---|
| US (4) | US11439592B2 (hr) |
| EP (2) | EP4252725A3 (hr) |
| JP (2) | JP7378638B2 (hr) |
| KR (2) | KR102707942B1 (hr) |
| CN (1) | CN115461040A (hr) |
| AU (2) | AU2021244485B2 (hr) |
| BR (1) | BR112022018815A2 (hr) |
| CA (2) | CA3234679A1 (hr) |
| CL (1) | CL2022002606A1 (hr) |
| DK (1) | DK3884929T3 (hr) |
| ES (1) | ES2952677T3 (hr) |
| FI (1) | FI3884929T3 (hr) |
| HR (1) | HRP20230800T1 (hr) |
| HU (1) | HUE062928T2 (hr) |
| IL (1) | IL296687A (hr) |
| MX (1) | MX2022010333A (hr) |
| PL (1) | PL3884929T3 (hr) |
| PT (1) | PT3884929T (hr) |
| TW (1) | TW202202138A (hr) |
| WO (1) | WO2021195163A1 (hr) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113939271A (zh) * | 2019-04-25 | 2022-01-14 | 视觉治疗股份有限公司 | 眼用水凝胶酪氨酸激酶抑制剂植入物 |
| HUE062928T2 (hu) | 2020-03-25 | 2023-12-28 | Ocular Therapeutix Inc | Tirozin-kináz inhibitort tartalmazó szemészeti készítmény |
| MX2023004614A (es) * | 2020-10-27 | 2023-05-09 | Ocular Therapeutix Inc | Implante ocular que contiene un agente activo. |
| US20240041647A1 (en) * | 2021-03-24 | 2024-02-08 | Ocular Therapeutix, Inc. | Implant injector device |
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