HRP20210980T1 - Stabilna bez konzervansa midrijatska i protuupalna otopina za injekciju - Google Patents
Stabilna bez konzervansa midrijatska i protuupalna otopina za injekciju Download PDFInfo
- Publication number
- HRP20210980T1 HRP20210980T1 HRP20210980TT HRP20210980T HRP20210980T1 HR P20210980 T1 HRP20210980 T1 HR P20210980T1 HR P20210980T T HRP20210980T T HR P20210980TT HR P20210980 T HRP20210980 T HR P20210980T HR P20210980 T1 HRP20210980 T1 HR P20210980T1
- Authority
- HR
- Croatia
- Prior art keywords
- pharmaceutical composition
- ketorolac
- phenylephrine
- use according
- sterile pharmaceutical
- Prior art date
Links
- 239000007924 injection Substances 0.000 title claims 6
- 238000002347 injection Methods 0.000 title claims 6
- 239000000243 solution Substances 0.000 title claims 4
- 230000003110 anti-inflammatory effect Effects 0.000 title 1
- 230000002911 mydriatic effect Effects 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 13
- OZWKMVRBQXNZKK-UHFFFAOYSA-N ketorolac Chemical compound OC(=O)C1CCN2C1=CC=C2C(=O)C1=CC=CC=C1 OZWKMVRBQXNZKK-UHFFFAOYSA-N 0.000 claims 11
- 229960004752 ketorolac Drugs 0.000 claims 11
- SONNWYBIRXJNDC-VIFPVBQESA-N phenylephrine Chemical compound CNC[C@H](O)C1=CC=CC(O)=C1 SONNWYBIRXJNDC-VIFPVBQESA-N 0.000 claims 11
- 229960001802 phenylephrine Drugs 0.000 claims 11
- 239000007853 buffer solution Substances 0.000 claims 6
- 239000000203 mixture Substances 0.000 claims 5
- 239000002552 dosage form Substances 0.000 claims 3
- 239000011261 inert gas Substances 0.000 claims 3
- 239000001509 sodium citrate Substances 0.000 claims 3
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims 2
- 239000006172 buffering agent Substances 0.000 claims 2
- 238000002425 crystallisation Methods 0.000 claims 2
- 230000008025 crystallization Effects 0.000 claims 2
- 238000003973 irrigation Methods 0.000 claims 2
- 230000002262 irrigation Effects 0.000 claims 2
- 238000001556 precipitation Methods 0.000 claims 2
- 239000012064 sodium phosphate buffer Substances 0.000 claims 2
- 239000003963 antioxidant agent Substances 0.000 claims 1
- 230000003078 antioxidant effect Effects 0.000 claims 1
- 239000008365 aqueous carrier Substances 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 230000015556 catabolic process Effects 0.000 claims 1
- 239000011521 glass Substances 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 229910052757 nitrogen Inorganic materials 0.000 claims 1
- 239000002997 ophthalmic solution Substances 0.000 claims 1
- 229940054534 ophthalmic solution Drugs 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 230000002335 preservative effect Effects 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- 238000001356 surgical procedure Methods 0.000 claims 1
- 238000005406 washing Methods 0.000 claims 1
Classifications
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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
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N43/00—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds
- A01N43/48—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having rings with two nitrogen atoms as the only ring hetero atoms
-
- 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
-
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/407—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
-
- 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
-
- 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
-
- 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
- A61P27/04—Artificial tears; Irrigation solutions
-
- 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
- A61P27/08—Mydriatics or cycloplegics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P41/00—Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
Claims (12)
1. Sterilni farmaceutski sastav koji sadrži vodenastu otopinu fenilefrina i ketorolaka u količini dovoljnoj za jedokratnu injekciju intraokularne oftalmološke otopine za ispiranje i uporabu u intraokularnom kirurškom zahvatu, pri čemu je taj sastav sadržan u spremniku i taj spremnik olakšava pojedinačnu uporabu i ne olakšava višestruku uporabu otopine, pri čemu ta otopina nadalje sadrži puferski sustav i ne sadrži konzervans, antioksidans i bez otapajućih sredstava i nema vidljivih taloženja i kristalizaciju tijekom šest mjeseci na 60°C, i pri čemu se puferski sustav izabire između puferskog sustava natrijevog fosfata i puferskog sustava natrijevog citrata, i otopina je prekrivena inertnim plinom u spremniku.
2. Sterilni farmaceutski sastav za uporabu sukladno patentnom zahtjevu 1, pri čemu puferski sustav sadrži količinu oko 20 mM sustava pufera natrijevog citrata.
3. Sterilni farmaceutski sastav za uporabu sukladno patentnom zahtjevu 1, pri čemu taj farmaceutski sastav ima pH vrijednost od 5,8 do 6,8.
4. Sterilni farmaceutski sastav za uporabu sukladno patentnom zahtjevu 1, pri čemu taj sastav sadrži manje od 5% proizvoda ukupne razgradnje fenilefrina i ketorolaka nakon skladištenja tijekom perioda od najmanje 24 mjeseca na temperaturi od 5+/-3°C do 25+/-2°C.
5. Sterilni farmaceutski sastav za uporabu sukladno patentnom zahtjevu 1, pri čemu je inertni plin dušik.
6. Sterilni farmaceutski sastav za uporabu sukladno patentnom zahtjevu 1, pri čemu taj farmaceutski sastav sadrži 46 do 76 mM fenilefrina i od 8,5 do 14 mM ketorolaka.
7. Sterilni farmaceutski sastav za uporabu sukladno patentnom zahtjevu 6, pri čemu taj sastav sadrži oko 60,75 mM fenilefrina i oko 11,25 mM ketorolaka.
8. Sterilni farmaceutski sastav za uporabu sukladno patentnom zahtjevu 1, i nosač za intraokularno ispiranje u koji se ubrizgava sastav, pri čemu je nakon ubrizgavanja fenilefrin prisutan u koncentraciji od 30 do 720 µM i ketorolak je prisutan u koncentraciji od 44 do 134 µM.
9. Sterilni farmaceutski sastav za uporabu sukladno patentnom zahtjevu 1, i nosač za intraoklarno ispiranje u koji se ubrizgava sastav, pri čemu je nakon ubrizgavanja fenilefrin prisutan u koncentraciji od 240 do 720 µM i ketorolak je prisutan u koncentraciji od 10 do 270 µM.
10. Sterilni farmaceutski sastav za uporabu sukladno patentnom zahtjevu 1, pri čemu su uključeni fenilefrin i ketorolak u molarnom odnosu od 1:1 do 13:1 količine fenilefrina sukladno količini ketorolaka.
11. Sterilni farmaceutski sastav za uporabu sukladno patentnom zahtjevu 1, pri čemu su uključeni fenilefrin i ketorolak u molarnom odnosu od 3:1 do 10:1 količine fenilefrina sukladno količini ketorolaka.
12. Sterilni tekući farmaceutski oblik doze za ubrizgavanje, koji sadrži fenilefrin, ketorolak, sustav puferskog sredstva i vodenasti nosač upakiran u spremniku za pojedinačnu uporabu za ubrizgravanje, pri čemu je taj spremnik staklena bočica zatvorena čepom ili zatvaračem koji uključuje septum, pri čemu taj oblik doze nema konzervans, antioksidans i sredstva otapanja i nema vidljivih taloženja i kristalizaciju tijekom šest mjeseci na 60°C, pri čemu je pufersko sredstvo izabrano između sustava pufera natrijevog fosfata i sustava pufera natrijevog citrata, i pri čemu je oblik doze prekriven inertnim plinom u spremniku.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261718026P | 2012-10-24 | 2012-10-24 | |
| US201261736179P | 2012-12-12 | 2012-12-12 | |
| PCT/US2013/066349 WO2014066485A1 (en) | 2012-10-24 | 2013-10-23 | Stable preservative-free mydriatic and anti-inflammatory solutions for injection |
| EP13848382.1A EP2911511B1 (en) | 2012-10-24 | 2013-10-23 | Stable preservative-free mydriatic and anti-inflammatory solutions for injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20210980T1 true HRP20210980T1 (hr) | 2021-09-17 |
Family
ID=50545210
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20210980TT HRP20210980T1 (hr) | 2012-10-24 | 2021-06-21 | Stabilna bez konzervansa midrijatska i protuupalna otopina za injekciju |
Country Status (39)
| Country | Link |
|---|---|
| US (5) | US9066856B2 (hr) |
| EP (2) | EP3909572A1 (hr) |
| JP (7) | JP6017053B2 (hr) |
| KR (4) | KR20170128640A (hr) |
| CN (2) | CN108721210A (hr) |
| AP (1) | AP2015008459A0 (hr) |
| AR (1) | AR093115A1 (hr) |
| AU (1) | AU2013201465B2 (hr) |
| BR (1) | BR112015009228B1 (hr) |
| CA (1) | CA2887772C (hr) |
| CL (1) | CL2015001078A1 (hr) |
| CR (1) | CR20150233A (hr) |
| CU (1) | CU20150037A7 (hr) |
| CY (1) | CY1124481T1 (hr) |
| DK (1) | DK2911511T3 (hr) |
| EA (1) | EA033811B1 (hr) |
| ES (1) | ES2875432T3 (hr) |
| GE (1) | GEP20186891B (hr) |
| HK (1) | HK1213434A1 (hr) |
| HR (1) | HRP20210980T1 (hr) |
| HU (1) | HUE055537T2 (hr) |
| IL (1) | IL238439B2 (hr) |
| IN (1) | IN2015DN03029A (hr) |
| LT (1) | LT2911511T (hr) |
| MA (1) | MA38096B1 (hr) |
| MD (1) | MD20150050A2 (hr) |
| MX (2) | MX2015005089A (hr) |
| MY (1) | MY188474A (hr) |
| NZ (1) | NZ628398A (hr) |
| PE (1) | PE20150958A1 (hr) |
| PH (1) | PH12015500850B1 (hr) |
| PL (1) | PL2911511T3 (hr) |
| PT (1) | PT2911511T (hr) |
| RS (1) | RS62188B1 (hr) |
| SG (1) | SG11201502602WA (hr) |
| SI (1) | SI2911511T1 (hr) |
| UA (1) | UA114650C2 (hr) |
| WO (1) | WO2014066485A1 (hr) |
| ZA (1) | ZA201502684B (hr) |
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|---|---|---|---|---|
| PT1534313E (pt) | 2002-07-30 | 2013-01-25 | Omeros Corp | Soluções e método de irrigação oftalmológica |
| AU2013201465B2 (en) * | 2012-10-24 | 2016-03-03 | Rayner Surgical (Ireland) Limited | Stable preservative-free mydriatic and anti-inflammatory solutions for injection |
| US10993921B2 (en) | 2013-10-03 | 2021-05-04 | Harrow Ip, Llc | Epinephrine-based ophthalmic compositions for intraocular administration and methods for fabricating thereof |
| TWI809304B (zh) * | 2014-12-01 | 2023-07-21 | 奥默羅斯公司 | 用於抑制術後眼睛炎性病況的抗炎和散瞳前房溶液 |
| CN104856990A (zh) * | 2015-05-07 | 2015-08-26 | 武汉武药科技有限公司 | 去氧肾上腺素酮咯酸溶液及制备方法 |
| US11213480B1 (en) * | 2015-08-06 | 2022-01-04 | Hikma Pharmaceuticals International Limited | Phenylephrine hydrochloride ready-to-use solution |
| USD831868S1 (en) | 2015-09-17 | 2018-10-23 | Lume Cube, Inc. | Compact external light |
| US10704745B2 (en) | 2015-10-13 | 2020-07-07 | Lume Cube, Inc. | Mobile light source |
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| JP7078843B2 (ja) * | 2018-03-26 | 2022-06-01 | サミー株式会社 | 遊技機 |
| BR112021007725A2 (pt) * | 2018-10-26 | 2021-07-27 | Ocuphire Pharma, Inc. | métodos e composições para tratamento de presbiopia, midríase e outros distúrbios oculares |
| US11071724B2 (en) | 2019-05-17 | 2021-07-27 | Ocular Science, Inc. | Compositions and methods for treating presbyopia |
| DE102019125430B3 (de) * | 2019-09-20 | 2020-11-19 | Carl Zeiss Meditec Ag | Steuerungsvorrichtung für ein ophthalmochirurgisches System, ophthalmochirurgisches System sowie Computerprogrammprodukt |
| KR20210087352A (ko) | 2020-01-02 | 2021-07-12 | 삼성전자주식회사 | 에어 스페이서를 가지는 반도체 소자 |
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| US11696910B2 (en) | 2021-07-23 | 2023-07-11 | Somerset Therapeutics, Llc | Buffer-free, stable ophthalmological compositions of ketorolac and phenylephrine and applications thereof |
| CN115950992B (zh) * | 2023-03-15 | 2023-06-09 | 苏州朗易生物医药研究有限公司 | 一种去氧肾上腺素酮咯酸溶液中有关物质的检测方法及其应用 |
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