HRP20220793T1 - Oftalmološki vodeni sastav - Google Patents
Oftalmološki vodeni sastav Download PDFInfo
- Publication number
- HRP20220793T1 HRP20220793T1 HRP20220793TT HRP20220793T HRP20220793T1 HR P20220793 T1 HRP20220793 T1 HR P20220793T1 HR P20220793T T HRP20220793T T HR P20220793TT HR P20220793 T HRP20220793 T HR P20220793T HR P20220793 T1 HRP20220793 T1 HR P20220793T1
- Authority
- HR
- Croatia
- Prior art keywords
- aqueous composition
- ophthalmic aqueous
- composition according
- salt
- ophthalmic
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 21
- 239000007951 isotonicity adjuster Substances 0.000 claims 8
- 229960004833 dexamethasone phosphate Drugs 0.000 claims 4
- -1 dexamethasone phosphate ester Chemical class 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 3
- 230000003204 osmotic effect Effects 0.000 claims 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 2
- GSDSWSVVBLHKDQ-JTQLQIEISA-N Levofloxacin Chemical compound C([C@@H](N1C2=C(C(C(C(O)=O)=C1)=O)C=C1F)C)OC2=C1N1CCN(C)CC1 GSDSWSVVBLHKDQ-JTQLQIEISA-N 0.000 claims 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 2
- 229960000686 benzalkonium chloride Drugs 0.000 claims 2
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 claims 2
- 229910017053 inorganic salt Inorganic materials 0.000 claims 2
- 229960003376 levofloxacin Drugs 0.000 claims 2
- 239000000243 solution Substances 0.000 claims 2
- 239000012453 solvate Substances 0.000 claims 2
- 150000005846 sugar alcohols Chemical group 0.000 claims 2
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 229910021538 borax Inorganic materials 0.000 claims 1
- 239000004327 boric acid Substances 0.000 claims 1
- 125000005619 boric acid group Chemical group 0.000 claims 1
- 239000003889 eye drop Substances 0.000 claims 1
- 229940012356 eye drops Drugs 0.000 claims 1
- 235000011187 glycerol Nutrition 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- 239000004328 sodium tetraborate Substances 0.000 claims 1
- 235000010339 sodium tetraborate Nutrition 0.000 claims 1
Classifications
-
- 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
- A61K31/66—Phosphorus compounds
- A61K31/661—Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion or mevinphos
-
- 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
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
-
- 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
- A61K31/535—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 oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
- A61K31/538—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with carbocyclic ring systems
-
- 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
- A61K31/535—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 oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
- A61K31/5383—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
-
- 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
- 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
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07J—STEROIDS
- C07J5/00—Normal steroids containing carbon, hydrogen, halogen or oxygen, substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane and substituted in position 21 by only one singly bound oxygen atom, i.e. only one oxygen bound to position 21 by a single bond
- C07J5/0046—Normal steroids containing carbon, hydrogen, halogen or oxygen, substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane and substituted in position 21 by only one singly bound oxygen atom, i.e. only one oxygen bound to position 21 by a single bond substituted in position 17 alfa
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C31/00—Saturated compounds having hydroxy or O-metal groups bound to acyclic carbon atoms
- C07C31/18—Polyhydroxylic acyclic alcohols
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G65/00—Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Ophthalmology & Optometry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Inorganic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (12)
1. Oftalmološki vodeni sastav koji sadrži levofloksacin, njegovu sol, ili njegov solvat; fosfatni ester deksametazona, ili sol fosfatnog estera deksametazona; jedno ili barem dva izotonična sredstva; i benzalkonijev klorid, gdje oftalmološki vodeni sastav ima sadržaj natrijevog klorida od 0.5% (mas/v) ili manji, i gdje oftalmološki vodeni sastav ima pH od 6.5 do 8.8.
2. Oftalmološki vodeni sastav prema zahtjevu 1, gdje oftalmološki vodeni sastav dalje sadrži pufer i/ili regulator pH.
3. Oftalmološki vodeni sastav prema zahtjevu 1 ili 2, gdje oftalmološki vodeni sastav ima odnos osmotskog tlaka sastava prema fiziološkoj otopini od 1.2 ili niži.
4. Oftalmološki vodeni sastav prema zahtjevu 1 ili 2, koji sadrži izotonični agens u takvoj koncentraciji da se podesi osmotski tlak oftalmološkog vodenog sastava u raspon 60 do 340 mOsm.
5. Oftalmološki vodeni sastav prema zahtjevu 1, gdje su izotonični agensi neionski izotonični agensi ili ionski izotonični agensi.
6. Oftalmološki vodeni sastav prema zahtjevu 5, gdje je neionski izotonični agens šećerni alkohol.
7. Oftalmološki vodeni sastav prema zahtjevu 6, gdje je šećerni alkohol jedan ili barem dva izabrana iz grupe koju čine glicerin, propilen glikol, i polietilen glikol.
8. Oftalmološki vodeni sastav prema zahtjevu 5, gdje je ionski izotonični agens izabran iz grupe koju čine neorganske soli i organske soli.
9. Oftalmološki vodeni sastav prema zahtjevu 5, gdje je ionski izotonični agens neorganska sol.
10. Oftalmološki vodeni sastav prema zahtjevu 9, gdje je neorganska sol borna kiselina ili boraks.
11. Oftalmološki vodeni sastav prema zahtjevu 1, gdje je koncentracija levofloksacina, njegove soli, ili njegovog solvata 0.5% do 1.5% (mas/v); koncentracija fosfatnog estera deksametazona, ili sol fosfatnog estera deksametazona je 0.025% do 0.2% (mas/v); koncentracija benzalkonijevog klorida je 0.001% do 0.02% (mas/v); i oftalmološki vodeni sastav ima odnos osmotskog tlaka sastava prema fiziološkoj otopini od 0.3 do 1.2.
12. Oftalmološki vodeni sastav prema bilo kojem od zahtjeva 1 do 11, koja je u obliku kapi za oči.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2014227039 | 2014-11-07 | ||
| EP15857116.6A EP3216451B1 (en) | 2014-11-07 | 2015-11-05 | Ophthalmic aqueous composition |
| PCT/JP2015/081121 WO2016072440A1 (ja) | 2014-11-07 | 2015-11-05 | 眼科用水性組成物 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20220793T1 true HRP20220793T1 (hr) | 2022-09-16 |
Family
ID=55909164
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20220793TT HRP20220793T1 (hr) | 2014-11-07 | 2015-11-05 | Oftalmološki vodeni sastav |
Country Status (14)
| Country | Link |
|---|---|
| US (2) | US10758554B2 (hr) |
| EP (2) | EP3216451B1 (hr) |
| JP (1) | JP6683622B2 (hr) |
| KR (1) | KR20170080666A (hr) |
| CN (2) | CN115381840A (hr) |
| DK (1) | DK3216451T3 (hr) |
| ES (1) | ES2912327T3 (hr) |
| HR (1) | HRP20220793T1 (hr) |
| HU (1) | HUE059052T2 (hr) |
| LT (1) | LT3216451T (hr) |
| PL (1) | PL3216451T3 (hr) |
| RS (1) | RS63304B1 (hr) |
| SI (1) | SI3216451T1 (hr) |
| WO (1) | WO2016072440A1 (hr) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3216451B1 (en) * | 2014-11-07 | 2022-04-13 | Santen Pharmaceutical Co., Ltd. | Ophthalmic aqueous composition |
| CN109316445A (zh) * | 2018-11-15 | 2019-02-12 | 塔里木大学 | 一种用于牛、羊眼部疾病的喷剂 |
| IT201900003529A1 (it) * | 2019-03-11 | 2020-09-11 | Ntc S R L | Riduzione della posologia antibiotica in composizioni antibiotico/antinfiammatorio in associazione tra loro per uso oftalmico |
| IT201900005280A1 (it) * | 2019-04-05 | 2020-10-05 | Ntc S R L | Composizione otologica |
| CN112649531A (zh) * | 2020-12-18 | 2021-04-13 | 西安国康瑞金制药有限公司 | 地塞米松磷酸钠生产过程中酯化阶段反应液中地塞米松的检测方法 |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ZA864518B (en) | 1985-06-20 | 1987-03-25 | Daiichi Seiyaku Co | Optically active pyridobenzoxazine derivatives and intermediates thereof |
| JPH0747592B2 (ja) | 1985-06-20 | 1995-05-24 | 第一製薬株式会社 | ピリドベンゾオキサジン誘導体 |
| US5540930A (en) * | 1993-10-25 | 1996-07-30 | Pharmos Corporation | Suspension of loteprednol etabonate for ear, eye, or nose treatment |
| US20010049366A1 (en) * | 2000-02-09 | 2001-12-06 | Alcon Universal Ltd. | Topical solution formulations containing an antibiotic and a corticosteroid |
| US20050009836A1 (en) | 2003-06-26 | 2005-01-13 | Laskar Paul A. | Ophthalmic composition containing quinolones and method of use |
| CN101199855A (zh) * | 2006-12-13 | 2008-06-18 | 天津药业研究院有限公司 | 皮质激素包合物水溶液及其应用 |
| JP5624281B2 (ja) * | 2009-04-21 | 2014-11-12 | 東亜薬品株式会社 | 光安定性に優れたキノロン系抗菌薬含有液体製剤 |
| SK7084Y1 (sk) * | 2014-06-30 | 2015-04-01 | Unimed Pharma Spol Sro | Oftalmologický prípravok na báze širokospektrálneho antibiotika a glukokortikoidu |
| EP3216451B1 (en) * | 2014-11-07 | 2022-04-13 | Santen Pharmaceutical Co., Ltd. | Ophthalmic aqueous composition |
-
2015
- 2015-11-05 EP EP15857116.6A patent/EP3216451B1/en active Active
- 2015-11-05 CN CN202211059648.7A patent/CN115381840A/zh active Pending
- 2015-11-05 HR HRP20220793TT patent/HRP20220793T1/hr unknown
- 2015-11-05 KR KR1020177015148A patent/KR20170080666A/ko not_active IP Right Cessation
- 2015-11-05 DK DK15857116.6T patent/DK3216451T3/da active
- 2015-11-05 US US15/523,970 patent/US10758554B2/en active Active
- 2015-11-05 LT LTEPPCT/JP2015/081121T patent/LT3216451T/lt unknown
- 2015-11-05 WO PCT/JP2015/081121 patent/WO2016072440A1/ja active Application Filing
- 2015-11-05 CN CN201580060296.9A patent/CN107073008A/zh active Pending
- 2015-11-05 EP EP22158818.9A patent/EP4026537A1/en active Pending
- 2015-11-05 ES ES15857116T patent/ES2912327T3/es active Active
- 2015-11-05 RS RS20220571A patent/RS63304B1/sr unknown
- 2015-11-05 HU HUE15857116A patent/HUE059052T2/hu unknown
- 2015-11-05 SI SI201531845T patent/SI3216451T1/sl unknown
- 2015-11-05 JP JP2016557790A patent/JP6683622B2/ja active Active
- 2015-11-05 PL PL15857116.6T patent/PL3216451T3/pl unknown
-
2020
- 2020-07-24 US US16/937,792 patent/US11439652B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| JPWO2016072440A1 (ja) | 2017-09-28 |
| HUE059052T2 (hu) | 2022-10-28 |
| US20170340644A1 (en) | 2017-11-30 |
| US10758554B2 (en) | 2020-09-01 |
| KR20170080666A (ko) | 2017-07-10 |
| CN115381840A (zh) | 2022-11-25 |
| WO2016072440A1 (ja) | 2016-05-12 |
| PL3216451T3 (pl) | 2022-08-08 |
| LT3216451T (lt) | 2022-06-27 |
| JP6683622B2 (ja) | 2020-04-22 |
| DK3216451T3 (da) | 2022-05-23 |
| CN107073008A (zh) | 2017-08-18 |
| EP3216451B1 (en) | 2022-04-13 |
| US20200352964A1 (en) | 2020-11-12 |
| EP4026537A1 (en) | 2022-07-13 |
| ES2912327T3 (es) | 2022-05-25 |
| EP3216451A4 (en) | 2018-06-13 |
| RS63304B1 (sr) | 2022-07-29 |
| SI3216451T1 (sl) | 2022-08-31 |
| EP3216451A1 (en) | 2017-09-13 |
| US11439652B2 (en) | 2022-09-13 |
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