DK2797601T3 - Farmaceutisk sammensætninger til reduktion af komplikationer ved okulær steroid - Google Patents
Farmaceutisk sammensætninger til reduktion af komplikationer ved okulær steroid Download PDFInfo
- Publication number
- DK2797601T3 DK2797601T3 DK13747021.7T DK13747021T DK2797601T3 DK 2797601 T3 DK2797601 T3 DK 2797601T3 DK 13747021 T DK13747021 T DK 13747021T DK 2797601 T3 DK2797601 T3 DK 2797601T3
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- Denmark
- Prior art keywords
- composition
- pharmaceutical composition
- steroid
- ocular
- phospholipids
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- 150000003431 steroids Chemical class 0.000 title claims abstract description 51
- 150000003904 phospholipids Chemical class 0.000 claims abstract description 64
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- 230000000694 effects Effects 0.000 claims abstract description 18
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Classifications
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- 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
- A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/66—Phosphorus compounds
- A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/66—Phosphorus compounds
- A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
- A61K31/685—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
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- A—HUMAN NECESSITIES
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- 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
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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
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- A—HUMAN NECESSITIES
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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- A—HUMAN NECESSITIES
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- 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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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
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- Dispersion Chemistry (AREA)
- Molecular Biology (AREA)
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- Organic Chemistry (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (24)
1. Farmaceutisk sammensætning, der er egnet til okulær afgivelse af et steroid omfattende en kombination af: (a) en lipidkageblanding omfattende et phospholipid eller en blanding af phospholipider; og (b) en steroidopløsning omfattende en virksom mængde af et okulært steroid eller et farmaceutisk acceptabelt salt deraf; hvor den samlede mængde af phospholipider i sammensætningen er ca. 0,1 umol til mindre end ca. 2,5 umol pr. 50 ul farmaceutisk sammensætning, og hvor bivirkningsprofilen af sammensætningen er reduceret i forhold til bivirkningen af sammensætningen med mindst ca. 5 umol phospholipider pr. 50 ul farmaceutisk sammensætning.
2. Farmaceutisk sammensætning ifølge krav 1, hvor lipidkageblandingen yderligere omfatter kolesterol.
3. Farmaceutisk sammensætning ifølge krav 2, hvor molforholdet af kolesterol er 10 % til 33 %.
4. Farmaceutisk sammensætning ifølge krav 1, hvor det okulære steroid er et vandopløseligt steroid.
5. Farmaceutisk sammensætning ifølge krav 4, hvor det okulære steroid er udvalgt fra gruppen bestående af dexamethason-natriumphosphat, dexame-thason, betamethason, betamethason-natriumphosphat og fluocortolon.
6. Farmaceutisk sammensætning ifølge krav 5, hvor dosen af dexamethason-natriumphosphat er ca. 0,6 til ca. 0,7 mg dexamethason.
7. Farmaceutisk sammensætning ifølge krav 1, hvor lipidkageblandingen yderligere omfatter et cryobeskyttende stof.
8. Farmaceutisk sammensætning ifølge krav 7, hvor det cryobeskyttende stof er mannitol.
9. Farmaceutisk sammensætning ifølge krav 1, hvor lipidkageblandingen yderligere omfatter en buffer.
10. Farmaceutisk sammensætning ifølge krav 9, hvor bufferen omfatter monobasisk natriumphosphat-dihydrat og vandfrit dibasisk natriumphosphat.
11. Farmaceutisk sammensætning ifølge krav 1, hvor lipidkageblandingen omfatter DOPC og DOPG.
12. Sammensætning ifølge krav 1 til anvendelse ved behandling af en oftal-misk sygdom.
13. Sammensætning ifølge krav 12, hvor den oftalmiske sygdom er begrænset til det bageste segment af øjet.
14. Sammensætning ifølge krav 13, hvor den oftalmiske sygdom er makulært ødem.
15. Sammensætning ifølge krav 13, hvor den oftalmiske sygdom er uveitis.
16. Sammensætning ifølge krav 13, hvor den oftalmiske sygdom er retinal grenveneokklusion.
17. Sammensætning ifølge krav 13, hvor den oftalmiske sygdom er retinal cen-tralveneokklusion.
18. Sammensætning ifølge krav 13, hvor den oftalmiske sygdom er aldersrelateret makuladegeneration.
19. Sammensætning ifølge krav 12, hvor den farmaceutiske sammensætning indgives ved intravitreal injektion.
20. Sammensætning ifølge krav 12, hvor lipidkageblandingen yderligere omfatter kolesterol.
21. farmaceutisk sammensætning, der er egnet til okulær afgivelse, omfattende: (a) en lipidkageblanding omfattende et phospholipid eller en blanding af phospholipider; og (b) en steroidopløsning omfattende en virksom mængde på ca. 0,6 mg til ca. 0,7 mg dexamethason-natriumphosphat, dexamethason eller et farmaceutisk acceptabelt salt deraf; hvor den samlede mængde af phospholipider i sammensætningen er ca. 0,1 umol til mindre end ca. 2,5 umol pr. 50 ul farmaceutisk sammensætning, og hvor den okulære bivirkning ved sammensætningen er reduceret i forhold til den okulære bivirkning af sammensætningen med mindst ca. 5 umol phospholipider pr. 50 ul farmaceutisk sammensætning.
22. Farmaceutisk sammensætning ifølge krav 21, hvor lipidkageblandingen yderligere omfatter kolesterol.
23. Farmaceutisk sammensætning ifølge krav 21, hvor lipidkageblandingen omfatter mindst en af DOPC og DOPG.
24. Farmaceutisk sammensætning ifølge krav 23, hvor molforholdet mellem DOPC, DOPG og kolesterol er 29,5 % til 90 %:3 % til 37,5 %:10 % til 33 %.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
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| US201261597189P | 2012-02-10 | 2012-02-10 | |
| PCT/US2013/025390 WO2013119988A1 (en) | 2012-02-10 | 2013-02-08 | Pharmaceutical compositions to reduce complications of ocular steroid |
Publications (1)
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| TR (1) | TR201808592T4 (da) |
| TW (1) | TWI620578B (da) |
| WO (1) | WO2013119988A1 (da) |
Families Citing this family (8)
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|---|---|---|---|---|
| SG11201809136UA (en) * | 2016-04-19 | 2018-11-29 | Univ Nanyang Tech | Subconjuctival depot forming formulations for ocular drug delivery |
| WO2019060696A1 (en) | 2017-09-25 | 2019-03-28 | Surface Pharmaceuticals, Inc. | OPTHALMIC PHARMACEUTICAL COMPOSITIONS AND METHODS FOR THE TREATMENT OF OCULAR SURFACE DISEASE |
| US11759472B2 (en) | 2017-11-21 | 2023-09-19 | Cs Pharmaceuticals Limited | Compositions and methods of use for treating aberrant inflammation in peri-ocular secretory glands or at the ocular surface |
| RU2020116802A (ru) * | 2017-11-21 | 2021-11-22 | Аксеровижн, Инк. | Композиции и способы их применения для лечения аберрантного воспаления в периокулярных секреторных железах или на глазной поверхности |
| SG11202100054YA (en) * | 2018-07-09 | 2021-02-25 | Taiwan Liposome Co Ltd | Methods to reduce complications of intra-articular steroid |
| JP2022516099A (ja) * | 2018-12-27 | 2022-02-24 | サーフィス オフサルミクス，インコーポレイテッド | 眼科用医薬組成物及び癌表面疾患の処置方法 |
| RU2716429C1 (ru) * | 2019-05-29 | 2020-03-11 | федеральное государственное автономное учреждение "Национальный медицинский исследовательский центр "Межотраслевой научно-технический комплекс "Микрохирургия глаза" имени академика С.Н. Федорова" Министерства здравоохранения Российской Федерации | Способ лечения рецидивирующей эрозии роговицы различного генеза |
| CN111415822A (zh) * | 2020-03-05 | 2020-07-14 | 沈阳农业大学 | 一种洋葱碳/二氧化锰阵列电极及其制备方法和应用 |
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| US4804539A (en) | 1986-07-28 | 1989-02-14 | Liposome Technology, Inc. | Ophthalmic liposomes |
| SE9100342D0 (sv) | 1991-02-04 | 1991-02-04 | Astra Ab | Novel steroid esters |
| IL103907A0 (en) * | 1992-11-27 | 1993-04-04 | Pharmos Corp | Ophthalmic compositions |
| EP1599183A2 (en) * | 2002-11-26 | 2005-11-30 | Gilead Sciences, Inc. | Method of drug loading in liposomes by gradient |
| MXPA05007730A (es) | 2003-02-04 | 2006-01-31 | Bracco Int Bv | Agentes de contraste para ultrasonido y proceso para la preparacion de los mismos. |
| DK1768657T3 (da) * | 2004-06-23 | 2008-12-01 | Sirion Therapeutics Inc | Fremgangsmåder og sammensætninger til at behandle ophthalmiske tilstande med retinylderivater |
| US7767217B2 (en) * | 2006-03-14 | 2010-08-03 | Foresight Biotherapeutics | Ophthalmic compositions comprising povidone-iodine |
| SI1864668T1 (sl) | 2006-06-01 | 2013-04-30 | Novagali Pharma S.A. | Uporaba predzdravil za okularno intravitrealno dajanje |
| EP2037951A2 (en) * | 2006-06-22 | 2009-03-25 | Sirion Therapeutics, Inc. | Methods and compositions for treating ophthalmic conditions via modulation of megalin activity |
| US20080118500A1 (en) * | 2006-11-16 | 2008-05-22 | Taiwan Liposome Company | Sustained releasing composition via local injection for treating eye diseases |
| CN101959503A (zh) * | 2008-02-29 | 2011-01-26 | 财团法人名古屋产业科学研究所 | 眼后节到达用脂质体和眼后节疾病用医药组合物 |
| CN101502485A (zh) * | 2009-03-20 | 2009-08-12 | 中国药科大学 | 地塞米松眼用纳米立方液晶制剂及其制备方法 |
| CN101926769A (zh) * | 2009-06-24 | 2010-12-29 | 天津金耀集团有限公司 | 地塞米松磷酸钠脂质体注射液 |
| US8956600B2 (en) * | 2009-08-10 | 2015-02-17 | Taiwan Liposome Co. Ltd. | Ophthalmic drug delivery system containing phospholipid and cholesterol |
| RU2595872C2 (ru) | 2010-03-19 | 2016-08-27 | Массачусетс Интитут Оф Текнолоджи | Композиции липидных везикул и способы применения |
| US20130217657A1 (en) * | 2011-12-21 | 2013-08-22 | Insite Vision Incorporated | Combination anti-inflammatory ophthalmic compositions |
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2013
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