RU2017142694A - Водная суспензия, содержащая наночастицы глюкокортикостероида - Google Patents
Водная суспензия, содержащая наночастицы глюкокортикостероида Download PDFInfo
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- RU2017142694A RU2017142694A RU2017142694A RU2017142694A RU2017142694A RU 2017142694 A RU2017142694 A RU 2017142694A RU 2017142694 A RU2017142694 A RU 2017142694A RU 2017142694 A RU2017142694 A RU 2017142694A RU 2017142694 A RU2017142694 A RU 2017142694A
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- 239000007900 aqueous suspension Substances 0.000 title claims 11
- 239000003862 glucocorticoid Substances 0.000 title claims 7
- 239000002105 nanoparticle Substances 0.000 title claims 6
- 239000008194 pharmaceutical composition Substances 0.000 claims 11
- 150000001875 compounds Chemical class 0.000 claims 6
- 208000035473 Communicable disease Diseases 0.000 claims 5
- 208000015181 infectious disease Diseases 0.000 claims 5
- 230000002757 inflammatory effect Effects 0.000 claims 5
- 208000027866 inflammatory disease Diseases 0.000 claims 4
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 3
- -1 diflorazondiatsetata Chemical compound 0.000 claims 3
- 239000006185 dispersion Substances 0.000 claims 3
- 238000002360 preparation method Methods 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- 239000003381 stabilizer Substances 0.000 claims 3
- 239000004034 viscosity adjusting agent Substances 0.000 claims 3
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 2
- 239000004372 Polyvinyl alcohol Substances 0.000 claims 2
- XBDQKXXYIPTUBI-UHFFFAOYSA-M Propionate Chemical compound CCC([O-])=O XBDQKXXYIPTUBI-UHFFFAOYSA-M 0.000 claims 2
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 2
- JYGXADMDTFJGBT-VWUMJDOOSA-N hydrocortisone Chemical compound O=C1CC[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 JYGXADMDTFJGBT-VWUMJDOOSA-N 0.000 claims 2
- 210000004072 lung Anatomy 0.000 claims 2
- 239000002245 particle Substances 0.000 claims 2
- 229920005862 polyol Polymers 0.000 claims 2
- 150000003077 polyols Chemical class 0.000 claims 2
- 229920002451 polyvinyl alcohol Polymers 0.000 claims 2
- 210000002345 respiratory system Anatomy 0.000 claims 2
- 239000000126 substance Substances 0.000 claims 2
- 230000000699 topical effect Effects 0.000 claims 2
- PZNPLUBHRSSFHT-RRHRGVEJSA-N 1-hexadecanoyl-2-octadecanoyl-sn-glycero-3-phosphocholine Chemical class CCCCCCCCCCCCCCCCCC(=O)O[C@@H](COP([O-])(=O)OCC[N+](C)(C)C)COC(=O)CCCCCCCCCCCCCCC PZNPLUBHRSSFHT-RRHRGVEJSA-N 0.000 claims 1
- KUVIULQEHSCUHY-XYWKZLDCSA-N Beclometasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(Cl)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)COC(=O)CC)(OC(=O)CC)[C@@]1(C)C[C@@H]2O KUVIULQEHSCUHY-XYWKZLDCSA-N 0.000 claims 1
- WYQPLTPSGFELIB-JTQPXKBDSA-N Difluprednate Chemical compound C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@]1(F)[C@@H]2[C@@H]2CC[C@@](C(=O)COC(C)=O)(OC(=O)CCC)[C@@]2(C)C[C@@H]1O WYQPLTPSGFELIB-JTQPXKBDSA-N 0.000 claims 1
- WJOHZNCJWYWUJD-IUGZLZTKSA-N Fluocinonide Chemical compound C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@]1(F)[C@@H]2[C@@H]2C[C@H]3OC(C)(C)O[C@@]3(C(=O)COC(=O)C)[C@@]2(C)C[C@@H]1O WJOHZNCJWYWUJD-IUGZLZTKSA-N 0.000 claims 1
- FBRAWBYQGRLCEK-UHFFFAOYSA-N [17-(2-chloroacetyl)-9-fluoro-10,13,16-trimethyl-3,11-dioxo-7,8,12,14,15,16-hexahydro-6h-cyclopenta[a]phenanthren-17-yl] butanoate Chemical compound C1CC2=CC(=O)C=CC2(C)C2(F)C1C1CC(C)C(C(=O)CCl)(OC(=O)CCC)C1(C)CC2=O FBRAWBYQGRLCEK-UHFFFAOYSA-N 0.000 claims 1
- 229960004543 anhydrous citric acid Drugs 0.000 claims 1
- 229950000210 beclometasone dipropionate Drugs 0.000 claims 1
- 229960004311 betamethasone valerate Drugs 0.000 claims 1
- SNHRLVCMMWUAJD-SUYDQAKGSA-N betamethasone valerate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)CO)(OC(=O)CCCC)[C@@]1(C)C[C@@H]2O SNHRLVCMMWUAJD-SUYDQAKGSA-N 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 229960004703 clobetasol propionate Drugs 0.000 claims 1
- CBGUOGMQLZIXBE-XGQKBEPLSA-N clobetasol propionate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)CCl)(OC(=O)CC)[C@@]1(C)C[C@@H]2O CBGUOGMQLZIXBE-XGQKBEPLSA-N 0.000 claims 1
- 229960005465 clobetasone butyrate Drugs 0.000 claims 1
- BMCQMVFGOVHVNG-TUFAYURCSA-N cortisol 17-butyrate Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(=O)CO)(OC(=O)CCC)[C@@]1(C)C[C@@H]2O BMCQMVFGOVHVNG-TUFAYURCSA-N 0.000 claims 1
- UREBDLICKHMUKA-CXSFZGCWSA-N dexamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-CXSFZGCWSA-N 0.000 claims 1
- 229960004875 difluprednate Drugs 0.000 claims 1
- 239000003221 ear drop Substances 0.000 claims 1
- 229940047652 ear drops Drugs 0.000 claims 1
- 239000003889 eye drop Substances 0.000 claims 1
- 229940012356 eye drops Drugs 0.000 claims 1
- 229960001347 fluocinolone acetonide Drugs 0.000 claims 1
- FEBLZLNTKCEFIT-VSXGLTOVSA-N fluocinolone acetonide Chemical compound C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@]1(F)[C@@H]2[C@@H]2C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]2(C)C[C@@H]1O FEBLZLNTKCEFIT-VSXGLTOVSA-N 0.000 claims 1
- 229960000785 fluocinonide Drugs 0.000 claims 1
- 229960000890 hydrocortisone Drugs 0.000 claims 1
- 229960001524 hydrocortisone butyrate Drugs 0.000 claims 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 claims 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 229920000609 methyl cellulose Polymers 0.000 claims 1
- 239000001923 methylcellulose Substances 0.000 claims 1
- 239000003607 modifier Substances 0.000 claims 1
- 239000007923 nasal drop Substances 0.000 claims 1
- 229940100662 nasal drops Drugs 0.000 claims 1
- 210000000056 organ Anatomy 0.000 claims 1
- 238000007911 parenteral administration Methods 0.000 claims 1
- 229920002503 polyoxyethylene-polyoxypropylene Polymers 0.000 claims 1
- 229960005205 prednisolone Drugs 0.000 claims 1
- OIGNJSKKLXVSLS-VWUMJDOOSA-N prednisolone Chemical compound O=C1C=C[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 OIGNJSKKLXVSLS-VWUMJDOOSA-N 0.000 claims 1
- 230000000069 prophylactic effect Effects 0.000 claims 1
- 239000000243 solution Substances 0.000 claims 1
- 230000009885 systemic effect Effects 0.000 claims 1
- 230000001225 therapeutic effect Effects 0.000 claims 1
- 229960002117 triamcinolone acetonide Drugs 0.000 claims 1
- YNDXUCZADRHECN-JNQJZLCISA-N triamcinolone acetonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O YNDXUCZADRHECN-JNQJZLCISA-N 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
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- 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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Claims (21)
1. Водная суспензия, содержащая наночастицы глюкокортикостероидного соединения.
2. Водная суспензия по п. 1, где средний диаметр частиц для наночастиц составляет 300 нм и менее, а диаметр частиц D90 для наночастиц составляет 450 нм и менее.
3. Водная суспензия по п. 1 или 2, где наночастицы производят в результате смешивания глюкокортикостероидного соединения, физиологически приемлемой соли, физиологически приемлемого полиола и модификатора поверхности.
4. Водная суспензия по любому одному из пп. 1-3, где глюкокортикостероидное соединение представляет собой одно или несколько веществ, выбираемых из клобетазолпропионата, дифлоразондиацетата, дексаметазонпропионата, дифлупредната, мометазонфуроата, дифлукортолонвалерата, бетаметазонбутирата-пропионата, флуоцинонида, гидрокортизонбутирата-пропионата, беклометазондипропионата, депродонпропионата, бетаметазонвалерата, дексаметазонвалерата, преднизолонвалерата-ацетата, флуоцинолонацетонида, гидрокортизонбутирата, клобетазонбутирата, алклометазондипропионата, триамцинолонацетонида, флуметазонпивалата, преднизолона и гидрокортизона.
5. Водная суспензия по любому одному из пп. 1-4, содержащая, кроме того, стабилизатор дисперсии.
6. Водная суспензия по п. 5, где стабилизатор дисперсии представляет собой полиоксиэтиленполиоксипропиленгликоль и/или поливиниловый спирт.
7. Водная суспензия по любому одному из пп. 1-6, содержащая, кроме того, модификатор вязкости.
8. Водная суспензия по п. 7, где модификатор вязкости представляет собой одно или несколько веществ, выбираемых из метилцеллюлозы, гидроксипропилметилцеллюлозы и поливинилового спирта.
9. Водная суспензия по п. 7 или 8, содержащая от 1 до 10 мг/мл модификатора вязкости.
10. Фармацевтическая композиция, содержащая водную суспензию по любому одному из пп. 1-9.
11. Фармацевтическая композиция по п. 10, предназначенная для парентерального введения.
12. Фармацевтическая композиция по п. 11, которая предназначена для инъекционного раствора или для препарата местного применения.
13. Фармацевтическая композиция по п. 12, которая предназначена для препарата местного применения для глаза, уха, носа или легкого.
14. Фармацевтическая композиция по п. 13, которая представляет собой капли для глаз, капли для ушей, капли для носа или ингаляционный препарат.
15. Фармацевтическая композиция по любому одному из пп. 10-14, которое представляет собой лечебное средство или профилактическое средство для воспалительного или инфекционного заболевания.
16. Фармацевтическая композиция по п. 15, где воспалительное или инфекционное заболевание является системным воспалительным или инфекционным заболеванием.
17. Фармацевтическая композиция по п. 15, где воспалительное или инфекционное заболевание является местным воспалительным или инфекционным заболеванием.
18. Фармацевтическая композиция по п. 17, где областью местного применения являются один или несколько представителей, выбираемых из тканей или органов, выбираемых из глаза, уха, носа (верхние дыхательные пути) и легкого (нижние дыхательные пути).
19. Набор для получения фармацевтической композиции по любому одному из пп. 10-18, содержащей наночастицы глюкокортикостероидного соединения.
20. Способ изготовления фармацевтической композиции по любому одному из пп. 10-18, включающий смешивание глюкокортикостероидного соединения, физиологически приемлемой соли, физиологически приемлемого полиола и/или воды и стабилизатора дисперсии.
21. Способ по п. 20, включающий смешивание глюкокортикостероидного соединения, физиологически приемлемой соли, глицерина, безводной лимонной кислоты и гидрогенизированного соевого лецитина.
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| MX2019011603A (es) * | 2017-03-26 | 2021-08-16 | Robyn Vivi Stafford | Metodo de tratamiento de las condiciones de la piel de los parpados. |
| JP7065895B2 (ja) * | 2017-06-23 | 2022-05-12 | ラボラトリオス・サルバト・ソシエダッド・アノニマ | クロベタゾールの水中油型ナノエマルジョン組成物 |
| WO2019060696A1 (en) | 2017-09-25 | 2019-03-28 | Surface Pharmaceuticals, Inc. | OPTHALMIC PHARMACEUTICAL COMPOSITIONS AND METHODS FOR THE TREATMENT OF OCULAR SURFACE DISEASE |
| CN113473970A (zh) | 2018-12-27 | 2021-10-01 | 瑟菲斯眼科股份有限公司 | 用以治疗眼表疾病的眼科药物组合物和方法 |
| US11197820B2 (en) * | 2019-04-30 | 2021-12-14 | The Medical College Of Wisconsin, Inc. | Trans-tympanic membrane delivery platform and uses thereof |
| ES2905793T3 (es) | 2019-07-23 | 2022-04-12 | Nicox Ophthalmics Inc | Procedimiento para la preparación de suspensiones acuosas estériles oftálmicas de nanocristales de propionato de fluticasona de Forma A |
| CN112656760B (zh) * | 2019-09-27 | 2022-04-12 | 武汉科福新药有限责任公司 | 一种二氟泼尼酯混悬滴眼液及其制备方法 |
| JP7641566B2 (ja) * | 2021-04-21 | 2025-03-07 | 学校法人近畿大学 | 超微細化水難溶性薬物及び水溶性薬物を含む点眼剤並びにその製造方法及び使用方法 |
| WO2022240598A1 (en) | 2021-05-10 | 2022-11-17 | Surface Ophthalmics, Inc. | Use of chondroitin sulfate for relieving ocular pain |
| US12440510B2 (en) | 2021-05-10 | 2025-10-14 | Surface Ophthalmics, Inc. | Use of chondroitin sulfate for relieving ocular pain |
| KR102653853B1 (ko) * | 2021-06-21 | 2024-04-01 | 가톨릭대학교 산학협력단 | 약물 전달용 나노서스펜션 및 이의 용도 |
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| CN116077669B (zh) * | 2022-12-15 | 2024-11-15 | 中南大学湘雅医院 | 用于治疗关节痛的糖皮质激素纳米脂质载体、制法及应用 |
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| ZA966579B (en) | 1995-08-04 | 1998-02-02 | Wakamoto Pharma Co Ltd | O/W emulsion composition for eye drops. |
| US6274634B1 (en) | 1997-05-14 | 2001-08-14 | Senju Pharmaceutical Co., Ltd. | Aqueous suspension preparations with excellent redispersibility |
| JP4167463B2 (ja) * | 1997-05-14 | 2008-10-15 | 千寿製薬株式会社 | 再分散性の良い水性懸濁液剤 |
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| EP2283864A1 (en) * | 2002-07-16 | 2011-02-16 | Elan Pharma International Ltd. | Liquid dosage compositions fo stable nanoparticulate active agents |
| US20070178051A1 (en) | 2006-01-27 | 2007-08-02 | Elan Pharma International, Ltd. | Sterilized nanoparticulate glucocorticosteroid formulations |
| WO2008066899A2 (en) | 2006-11-28 | 2008-06-05 | Marinus Pharmaceuticals | Nanoparticulate formulations and methods for the making and use thereof |
| TWI405590B (zh) * | 2007-04-06 | 2013-08-21 | 活效製藥股份有限公司 | 微粉碎化有機化合物粒子之製法 |
| WO2009139924A2 (en) | 2008-05-14 | 2009-11-19 | Otonomy, Inc. | Controlled release corticosteroid compositions and methods for the treatment of otic disorders |
| MX2011002847A (es) * | 2008-09-19 | 2011-04-07 | Activus Pharma Co Ltd | Polvo de compuesto organico combinado para uso medico y metodo de produccion y suspension del mismo. |
| WO2012051426A2 (en) * | 2010-10-15 | 2012-04-19 | Glaxo Group Limited | Aggregate nanoparticulate medicament formulations, manufacture and use thereof |
| KR20140031227A (ko) * | 2011-03-24 | 2014-03-12 | 레오 파마 에이/에스 | 지질 나노입자들 및 코르티코스테로이드 또는 비타민 ｄ 유도체를 포함하는 조성물 |
| PL2848243T3 (pl) | 2012-05-11 | 2024-04-08 | Activus Pharma Co., Ltd. | Nanoproszek związku organicznego, sposób wytwarzania i zawiesina |
| KR102467714B1 (ko) * | 2012-11-08 | 2022-11-16 | 클리어사이드 바이오메디컬, 인코포레이드 | 인간 대상체에서 안구 질병을 치료하기 위한 방법 및 장치 |
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