JP2016510329A5 - - Google Patents
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- Publication number
- JP2016510329A5 JP2016510329A5 JP2015553933A JP2015553933A JP2016510329A5 JP 2016510329 A5 JP2016510329 A5 JP 2016510329A5 JP 2015553933 A JP2015553933 A JP 2015553933A JP 2015553933 A JP2015553933 A JP 2015553933A JP 2016510329 A5 JP2016510329 A5 JP 2016510329A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- aqueous pharmaceutical
- corticosteroid
- thickener
- acetate
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000008194 pharmaceutical composition Substances 0.000 claims description 54
- 239000003246 corticosteroid Substances 0.000 claims description 42
- 239000002562 thickening agent Substances 0.000 claims description 21
- 229920002385 Sodium hyaluronate Polymers 0.000 claims description 11
- 229940010747 sodium hyaluronate Drugs 0.000 claims description 11
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical group [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 claims description 11
- FQISKWAFAHGMGT-SGJOWKDISA-M Methylprednisolone sodium succinate Chemical compound [Na+].C([C@@]12C)=CC(=O)C=C1[C@@H](C)C[C@@H]1[C@@H]2[C@@H](O)C[C@]2(C)[C@@](O)(C(=O)COC(=O)CCC([O-])=O)CC[C@H]21 FQISKWAFAHGMGT-SGJOWKDISA-M 0.000 claims description 10
- 206010061218 Inflammation Diseases 0.000 claims description 8
- 229960001334 corticosteroids Drugs 0.000 claims description 8
- 230000004054 inflammatory process Effects 0.000 claims description 8
- 229960005294 triamcinolone Drugs 0.000 claims description 8
- GFNANZIMVAIWHM-OBYCQNJPSA-N triamcinolone Chemical compound O=C1C=C[C@]2(C)[C@@]3(F)[C@@H](O)C[C@](C)([C@@]([C@H](O)C4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 GFNANZIMVAIWHM-OBYCQNJPSA-N 0.000 claims description 8
- FPVRUILUEYSIMD-RPRRAYFGSA-N [(8s,9r,10s,11s,13s,14s,16r,17r)-9-fluoro-11-hydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] acetate 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(C)=O)[C@@]1(C)C[C@@H]2O FPVRUILUEYSIMD-RPRRAYFGSA-N 0.000 claims description 7
- 229960003657 dexamethasone acetate Drugs 0.000 claims description 7
- PLCQGRYPOISRTQ-FCJDYXGNSA-L dexamethasone sodium phosphate Chemical compound [Na+].[Na+].C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)COP([O-])([O-])=O)(O)[C@@]1(C)C[C@@H]2O PLCQGRYPOISRTQ-FCJDYXGNSA-L 0.000 claims description 7
- 150000002148 esters Chemical class 0.000 claims description 7
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims description 5
- LRJOMUJRLNCICJ-JZYPGELDSA-N Prednisolone acetate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(=O)COC(=O)C)(O)[C@@]1(C)C[C@@H]2O LRJOMUJRLNCICJ-JZYPGELDSA-N 0.000 claims description 5
- 230000003444 anaesthetic effect Effects 0.000 claims description 5
- 229960003957 dexamethasone Drugs 0.000 claims description 5
- 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 description 5
- 229960002344 dexamethasone sodium phosphate Drugs 0.000 claims description 5
- 229920002674 hyaluronan Polymers 0.000 claims description 5
- 229960003160 hyaluronic acid Drugs 0.000 claims description 5
- 229960004584 methylprednisolone Drugs 0.000 claims description 5
- 229960001293 methylprednisolone acetate Drugs 0.000 claims description 5
- PLBHSZGDDKCEHR-LFYFAGGJSA-N methylprednisolone acetate Chemical compound C([C@@]12C)=CC(=O)C=C1[C@@H](C)C[C@@H]1[C@@H]2[C@@H](O)C[C@]2(C)[C@@](O)(C(=O)COC(C)=O)CC[C@H]21 PLBHSZGDDKCEHR-LFYFAGGJSA-N 0.000 claims description 5
- 229960005205 prednisolone Drugs 0.000 claims description 5
- 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 description 5
- 229960002800 prednisolone acetate Drugs 0.000 claims description 5
- 239000003755 preservative agent Substances 0.000 claims description 5
- 230000002335 preservative effect Effects 0.000 claims description 5
- 150000003839 salts Chemical class 0.000 claims description 5
- VOBDXTSTTMAKHK-VHDCPBDGSA-N 3870-07-3 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)COC(=O)C)[C@@]1(C)C[C@@H]2O VOBDXTSTTMAKHK-VHDCPBDGSA-N 0.000 claims description 4
- 239000000203 mixture Substances 0.000 claims description 4
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 3
- 229960000334 methylprednisolone sodium succinate Drugs 0.000 claims description 3
- 239000002245 particle Substances 0.000 claims description 3
- 229950004597 prednisolone succinate Drugs 0.000 claims description 3
- APGDTXUMTIZLCJ-CGVGKPPMSA-N prednisolone succinate Chemical compound O=C1C=C[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)COC(=O)CCC(O)=O)[C@@H]4[C@@H]3CCC2=C1 APGDTXUMTIZLCJ-CGVGKPPMSA-N 0.000 claims description 3
- 229910052708 sodium Inorganic materials 0.000 claims description 3
- 239000011734 sodium Substances 0.000 claims description 3
- 229960002117 triamcinolone acetonide Drugs 0.000 claims description 3
- 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 description 3
- 229960002537 betamethasone Drugs 0.000 claims description 2
- UREBDLICKHMUKA-DVTGEIKXSA-N betamethasone 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-DVTGEIKXSA-N 0.000 claims description 2
- AKUJBENLRBOFTD-QZIXMDIESA-N betamethasone acetate 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)COC(C)=O)(O)[C@@]1(C)C[C@@H]2O AKUJBENLRBOFTD-QZIXMDIESA-N 0.000 claims description 2
- 229960004648 betamethasone acetate Drugs 0.000 claims description 2
- 229960005354 betamethasone sodium phosphate Drugs 0.000 claims description 2
- PLCQGRYPOISRTQ-LWCNAHDDSA-L betamethasone sodium phosphate Chemical compound [Na+].[Na+].C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)COP([O-])([O-])=O)(O)[C@@]1(C)C[C@@H]2O PLCQGRYPOISRTQ-LWCNAHDDSA-L 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 150000003431 steroids Chemical class 0.000 claims description 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 3
- 239000003814 drug Substances 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 229940083542 sodium Drugs 0.000 claims 1
- 229940074404 sodium succinate Drugs 0.000 claims 1
- ZDQYSKICYIVCPN-UHFFFAOYSA-L sodium succinate (anhydrous) Chemical compound [Na+].[Na+].[O-]C(=O)CCC([O-])=O ZDQYSKICYIVCPN-UHFFFAOYSA-L 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 238000000034 method Methods 0.000 description 13
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 6
- 238000009472 formulation Methods 0.000 description 3
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 description 2
- 239000004354 Hydroxyethyl cellulose Substances 0.000 description 2
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 2
- 235000011187 glycerol Nutrition 0.000 description 2
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 description 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 2
- 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 description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 2
- 239000002253 acid Substances 0.000 description 1
- FKKAEMQFOIDZNY-CODXZCKSSA-M prednisolone sodium succinate Chemical compound [Na+].O=C1C=C[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)COC(=O)CCC([O-])=O)[C@@H]4[C@@H]3CCC2=C1 FKKAEMQFOIDZNY-CODXZCKSSA-M 0.000 description 1
- 229960002176 prednisolone sodium succinate Drugs 0.000 description 1
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361755723P | 2013-01-23 | 2013-01-23 | |
| US61/755,723 | 2013-01-23 | ||
| US201361776617P | 2013-03-11 | 2013-03-11 | |
| US61/776,617 | 2013-03-11 | ||
| PCT/US2014/012824 WO2014116876A1 (en) | 2013-01-23 | 2014-01-23 | Pharmaceutical formulation comprising an insoluble corticosteroid and a soluble corticosteroid |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2016510329A JP2016510329A (ja) | 2016-04-07 |
| JP2016510329A5 true JP2016510329A5 (enExample) | 2017-02-09 |
| JP6215354B2 JP6215354B2 (ja) | 2017-10-18 |
Family
ID=50097866
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015553933A Active JP6215354B2 (ja) | 2013-01-23 | 2014-01-23 | 不溶性コルチコステロイドおよび可溶性コルチコステロイドを含む医薬処方物 |
Country Status (13)
| Country | Link |
|---|---|
| US (4) | US9833460B2 (enExample) |
| EP (1) | EP2948182B1 (enExample) |
| JP (1) | JP6215354B2 (enExample) |
| KR (1) | KR102055937B1 (enExample) |
| CN (1) | CN105073138B (enExample) |
| AU (2) | AU2014209346B2 (enExample) |
| BR (1) | BR112015017246B1 (enExample) |
| CA (1) | CA2897467C (enExample) |
| IL (1) | IL239791B (enExample) |
| MX (1) | MX366654B (enExample) |
| NZ (1) | NZ709620A (enExample) |
| TW (1) | TWI624262B (enExample) |
| WO (1) | WO2014116876A1 (enExample) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BRPI0610308A8 (pt) | 2005-05-26 | 2017-04-25 | Neuron Systems Inc | Composições e métodos para o tratamento de doença retinal |
| US9814701B2 (en) | 2009-12-11 | 2017-11-14 | Aldeyra Therapeutics, Inc. | Compositions and methods for the treatment of macular degeneration |
| JP6215354B2 (ja) | 2013-01-23 | 2017-10-18 | セムヌール ファーマシューティカルズ， インコーポレイテッド | 不溶性コルチコステロイドおよび可溶性コルチコステロイドを含む医薬処方物 |
| CN105120866B (zh) | 2013-01-23 | 2020-02-14 | 奥尔德拉医疗公司 | 与毒性醛相关的疾病和治疗 |
| TWI772659B (zh) * | 2015-01-21 | 2022-08-01 | 美商桑紐爾製藥公司 | 醫藥配方 |
| US11857554B2 (en) | 2015-06-02 | 2024-01-02 | Intravital Pty Ltd. | Drug delivery device with pre-assembled cartridge |
| WO2017035077A1 (en) | 2015-08-21 | 2017-03-02 | Aldeyra Therapeutics, Inc. | Deuterated compounds and uses thereof |
| CA3022665A1 (en) | 2016-05-09 | 2017-11-16 | Aldeyra Therapeutics, Inc. | Combination treatment of ocular inflammatory disorders and diseases |
| CN111356451A (zh) | 2017-10-10 | 2020-06-30 | 奥尔德拉医疗公司 | 炎性病症的治疗 |
| US12006298B2 (en) | 2018-08-06 | 2024-06-11 | Aldeyra Therapeutics, Inc. | Polymorphic compounds and uses thereof |
| JP2022511030A (ja) * | 2018-12-05 | 2022-01-28 | アルデイラ セラピューティクス， インコーポレイテッド | 注射可能な製剤 |
| CA3137301A1 (en) | 2019-05-02 | 2020-11-05 | Aldeyra Therapeutics, Inc. | Polymorphic compounds and uses thereof |
| US12098132B2 (en) | 2019-05-02 | 2024-09-24 | Aldeyra Therapeutics, Inc. | Process for preparation of aldehyde scavenger and intermediates |
| US11382863B2 (en) * | 2020-03-04 | 2022-07-12 | Somerset Therapeutics Llc | Injectable suspension comprising an insoluble corticosteroid and a soluble corticosteroid |
| EP4149470A4 (en) | 2020-05-13 | 2024-04-24 | Aldeyra Therapeutics, Inc. | Pharmaceutical formulations and uses thereof |
| CA3199093A1 (en) * | 2020-10-22 | 2022-04-28 | Pfizer Inc. | Peg-free aqueous suspensions for parenteral administration of a corticosteroid |
| WO2024159191A1 (en) * | 2023-01-26 | 2024-08-02 | Insignia Pharmaceuticals, Llc | Pharmaceutical compositions for treating osteoarthritis |
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| RU2459615C1 (ru) | 2011-03-05 | 2012-08-27 | Илья Александрович Марков | Глазные капли для лечения болезни сухого глаза |
| MX2014006056A (es) | 2011-12-06 | 2014-08-08 | Alcon Res Ltd | Composicion de gel de celulosa con una mejor estabilidad de la viscosidad. |
| US20130165419A1 (en) | 2011-12-21 | 2013-06-27 | Insite Vision Incorporated | Combination anti-inflammatory ophthalmic compositions |
| JP6215354B2 (ja) | 2013-01-23 | 2017-10-18 | セムヌール ファーマシューティカルズ， インコーポレイテッド | 不溶性コルチコステロイドおよび可溶性コルチコステロイドを含む医薬処方物 |
| TWI772659B (zh) | 2015-01-21 | 2022-08-01 | 美商桑紐爾製藥公司 | 醫藥配方 |
-
2014
- 2014-01-23 JP JP2015553933A patent/JP6215354B2/ja active Active
- 2014-01-23 WO PCT/US2014/012824 patent/WO2014116876A1/en not_active Ceased
- 2014-01-23 TW TW103102506A patent/TWI624262B/zh active
- 2014-01-23 KR KR1020157022624A patent/KR102055937B1/ko active Active
- 2014-01-23 CN CN201480005642.9A patent/CN105073138B/zh active Active
- 2014-01-23 MX MX2015009455A patent/MX366654B/es active IP Right Grant
- 2014-01-23 US US14/162,625 patent/US9833460B2/en active Active
- 2014-01-23 BR BR112015017246-6A patent/BR112015017246B1/pt active IP Right Grant
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