JP2020511417A5 - - Google Patents
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- JP2020511417A5 JP2020511417A5 JP2019532920A JP2019532920A JP2020511417A5 JP 2020511417 A5 JP2020511417 A5 JP 2020511417A5 JP 2019532920 A JP2019532920 A JP 2019532920A JP 2019532920 A JP2019532920 A JP 2019532920A JP 2020511417 A5 JP2020511417 A5 JP 2020511417A5
- Authority
- JP
- Japan
- Prior art keywords
- cyclodextrin
- pharmaceutical composition
- concentration
- composition according
- additive
- 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
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- 239000003814 drug Substances 0.000 claims description 27
- 229940079593 drug Drugs 0.000 claims description 27
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims description 20
- 229920000858 Cyclodextrin Polymers 0.000 claims description 18
- ODLHGICHYURWBS-LKONHMLTSA-N trappsol cyclo Chemical compound CC(O)COC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)COCC(O)C)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1COCC(C)O ODLHGICHYURWBS-LKONHMLTSA-N 0.000 claims description 5
- 239000000203 mixture Substances 0.000 claims description 3
- 239000008194 pharmaceutical composition Substances 0.000 claims 24
- 229940100389 Sulfonylurea Drugs 0.000 claims 19
- YROXIXLRRCOBKF-UHFFFAOYSA-N sulfonylurea Chemical class OC(=N)N=S(=O)=O YROXIXLRRCOBKF-UHFFFAOYSA-N 0.000 claims 19
- 239000000654 additive Substances 0.000 claims 17
- 230000000996 additive effect Effects 0.000 claims 15
- 238000002347 injection Methods 0.000 claims 8
- 239000007924 injection Substances 0.000 claims 8
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims 6
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims 6
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 6
- 239000001116 FEMA 4028 Substances 0.000 claims 4
- 229960004853 betadex Drugs 0.000 claims 4
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 claims 3
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims 3
- 235000017557 sodium bicarbonate Nutrition 0.000 claims 3
- 229910000029 sodium carbonate Inorganic materials 0.000 claims 3
- 206010048962 Brain oedema Diseases 0.000 claims 2
- MBBZMMPHUWSWHV-BDVNFPICSA-N N-methylglucamine Chemical compound CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO MBBZMMPHUWSWHV-BDVNFPICSA-N 0.000 claims 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 2
- 208000006011 Stroke Diseases 0.000 claims 2
- 208000030886 Traumatic Brain injury Diseases 0.000 claims 2
- 206010067584 Type 1 diabetes mellitus Diseases 0.000 claims 2
- 206010047281 Ventricular arrhythmia Diseases 0.000 claims 2
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims 2
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims 2
- 208000006752 brain edema Diseases 0.000 claims 2
- 208000028867 ischemia Diseases 0.000 claims 2
- 229960003194 meglumine Drugs 0.000 claims 2
- 208000010125 myocardial infarction Diseases 0.000 claims 2
- 210000000056 organ Anatomy 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- 229920006395 saturated elastomer Polymers 0.000 claims 2
- 230000035939 shock Effects 0.000 claims 2
- 239000000243 solution Substances 0.000 claims 2
- 208000020431 spinal cord injury Diseases 0.000 claims 2
- 230000009529 traumatic brain injury Effects 0.000 claims 2
- 208000001072 type 2 diabetes mellitus Diseases 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- HZAXFHJVJLSVMW-UHFFFAOYSA-N 2-Aminoethan-1-ol Chemical compound NCCO HZAXFHJVJLSVMW-UHFFFAOYSA-N 0.000 claims 1
- NZAQRZWBQUIBSF-UHFFFAOYSA-N 4-(4-sulfobutoxy)butane-1-sulfonic acid Chemical compound OS(=O)(=O)CCCCOCCCCS(O)(=O)=O NZAQRZWBQUIBSF-UHFFFAOYSA-N 0.000 claims 1
- 229920001450 Alpha-Cyclodextrin Polymers 0.000 claims 1
- 239000004475 Arginine Substances 0.000 claims 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 1
- 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 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims 1
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 1
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 claims 1
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 claims 1
- 239000004472 Lysine Substances 0.000 claims 1
- HFHDHCJBZVLPGP-RWMJIURBSA-N alpha-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO HFHDHCJBZVLPGP-RWMJIURBSA-N 0.000 claims 1
- 229940043377 alpha-cyclodextrin Drugs 0.000 claims 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims 1
- 229910021538 borax Inorganic materials 0.000 claims 1
- -1 borosand Chemical compound 0.000 claims 1
- ZBCBWPMODOFKDW-UHFFFAOYSA-N diethanolamine Chemical compound OCCNCCO ZBCBWPMODOFKDW-UHFFFAOYSA-N 0.000 claims 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims 1
- CEYULKASIQJZGP-UHFFFAOYSA-L disodium;2-(carboxymethyl)-2-hydroxybutanedioate Chemical compound [Na+].[Na+].[O-]C(=O)CC(O)(C(=O)O)CC([O-])=O CEYULKASIQJZGP-UHFFFAOYSA-L 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- GDSRMADSINPKSL-HSEONFRVSA-N gamma-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO GDSRMADSINPKSL-HSEONFRVSA-N 0.000 claims 1
- 229960004580 glibenclamide Drugs 0.000 claims 1
- 239000008103 glucose Substances 0.000 claims 1
- ZNNLBTZKUZBEKO-UHFFFAOYSA-N glyburide Chemical compound COC1=CC=C(Cl)C=C1C(=O)NCCC1=CC=C(S(=O)(=O)NC(=O)NC2CCCCC2)C=C1 ZNNLBTZKUZBEKO-UHFFFAOYSA-N 0.000 claims 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- HWPKGOGLCKPRLZ-UHFFFAOYSA-M monosodium citrate Chemical compound [Na+].OC(=O)CC(O)(C([O-])=O)CC(O)=O HWPKGOGLCKPRLZ-UHFFFAOYSA-M 0.000 claims 1
- 235000018342 monosodium citrate Nutrition 0.000 claims 1
- 239000002524 monosodium citrate Substances 0.000 claims 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 claims 1
- 235000019799 monosodium phosphate Nutrition 0.000 claims 1
- 230000007971 neurological deficit Effects 0.000 claims 1
- 201000001119 neuropathy Diseases 0.000 claims 1
- 230000007823 neuropathy Effects 0.000 claims 1
- 230000003647 oxidation Effects 0.000 claims 1
- 238000007254 oxidation reaction Methods 0.000 claims 1
- 239000003002 pH adjusting agent Substances 0.000 claims 1
- 208000033808 peripheral neuropathy Diseases 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- 239000011734 sodium Substances 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- 239000001509 sodium citrate Substances 0.000 claims 1
- 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 1
- 235000011083 sodium citrates Nutrition 0.000 claims 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims 1
- 239000004328 sodium tetraborate Substances 0.000 claims 1
- 235000010339 sodium tetraborate Nutrition 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- 230000001954 sterilising effect Effects 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 229940097346 sulfobutylether-beta-cyclodextrin Drugs 0.000 claims 1
- DSDAICPXUXPBCC-MWDJDSKUSA-N trimethyl-β-cyclodextrin Chemical compound COC[C@H]([C@H]([C@@H]([C@H]1OC)OC)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COC)[C@H]([C@@H]([C@H]3OC)OC)O[C@H]3O[C@H](COC)[C@H]([C@@H]([C@H]3OC)OC)O[C@H]3O[C@H](COC)[C@H]([C@@H]([C@H]3OC)OC)O[C@H]3O[C@H](COC)[C@H]([C@@H]([C@H]3OC)OC)O3)[C@H](OC)[C@H]2OC)COC)O[C@@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@@H]3O[C@@H]1COC DSDAICPXUXPBCC-MWDJDSKUSA-N 0.000 claims 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims 1
- 238000001179 sorption measurement Methods 0.000 description 5
- 238000001802 infusion Methods 0.000 description 3
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611149802.4A CN108210501B (zh) | 2016-12-14 | 2016-12-14 | 一种磺酰脲类药物的注射用药物组合物及其制备方法 |
| CN201611149802.4 | 2016-12-14 | ||
| PCT/CN2017/115993 WO2018108111A1 (zh) | 2016-12-14 | 2017-12-13 | 一种磺酰脲类药物的药物组合物及其制备方法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2020511417A JP2020511417A (ja) | 2020-04-16 |
| JP2020511417A5 true JP2020511417A5 (https=) | 2021-02-25 |
| JP6888091B2 JP6888091B2 (ja) | 2021-06-16 |
Family
ID=62558059
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019532920A Active JP6888091B2 (ja) | 2016-12-14 | 2017-12-13 | スルホニル尿素系薬の医薬組成物及びその調製方法 |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US10966993B2 (https=) |
| EP (1) | EP3556371B1 (https=) |
| JP (1) | JP6888091B2 (https=) |
| CN (2) | CN108210501B (https=) |
| WO (1) | WO2018108111A1 (https=) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108553428A (zh) * | 2018-05-29 | 2018-09-21 | 昆药集团股份有限公司 | 格列本脲制剂及其制备方法 |
| CN109432031A (zh) * | 2018-12-24 | 2019-03-08 | 扬子江药业集团广州海瑞药业有限公司 | 一种格列美脲片剂及其制备方法 |
| CN111759323B (zh) * | 2020-07-08 | 2021-06-29 | 刘明明 | 一种多模块微循环功能测评装置及基于其的生物组织微循环可视化方法 |
| US11672761B2 (en) | 2020-11-16 | 2023-06-13 | Orcosa Inc. | Rapidly infusing platform and compositions for therapeutic treatment in humans |
| CN116648251A (zh) * | 2020-11-16 | 2023-08-25 | 江苏先声药业有限公司 | 一种格列本脲的经鼻给药的药物组合物 |
| WO2022103638A1 (en) | 2020-11-16 | 2022-05-19 | Orcosa Inc. | Cannabinoids in the treatment of autism spectrum disorder |
| CN114642673A (zh) * | 2020-12-21 | 2022-06-21 | 江苏奥赛康药业有限公司 | 格列本脲组合物在制备治疗脑含水量升高药物中的应用 |
| CN114642671A (zh) * | 2020-12-21 | 2022-06-21 | 江苏奥赛康药业有限公司 | 格列本脲组合物在制备治疗脊髓出血药物中的应用 |
| CN114642672A (zh) * | 2020-12-21 | 2022-06-21 | 江苏奥赛康药业有限公司 | 格列本脲组合物在制备治疗脊髓神经元减少药物中的应用 |
| CN114642674A (zh) * | 2020-12-21 | 2022-06-21 | 江苏奥赛康药业有限公司 | 格列本脲组合物在制备治疗神经细胞凋亡药物中的应用 |
| JP2024512310A (ja) * | 2021-03-04 | 2024-03-19 | バイオジェン チェサピーク エルエルシー | 低吸着グリブリド製剤および方法 |
| CN113413389B (zh) * | 2021-07-19 | 2024-03-15 | 成都赜灵生物医药科技有限公司 | 一种组蛋白去乙酰化酶抑制剂的制剂及其制备方法和用途 |
| EP4486304A1 (en) * | 2022-03-03 | 2025-01-08 | Remedy Pharmaceuticals, Inc. | Low-sorbing glyburide kit, formulation and methods |
Family Cites Families (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT1269578B (it) | 1994-04-22 | 1997-04-08 | Chiesi Farma Spa | Complessi di inclusione multicomponente ad elevata solubilita' costituiti da un farmaco di tipo acido, una ciclodestrina e una base. |
| US6555139B2 (en) * | 1999-06-28 | 2003-04-29 | Wockhardt Europe Limited | Preparation of micron-size pharmaceutical particles by microfluidization |
| US6464988B1 (en) * | 2001-05-09 | 2002-10-15 | Usv Limited | Glipizide-cyclodextrin inclusion complexes and their pharmaceutical composition |
| GB0205253D0 (en) * | 2002-03-06 | 2002-04-17 | Univ Gent | Immediate release pharmaceutical granule compositions and a continuous process for making them |
| US8980952B2 (en) * | 2002-03-20 | 2015-03-17 | University Of Maryland, Baltimore | Methods for treating brain swelling with a compound that blocks a non-selective cation channel |
| US20030219482A1 (en) * | 2002-03-21 | 2003-11-27 | Chaudhari Sunil Sudhakar | Multiparticulate compositions for once-a-day administration |
| JP2003321364A (ja) * | 2002-05-07 | 2003-11-11 | Eisai Co Ltd | シクロデキストリンにより可溶化及び安定化された抗腫瘍剤含有組成物 |
| DE10341414A1 (de) * | 2003-09-05 | 2005-03-31 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Oral zu applizierende Darreichungsform für schwerlösliche saure und amphotere Wirkstoffe |
| CN1267488C (zh) * | 2003-09-26 | 2006-08-02 | 清华大学 | 格列吡嗪－环糊精包合物的制备方法 |
| WO2006038552A1 (ja) * | 2004-10-01 | 2006-04-13 | Eisai R & D Management Co., Ltd. | 微粒子含有組成物およびその製造方法 |
| CN101189003B (zh) * | 2005-05-13 | 2012-02-08 | 托波塔吉特英国有限公司 | Hdac抑制剂的药物制剂 |
| CN1872231B (zh) * | 2005-06-01 | 2011-10-05 | 天津天士力制药股份有限公司 | 一种治疗糖尿病的滴丸及其制备方法 |
| CN1823755A (zh) * | 2006-01-11 | 2006-08-30 | 宛六一 | 那格列奈软胶囊及其制备方法 |
| PT2868315T (pt) | 2007-12-04 | 2017-09-04 | Remedy Pharmaceuticals Inc | Formulações melhoradas e métodos para liofilização e liofilizados assim produzidos |
| US20110034560A1 (en) | 2008-01-29 | 2011-02-10 | Sven Jacobson | Liquid formulations of compounds active at sulfonylurea receptors |
| CN101658487B (zh) * | 2008-08-28 | 2011-10-05 | 北京天川军威医药技术开发有限公司 | 格列美脲水溶液给药系统及其制备方法 |
| US20130131089A1 (en) | 2010-04-30 | 2013-05-23 | Portola Phamaceuticals Inc. | Dosage forms of elinogrel and methods of injectable administration thereof |
| CN104644591A (zh) * | 2013-11-25 | 2015-05-27 | 天津市汉康医药生物技术有限公司 | 一种沙格列汀药物组合物及其制备方法 |
-
2016
- 2016-12-14 CN CN201611149802.4A patent/CN108210501B/zh not_active Expired - Fee Related
-
2017
- 2017-12-13 CN CN201780075125.2A patent/CN111093674B/zh active Active
- 2017-12-13 EP EP17881816.7A patent/EP3556371B1/en active Active
- 2017-12-13 US US16/469,124 patent/US10966993B2/en active Active
- 2017-12-13 JP JP2019532920A patent/JP6888091B2/ja active Active
- 2017-12-13 WO PCT/CN2017/115993 patent/WO2018108111A1/zh not_active Ceased
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