RU2016121401A - Устойчивые при хранении лиофилизованные составы трипептидов - Google Patents
Устойчивые при хранении лиофилизованные составы трипептидов Download PDFInfo
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- RU2016121401A RU2016121401A RU2016121401A RU2016121401A RU2016121401A RU 2016121401 A RU2016121401 A RU 2016121401A RU 2016121401 A RU2016121401 A RU 2016121401A RU 2016121401 A RU2016121401 A RU 2016121401A RU 2016121401 A RU2016121401 A RU 2016121401A
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- 239000000203 mixture Substances 0.000 title claims 21
- 238000002360 preparation method Methods 0.000 claims 10
- LOGFVTREOLYCPF-KXNHARMFSA-N (2s,3r)-2-[[(2r)-1-[(2s)-2,6-diaminohexanoyl]pyrrolidine-2-carbonyl]amino]-3-hydroxybutanoic acid Chemical compound C[C@@H](O)[C@@H](C(O)=O)NC(=O)[C@H]1CCCN1C(=O)[C@@H](N)CCCCN LOGFVTREOLYCPF-KXNHARMFSA-N 0.000 claims 5
- 108010013842 interleukin 1beta (193-195) Proteins 0.000 claims 5
- 239000008365 aqueous carrier Substances 0.000 claims 4
- 239000006172 buffering agent Substances 0.000 claims 4
- 239000002537 cosmetic Substances 0.000 claims 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 4
- 239000000546 pharmaceutical excipient Substances 0.000 claims 4
- 239000007787 solid Substances 0.000 claims 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 3
- 201000010099 disease Diseases 0.000 claims 3
- 239000003002 pH adjusting agent Substances 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims 2
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 2
- 239000000945 filler Substances 0.000 claims 2
- 239000012458 free base Substances 0.000 claims 2
- 238000004108 freeze drying Methods 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 1
- 208000024827 Alzheimer disease Diseases 0.000 claims 1
- 206010011224 Cough Diseases 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- 108010010803 Gelatin Proteins 0.000 claims 1
- 208000010412 Glaucoma Diseases 0.000 claims 1
- 239000004471 Glycine Substances 0.000 claims 1
- 206010021036 Hyponatraemia Diseases 0.000 claims 1
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 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
- 241000124008 Mammalia Species 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- 206010030113 Oedema Diseases 0.000 claims 1
- 208000018737 Parkinson disease Diseases 0.000 claims 1
- 208000003251 Pruritus Diseases 0.000 claims 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 1
- 239000007983 Tris buffer Substances 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 1
- 239000002585 base Substances 0.000 claims 1
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 claims 1
- 229910000019 calcium carbonate Inorganic materials 0.000 claims 1
- 235000010216 calcium carbonate Nutrition 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 238000010790 dilution Methods 0.000 claims 1
- 239000012895 dilution Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000008273 gelatin Substances 0.000 claims 1
- 229920000159 gelatin Polymers 0.000 claims 1
- 235000019322 gelatine Nutrition 0.000 claims 1
- 235000011852 gelatine desserts Nutrition 0.000 claims 1
- 229930195712 glutamate Natural products 0.000 claims 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 1
- 239000001341 hydroxy propyl starch Substances 0.000 claims 1
- 235000013828 hydroxypropyl starch Nutrition 0.000 claims 1
- 208000027866 inflammatory disease Diseases 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 208000003243 intestinal obstruction Diseases 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 claims 1
- 235000019799 monosodium phosphate Nutrition 0.000 claims 1
- 210000004400 mucous membrane Anatomy 0.000 claims 1
- 201000006417 multiple sclerosis Diseases 0.000 claims 1
- 229940124531 pharmaceutical excipient Drugs 0.000 claims 1
- 238000011321 prophylaxis Methods 0.000 claims 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
- 230000001225 therapeutic effect Effects 0.000 claims 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
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Claims (28)
1. Лиофилизованный состав, содержащий лизил-пролил-треонин или его фармацевтически приемлемую соль.
2. Лиофилизованный состав по п. 1, дополнительно содержащий один или несколько наполнителей, один или несколько буферных агентов и, необязательно, один или несколько агентов для регулирования рН.
3. Лиофилизованный состав по п. 1 и/или 2, получаемый путем лиофилизации водного препарата, имеющего рН 3,0-5,0, где водный препарат включает:
(i) лизил-пролил-треонин или его фармацевтически приемлемую соль, где свободное основание имеет концентрацию 0,1-175 мг/г в пересчете на водный препарат,
(ii) водный носитель, предпочтительно воду,
(iii) необязательно один или несколько наполнителей,
(iv) необязательно один или несколько буферных агентов, и
(v) необязательно один или несколько агентов для регулирования рН.
4. Лиофилизованный состав по любому из пп. 1-3, где лизил-пролил-треонин представляет собой (L)Lys-(D)Pro-(L)Thr, (L)Lys-(L)Pro-(D)Thr, (L)Lys-(D)Pro-(D)Thr, (L)Lys-(L)Pro-(L)Thr, (D)Lys-(D)Pro-(L)Thr, (D)Lys-(D)Pro-(D)Thr, (D)Lys-(L)Pro-(L)Thr, (D)Lys-(L)Pro-(D)Thr или их смеси.
5. Лиофилизованный состав по любому из пп. 1-4, где наполнитель выбран из группы, состоящей из маннита, сахарозы, глицина, желатина, гидроксипропилкрахмала, карбоната кальция и трегалозы.
6. Лиофилизованный состав по любому из пп. 1-5, где буферный агент выбран из группы, состоящей из лимонной кислоты, дигидрофосфата натрия, уксусной кислоты, янтарной кислоты, глутамата, Tris и гистидина.
7. Лиофилизованный состав по любому из пп. 1-6, где агент для регулирования рН представляет собой кислоту или основание, поддерживающее значение рН на уровне 3,0-5,0, которое выбрано из гидроксида натрия и хлористоводородной кислоты.
8. Лиофилизованный состав по любому из пп. 1-7 для использования в качестве лекарственного средства, предпочтительно, для использования при терапевтическом и/или профилактическом лечении заболеваний, выбранных из группы, которая включает сопровождающиеся болью заболевания, сопровождающиеся зудом заболевания, воспалительные заболевания и/или другие заболевания, предпочтительно, выбранные из гипонатриемии, отека, непроходимости кишечника, кашля, глаукомы, рассеянного склероза, болезни Паркинсона и болезни Альцгеймера.
9. Лиофилизованный состав для использования по п. 8, где лиофилизованный состав вводят пациенту в твердой форме, предпочтительно, путем перорального введения, или где твердый лиофилизованный состав восстанавливают водным носителем с получением водного препарата, а указанный водный препарат впоследствии вводят пациенту, предпочтительно путем перорального введения или путем инъекции.
10. Способ получения лиофилизованного состава по любому из пп. 1-9, который включает следующие стадии:
(a) смешивание в любом порядке следующих компонентов:
(i) лизил-пролил-треонина или его фармацевтически приемлемой соли,
(ii) водного носителя,
(iii) необязательно одного или нескольких наполнителей,
(iv) необязательно одного или нескольких буферных агентов, и
(v) необязательно одного или нескольких агентов для регулирования рН;
с получением водного препарата, имеющего рН в интервале 3,0-5,0, где свободное основание лизил-пролил-треонина имеет концентрацию 0,1-175 мг/г в пересчете на водный препарат;
(b) лиофилизация водного препарата с получением лиофилизованного состава в твердой форме.
11. Лиофилизованный состава, получаемый способом по п. 10.
12. Фармацевтическая композиция, содержащая лиофилизованный состав по любому из пп. 1-9 и/или 11 и один или несколько фармацевтических наполнителей.
13. Фармацевтическая композиция по п. 12 либо в форме водного препарата, получаемого путем восстановления лиофилизованного состава с помощью водного носителя, где степень разведения, предпочтительно составляет от 1:0,5 до 1:1000; либо в твердой форме.
14. Косметическая композиция, содержащая лиофилизованный состав по любому из пп. 1-9 и/или 11 и один или несколько косметических наполнителей.
15. Нетерапевтическое применение лиофилизованного состава по любому из пп. 1-9 и/или 11 в качестве косметического препарата, предпочтительно, для косметического ухода за кожей и/или слизистыми оболочками у млекопитающего.
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CN111303242B (zh) * | 2020-02-27 | 2022-04-26 | 广州领晟医疗科技有限公司 | 一种KdPT的修饰肽 |
CN111150831B (zh) * | 2020-02-27 | 2023-06-09 | 广州领晟医疗科技有限公司 | 多肽KdPT的应用 |
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US20090011819A9 (en) * | 2000-10-20 | 2009-01-08 | Marcel Huard | Method and apparatus for the rewarding of the interest of a user in an activity |
DE10106852A1 (de) | 2001-02-14 | 2002-09-05 | T Luger | Entzündungshemmende Verbindungen |
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WO2008095195A2 (en) * | 2007-02-02 | 2008-08-07 | Nereus Pharmaceuticals, Inc. | Lyophilized formulations of salinosporamide a |
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ES2727324T3 (es) | 2019-10-15 |
RU2684915C2 (ru) | 2019-04-16 |
CN105744945B (zh) | 2019-07-02 |
EP3065756B1 (en) | 2019-02-20 |
EP3065756A1 (en) | 2016-09-14 |
MX2016005976A (es) | 2016-08-11 |
MX368943B (es) | 2019-10-22 |
AU2014345802B2 (en) | 2018-01-25 |
US10383911B2 (en) | 2019-08-20 |
CA2927690C (en) | 2020-10-27 |
DK3065756T3 (da) | 2019-05-27 |
TR201902755T4 (tr) | 2019-03-21 |
WO2015067493A1 (en) | 2015-05-14 |
JP2016535747A (ja) | 2016-11-17 |
JP6475714B2 (ja) | 2019-02-27 |
CN105744945A (zh) | 2016-07-06 |
CA2927690A1 (en) | 2015-05-14 |
HUE043367T2 (hu) | 2019-08-28 |
HK1222801A1 (zh) | 2017-07-14 |
KR20160072266A (ko) | 2016-06-22 |
US20160279188A1 (en) | 2016-09-29 |
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