RU2013157119A - Антагонисты периферических рецепторов опиоидов и их применения - Google Patents
Антагонисты периферических рецепторов опиоидов и их применения Download PDFInfo
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- C07D489/06—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula: with a hetero atom directly attached in position 14
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Abstract
1. Соединение формулы I:где:Rи Rпредставляют собой, каждый, независимо Cалифатическую группу иXпредставляет собой соответствующий анион.2. Соединение по п. 1, где Xпредставляет собой анион соответствующей кислоты Бренстеда.3. Соединение по п. 2, в котором кислота Бренстеда представляет собой гидрогалогенид, карбоновую кислоту, сульфоновую кислоту, серную кислоту или фосфорную кислоту.4. Соединение по п. 2, в котором Xпредставляет собой хлорид, бромид, йодид, фторид, сульфат, бисульфат, тартрат, нитрат, цитрат, битартрат, карбонат, фосфат, малат, малеат, фумарат сульфонат, метилсульфонат, формиат, карбоксилат, сульфат, метилсульфат, трифторацетат или сукцинат.5. Соединение по п. 4, в котором Xпредставляет собой бромид.6. Соединение по п. 1, в котором Rпредставляет собой Cалифатическую группу и Rпредставляет собой низший алкил.7. Соединение по п. 6, в котором Rпредставляет собой (циклоалкил)алкильную группу или алкенильную группу.8. Соединение по п. 7, в котором Rпредставляет собой циклопропилметил или аллил и Rпредставляет собой метил.9. Соединение по п. 1, в котором указанное соединение представляет собой формулы II или II':где каждый Xпредставляет собой соответствующий анион.10. Соединение по п. 9, в котором указанное соединение представляет собой соединение II-1 или II-2:11. Кристаллическая форма соединения II-1:12. Способ, включающий стадии:(a) получения образца (R)-N-метилналтрексона бромида;(b) осуществления анализа образца (R)-N-метилналтрексона бромида и(c) определения количества соединения II-1 в образце (R)-N-метилналтрексона бромида.13. Способ по п. 12, в котором стадия (c) дополнительно включает стадию определения количества соединения IV-1 в образце
Claims (46)
2. Соединение по п. 1, где X- представляет собой анион соответствующей кислоты Бренстеда.
3. Соединение по п. 2, в котором кислота Бренстеда представляет собой гидрогалогенид, карбоновую кислоту, сульфоновую кислоту, серную кислоту или фосфорную кислоту.
4. Соединение по п. 2, в котором X- представляет собой хлорид, бромид, йодид, фторид, сульфат, бисульфат, тартрат, нитрат, цитрат, битартрат, карбонат, фосфат, малат, малеат, фумарат сульфонат, метилсульфонат, формиат, карбоксилат, сульфат, метилсульфат, трифторацетат или сукцинат.
5. Соединение по п. 4, в котором X- представляет собой бромид.
6. Соединение по п. 1, в котором R1 представляет собой C1-4 алифатическую группу и R2 представляет собой низший алкил.
7. Соединение по п. 6, в котором R1 представляет собой (циклоалкил)алкильную группу или алкенильную группу.
8. Соединение по п. 7, в котором R1 представляет собой циклопропилметил или аллил и R2 представляет собой метил.
12. Способ, включающий стадии:
(a) получения образца (R)-N-метилналтрексона бромида;
(b) осуществления анализа образца (R)-N-метилналтрексона бромида и
(c) определения количества соединения II-1 в образце (R)-N-метилналтрексона бромида.
13. Способ по п. 12, в котором стадия (c) дополнительно включает стадию определения количества соединения IV-1 в образце (R)-N-метилналтрексона бромида.
14. Способ по п. 13, в котором стадия (c) включает определение того, является ли количество соединения II-1 и соединения IV-1 в образце (R)-N-метилналтрексона бромида меньшим, чем примерно 60 млн.частей, примерно 10 млн.частей, примерно 5 млн.частей, примерно 3,3 млн.частей, примерно 2,5 млн.частей или примерно 1 млн.частей, в целом.
15. Способ по п. 13, в котором стадия (c) включает определение того, является ли количество соединения II-1 и соединения IV-1 в образце (R)-N-метилналтрексона бромида меньшим, чем примерно 25, примерно 100, примерно 125, примерно 150, примерно 185, примерно 187 или примерно 190 млн.частей, в целом.
16. Способ, включающий стадии:
(a) получения образца (R)-N-метилналтрексона бромида;
(b) получения образца соединения II-1:
(c) осуществления анализа ВЭЖХ образца (R)-N-метилналтрексона бромида и образца соединения II-1; и
(d) определения количества соединения II-1 в образце (R)-N-метилналтрексона бромида.
20. Набор по п. 19, в котором каждый стандарт сравнения предоставляется в отдельном флаконе.
21. Набор по п. 19, в котором все стандарты сравнения предоставляются вместе в одном и том же флаконе.
24. Предварительно заполненный шприц по п. 23, в котором жидкая композиция содержит меньше, чем примерно 25, примерно 100, примерно 125, примерно 150, примерно 185, примерно 187 или примерно 190 млн.частей, в целом соединения формулы II и соединения формулы IV:
где:
R1 и R2 представляют собой, каждый, независимо C1-6 алифатическую группу и
X- представляет собой соответствующий анион.
28. Предварительно заполненный шприц, содержащий жидкую композицию, содержащую 8 мг соединения III-1:
в 0,4 мл воды и соединение II-1:
где соединение II-1 присутствует в количестве меньше, чем примерно 25, примерно 100, примерно 125, примерно 150, примерно 185, примерно 187 или примерно 190 млн.частей, и где предварительно заполненный шприц по существу не содержит вольфрама.
29. Предварительно заполненный шприц по п. 28, в котором жидкая композиция дополнительно содержит 2,6 мг хлорида натрия, 0,16 мг кальция динатрия эдетата и 0,12 мг гидрохлорида глицина.
30. Предварительно заполненный шприц, содержащий жидкую композицию, содержащую 12 мг соединения III-1:
в 0,6 мл воды и соединение II-1:
где соединение II-1 присутствует в количестве меньшем, чем примерно 25, примерно 100, примерно 125, примерно 150, примерно 185, примерно 187 или примерно 190 млн.частей, и где предварительно заполненный шприц по существу не содержит вольфрама.
31. Предварительно заполненный шприц по п. 30, в котором жидкая композиция дополнительно содержит 3,9 мг хлорида натрия, 0,24 мг кальция динатрия эдетата и 0,18 мг гидрохлорида глицина.
32. Способ, включающий стадии:
(i) обеспечения предварительно заполненного шприца, по существу не содержащего вольфрама, содержащего стандартную дозу жидкой композиции, содержащей 8 мг соединения III-1:
в 0,4 мл воды и соединение II-1:
где соединение II-1 присутствует в количестве меньшем, чем примерно 25, примерно 100, примерно 125, примерно 150, примерно 185, примерно 187 или примерно 190 млн. частей;
(ii) введения стандартной дозы субъекту путем подкожной инъекции.
33. Способ по п. 32, в котором субъект страдает от запора, вызванного опиоидами.
34. Способ по п. 32, в котором вольфрам присутствует в количестве меньшем, чем 50 миллиардных частей.
35. Способ по п. 34, в котором вольфрам присутствует в количестве меньшем, чем 12 миллиардных частей.
36. Способ по п. 32, в котором жидкая композиция дополнительно содержит кальций динатрий эдетат и гидрохлорид глицина.
37. Способ, включающий стадии:
(i) обеспечения предварительно заполненного шприца, по существу не содержащего вольфрама, содержащего стандартную дозу жидкой композиции, содержащей 12 мг соединения III-1:
в 0,6 мл воды и соединение II-1:
где соединение II-1 присутствует в количестве меньшем, чем примерно 25, примерно 100, примерно 125, примерно 150, примерно 185, примерно 187 или примерно 190 млн.частей;
(ii) введения стандартной дозы субъекту путем подкожной инъекции.
38. Способ по п. 37, в котором субъект страдает от запора, вызванного опиоидами.
39. Способ по п. 37, в котором вольфрам присутствует в количестве меньшем, чем 50 миллиардных частей.
40. Способ по п. 39, в котором вольфрам присутствует в количестве меньшем, чем 12 миллиардных частей.
41. Способ по п. 37, в котором жидкая композиция дополнительно содержит кальций динатрий эдетат и гидрохлорид глицина.
45. Способ по п. 42, в котором окисляющий агент выбирают из пероксида, бензохинона или перкислоты.
46. Способ по п. 42, в котором окисляющий агент выбирают из пероксида водорода, трет-бутил пероксида водорода, MCPBA (мета-хлорпербензойной кислоты), перуксусной кислоты, оксона (калия пероксимоносульфата) или DDQ (2,3-дихлор-5,6-дицианобензохинона).
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