RU2000119778A - COMBINATIONS AGONIST / OPIOID ANTAGONIST - Google Patents

COMBINATIONS AGONIST / OPIOID ANTAGONIST

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Publication number
RU2000119778A
RU2000119778A RU2000119778/14A RU2000119778A RU2000119778A RU 2000119778 A RU2000119778 A RU 2000119778A RU 2000119778/14 A RU2000119778/14 A RU 2000119778/14A RU 2000119778 A RU2000119778 A RU 2000119778A RU 2000119778 A RU2000119778 A RU 2000119778A
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naltrexone
ratio
opioid
dosage form
hydrocodone
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RU2000119778/14A
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Russian (ru)
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RU2241458C2 (en
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Роберт Ф. КАИКО
Роберт Д. КОЛУЧЧИ
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Эро-Селтик, С.А.
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Claims (21)

1. Лекарственная форма для перорального введения, включающая перорально терапевтически эффективное количество опиоидного агониста, и опиоидный антагонист при соотношении опиоидного антагониста к опиоидному агонисту, позволяющем получить комбинированный продукт, который анальгетически эффективен, когда комбинация вводится перорально, но который вызывает отвращение у физически зависимых субъектов, когда он вводится в такой же дозе или в более высокой дозе, чем обычно предписываемая доза опиоидного агониста.1. A dosage form for oral administration, comprising an orally therapeutically effective amount of an opioid agonist, and an opioid antagonist in a ratio of opioid antagonist to opioid agonist, which allows to obtain a combination product that is analgesically effective when the combination is administered orally, but which causes disgust in physically dependent subjects, when administered at the same dose or at a higher dose than the usually prescribed dose of an opioid agonist. 2. Лекарственная форма для перорального введения по п. 1, в которой количество антагониста, включенное в пероральную лекарственную форму, вызывает отвращение у физически зависимых наркоманов, принимающих дозу примерно в 2-3 раза выше, чем обычно предписываемая доза опиоида. 2. The oral dosage form of claim 1, wherein the amount of antagonist included in the oral dosage form is disgusted by physically dependent drug users taking a dose of about 2 to 3 times higher than the usually prescribed dose of an opioid. 3. Лекарственная форма для перорального введения по п. 1, дополнительно включающая один или несколько фармацевтически приемлемых вспомогательных веществ. 3. A dosage form for oral administration according to claim 1, further comprising one or more pharmaceutically acceptable excipients. 4. Лекарственная форма для перорального введения по любому из пп. 1-3, дополнительно включающая носитель для замедленного высвобождения, позволяющий вводить лекарственную форму по схеме дважды в день или один раз в день. 4. Dosage form for oral administration according to any one of paragraphs. 1-3, further comprising a carrier for sustained release, allowing you to enter the dosage form according to the scheme twice a day or once a day. 5. Лекарственная форма для перорального введения по любому из пп. 1-4, в которой опиоидным агонистом является гидрокодон и опиоидным антагонистом является налтрексон, и соотношение налтрексона к гидрокодону составляет от примерно 0,03: 1 до примерно 0,27: 1. 5. Dosage form for oral administration according to any one of paragraphs. 1-4, in which the opioid agonist is hydrocodone and the opioid antagonist is naltrexone, and the ratio of naltrexone to hydrocodone is from about 0.03: 1 to about 0.27: 1. 6. Лекарственная форма для перорального введения по пп. 1-4, в которой опиоидным агонистом является гидрокодон и опиоидным антагонистом является налтрексон и соотношение налтрексона к гидрокодону составляет от примерно 0,05: 1 до примерно 0,20: 1. 6. Dosage form for oral administration according to paragraphs. 1-4, in which the opioid agonist is hydrocodone and the opioid antagonist is naltrexone and the ratio of naltrexone to hydrocodone is from about 0.05: 1 to about 0.20: 1. 7. Лекарственная форма для перорального введения по пп. 1-4, в которой опиоидный агонист или анальгетик выбирают из группы, состоящей из морфина, гидроморфина, гидрокодона, оксикодона, кодеина, леворфанола, меперидина, метадона и их смесей; и указанный опиоидный антагонист выбирают из группы, состоящей из налтрексона, налоксона, нальмефена, циклазоцина, леваллорфана и их смесей. 7. Dosage form for oral administration according to paragraphs. 1-4, in which the opioid agonist or analgesic is selected from the group consisting of morphine, hydromorphine, hydrocodone, oxycodone, codeine, levorphanol, meperidine, methadone, and mixtures thereof; and said opioid antagonist is selected from the group consisting of naltrexone, naloxone, nalmefene, cyclazocine, levallorphan and mixtures thereof. 8. Лекарственная форма для перорального введения по пп. 1-4, в которой указанным опиоидным антагонистом является налтрексон. 8. Dosage form for oral administration according to claims. 1-4, in which the indicated opioid antagonist is naltrexone. 9. Лекарственная форма для перорального введения по любому из пп. 1-8, включающая дополнительно неопиоидное лекарство, выбранное из группы, состоящей из NSAID, ингибитора СОХ-2, ацетаминофена, аспирина, антагониста рецептора NMDA, препарата, который блокирует главную внутриклеточную последовательность активации рецептора NMDA, противокашлевого агента, отхаркивающего агента, противозастойного агента, антигистамина и их смесей. 9. Dosage form for oral administration according to any one of paragraphs. 1-8, including an additional non-opioid drug selected from the group consisting of NSAID, COX-2 inhibitor, acetaminophen, aspirin, NMDA receptor antagonist, a drug that blocks the main intracellular activation sequence of NMDA receptor, antitussive agent, expectorant agent, decongestant, antihistamine and mixtures thereof. 10. Лекарственная форма для перорального введения по любому из пп. 1-4 и 9, в которой опиоидным антагонистом является налтрексон и опиоидный агонист выбирают из группы, состоящей из гидрокодона при соотношении налтрексон/гидрокодон от примерно 0,03: 1 до примерно 0,27: 1; оксикодона при соотношении налтрексон/оксикодон от примерно 0,037: 1 до примерно 0,296: 1; кодеина при соотношении налтрексон/кодеин от примерно 0,005: 1 до примерно 0,044: 1; гидроморфона при соотношении налтрексон/гидроморфон от примерно 0,148: 1 до примерно 1,185: 1; леворфанола при соотношении налтрексон/леворфанол от примерно 0,278: 1 до примерно 2,222: 1; меперидина при соотношении налтрексон/меперидин от примерно 0,0037: 1 до примерно 0,0296: 1; метадона при соотношении налтрексон/метадон от примерно 0,056: 1 до примерно 0,444: 1; и морфина при соотношении налтрексон/морфин от примерно 0,018: 1 до примерно 0,148: 1. 10. Dosage form for oral administration according to any one of paragraphs. 1-4 and 9, in which the opioid antagonist is naltrexone and the opioid agonist is selected from the group consisting of hydrocodone with a naltrexone / hydrocodone ratio of from about 0.03: 1 to about 0.27: 1; oxycodone with a naltrexone / oxycodone ratio of from about 0.037: 1 to about 0.296: 1; codeine with a naltrexone / codeine ratio of from about 0.005: 1 to about 0.044: 1; hydromorphone at a naltrexone / hydromorphone ratio of from about 0.148: 1 to about 1.185: 1; levorphanol with a naltrexone / levorphanol ratio of from about 0.278: 1 to about 2.222: 1; meperidine with a naltrexone / meperidine ratio of from about 0.0037: 1 to about 0.0296: 1; methadone with a naltrexone / methadone ratio of from about 0.056: 1 to about 0.444: 1; and morphine with a naltrexone / morphine ratio of from about 0.018: 1 to about 0.148: 1. 11. Лекарственная форма по любому из пп. 1-4 и 9, в которой опиоидным антагонистом является налтрексон и опиоидный агонист выбирают из группы, состоящей из гидрокодона при соотношении налтрексон/гидрокодон от примерно 0,05: 1 до 0,20: 1; оксикодона при соотношении налтрексон/оксикодон от примерно 0,056: 1 до примерно 0,222: 1; кодеина при соотношении налтрексон/кодеин от примерно 0,0083: 1 до примерно 0,033: 1; гидроморфона при соотношении налтрексон/гидроморфон от примерно 0,222: 1 до примерно 0,889: 1; леворфанола при соотношении налтрексон/ леворфанол от примерно 0,417: 1 до примерно 1,667: 1; меперидина при соотношении налтрексон/меперидин от примерно 0,0056: 1 до примерно 0,022: 1; метадона при соотношении налтрексон/метадон от примерно 0,083: 1 до примерно 0,333: 1; и морфина при соотношении налтрексон/морфин от примерно 0,028: 1 до примерно 0,111: 1. 11. The dosage form according to any one of paragraphs. 1-4 and 9, in which the opioid antagonist is naltrexone and the opioid agonist is selected from the group consisting of hydrocodone with a naltrexone / hydrocodone ratio of from about 0.05: 1 to 0.20: 1; oxycodone with a naltrexone / oxycodone ratio of from about 0.056: 1 to about 0.222: 1; codeine with a naltrexone / codeine ratio of from about 0.0083: 1 to about 0.033: 1; hydromorphone at a naltrexone / hydromorphone ratio of from about 0.222: 1 to about 0.889: 1; levorphanol with a naltrexone / levorphanol ratio of from about 0.417: 1 to about 1.667: 1; meperidine with a naltrexone / meperidine ratio of from about 0.0056: 1 to about 0.022: 1; methadone with a naltrexone / methadone ratio of from about 0.083: 1 to about 0.333: 1; and morphine at a naltrexone / morphine ratio of from about 0.028: 1 to about 0.111: 1. 12. Способ предотвращения перорального злоупотребления пероральной опиоидной композицией, включающий получение лекарственной формы для перорального введения, которая включает перорально терапевтически эффективное количество опиоидного агониста, и введенный в нее опиоидный антагонист при таком соотношении к указанному опиоидному агонисту, что лекарственная форма для перорального введения является анальгетически эффективной при пероральном введении, но вызывает отвращение у физически зависимых субъектов, когда вводится в такой же дозе или в более высокой дозе, чем обычно предписываемая доза опиоидного агониста. 12. A method for preventing oral abuse of an oral opioid composition, comprising the preparation of an oral dosage form that includes an orally therapeutically effective amount of an opioid agonist, and an opioid antagonist introduced therein in such a ratio to said opioid agonist that the oral dosage form is an analgesically effective when administered orally, but disgusts physically dependent subjects when administered in the same Oz or at a higher dose than the usually prescribed dose of the opioid agonist. 13. Способ по п. 12, в котором количество антагониста, включенное в пероральную лекарственную форму вызывает отвращение у физически зависимых наркоманов, принимающих дозу примерно в 2-3 раза выше, чем обычно предписываемая доза опиоида. 13. The method of claim 12, wherein the amount of antagonist included in the oral dosage form is disgusted by physically dependent drug addicts taking a dose of about 2-3 times higher than the usually prescribed dose of the opioid. 14. Способ по п. 12, в котором опиоидным агонистом является гидрокодон и антагонистом является налтрексон. 14. The method of claim 12, wherein the opioid agonist is hydrocodone and the antagonist is naltrexone. 15. Способ по п. 12, в котором соотношение налтрексона к гидрокодону составляет от примерно 0,03: 1 до примерно 0,27: 1. 15. The method according to p. 12, in which the ratio of naltrexone to hydrocodone is from about 0.03: 1 to about 0.27: 1. 16. Способ по п. 12, в котором соотношение налтрексона к гидрокодону составляет от примерно 0,05: 1 до примерно 0,20: 1. 16. The method according to p. 12, in which the ratio of naltrexone to hydrocodone is from about 0.05: 1 to about 0.20: 1. 17. Способ по п. 12, в котором опиоидный агонист или анальгетик выбирают из группы, состоящей из морфина, гидроморфина, гидрокодона, оксикодона, кодеина, леворфанола, меперидина, метадона и их смесей; и указанный опиоидный антагонист выбирают из группы, состоящей из налтрексона, налоксона, нальмефена, циклазоцина, леваллорфана и их смесей. 17. The method of claim 12, wherein the opioid agonist or analgesic is selected from the group consisting of morphine, hydromorphone, hydrocodone, oxycodone, codeine, levorphanol, meperidine, methadone, and mixtures thereof; and said opioid antagonist is selected from the group consisting of naltrexone, naloxone, nalmefene, cyclazocine, levallorphan and mixtures thereof. 18. Способ по любому из пп. 12-17, дополнительно включающий введение в указанную лекарственную форму для перорального введения дополнительно неопиоидного лекарства, выбранного из группы, состоящей из NSAID, ингибитора СОХ-2, ацетаминофена, аспирина, антагониста рецептора NMDA, препарата, который блокирует главную внутриклеточную последовательность активации рецептора NMDA, противокашлевого агента, отхаркивающего агента, противозастойного агента, антигистамина и их смесей. 18. The method according to any one of paragraphs. 12-17, further comprising administering to said dosage form for oral administration an additional non-opioid drug selected from the group consisting of NSAID, COX-2 inhibitor, acetaminophen, aspirin, NMDA receptor antagonist, a drug that blocks the main intracellular NMDA receptor activation sequence, antitussive agent, expectorant agent, decongestant, antihistamine and mixtures thereof. 19. Способ по любому из пп. 12-18, включающий получение указанной лекарственной формы для перорального введения с носителем для замедленного высвобождения, обеспечивающим введение лекарственной формы по схеме дважды в день или один раз в день. 19. The method according to any one of paragraphs. 12-18, including obtaining the specified dosage form for oral administration with a carrier for sustained release, providing the introduction of the dosage form according to the scheme twice a day or once a day. 20. Способ по любому из пп. 12 и 17-19, в котором опиоидным антагонистом является налтрексон и опиоидный агонист выбирают из группы, состоящей из гидрокодона при соотношении налтрексон/гидрокодон от примерно 0,03: 1 до примерно 0,27: 1; оксикодона при соотношении налтрексон/оксикодон от примерно 0,037: 1 до примерно 0,296: 1; кодеина при соотношении налтрексон/кодеин от примерно 0,005: 1 до примерно 0,044: 1; гидроморфона при соотношении налтрексон/гидроморфон от примерно 0,148: 1 до примерно 1,185: 1; леворфанола при соотношении налтрексон/леворфанол от примерно 0,278: 1 до примерно 2,222: 1; меперидина при соотношении налтрексон/меперидин от примерно 0,0037: 1 до примерно 0,0296: 1; метадона при соотношении налтрексон/метадон от примерно 0,056: 1 до примерно 0,444: 1; и морфина при соотношении налтрексон/морфин от примерно 0,018: 1 до примерно 0,148: 1. 20. The method according to any one of paragraphs. 12 and 17-19, in which the opioid antagonist is naltrexone and the opioid agonist is selected from the group consisting of hydrocodone with a naltrexone / hydrocodone ratio of from about 0.03: 1 to about 0.27: 1; oxycodone with a naltrexone / oxycodone ratio of from about 0.037: 1 to about 0.296: 1; codeine with a naltrexone / codeine ratio of from about 0.005: 1 to about 0.044: 1; hydromorphone at a naltrexone / hydromorphone ratio of from about 0.148: 1 to about 1.185: 1; levorphanol with a naltrexone / levorphanol ratio of from about 0.278: 1 to about 2.222: 1; meperidine with a naltrexone / meperidine ratio of from about 0.0037: 1 to about 0.0296: 1; methadone with a naltrexone / methadone ratio of from about 0.056: 1 to about 0.444: 1; and morphine with a naltrexone / morphine ratio of from about 0.018: 1 to about 0.148: 1. 21. Способ по любому из пп. 12 и 17-19, в котором опиоидным антагонистом является налтрексон и опиоидный агонист выбирают из группы, состоящей из гидрокодона при соотношении налтрексон/гидрокодон от примерно 0,05: 1 до примерно 0,20: 1; оксикодона при соотношении налтрексон/оксикодон от примерно 0,056: 1 до примерно 0,222: 1; кодеина при соотношении налтрексон/кодеин от примерно 0,0083: 1 до примерно 0,033: 1; гидроморфона при соотношении налтрексон/гидроморфон от примерно 0,222: 1 до примерно 0,889: 1; леворфанола при соотношении налтрексон/леворфанол от примерно 0,417: 1 до примерно 1,667: 1; меперидина при соотношении налтрексон/меперидин от примерно 0,0056: 1 до примерно 0,022: 1; метадона при соотношении налтрексон/метадон от примерно 0,083: 1 до примерно 0,333: 1; и морфина при соотношении налтрексон/морфин от примерно 0,028: 1 до примерно 0,111: 1 21. The method according to any one of paragraphs. 12 and 17-19, wherein the opioid antagonist is naltrexone and the opioid agonist is selected from the group consisting of hydrocodone with a naltrexone / hydrocodone ratio of from about 0.05: 1 to about 0.20: 1; oxycodone with a naltrexone / oxycodone ratio of from about 0.056: 1 to about 0.222: 1; codeine with a naltrexone / codeine ratio of from about 0.0083: 1 to about 0.033: 1; hydromorphone at a naltrexone / hydromorphone ratio of from about 0.222: 1 to about 0.889: 1; levorphanol with a naltrexone / levorphanol ratio of from about 0.417: 1 to about 1.667: 1; meperidine with a naltrexone / meperidine ratio of from about 0.0056: 1 to about 0.022: 1; methadone with a naltrexone / methadone ratio of from about 0.083: 1 to about 0.333: 1; and morphine at a naltrexone / morphine ratio of from about 0.028: 1 to about 0.111: 1
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