RU2018121855A - Сублингвальные и буккальные пленочные композиции - Google Patents

Сублингвальные и буккальные пленочные композиции Download PDF

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RU2018121855A
RU2018121855A RU2018121855A RU2018121855A RU2018121855A RU 2018121855 A RU2018121855 A RU 2018121855A RU 2018121855 A RU2018121855 A RU 2018121855A RU 2018121855 A RU2018121855 A RU 2018121855A RU 2018121855 A RU2018121855 A RU 2018121855A
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buprenorphine
film
pharmaceutically acceptable
acceptable salt
naloxone
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Гарри Л. МАЙЕРС
Сэмюэл Д. ХИЛБЕРТ
Билл Дж. БУН
Б. Арли БОУГ
Прадип САНГХВИ
Мадхусудан ХАРИХАРАН
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Индивиор ЮКей Лимитед
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    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
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    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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Claims (55)

1. Мукоадгезивная пленка для сублингвального или буккального введения, содержащая:
а. по меньшей мере 25 мас.% водорастворимого полимера, выбранного из группы, включающей полиэтиленоксид, пуллулан, гидроксипропилметилцеллюлозу, гидроксиэтилцеллюлозу, гидроксипропилцеллюлозу, поливинилпирролидон, карбоксиметилцеллюлозу, поливиниловый спирт, альгинат натрия, полиэтиленгликоль, ксантановую камедь, трагакантовую камедь, гуаровую камедь, гуммиарабик, аравийскую камедь, полиакриловую кислоту, сополимер метилметакрилата, сополимеры карбоксивинила, крахмал, желатин и их сочетания от двух и более;
б. от примерно 2 мг до примерно 16 мг бупренорфина или его фармацевтически приемлемой соли;
в. налоксон или его фармацевтически приемлемую соль, где весовое соотношение бупренорфина к налоксону составляет от 6:1 до 2:1; и
г. буфер в таком количестве, где весовое соотношение буфера к бупренорфину составляет от примерно 2:1 до примерно 1:5.
2. Пленка по п.1, где весовое соотношение бупренорфина к налоксону составляет от примерно 4:1.
3. Пленка по п.1, где пленка содержит:
(i) около 2 мг бупренорфина или его фармацевтически приемлемой соли;
(ii) около 4 мг бупренорфина или его фармацевтически приемлемой соли;
(iii) около 8 мг бупренорфина или его фармацевтически приемлемой соли; или
(iv) около 12 мг бупренорфина или его фармацевтически приемлемой соли.
4. Пленка по п.1, где буфер обеспечивает локальное значение pH пленки от приблизительно 3 до приблизительно 4.
5. Пленка по п.1, где буфер обеспечивает локальное значение pH пленки от приблизительно 3 до приблизительно 3,5
6. Пленка по п.1, где водорастворимый полимер включает полиэтиленоксид.
7. Пленка по п.6, где водорастворимый полимер дополнительно включает гидроксипропилметилцеллюлозу, гидроксиэтилцеллюлозу, гидроксипропилцеллюлозу или их комбинацию от двух и более.
8. Пленка по п.1, где буфер включает цитрат натрия, лимонную кислоту иди их сочетание
9. Пленка по п.1, где указанный буфер содержит уксусную кислоту, ацетат натрия и их сочетания.
10. Пленка по п.1, где пленка включает состав (i), (ii), (iii) или (iv):
Компоненты Состав (мг) (i) (ii) (iii) (iv) Бупренорфин HCl 17,28 12.96 8,64 2,16 Налоксон НCl дигидрат 4,88 3,66 2,44 0,61 Полиэтиленоксид (MW 200000) 27,09 20,32 13,55 0 Полиэтиленоксид (MW 100000) 12,04 9,03 6,02 19,06 Полиэтиленоксид (MW 900000) 4,82 3,62 2,41 2,05 Мальтит 12,04 9,03 6,02 5,87 Вкусоароматическая добавка 6,0 4,5 3,0 2,4 Лимонная кислота 5,92 4,44 2,96 2,96 Гидросипропилцеллюлоза 4,22 3,16 2,11 2,34 Ацесульфам калия (Ace-K) 3,0 2,25 1,5 1,2 Цитрат натрия 2,68 2,01 1,34 1,34 Краситель 0,03 0,02 0,01 0,01
11. Способ лечения наркотической зависимости пользователя, включающий стадии:
а. предоставление мукоадгезивной пленки, содержащей:
i. по меньшей мере 25 мас.% водорастворимого полимера, выбранного из группы, включающей полиэтиленоксид, пуллулан, гидроксипропилметилцеллюлозу, гидроксиэтилцеллюлозу, гидроксипропилцеллюлозу, поливинилпирролидон, карбоксиметилцеллюлозу, поливиниловый спирт, альгинат натрия, полиэтиленгликоль, ксантановую камедь, трагакантовую камедь, гуаровую камедь, гуммиарабик, аравийскую камедь, полиакриловую кислоту, сополимер метилметакрилата, сополимеры карбоксивинила, крахмал, желатин и их сочетания от двух или более;
ii. от примерно 2 мг до примерно 16 мг бупренорфина или его фармацевтически приемлемой соли;
iii. налоксон или его фармацевтически приемлемую соль, где весовое соотношение бупренорфина к налоксону составляет от 6:1 до 2:1; и
iv. буфер в таком количестве, где весовое соотношение буфера к бупренорфину составляет от примерно 2:1 до примерно 1:5; и
б. сублингвальное или буккального введение мукоадгезивной пленки в полость рта пользователя.
12. Способ по п.11, где способ обеспечивает среднее AUC от приблизительно 5,431 час*нг/мл до приблизительно 56,238 час*нг/мл для бупренорфина; и обеспечивает среднее AUC от приблизительно 102,88 час*пг/мл до приблизительно 812,00 час*пг/мл для налоксона.
13. Способ по п.11, где способ обеспечивает in vivo кривую содержания в плазме, имеющую Cmax от приблизительно 0,624 нг/мл до приблизительно 5,638 нг/мл для бупренорфина и in vivo кривую содержания в плазме, имеющую Cmax от приблизительно 41,04 пг/мл до приблизительно 323,75 пг/мл для налоксона.
14. Способ по п.11, где пленка имеет весовое соотношение бупренорфина к налоксону составляет от примерно 4:1.
15. Способ по п.11, где пленка содержит:
(i) около 2 мг бупренорфина или его фармацевтически приемлемой соли;
(ii) около 4 мг бупренорфина или его фармацевтически приемлемой соли;
(iii) около 8 мг бупренорфина или его фармацевтически приемлемой соли; или
(iv) около 12 мг бупренорфина или его фармацевтически приемлемой соли.
16. Способ по п.11, где буфер обеспечивает локальное значение pH пленки от приблизительно 3 до приблизительно 4.
17. Способ по п.11, где буфер обеспечивает локальное значение pH пленки от приблизительно 3 до приблизительно 3,5
18. Способ по п.11, где водорастворимый полимер включает полиэтиленоксид.
19. Способ по п.11, где водорастворимый полимер дополнительно включает гидроксипропилметилцеллюлозу, гидроксиэтилцеллюлозу, гидроксипропилцеллюлозу или их комбинацию от двух и более.
20. Способ формирования мукоадгезивной пленки, включающий стадии:
а. Отливка пленки из композиции для пленочной лекарственной формы, содержащей:
i. по меньшей мере 25 мас.% от указанной композиции водорастворимого полимера, выбранного из группы, включающей полиэтиленоксид, пуллулан, гидроксипропилметилцеллюлозу, гидроксиэтилцеллюлозу, гидроксипропилцеллюлозу, поливинилпирролидон, карбоксиметилцеллюлозу, поливиниловый спирт, альгинат натрия, полиэтиленгликоль, ксантановую камедь, трагакантовую камедь, гуаровую камедь, гуммиарабик, аравийскую камедь, полиакриловую кислоту, сополимер метилметакрилата, сополимеры карбоксивинила, крахмал, желатин и их сочетания от двух и более;
ii. от примерно 2 мг до примерно 16 мг бупренорфина или его фармацевтически приемлемой соли;
iii. налоксон или его фармацевтически приемлемую соль, где весовое соотношение бупренорфина к налоксону составляет от 6:1 до 2:1; и
iv. буфер в таком количестве, где весовое соотношение буфера к бупренорфину составляет от примерно 2:1 до примерно 1:5; и
б. Сушка указанной пленкообразующей композиции с формированием самоподдерживающейся пленки из композиции для пленочной лекарственной формы.
21. Способ по п.20, где пленка имеет весовое соотношение бупренорфина к налоксону составляет от примерно 4:1.
22. Способ по п.20, где пленка содержит:
(i) около 2 мг бупренорфина или его фармацевтически приемлемой соли;
(ii) около 4 мг бупренорфина или его фармацевтически приемлемой соли;
(iii) около 8 мг бупренорфина или его фармацевтически приемлемой соли; или
(iv) около 12 мг бупренорфина или его фармацевтически приемлемой соли.
23. Способ по п.20, где буфер обеспечивает локальное значение pH пленки от приблизительно 3 до приблизительно 4.
24. Способ по п.20, где буфер обеспечивает локальное значение pH пленки от приблизительно 3 до приблизительно 3,5
25. Способ по п.20, где водорастворимый полимер включает полиэтиленоксид.
26. Способ по п.20, где водорастворимый полимер дополнительно включает гидроксипропилметилцеллюлозу, гидроксиэтилцеллюлозу, гидроксипропилцеллюлозу или их комбинацию от двух и более.
RU2018121855A 2009-08-07 2010-08-05 Сублингвальные и буккальные пленочные композиции RU2018121855A (ru)

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US12/537,571 US8475832B2 (en) 2009-08-07 2009-08-07 Sublingual and buccal film compositions
US12/537,571 2009-08-07

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