RU2019133676A - Новые композиции и способы - Google Patents
Новые композиции и способы Download PDFInfo
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- RU2019133676A RU2019133676A RU2019133676A RU2019133676A RU2019133676A RU 2019133676 A RU2019133676 A RU 2019133676A RU 2019133676 A RU2019133676 A RU 2019133676A RU 2019133676 A RU2019133676 A RU 2019133676A RU 2019133676 A RU2019133676 A RU 2019133676A
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- 239000000203 mixture Substances 0.000 title claims 33
- 150000001875 compounds Chemical class 0.000 claims 15
- 150000003839 salts Chemical class 0.000 claims 11
- 239000012458 free base Substances 0.000 claims 10
- LMBFAGIMSUYTBN-MPZNNTNKSA-N teixobactin Chemical compound C([C@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CO)C(=O)N[C@H](CCC(N)=O)C(=O)N[C@H]([C@@H](C)CC)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CO)C(=O)N[C@H]1C(N[C@@H](C)C(=O)N[C@@H](C[C@@H]2NC(=N)NC2)C(=O)N[C@H](C(=O)O[C@H]1C)[C@@H](C)CC)=O)NC)C1=CC=CC=C1 LMBFAGIMSUYTBN-MPZNNTNKSA-N 0.000 claims 7
- 239000013078 crystal Substances 0.000 claims 6
- 229920000642 polymer Polymers 0.000 claims 5
- 125000001255 4-fluorophenyl group Chemical group [H]C1=C([H])C(*)=C([H])C([H])=C1F 0.000 claims 4
- -1 7H-pyrido [3 ', 4': 4,5] pyrrolo [1,2,3-de] quinoxalin-8-yl Chemical group 0.000 claims 4
- 239000007921 spray Substances 0.000 claims 4
- HOIIHACBCFLJET-SFTDATJTSA-N 4-((6br,10as)-3-methyl-2,3,6b,9,10,10a-hexahydro-1h-pyrido-[3',4':4,5]-pyrrolo[1,2,3-de]quinoxalin-8-(7h)-yl)-1-(4-fluorophenyl)-1-butanone Chemical compound C([C@@H]1N2CCN(C=3C=CC=C(C2=3)[C@@H]1C1)C)CN1CCCC(=O)C1=CC=C(F)C=C1 HOIIHACBCFLJET-SFTDATJTSA-N 0.000 claims 2
- 229920000881 Modified starch Polymers 0.000 claims 2
- 239000011859 microparticle Substances 0.000 claims 2
- 239000002245 particle Substances 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 239000003826 tablet Substances 0.000 claims 2
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 claims 1
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims 1
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 claims 1
- GOOHAUXETOMSMM-UHFFFAOYSA-N Propylene oxide Chemical compound CC1CO1 GOOHAUXETOMSMM-UHFFFAOYSA-N 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 150000007513 acids Chemical class 0.000 claims 1
- 239000003963 antioxidant agent Substances 0.000 claims 1
- 239000002585 base Substances 0.000 claims 1
- 239000011230 binding agent Substances 0.000 claims 1
- 229940002226 buccal film Drugs 0.000 claims 1
- 239000006172 buffering agent Substances 0.000 claims 1
- 239000002274 desiccant Substances 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- 239000000796 flavoring agent Substances 0.000 claims 1
- 235000019634 flavors Nutrition 0.000 claims 1
- 235000003599 food sweetener Nutrition 0.000 claims 1
- 239000003349 gelling agent Substances 0.000 claims 1
- 239000003906 humectant Substances 0.000 claims 1
- 235000019426 modified starch Nutrition 0.000 claims 1
- 239000000178 monomer Substances 0.000 claims 1
- 210000004400 mucous membrane Anatomy 0.000 claims 1
- 229940041672 oral gel Drugs 0.000 claims 1
- 229940041678 oral spray Drugs 0.000 claims 1
- 239000000668 oral spray Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000004014 plasticizer Substances 0.000 claims 1
- 229920005862 polyol Polymers 0.000 claims 1
- 150000003077 polyols Chemical class 0.000 claims 1
- 229920005989 resin Polymers 0.000 claims 1
- 239000011347 resin Substances 0.000 claims 1
- 239000006190 sub-lingual tablet Substances 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
- 229940098466 sublingual tablet Drugs 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 239000003765 sweetening agent Substances 0.000 claims 1
- 239000002562 thickening agent Substances 0.000 claims 1
- JOXIMZWYDAKGHI-UHFFFAOYSA-N toluene-4-sulfonic acid Chemical compound CC1=CC=C(S(O)(=O)=O)C=C1 JOXIMZWYDAKGHI-UHFFFAOYSA-N 0.000 claims 1
- 239000000080 wetting agent Substances 0.000 claims 1
- 229920001285 xanthan gum Polymers 0.000 claims 1
- 235000010493 xanthan gum Nutrition 0.000 claims 1
- 239000000230 xanthan gum Substances 0.000 claims 1
- 229940082509 xanthan gum Drugs 0.000 claims 1
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
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Claims (20)
1. Трансмукозальная фармацевтическая композиция, включающая 1-(4-фтор-фенил)-4-((6bR,10aS)-3-метил-2,3,6b,9,10,10a-гексагидро-1H,7H-пиридо[3′,4′:4,5]пирроло[1,2,3-de]хиноксалин-8-ил)-бутан-1-он (Соединение формулы I) в форме свободного основания, со-кристалла или соли, или включающая 1-(4-фтор-фенил)-4-((6bR,10aS)-2,2-d2-3-метил-2,3,6b,9,10,10a-гексагидро-1H,7H-пиридо[3′,4′:4,5]пирроло[1,2,3-de]хиноксалин-8-ил)-бутан-1-он (Соединение формулы II) в форме свободного основания, со-кристалла или соли, или включающая -(4-фтор-фенил)-4-((6bR,10aS)-1,1,2,2-d4-3-метил-2,3,6b,9,10,10a-гексагидро-1H,7H-пиридо[3′,4′:4,5]пирроло[1,2,3-de]хиноксалин-8-ил)-бутан-1-он (Соединение формулы III) в форме свободного основания, со-кристалла или соли.
2. Композиция по п. 1, где композиция включает соединение формулы I или соединение формулы II или соединение формулы III в форме свободного основания.
3. Композиция по п. 1, где композиция включает соединение формулы I или соединение формулы II или соединение формулы III в форме соли, например, в форме фармацевтически приемлемой соли.
4. Композиция по п. 3, где солевая форма представляет собой тозилат, например, в форме кристаллической соли.
5. Композиция по любому из предшествующих пунктов, где композиция включает от 0,01 до 10 мг соединения формулы I (эквивалент свободного основания) или соединения формулы II (эквивалент свободного основания) или соединения формулы III (эквивалент свободного основания).
6. Композиция по любому из предшествующих пунктов, дополнительно включающая один или несколько гидрофильных водорастворимых или набухающих в воде полимеров.
7. Композиция по п. 6, где полимер выбран из группы, состоящей из природных или модифицированных целлюлозных полимеров, полимеров этиленоксида и/или пропиленоксида, полимеров, включающих мономеры акриловой кислоты, природных или модифицированных смол (например, ксантановой камеди), природных или модифицированных крахмалов (например, предварительно желатинизированных крахмалов) или любой их смеси.
8. Композиция по любому из предшествующих пунктов, дополнительно включающая один или несколько эксципиентов, выбранных из группы, состоящей из пластификаторов, поверхностно-активных веществ, осушителей, ароматизаторов, подсластителей, связующих, разрыхлителей, увлажнителей (например, полиолов), смачивающих агентов, антиоксидантов, буферных агентов (например, кислот, оснований и/или их солей) и загустителей (например, гелеобразующих агентов).
9. Композиция по любому из предшествующих пунктов, где композиция представляет собой быстрорастворимую таблетку или облатку, например сублингвальную таблетку или облатку.
10. Композиция по любому из пп. 1-8, где композиция представляет собой пероральный спрей, например сублингвальный спрей или буккальный спрей.
11. Композиция по любому из пп. 1-8, где композиция представляет собой быстрорастворимую пленку, например сублингвальную пленку или буккальную пленку.
12. Композиция по п. 11, где пленка имеет однородную или по существу однородную толщину.
13. Композиция по п. 11 или 12, где соединение формулы I или II или III равномерно или по существу равномерно распределено по всей пленке.
14. Композиция по любому из пп. 1-8, где композиция представляет собой интраназальный спрей.
15. Композиция по любому из пп. 1-8, где композиция представляет собой пероральный гель, например быстрорастворимый сублингвальный или буккальный гель.
16. Композиция по любому из пп. 1-8, где композиция представляет собой интравагинальную композицию, например интравагинальную быстрорастворимую таблетку, облатку или гель, или интравагинальный спрей, или интравагинальную быстрорастворимую пленку.
17. Композиция по любому из предшествующих пунктов, где соединение формулы I, или соединение формулы II, или соединение формулы III включено в композицию в виде микрочастиц (например, частиц, имеющих средний диаметр менее 50 мкм, менее 30 мкм, менее 10 мкм или менее 5 мкм, или менее 1 мкм).
18. Композиция по любому из предшествующих пунктов, где соединение формулы I, или соединение формулы II, или соединение формулы III включено в композицию в виде микрочастиц (например, частиц, имеющих средний диаметр менее 100 нм, менее 50 нм или менее 10 нм).
19. Композиция по любому из предшествующих пунктов, где композиция абсорбируется слизистой оболочкой (например, растворяется) менее чем через 30 секунд после введения.
20. Подкожная фармацевтическая композиция, включающая 1-(4-фтор-фенил)-4-((6bR,10aS)-3-метил-2,3,6b,9,10,10a-гексагидро-1H,7H-пиридо[3′,4′:4,5]пирроло[1,2,3-de]хиноксалин-8-ил)-бутан-1-он (Соединение формулы I) в форме свободного основания, со-кристалла или соли, или включающая 1-(4-фтор-фенил)-4-((6bR,10aS)-2,2-d2-3-метил-2,3,6b,9,10,10a-гексагидро-1H,7H-пиридо[3′,4′:4,5]пирроло[1,2,3-de]хиноксалин-8-ил)-бутан-1-он (Соединение формулы II) в форме свободного основания, со-кристалла или соли, или включающая 1-(4-фтор-фенил)-4-((6bR,10aS)-1,1,2,2-d4-3-метил-2,3,6b,9,10,10a-гексагидро-1H,7H-пиридо[3′,4′:4,5]пирроло[1,2,3-de]хиноксалин-8-ил)-бутан-1-он (Соединение формулы III) в форме свободного основания, со-кристалла или соли.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
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