RU2019118034A - Способ трансмукозальной доставки лекарства, средство трансмукозальной доставки лекарства (варианты) и способ лечения боли - Google Patents
Способ трансмукозальной доставки лекарства, средство трансмукозальной доставки лекарства (варианты) и способ лечения боли Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4468—Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
Claims (45)
1. Способ доставки фентанила субъекту, включающий:
введение мукоадгезивного биоразлагаемого средства для трансмукозальной доставки лекарства к слизистой оболочке рта субъекта, при этом указанное средство доставки содержит:
биоразлагаемый мукоадгезивный слой, содержащий фентанил в полимерной диффузионной среде, причем указанная полимерная диффузионная среда имеет pH от 6,5 до 8,5; и
полимерную барьерную среду, прилегающую к указанному мукоадгезивному слою, при этом при применении на буккальной поверхности обеспечивается однонаправленный градиент диффузии фентанила,
при этом общая биодоступность фентанила составляет по меньшей мере 60%; и
при этом доставка фентанила происходит менее чем за 30 минут.
2. Способ по п. 1, в котором общая биодоступность фентанила составляет по меньшей мере 70%.
3. Способ по п. 1, в котором полимерная диффузионная среда содержит по меньшей мере один пленкообразующий водоразлагаемый адгезивный полимер и по меньшей мере один биоразлагаемый полимер.
4. Способ по п. 1, в котором указанная полимерная барьерная среда содержит по меньшей мере один пленкообразующий водоразлагаемый полимер.
5. Способ по п. 1, в котором полимерная дуффузионная среда имеет pH от 7 до 7,5.
6. Способ по п. 1, в котором указанное мукоадгезивное биоразлагаемое средство для трансмукозальной доставки лекарства дополнительно содержит опиоидный антагонист.
7. Способ по п. 1, в котором указанное мукоадгезивное биоразлагаемое средство для трансмукозальной доставки лекарства дополнительно содержит третий слой или покрытие.
8. Способ по п. 1, в котором полимерная дуффузионная среда имеет pH, забуференный до значений от 6,5 до 8,5.
9. Способ по п. 1, в котором полимерная диффузионная среда имеет pH, забуференный до значений от 7 до 7,5.
10. Способ по п. 8, в котором общая биодоступность фентанила составляет по меньшей мере 70%.
11. Способ по п. 8, в котором полимерная диффузионная среда содержит по меньшей мере один пленкообразующий водоразлагаемый адгезивный полимер и по меньшей мере один биоадгезивный полимер.
12. Способ по п. 8, в котором указанная полимерная барьерная среда содержит по меньшей мере один пленкообразующий водоразлагаемый полимер.
13. Способ по п. 8, в котором указанное мукоадгезивное биоразлагаемое средство для трансмукозальной доставки лекарства дополнительно содержит опиоидный антагонист.
14. Способ по п. 8, в котором указанное мукоадгезивное биоразлагаемое средство для трансмукозальной доставки лекарства дополнительно содержит третий слой или покрытие.
15. Средство для доставки фентанила субъекту, содержащее:
биоразлагаемый мукоадгезивный слой, содержащий фентанил в полимерной диффузионной среде, причем указанная полимерная диффузионная среда имеет рН от 6,5 до 8,5, и
полимерную барьерную среду, прилегающую к указанному мукоадгезивному слою, при этом при применении на буккальной поверхности субъекта обеспечивается однонаправленный градиент диффузии фентанила и
причем при применении на буккальной поверхности общая биодоступность фентанила составляет по меньшей мере 60%; и
при этом доставка фентанила происходит менее чем за 30 минут.
16. Средство по п. 15, в котором общая биодоступность фентанила составляет по меньшей мере 70%.
17. Средство по п. 15, в котором полимерная дуффузионная среда содержит по меньшей мере один пленкообразующий водоразлагаемый полимер и по меньшей мере один биоразлагаемый полимер.
18. Средство по п. 15, в котором указанная полимерная барьерная среда содержит по меньшей мере один пленкообразующий водоразлагаемый полимер.
19. Средство по п. 15, в котором полимерная дуффузионная среда имеет pH от 7 до 7,5.
20. Средство по п. 15, в котором указанное мукоадгезивное биоразлагаемое средство для трансмукозальной доставки лекарства дополнительно содержит опиоидный антагонист.
21. Средство по п. 15, в котором указанное мукоадгезивное биоразлагаемое средство для трансмукозальной доставки лекарства дополнительно содержит третий слой или покрытие.
22. Средство по п. 15, в котором полимерная дуффузионная среда имеет pH, забуференный до значений от 6,5 до 8,5.
23. Средство по п. 15, в котором полимерная диффузионная среда имеет pH, забуференный до значений от 7 до 7,5.
24. Средство по п. 22, в котором общая биодоступность фентанила составляет по меньшей мере 70%.
25. Средство по п. 22, в котором полимерная диффузионная среда содержит по меньшей мере один пленкообразующий водоразлагаемый адгезивный полимер и по меньшей мере один биоразлагаемый полимер.
26. Средство по п. 22, в котором указанная полимерная барьерная среда содержит по меньшей мере один пленкообразующий водоразлагаемый полимер.
27. Средство по п. 22, в котором указанное мукоадгезивное биоразлагаемое средство для трансмукозальной доставки лекарства дополнительно содержит опиоидный антагонист.
28. Средство по п. 27, в котором указанный опиоидный антагонист представляет собой налоксон.
29. Средство по п. 22, в котором указанное мукоадгезивное биоразлагаемое средство для трансмукозальной доставки лекарства дополнительно содержит третий слой или покрытие.
30. Способ лечения боли, включающий:
адгезивное прикрепление мукоадгезивного биоразлагаемого средства доставки лекарства к буккальной поверхности субъекта, при этом указанное средство доставки содержит:
биоразлагаемый мукоадгезивный слой, содержащий терапевтически эффективное для лечения боли количество фентанила в полимерной диффузионной среде, причем указанная полимерная диффузионная среда имеет pH, забуференный до значений от 6,5 до 8,5, и
полимерную барьерную среду, прилегающую к указанному мукоадгезивному слою, при этом при применении на буккальной поверхности обеспечивается однонаправленный градиент диффузии фентанила,
при этом указанная трансмукозальная доставка фентанила по меньшей мере на 50% осуществляется за счет прямой трансбуккальной абсорбции,
при этом общая биодоступность фентанила составляет по меньшей мере 70%; и
при этом доставка фентанила происходит менее чем за 30 минут.
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
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US83272506P | 2006-07-21 | 2006-07-21 | |
US83272606P | 2006-07-21 | 2006-07-21 | |
US60/832,725 | 2006-07-21 | ||
US60/832,726 | 2006-07-21 | ||
US83950406P | 2006-08-23 | 2006-08-23 | |
US60/839,504 | 2006-08-23 |
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RU2019118034A true RU2019118034A (ru) | 2020-12-10 |
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Application Number | Title | Priority Date | Filing Date |
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RU2009106177/15A RU2504377C2 (ru) | 2006-07-21 | 2007-07-23 | Способ трансмукозальной доставки лекарства, средство трансмукозальной доставки лекарства (варианты) и способ лечения боли |
RU2013141051/15A RU2013141051A (ru) | 2006-07-21 | 2013-09-06 | Способ трансмукозальной доставки лекарства, средство трансмукозальной доставки лекарства (варианты) и способ лечения боли |
RU2019118034A RU2019118034A (ru) | 2006-07-21 | 2019-06-10 | Способ трансмукозальной доставки лекарства, средство трансмукозальной доставки лекарства (варианты) и способ лечения боли |
Family Applications Before (2)
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RU2009106177/15A RU2504377C2 (ru) | 2006-07-21 | 2007-07-23 | Способ трансмукозальной доставки лекарства, средство трансмукозальной доставки лекарства (варианты) и способ лечения боли |
RU2013141051/15A RU2013141051A (ru) | 2006-07-21 | 2013-09-06 | Способ трансмукозальной доставки лекарства, средство трансмукозальной доставки лекарства (варианты) и способ лечения боли |
Country Status (23)
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US (12) | US20100015183A1 (ru) |
EP (3) | EP2054031B1 (ru) |
JP (2) | JP5448814B2 (ru) |
KR (2) | KR101230804B1 (ru) |
CN (2) | CN101511337B (ru) |
AU (1) | AU2007275581B2 (ru) |
BR (2) | BRPI0714712B8 (ru) |
CA (1) | CA2658585C (ru) |
DK (1) | DK2054031T3 (ru) |
ES (1) | ES2577390T3 (ru) |
HK (2) | HK1131344A1 (ru) |
HR (1) | HRP20160405T1 (ru) |
HU (1) | HUE027395T2 (ru) |
IL (2) | IL196529A (ru) |
MX (1) | MX2009000745A (ru) |
NO (3) | NO340668B1 (ru) |
NZ (2) | NZ574361A (ru) |
PL (1) | PL2054031T3 (ru) |
RS (1) | RS54764B1 (ru) |
RU (3) | RU2504377C2 (ru) |
SI (1) | SI2054031T1 (ru) |
WO (1) | WO2008011194A2 (ru) |
ZA (1) | ZA200900485B (ru) |
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