RU2009106177A - Способ трансмукозальной доставки лекарств, средство для его осуществления (варианты) и способ лечения боли - Google Patents
Способ трансмукозальной доставки лекарств, средство для его осуществления (варианты) и способ лечения боли Download PDFInfo
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- RU2009106177A RU2009106177A RU2009106177/15A RU2009106177A RU2009106177A RU 2009106177 A RU2009106177 A RU 2009106177A RU 2009106177/15 A RU2009106177/15 A RU 2009106177/15A RU 2009106177 A RU2009106177 A RU 2009106177A RU 2009106177 A RU2009106177 A RU 2009106177A
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- fentanyl
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- buprenorphine
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- 238000000034 method Methods 0.000 title claims abstract 20
- 208000002193 Pain Diseases 0.000 title claims abstract 17
- 239000003814 drug Substances 0.000 title 1
- 229960002428 fentanyl Drugs 0.000 claims abstract 37
- RMRJXGBAOAMLHD-IHFGGWKQSA-N buprenorphine Chemical compound C([C@]12[C@H]3OC=4C(O)=CC=C(C2=4)C[C@@H]2[C@]11CC[C@]3([C@H](C1)[C@](C)(O)C(C)(C)C)OC)CN2CC1CC1 RMRJXGBAOAMLHD-IHFGGWKQSA-N 0.000 claims abstract 34
- 229960001736 buprenorphine Drugs 0.000 claims abstract 17
- 239000013543 active substance Substances 0.000 claims abstract 12
- 238000009792 diffusion process Methods 0.000 claims abstract 9
- 238000012377 drug delivery Methods 0.000 claims abstract 8
- 229920002807 Thiomer Polymers 0.000 claims abstract 7
- 238000010521 absorption reaction Methods 0.000 claims abstract 5
- 230000004888 barrier function Effects 0.000 claims abstract 4
- 210000000214 mouth Anatomy 0.000 claims abstract 4
- 208000000094 Chronic Pain Diseases 0.000 claims abstract 3
- 208000005298 acute pain Diseases 0.000 claims abstract 3
- IVLVTNPOHDFFCJ-UHFFFAOYSA-N fentanyl citrate Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O.C=1C=CC=CC=1N(C(=O)CC)C(CC1)CCN1CCC1=CC=CC=C1 IVLVTNPOHDFFCJ-UHFFFAOYSA-N 0.000 claims 53
- 206010010774 Constipation Diseases 0.000 claims 2
- 208000025865 Ulcer Diseases 0.000 claims 2
- 229960004207 fentanyl citrate Drugs 0.000 claims 2
- 238000001727 in vivo Methods 0.000 claims 2
- 230000007794 irritation Effects 0.000 claims 2
- 238000007726 management method Methods 0.000 claims 2
- 210000004877 mucosa Anatomy 0.000 claims 2
- 210000004400 mucous membrane Anatomy 0.000 claims 2
- 230000036470 plasma concentration Effects 0.000 claims 2
- 230000009885 systemic effect Effects 0.000 claims 2
- 230000036269 ulceration Effects 0.000 claims 2
- 206010058019 Cancer Pain Diseases 0.000 claims 1
- 210000002200 mouth mucosa Anatomy 0.000 claims 1
- 230000003232 mucoadhesive effect Effects 0.000 claims 1
- 229920000642 polymer Polymers 0.000 claims 1
- PJMPHNIQZUBGLI-UHFFFAOYSA-N fentanyl Chemical compound C=1C=CC=CC=1N(C(=O)CC)C(CC1)CCN1CCC1=CC=CC=C1 PJMPHNIQZUBGLI-UHFFFAOYSA-N 0.000 abstract 11
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- 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
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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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
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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
- A61K9/0012—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
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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
- A61K9/7007—Drug-containing films, membranes or sheets
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- 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
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- 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
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- 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
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- 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]
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- 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
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Abstract
1. Способ прямой трансмукозальной доставки фентанила, производного фентанила, бупренорфина или производного бупренорфина в организм субъекта, включающий наложение на слизистую поверхность ротовой полости субъекта биоразлагаемого средства доставки лекарства, содержащего фентанил, производное фентанила, бупренорфин или производное бупренорфина, которые помещают в мукоадгезивную полимерную диффузионную среду, относительно которой располагают барьерную среду с однонаправленным градиентом при наложении на слизистую поверхность для доставки фентанила, производного фентанила, бупренорфина или производного бупренорфина в организм субъекта. ! 2. Способ по п.1, в котором при наложении на слизистую поверхность ротовой полости субъекта биоразлагаемого средства доставки лекарства облегчают хроническую боль, или острую боль, или оба типа боли. ! 3. Способ по п.1, в котором средство характеризуется значением рН мукоадгезивной полимерной диффузионной среды в интервале между приблизительно 4,0 и приблизительно 7,5 для активного вещества в виде бупренорфина или производного бупренорфина или в интервале между приблизительно 6,5 и приблизительно 8 для активного вещества в виде фентанила или производного фентанила. ! 4. Способ по п.1, в котором фентанил, содержащийся в указанном средстве доставки лекарства, является системно доступным при абсорбции слизистой оболочкой более 30%. ! 5. Способ лечения боли у субъекта, включающий трансмуказальное введение в организм указанного субъекта терапевтически эффективного количества фентанила, производного фентанила, бупренорфина или производного бупренорфина, которые помещают в м�
Claims (27)
1. Способ прямой трансмукозальной доставки фентанила, производного фентанила, бупренорфина или производного бупренорфина в организм субъекта, включающий наложение на слизистую поверхность ротовой полости субъекта биоразлагаемого средства доставки лекарства, содержащего фентанил, производное фентанила, бупренорфин или производное бупренорфина, которые помещают в мукоадгезивную полимерную диффузионную среду, относительно которой располагают барьерную среду с однонаправленным градиентом при наложении на слизистую поверхность для доставки фентанила, производного фентанила, бупренорфина или производного бупренорфина в организм субъекта.
2. Способ по п.1, в котором при наложении на слизистую поверхность ротовой полости субъекта биоразлагаемого средства доставки лекарства облегчают хроническую боль, или острую боль, или оба типа боли.
3. Способ по п.1, в котором средство характеризуется значением рН мукоадгезивной полимерной диффузионной среды в интервале между приблизительно 4,0 и приблизительно 7,5 для активного вещества в виде бупренорфина или производного бупренорфина или в интервале между приблизительно 6,5 и приблизительно 8 для активного вещества в виде фентанила или производного фентанила.
4. Способ по п.1, в котором фентанил, содержащийся в указанном средстве доставки лекарства, является системно доступным при абсорбции слизистой оболочкой более 30%.
5. Способ лечения боли у субъекта, включающий трансмуказальное введение в организм указанного субъекта терапевтически эффективного количества фентанила, производного фентанила, бупренорфина или производного бупренорфина, которые помещают в мукоадгезивную полимерную диффузионную среду при доставке эффективного количества фентанила, производного фентанила, бупренорфина или производного бупренорфина в организм субъекта за период времени менее чем приблизительно 30 мин.
6. Способ по п.5, в котором у субъекта наступает облегчение хронической боли, или острой боли, или обоих типов боли.
7. Способ по п.5, в котором боль представляет собой внезапную неконтролируемую раковую боль.
8. Способ, по п.5, в котором мукоадгезивная полимерная диффузионная среда характеризуется значением рН в интервале между приблизительно 4,0 и приблизительно 7,5 для активного вещества в виде бупренорфина или производного бупренорфина или в интервале между приблизительно 6,5 и приблизительно 8 для активного вещества в виде фентанила или производного фентанила.
9. Способ по п.5, в котором мукоадгезивная полимерная диффузионная среда характеризуется значением рН приблизительно 6,0 для активного вещества в виде бупренорфина или производного бупренорфина или приблизительно 7,25, для активного вещества в виде фентанила или производного фентанила.
10. Способ по п.5, в котором в состав средства доставки включают фентанил в количестве приблизительно 800 мкг.
11. Способ по п.5, в котором фентанил используют в виде цитрата фентанила.
12. Способ по п.5, в котором фентанил, содержащийся в указанном средстве доставки лекарства является системно доступным при абсорбции слизистой оболочкой более 30%.
13. Способ по п.5, в котором фентанил, содержащийся в указанном средстве доставки лекарства, является системно доступным более 55%.
14. Мукоадгезивное средство доставки посредством прямого трансмукозального введения эффективного количества фентанила, производного фентанила, бупренорфина или производного бупренорфина в организм субъекта, состоящее из фентанила, производного фентанила, бупренорфина или производного бупренорфина, помещенных в полимерную диффузионную среду, и из барьерной среды, расположенной относительно полимерной диффузионной среды с созданием однонаправленного градиента при наложении указанного средства на слизистую поверхность.
15. Средство по п.14, характеризующееся значением рН мукоадгезивной полимерной диффузионной среды в интервале между приблизительно 4,0 и приблизительно 7,5 для активного вещества в виде бупренорфина или производного бупренорфина или в интервале между приблизительно 6,5 и приблизительно 8 для активного вещества в виде фентанила или производного фентанила.
16. Средство по п.14, характеризующееся значением рН мукоадгезивной полимерной диффузионной среды приблизительно 6,0 для активного вещества в виде бупренорфина или производного бупренорфина или приблизительно 7,25, для активного вещества в виде фентанила или производного фентанила.
17. Средство по п.14, характеризующееся содержанием приблизительно 800 мкг фентанила в средстве.
18. Средство по п.14, характеризующееся содержанием в средстве фентанила в виде цитрата фентанила.
19. Средство по п.14, характеризующееся системной доступностью фентанила в средстве при абсорбции слизистой оболочкой более 30%.
20. Средство по п.14, характеризующееся системной доступностью фентанила в средстве более 55%.
21. Средство по п.14, характеризующееся при прямой трансмукозальной доставке фентанила или производного фентанила к слизистой оболочке начальным облегчением боли (Тнач) за время приблизительно 0,20 ч или менее и максимальной концентрацией в плазме (Тмакс) за время приблизительно 1,6 ч или более.
22. Средство по п.14, характеризующееся при трансмукозальном введении в организм субъекта приблизительно 800 мкг фентанила, по меньшей мере одним in vivo профилем в плазме крови, выбранным из группы, включающей Смакс равно по меньшей мере приблизительно 1,10 нг/мл, Тнач равно не более приблизительно 0,20 часов, и AUC0-24 равно по меньшей мере приблизительно 10,00 ч·нг/мл.
23. Средство по п.14, характеризующееся эффективным для лечения боли количеством фентанила или производного фентанила при отсутствии или незначительной степени раздражения или изъязвления ротовой полости и/или констипации, связанных с фентанилом или производным фентанила.
24. Средство трансмукозальной доставки фентанила или производного фентанила в организм, характеризующееся прямой трансбуккальной абсорбцией на уровне по меньшей мере 50% и абсолютной биодоступностью на уровне по меньшей мере приблизительно 70%.
25. Средство трансмукозальной доставки фентанила или производного фентанила прямо к слизистой оболочке, характеризующееся начальным облегчением боли (Тнач) за время приблизительно 0,20 ч или менее и максимальной концентрацией в плазме (Тмакс) за время приблизительно 1,6 ч или более.
26. Средство трансмукозальной доставки приблизительно 800 мкг фентанила, характеризующееся при трансмукозальном введении в организм субъекта по меньшей мере одним in vivo профилем в плазме крови, выбранным из группы, включающей Смакс равно по меньшей мере приблизительно 1,10 нг/мл, Тнач равно не более приблизительно 0,20 ч, и AUC0-24 равно по меньшей мере приблизительно 10,00 ч·нг/мл.
27. Средство трансмукозальной доставки фентанила или производного фентанила, характеризующееся эффективным для лечения боли количеством фентанила или производного фентанила при отсутствии или незначительной степени раздражения или изъязвления ротовой полости и/или констипации, связанных с фентанилом или производным фентанила.
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US83272606P | 2006-07-21 | 2006-07-21 | |
| US83272506P | 2006-07-21 | 2006-07-21 | |
| US60/832,726 | 2006-07-21 | ||
| US60/832,725 | 2006-07-21 | ||
| US83950406P | 2006-08-23 | 2006-08-23 | |
| US60/839,504 | 2006-08-23 | ||
| PCT/US2007/016634 WO2008011194A2 (en) | 2006-07-21 | 2007-07-23 | Transmucosal delivery devices with enhanced uptake |
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| RU2013141051/15A Division RU2013141051A (ru) | 2006-07-21 | 2013-09-06 | Способ трансмукозальной доставки лекарства, средство трансмукозальной доставки лекарства (варианты) и способ лечения боли |
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| Publication Number | Publication Date |
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| RU2009106177A true RU2009106177A (ru) | 2010-08-27 |
| RU2504377C2 RU2504377C2 (ru) | 2014-01-20 |
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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 |
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| RU2019118034A RU2019118034A (ru) | 2006-07-21 | 2019-06-10 | Способ трансмукозальной доставки лекарства, средство трансмукозальной доставки лекарства (варианты) и способ лечения боли |
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