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- JP2015500886A5 JP2015500886A5 JP2014548962A JP2014548962A JP2015500886A5 JP 2015500886 A5 JP2015500886 A5 JP 2015500886A5 JP 2014548962 A JP2014548962 A JP 2014548962A JP 2014548962 A JP2014548962 A JP 2014548962A JP 2015500886 A5 JP2015500886 A5 JP 2015500886A5
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- Prior art keywords
- mucoadhesive
- drug delivery
- delivery device
- bioerodible
- buprenorphine
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- 230000003232 mucoadhesive Effects 0.000 claims description 51
- 229940089114 Drug Delivery Device Drugs 0.000 claims description 41
- RMRJXGBAOAMLHD-CTAPUXPBSA-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-CTAPUXPBSA-N 0.000 claims description 33
- 229960001736 buprenorphine Drugs 0.000 claims description 33
- 229920000642 polymer Polymers 0.000 claims description 15
- 238000009792 diffusion process Methods 0.000 claims description 14
- 208000002193 Pain Diseases 0.000 claims description 12
- 230000003364 opioid Effects 0.000 claims description 11
- 208000008035 Back Pain Diseases 0.000 claims description 10
- 208000000094 Chronic Pain Diseases 0.000 claims description 9
- 231100000486 side effect Toxicity 0.000 claims description 7
- 208000008930 Low Back Pain Diseases 0.000 claims description 5
- 230000001684 chronic Effects 0.000 claims description 5
- 206010010774 Constipation Diseases 0.000 claims description 4
- 206010028813 Nausea Diseases 0.000 claims description 4
- 210000002381 Plasma Anatomy 0.000 claims description 4
- 208000004296 Neuralgia Diseases 0.000 claims description 3
- 230000003349 osteoarthritic Effects 0.000 claims description 3
- 230000035839 C max Effects 0.000 claims description 2
- 239000003814 drug Substances 0.000 claims 6
- 229940079593 drugs Drugs 0.000 claims 6
- 206010019233 Headache Diseases 0.000 claims 3
- 231100000869 headache Toxicity 0.000 claims 3
- 206010047700 Vomiting Diseases 0.000 claims 2
- 230000035533 AUC Effects 0.000 claims 1
- 208000002173 Dizziness Diseases 0.000 claims 1
- 230000000275 pharmacokinetic Effects 0.000 description 3
- 238000000034 method Methods 0.000 description 2
- 210000004369 Blood Anatomy 0.000 description 1
- 229940005483 OPIOID ANALGESICS Drugs 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
Description
実施例3.BEMAブプレノルフィンの薬物動態プロファイル
慢性疼痛の治療において使用されたBEMAブプレノルフィン薬用量の薬物動態パラメータが、別々の、多数の薬用量研究において測定された。BEMAブプレノルフィンは2×Aμg及び4×Aμgのブプレノルフィン薬用量を含んだ。各薬用量は1日に2回、3日間投与され、連続血液サンプルが採取された。選択された薬物動態パラメータを以下の表16に示す。
(1) 慢性疼痛を治療する方法であって、治療を必要とする被検体に粘膜付着性生体侵食性薬物送達デバイスを投与することを含んでおり、
デバイスは１日に２回投与され、ここで、デバイスは約100μg〜約0.9mgのブプレノルフィンを含み、
デバイスが、被検体の慢性疼痛が治療されるように、約0.1〜約1.2ng/mLの範囲の血漿中ブプレノルフィン濃度の定常状態C max を提供する、前記方法。
(2) デバイスが１日に１回投与される、(1)に記載の方法。
(3) 慢性疼痛が慢性的な腰痛である、(1)又は(2)に記載の方法。
(4) 慢性的な腰痛が中等度から重度の慢性的な腰痛である、(1)〜(3)のいずれかに記載の方法。
(5) 被検体がいずれの重度の共通したオピオイド副作用を経験することなく治療される、(1)〜(4)のいずれかに記載の方法。
(6) 被検体が軽度のもしくは中等度の共通したオピオイド副作用を経験して、又は共通したオピオイド副作用を経験しないで治療される、(1)〜(5)のいずれかに記載の方法。
(7) 患者が重大な便秘症がなく治療される、(1)〜(6)のいずれかに記載の方法。
(8) 被検体が重大な吐き気がなく治療される、(1)〜(7)のいずれかに記載の方法。
(9) 被検体がオピオイド未経験である、(1)〜(8)のいずれかに記載の方法。
(10) 被検体がオピオイド経験である、(1)〜(9)のいずれかに記載の方法。
(11) 被検体に投与されるブプレノルフィンの1日の総投薬量が、200μg、220μg、240μg、280μg、300μg、320μg、350μg、360μg、400μg、450μg、480μg、500μg、550μg、600μg、620μg、650μg、700μg、720μg、750μg、800μg、860μg、900μg、960μg、1000μg、1100μg、1200μg、1250μg、1300μg、1400μg、1500μg、1600μg及び1800μgのブプレノルフィンからなる群より選択される、(1)〜(10)のいずれかに記載の方法。
(12) デバイスが緩衝されたポリマー拡散環境に配置された有効量のブプレノルフィンを含む生体侵食性粘膜付着性層を含み、ここで、ポリマー拡散環境が約4〜約6のpHを有する緩衝された環境である、(1)〜(11)のいずれかに記載の方法。
(13) 粘膜付着性生体侵食性薬物送達デバイスが、粘膜表面へ適用された際にブプレノルフィンの迅速で効率的な送達のための一方向勾配を与えるように粘膜付着性層に隣接して配置されたポリマーバリア環境を含むバリア層を更に含み、ここで、一方向勾配は粘膜表面へ適用された際に緩衝されたポリマー拡散環境を横切ってブプレノルフィンを送達する、(1)〜(12)のいずれかに記載の方法。
(14) 被験体に対して、１日に２回の粘膜付着性生体侵食性薬物送達デバイスを被検体の口腔粘膜表面に投与する工程であって、デバイスが
緩衝されたポリマー拡散環境に配置された有効量のブプレノルフィンを含む生体侵食性粘膜付着性層、ここで、ポリマー拡散環境が約4〜約6のpHを有する緩衝された環境である、を含み、
被験体に投与されるブプレノルフィンの1日の総投薬量が中等度から重度の慢性的な腰痛を治療するのに有効である前記工程、
を含む中等度から重度の慢性的な腰痛を有する被験体を治療する方法。
(15) デバイスが約4.0〜約4.8のpHに緩衝されたバッキング層を更に含む、(14)に記載の方法。
(16) 方法が
被検体の神経障害性疼痛が治療されるように、被験体に対して、１日に２回の粘膜付着性生体侵食性薬物送達デバイスを被検体の口腔粘膜表面に投与する工程であって、デバイスが
緩衝されたポリマー拡散環境に配置された有効量のブプレノルフィンを含む生体侵食性粘膜付着性層、ここで、ポリマー拡散環境が約4〜約6のpHを有する緩衝された環境である、を含む前記工程、
を含む神経障害性疼痛を有する被験体を治療する方法。
(17) デバイスが約4.0〜約4.8のpHに緩衝されたバッキング層を更に含む、(16)に記載の方法。
(18) 被検体の骨関節炎性疼痛が治療されるように、被験体に対して、１日に２回の粘膜付着性生体侵食性薬物送達デバイスを被検体の口腔粘膜表面に投与する工程であって、デバイスが
緩衝されたポリマー拡散環境に配置された有効量のブプレノルフィンを含む生体侵食性粘膜付着性層、ここで、ポリマー拡散環境が約4〜約6のpHを有する緩衝された環境である、を含む前記工程、
を含む骨関節炎性疼痛を有する被験体を治療する方法。
(19) デバイスが約4.0〜約4.8のpHに緩衝されたバッキング層を更に含む、(18)に記載の方法。
(20) デバイスが
約4.0〜約6.0のpHに緩衝された有効量のブプレノルフィンを含む粘膜付着性層；及び
約4.0〜約4.8のpHに緩衝されたバッキング層
を含む、(1)〜(11)のいずれかに記載の方法。
Example 3. Pharmacokinetic profile of BEMA buprenorphine The pharmacokinetic parameters of BEMA buprenorphine dosage used in the treatment of chronic pain were measured in separate, multiple dosage studies. BEMA buprenorphine contained buprenorphine dosages of 2 × A μg and 4 × A μg. Each dose was administered twice a day for 3 days and serial blood samples were collected. Selected pharmacokinetic parameters are shown in Table 16 below.
(1) A method of treating chronic pain, comprising administering a mucoadhesive bioerodible drug delivery device to a subject in need of treatment,
The device is administered twice a day, wherein the device comprises from about 100 μg to about 0.9 mg buprenorphine,
The method, wherein the device provides a steady state C max of plasma buprenorphine concentration in the range of about 0.1 to about 1.2 ng / mL such that chronic pain in the subject is treated .
(2) The method according to (1), wherein the device is administered once a day.
(3) The method according to (1) or (2), wherein the chronic pain is chronic low back pain.
(4) The method according to any one of (1) to (3), wherein the chronic back pain is moderate to severe chronic back pain.
(5) The method according to any one of (1) to (4), wherein the subject is treated without experiencing any severe common opioid side effects.
(6) The method according to any one of (1) to (5), wherein the subject is treated with mild or moderate common opioid side effects, or without experiencing common opioid side effects.
(7) The method according to any one of (1) to (6), wherein the patient is treated without significant constipation.
(8) The method according to any one of (1) to (7), wherein the subject is treated without significant nausea.
(9) The method according to any one of (1) to (8), wherein the subject is inexperienced in opioids.
(10) The method according to any one of (1) to (9), wherein the subject has an opioid experience.
(11) The total daily dose of buprenorphine administered to the subject is 200 μg, 220 μg, 240 μg, 280 μg, 300 μg, 320 μg, 350 μg, 360 μg, 400 μg, 450 μg, 480 μg, 500 μg, 550 μg, 600 μg, 620 μg, 650 μg 700 μg, 720 μg, 750 μg, 800 μg, 860 μg, 900 μg, 960 μg, 1000 μg, 1100 μg, 1200 μg, 1250 μg, 1300 μg, 1400 μg, 1500 μg, 1600 μg and 1800 μg of buprenorphine, (1) to (10) The method according to any one.
(12) The device includes a bioerodible mucoadhesive layer comprising an effective amount of buprenorphine disposed in a buffered polymer diffusion environment, wherein the polymer diffusion environment has a pH of about 4 to about 6 The method according to any one of (1) to (11), which is an environment.
(13) A mucoadhesive bioerodible drug delivery device is placed adjacent to the mucoadhesive layer to provide a unidirectional gradient for rapid and efficient delivery of buprenorphine when applied to the mucosal surface. A barrier layer comprising a polymer barrier environment, wherein the unidirectional gradient delivers buprenorphine across the buffered polymer diffusion environment when applied to the mucosal surface. The method of crab.
(14) A step of administering to a subject a mucoadhesive bioerodible drug delivery device twice a day to the oral mucosal surface of a subject, the device comprising:
A bioerodible mucoadhesive layer comprising an effective amount of buprenorphine disposed in a buffered polymer diffusion environment, wherein the polymer diffusion environment is a buffered environment having a pH of about 4 to about 6,
The step wherein the total daily dosage of buprenorphine administered to the subject is effective to treat moderate to severe chronic low back pain;
A method of treating a subject having moderate to severe chronic low back pain.
(15) The method of (14), wherein the device further comprises a backing layer buffered to a pH of about 4.0 to about 4.8.
(16) Method is
Administering a mucoadhesive bioerodible drug delivery device to a subject twice a day to the oral mucosal surface of a subject so that the subject's neuropathic pain is treated; Device
A bioerodible mucoadhesive layer comprising an effective amount of buprenorphine disposed in a buffered polymer diffusion environment, wherein the polymer diffusion environment is a buffered environment having a pH of about 4 to about 6 Process,
A method of treating a subject having neuropathic pain comprising:
(17) The method of (16), wherein the device further comprises a backing layer buffered to a pH of about 4.0 to about 4.8.
(18) In the step of administering to the subject's oral mucosal surface twice a day a mucoadhesive bioerodible drug delivery device to the subject so that the subject's osteoarthritic pain is treated And the device is
A bioerodible mucoadhesive layer comprising an effective amount of buprenorphine disposed in a buffered polymer diffusion environment, wherein the polymer diffusion environment is a buffered environment having a pH of about 4 to about 6 Process,
A method of treating a subject having osteoarthritic pain comprising:
(19) The method of (18), wherein the device further comprises a backing layer buffered to a pH of about 4.0 to about 4.8.
(20) Device is
A mucoadhesive layer comprising an effective amount of buprenorphine buffered to a pH of about 4.0 to about 6.0; and
Backing layer buffered to a pH of about 4.0 to about 4.8
The method according to any one of (1) to (11), comprising:
Claims (33)
デバイスは１日に２回投与され、ここで、デバイスは約100μg〜約0.9mgのブプレノルフィンを含み、
デバイスが、被検体の慢性疼痛が治療されるように、約0.1〜約1.2ng/mLの範囲の血漿中ブプレノルフィン濃度の定常状態Cmaxを提供し、
被検体がオピオイド経験被検体であり、
治療される被検体が軽度のもしくは中等度の共通したオピオイド副作用を経験するか、又は共通したオピオイド副作用を経験しない、
前記粘膜付着性生体侵食性薬物送達デバイス。 A mucoadhesive bioerodible drug delivery device for treating chronic pain, wherein:
The device is administered twice a day, wherein the device comprises from about 100 μg to about 0.9 mg buprenorphine,
The device provides a steady state C max of plasma buprenorphine concentration in the range of about 0.1 to about 1.2 ng / mL so that chronic pain in the subject is treated ;
The subject is an opioid experience subject,
The subject being treated experiences mild or moderate common opioid side effects, or does not experience common opioid side effects,
The mucoadhesive bioerodible drug delivery device .
緩衝されたポリマー拡散環境に配置された有効量のブプレノルフィンを含む生体侵食性粘膜付着性層、ここで、ポリマー拡散環境が約4〜約6のpHを有する緩衝された環境である、を含み、
被験体に投与されるブプレノルフィンの1日の総投薬量が中等度から重度の慢性的な腰痛を治療するのに有効であり、
被検体がオピオイド経験被検体であり、
治療される被検体が軽度のもしくは中等度の共通したオピオイド副作用を経験するか、又は共通したオピオイド副作用を経験しない、
前記粘膜付着性生体侵食性薬物送達デバイス。 A mucoadhesive bioerodible drug delivery device for treating a subject having moderate to severe chronic low back pain, wherein the device is administered twice daily to the oral mucosal surface of a subject , A bioerodible mucoadhesive layer comprising an effective amount of buprenorphine disposed in a buffered polymer diffusion environment, wherein the polymer diffusion environment is a buffered environment having a pH of about 4 to about 6,
Becomes effective der in total daily dosage of buprenorphine to be administered to a subject to treat severe chronic back pain moderate,
The subject is an opioid experience subject,
The subject being treated experiences mild or moderate common opioid side effects, or does not experience common opioid side effects,
The mucoadhesive bioerodible drug delivery device .
約4.0〜約6.0のpHに緩衝された有効量のブプレノルフィンを含む粘膜付着性層；及び
約4.0〜約4.8のpHに緩衝されたバッキング層
を含む、請求項１に記載の粘膜付着性生体侵食性薬物送達デバイス。 The mucoadhesive property of claim 1, wherein the device comprises a mucoadhesive layer comprising an effective amount of buprenorphine buffered to a pH of about 4.0 to about 6.0; and a backing layer buffered to a pH of about 4.0 to about 4.8 . Bioerodible drug delivery device .
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161578755P | 2011-12-21 | 2011-12-21 | |
| US61/578,755 | 2011-12-21 | ||
| PCT/US2012/071330 WO2013096811A2 (en) | 2011-12-21 | 2012-12-21 | Transmucosal drug delivery devices for use in chronic pain relief |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2015500886A JP2015500886A (en) | 2015-01-08 |
| JP2015500886A5 true JP2015500886A5 (en) | 2016-02-04 |
| JP6255349B2 JP6255349B2 (en) | 2017-12-27 |
Family
ID=48669710
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014548962A Active JP6255349B2 (en) | 2011-12-21 | 2012-12-21 | Transmucosal drug delivery device for use in reducing chronic pain |
Country Status (16)
| Country | Link |
|---|---|
| EP (1) | EP2793870A4 (en) |
| JP (1) | JP6255349B2 (en) |
| KR (4) | KR20190110628A (en) |
| CN (2) | CN110123792A (en) |
| AU (4) | AU2012358308A1 (en) |
| BR (1) | BR112014015329A8 (en) |
| CA (1) | CA2859859A1 (en) |
| EA (2) | EA201992762A1 (en) |
| HK (1) | HK1203365A1 (en) |
| IL (2) | IL233075A0 (en) |
| IN (1) | IN2014DN06117A (en) |
| MX (2) | MX362217B (en) |
| SG (3) | SG10201710667YA (en) |
| UA (1) | UA118540C2 (en) |
| WO (1) | WO2013096811A2 (en) |
| ZA (1) | ZA201804381B (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021163529A2 (en) * | 2020-02-13 | 2021-08-19 | Biodelivery Sciences International, Inc. | Methods of treatment with buprenorphine |
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| US5800832A (en) | 1996-10-18 | 1998-09-01 | Virotex Corporation | Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces |
| DE19652188C2 (en) * | 1996-12-16 | 2002-02-14 | Lohmann Therapie Syst Lts | Flat drug preparation for application and release of buprenorphine or a pharmacologically comparable substance in the oral cavity and process for its preparation |
| US5968547A (en) * | 1997-02-24 | 1999-10-19 | Euro-Celtique, S.A. | Method of providing sustained analgesia with buprenorphine |
| DE19960154A1 (en) * | 1999-12-14 | 2001-07-12 | Lohmann Therapie Syst Lts | Flat pharmaceutical preparation for transmucosal administration of oxycodone or a comparable active ingredient in the oral cavity, for use in pain therapy and addiction therapy |
| CN1423559A (en) * | 2000-02-08 | 2003-06-11 | 欧罗赛铁克股份有限公司 | Controlled-release compositions containing opioid agonist and antagonist |
| EP1389621A4 (en) | 2001-04-27 | 2005-05-11 | Ajinomoto Kk | N-substituted pyrazolyl-o-glycoside derivatives and remedial agent for diabetes containing the same |
| US20110033542A1 (en) | 2009-08-07 | 2011-02-10 | Monosol Rx, Llc | Sublingual and buccal film compositions |
| DE102005007859A1 (en) * | 2005-02-21 | 2006-08-24 | Lts Lohmann Therapie-Systeme Ag | Procedures for a combination drug treatment, as well as suitable drug combinations |
| US20060281775A1 (en) * | 2005-06-14 | 2006-12-14 | Applied Pharmacy Services, Inc. | Two-component pharmaceutical composition for the treatment of pain |
| BRPI0619806A2 (en) | 2005-12-13 | 2011-10-18 | Biodelivery Sciences Int Inc | abuse resistant transmucosal drug delivery device |
| CA2649107A1 (en) | 2006-04-12 | 2007-10-25 | Spinal Motion, Inc. | Posterior spinal device and method |
| KR101329496B1 (en) * | 2006-07-21 | 2013-11-13 | 바이오딜리버리 사이언시스 인터내셔널 인코포레이티드 | Transmucosal delivery devices with enhanced uptake |
| EP1897543A1 (en) | 2006-08-30 | 2008-03-12 | Euro-Celtique S.A. | Buprenorphine- wafer for drug substitution therapy |
| GB0620661D0 (en) * | 2006-10-18 | 2006-11-29 | Pharmasol Ltd | Novel compounds |
| US20090270438A1 (en) * | 2006-10-18 | 2009-10-29 | Clive Booles | Novel compositions and formulations |
| GB2447016A (en) * | 2007-03-01 | 2008-09-03 | Reckitt Benckiser Healthcare | Buprenorphine/naloxone compositions |
| CN105833420A (en) * | 2008-06-23 | 2016-08-10 | 生物递送科学国际公司 | Multidirectional mucosal delivery devices and methods of use |
| US8475832B2 (en) | 2009-08-07 | 2013-07-02 | Rb Pharmaceuticals Limited | Sublingual and buccal film compositions |
-
2012
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- 2012-12-21 KR KR1020227011298A patent/KR20220047889A/en not_active Application Discontinuation
- 2012-12-21 SG SG10201710667YA patent/SG10201710667YA/en unknown
- 2012-12-21 JP JP2014548962A patent/JP6255349B2/en active Active
- 2012-12-21 WO PCT/US2012/071330 patent/WO2013096811A2/en active Application Filing
- 2012-12-21 SG SG10202012743WA patent/SG10202012743WA/en unknown
- 2012-12-21 KR KR1020147020237A patent/KR102026321B1/en active IP Right Grant
- 2012-12-21 AU AU2012358308A patent/AU2012358308A1/en not_active Abandoned
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- 2012-12-21 CN CN201280070389.6A patent/CN104125828A/en active Pending
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2014
- 2014-06-11 IL IL233075A patent/IL233075A0/en unknown
- 2014-06-18 MX MX2021012154A patent/MX2021012154A/en unknown
-
2015
- 2015-04-22 HK HK15103881.9A patent/HK1203365A1/en unknown
-
2017
- 2017-11-09 AU AU2017258916A patent/AU2017258916B2/en active Active
-
2018
- 2018-06-29 ZA ZA2018/04381A patent/ZA201804381B/en unknown
-
2019
- 2019-04-15 AU AU2019202602A patent/AU2019202602A1/en not_active Abandoned
-
2021
- 2021-04-01 AU AU2021202042A patent/AU2021202042A1/en active Pending
- 2021-07-23 IL IL285091A patent/IL285091A/en unknown
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