JP2016529328A5 - - Google Patents
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- Publication number
- JP2016529328A5 JP2016529328A5 JP2016541991A JP2016541991A JP2016529328A5 JP 2016529328 A5 JP2016529328 A5 JP 2016529328A5 JP 2016541991 A JP2016541991 A JP 2016541991A JP 2016541991 A JP2016541991 A JP 2016541991A JP 2016529328 A5 JP2016529328 A5 JP 2016529328A5
- Authority
- JP
- Japan
- Prior art keywords
- amount
- der
- spray formulation
- sublingual spray
- numerical value
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000000203 mixture Substances 0.000 claims 28
- 239000007921 spray Substances 0.000 claims 24
- 238000009472 formulation Methods 0.000 claims 23
- 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 7
- 229960001736 buprenorphine Drugs 0.000 claims 7
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 6
- 239000003963 antioxidant agent Substances 0.000 claims 5
- 230000003078 antioxidant effect Effects 0.000 claims 5
- 235000006708 antioxidants Nutrition 0.000 claims 5
- 239000006184 cosolvent Substances 0.000 claims 5
- 150000003839 salts Chemical class 0.000 claims 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 4
- UZHSEJADLWPNLE-GRGSLBFTSA-N naloxone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(O)C2=C5[C@@]13CCN4CC=C UZHSEJADLWPNLE-GRGSLBFTSA-N 0.000 claims 3
- 229960004127 naloxone Drugs 0.000 claims 3
- 239000002904 solvent Substances 0.000 claims 3
- 239000004322 Butylated hydroxytoluene Substances 0.000 claims 2
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 claims 2
- 235000010354 butylated hydroxytoluene Nutrition 0.000 claims 2
- 229940095259 butylated hydroxytoluene Drugs 0.000 claims 2
- MFRSJMQUIFQWSF-HITWJPLNSA-N (1S,2S,6R,14R,15R,19R)-5-(cyclopropylmethyl)-17,17,18,18-tetramethyl-13,16-dioxa-5-azaheptacyclo[13.5.2.12,8.01,6.02,14.015,19.012,23]tricosa-8(23),9,11-trien-11-ol Chemical compound CC1(C)O[C@]23CC[C@@]4(C[C@@H]2C1(C)C)[C@H]1Cc2ccc(O)c5O[C@@H]3[C@]4(CCN1CC1CC1)c25 MFRSJMQUIFQWSF-HITWJPLNSA-N 0.000 claims 1
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 1
- YOYLLRBMGQRFTN-IOMBULRVSA-N Norbuprenorphine Chemical compound C([C@@H](NCC1)[C@]23CC[C@]4([C@H](C3)[C@](C)(O)C(C)(C)C)OC)C3=CC=C(O)C5=C3[C@@]21[C@H]4O5 YOYLLRBMGQRFTN-IOMBULRVSA-N 0.000 claims 1
- 208000026251 Opioid-Related disease Diseases 0.000 claims 1
- 150000001298 alcohols Chemical class 0.000 claims 1
- 235000019282 butylated hydroxyanisole Nutrition 0.000 claims 1
- 150000002334 glycols Chemical class 0.000 claims 1
- LHGVFZTZFXWLCP-UHFFFAOYSA-N guaiacol Chemical compound COC1=CC=CC=C1O LHGVFZTZFXWLCP-UHFFFAOYSA-N 0.000 claims 1
- 229930182817 methionine Natural products 0.000 claims 1
- 229960004452 methionine Drugs 0.000 claims 1
- 235000006109 methionine Nutrition 0.000 claims 1
- PJUIMOJAAPLTRJ-UHFFFAOYSA-N monothioglycerol Chemical compound OCC(O)CS PJUIMOJAAPLTRJ-UHFFFAOYSA-N 0.000 claims 1
- 201000005040 opiate dependence Diseases 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 235000010378 sodium ascorbate Nutrition 0.000 claims 1
- PPASLZSBLFJQEF-RKJRWTFHSA-M sodium ascorbate Substances [Na+].OC[C@@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RKJRWTFHSA-M 0.000 claims 1
- 229960005055 sodium ascorbate Drugs 0.000 claims 1
- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 claims 1
- 229940001474 sodium thiosulfate Drugs 0.000 claims 1
- 235000019345 sodium thiosulphate Nutrition 0.000 claims 1
- PPASLZSBLFJQEF-RXSVEWSESA-M sodium-L-ascorbate Chemical compound [Na+].OC[C@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RXSVEWSESA-M 0.000 claims 1
- -1 tenorphine Chemical compound 0.000 claims 1
- 230000001225 therapeutic effect Effects 0.000 claims 1
- 229940035024 thioglycerol Drugs 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361875837P | 2013-09-10 | 2013-09-10 | |
| US61/875,837 | 2013-09-10 | ||
| PCT/US2014/052699 WO2015038327A1 (en) | 2013-09-10 | 2014-08-26 | Sublingual buprenorphine spray |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2016529328A JP2016529328A (ja) | 2016-09-23 |
| JP2016529328A5 true JP2016529328A5 (enExample) | 2017-11-16 |
Family
ID=52625856
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016541991A Pending JP2016529328A (ja) | 2013-09-10 | 2014-08-26 | 舌下ブプレノルフィンスプレー |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US9216175B2 (enExample) |
| EP (1) | EP3043777B1 (enExample) |
| JP (1) | JP2016529328A (enExample) |
| CA (1) | CA2923811C (enExample) |
| DK (1) | DK3043777T3 (enExample) |
| ES (1) | ES2802976T3 (enExample) |
| WO (1) | WO2015038327A1 (enExample) |
Families Citing this family (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20220054908A (ko) | 2014-04-04 | 2022-05-03 | 인트라-셀룰라 써래피스, 인코퍼레이티드. | 유기 화합물 |
| US10722510B2 (en) * | 2014-07-08 | 2020-07-28 | Hikma Pharmaceuticals Usa Inc. | Liquid naloxone spray |
| EP3177146A4 (en) * | 2014-07-08 | 2018-01-03 | Insys Pharma, Inc. | Sublingual naloxone spray |
| US10617686B2 (en) * | 2014-07-08 | 2020-04-14 | Hikma Pharmaceuticals Usa Inc. | Liquid naloxone spray |
| US11135155B2 (en) | 2014-07-08 | 2021-10-05 | Hikma Pharmaceuticals Usa Inc. | Liquid naloxone spray |
| DK3277283T3 (da) * | 2015-04-03 | 2021-04-12 | Benuvia Therapeutics Llc | Sublinguale sildenafilsprayformuerlinger |
| WO2016164158A1 (en) * | 2015-04-09 | 2016-10-13 | Insys Development Company, Inc. | Ketorolac sublingual spray formulations |
| JP2018531964A (ja) * | 2015-10-27 | 2018-11-01 | インシス・ディベロップメント・カンパニー・インコーポレイテッド | 液体ブプレノルフィン製剤 |
| RU2743513C2 (ru) | 2016-01-26 | 2021-02-19 | Интра-Селлулар Терапиз, Инк. | Органические соединения |
| IL281050B2 (en) | 2016-03-25 | 2023-04-01 | Intra Cellular Therapies Inc | A controlled or delayed release pharmaceutical preparation containing a deuterated compound |
| WO2018034920A1 (en) * | 2016-08-17 | 2018-02-22 | Insys Development Company, Inc. | Liquid naloxone spray |
| PT3548091T (pt) | 2016-11-29 | 2022-01-21 | Oculis SA | Preparação de complexos sólidos de ciclodextrina para administração oftálmica de ingrediente farmacêutico ativo |
| EP3562484B1 (en) | 2016-12-29 | 2021-08-25 | Intra-Cellular Therapies, Inc. | Pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxaline derivatives useful in the treatment of cns disorders |
| WO2018126140A1 (en) | 2016-12-29 | 2018-07-05 | Intra-Cellular Therapies, Inc. | Organic compounds |
| EP3600325A4 (en) | 2017-03-24 | 2021-01-06 | Intra-Cellular Therapies, Inc. | UNIQUE COMPOSITIONS AND PROCESSES |
| WO2019026085A1 (en) * | 2017-08-04 | 2019-02-07 | Alkem Laboratories Ltd. | SUBLINGUAL FILM COMPOSITION |
| US20180193332A1 (en) * | 2017-10-09 | 2018-07-12 | Adapt Pharma Operations Limited | Low-temperature stable opioid antagonist solutions |
| WO2019178484A1 (en) | 2018-03-16 | 2019-09-19 | Intra-Cellular Therapies, Inc. | Novel methods |
| SMT202600133T1 (it) | 2018-03-23 | 2026-05-12 | Intra Cellular Therapies Inc | Composti organici |
| AU2019240226B2 (en) | 2018-03-23 | 2024-11-28 | Intra-Cellular Therapies, Inc. | Organic compounds |
| US12144808B2 (en) | 2018-08-29 | 2024-11-19 | Intra-Cellular Therapies, Inc. | Compositions and methods |
| AU2019328528B2 (en) | 2018-08-31 | 2025-01-23 | Intra-Cellular Therapies, Inc. | Novel methods |
| WO2020047408A1 (en) | 2018-08-31 | 2020-03-05 | Intra-Cellular Therapies, Inc. | Novel methods |
| WO2021001366A1 (en) * | 2019-07-01 | 2021-01-07 | Oculis SA | Method for stabilizing the ph of an aqueous composition comprising a drug |
| JP2022549335A (ja) | 2019-09-25 | 2022-11-24 | イントラ－セルラー・セラピーズ・インコーポレイテッド | 新規方法 |
| JP2024536239A (ja) * | 2021-09-30 | 2024-10-04 | エランコ・ユーエス・インコーポレイテッド | ブプレノルフィンの安定な製剤 |
| US12414948B2 (en) | 2022-05-18 | 2025-09-16 | Intra-Cellular Therapies, Inc. | Methods |
Family Cites Families (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6512010B1 (en) * | 1996-07-15 | 2003-01-28 | Alza Corporation | Formulations for the administration of fluoxetine |
| US6413496B1 (en) | 1996-12-04 | 2002-07-02 | Biogland Ireland (R&D) Limited | Pharmaceutical compositions and devices for their administration |
| IT1302682B1 (it) | 1998-10-16 | 2000-09-29 | Formenti Farmaceutici Spa | Composizioni farmaceutiche orali contenenti buprenorfina |
| KR100383252B1 (ko) * | 1998-12-17 | 2003-07-16 | 주식회사 삼양사 | 부프레놀핀을함유하는경피투여조성물및이를포함하는패취 |
| AR031682A1 (es) | 1999-11-19 | 2003-10-01 | Reckitt Benckiser Helthcare Uk | Composiciones farmaceuticas |
| EP1296649A2 (en) | 2000-06-22 | 2003-04-02 | Pharmasol Limited | Pharmaceutical compositions comprising an opioid analgesic |
| EP1418862A4 (en) * | 2001-06-29 | 2010-06-09 | Leon J Lewandowski | INDIVIDUALIZED SEARCH THERAPY |
| US7666876B2 (en) | 2002-03-19 | 2010-02-23 | Vernalis (R&D) Limited | Buprenorphine formulations for intranasal delivery |
| US6946150B2 (en) | 2002-08-14 | 2005-09-20 | Gw Pharma Limited | Pharmaceutical formulation |
| JP4416653B2 (ja) * | 2002-08-21 | 2010-02-17 | ファルマシア コーポレーション | ２つのチャンバーを有するバイアルに収容された注射用医薬懸濁液 |
| EP1554290B1 (en) * | 2002-10-25 | 2009-09-30 | Euro-Celtique S.A. | Analogs and prodrugs of buprenorphine |
| WO2004071491A1 (en) | 2003-02-04 | 2004-08-26 | Chrysalis Technologies Incorporated | Aerosol formulations and aerosol delivery of buspirone, buprenorphine, triazolam, cyclobenzaprine and zolpidem |
| US20090117054A1 (en) * | 2005-03-29 | 2009-05-07 | University Of Kentucky Research Foundation | Sublingual spray for the treatment of pain |
| US9522188B2 (en) | 2005-12-13 | 2016-12-20 | Biodelivery Sciences International, Inc. | Abuse resistant transmucosal drug delivery device |
| SI1976521T1 (sl) * | 2006-01-25 | 2015-06-30 | Insys Therapeutics, Inc. | Podjezično fentanilno pršilo |
| EP2015632B1 (en) | 2006-04-19 | 2015-12-02 | Mist Pharmaceuticals, LLC | Stable hydroalcoholic oral spray formulations and methods |
| US20100233257A1 (en) * | 2006-06-09 | 2010-09-16 | Ethypharm | Low dose sublingual tablets of opioid analgesics and preparation process |
| ES2577390T3 (es) | 2006-07-21 | 2016-07-14 | Biodelivery Sciences International, Inc. | Dispositivos de administración transmucosa con mayor captación |
| EP1897543A1 (en) | 2006-08-30 | 2008-03-12 | Euro-Celtique S.A. | Buprenorphine- wafer for drug substitution therapy |
| GB2461681A (en) | 2008-04-17 | 2010-01-13 | Pharmasol Ltd | Buprenorphine liquid spray formulation with solvent and antioxidant |
| US20090270438A1 (en) | 2006-10-18 | 2009-10-29 | Clive Booles | Novel compositions and formulations |
| GB2447014A (en) | 2007-03-01 | 2008-09-03 | Reckitt Benckiser Healthcare | Analgesic composition comprising a specific ratio of buprenorphine and naltrexone |
| WO2009017837A2 (en) | 2007-08-02 | 2009-02-05 | Insys Therapeutics Inc. | Sublingual fentanyl spray |
| CA2718943A1 (en) | 2008-03-26 | 2009-10-01 | Alltranz Inc. | Abuse deterrent transdermal formulations of opiate agonists and agonist-antagonists |
| CN105833420A (zh) | 2008-06-23 | 2016-08-10 | 生物递送科学国际公司 | 多向粘膜给药装置及使用方法 |
| US8475832B2 (en) * | 2009-08-07 | 2013-07-02 | Rb Pharmaceuticals Limited | Sublingual and buccal film compositions |
| ES2555258T3 (es) * | 2010-04-02 | 2015-12-30 | Zynerba Pharmaceuticals, Inc. | Profármacos de opioides administrables por vía transdérmica, composiciones que no inducen al abuso y procedimientos de uso de los profármacos opioides |
-
2014
- 2014-08-26 DK DK14843903.7T patent/DK3043777T3/da active
- 2014-08-26 CA CA2923811A patent/CA2923811C/en active Active
- 2014-08-26 US US14/469,063 patent/US9216175B2/en active Active
- 2014-08-26 JP JP2016541991A patent/JP2016529328A/ja active Pending
- 2014-08-26 EP EP14843903.7A patent/EP3043777B1/en active Active
- 2014-08-26 WO PCT/US2014/052699 patent/WO2015038327A1/en not_active Ceased
- 2014-08-26 ES ES14843903T patent/ES2802976T3/es active Active
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