JP2017532374A5 - - Google Patents
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- Publication number
- JP2017532374A5 JP2017532374A5 JP2017535609A JP2017535609A JP2017532374A5 JP 2017532374 A5 JP2017532374 A5 JP 2017532374A5 JP 2017535609 A JP2017535609 A JP 2017535609A JP 2017535609 A JP2017535609 A JP 2017535609A JP 2017532374 A5 JP2017532374 A5 JP 2017532374A5
- Authority
- JP
- Japan
- Prior art keywords
- mannitol
- pharmaceutical composition
- eutectic
- item
- cyclobenzaprine hcl
- 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.)
- Granted
Links
- 239000000594 mannitol Substances 0.000 claims description 45
- 229930195725 Mannitol Natural products 0.000 claims description 37
- 235000010355 mannitol Nutrition 0.000 claims description 37
- 229960003572 cyclobenzaprine Drugs 0.000 claims description 36
- JURKNVYFZMSNLP-UHFFFAOYSA-N cyclobenzaprine Chemical compound C1=CC2=CC=CC=C2C(=CCCN(C)C)C2=CC=CC=C21 JURKNVYFZMSNLP-UHFFFAOYSA-N 0.000 claims description 35
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 32
- 239000008194 pharmaceutical composition Substances 0.000 claims description 26
- 230000005496 eutectics Effects 0.000 claims description 25
- 238000000034 method Methods 0.000 claims description 25
- 239000000203 mixture Substances 0.000 claims description 13
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 10
- 238000005550 wet granulation Methods 0.000 claims description 10
- 239000008187 granular material Substances 0.000 claims description 9
- 238000002156 mixing Methods 0.000 claims description 8
- 238000001035 drying Methods 0.000 claims description 7
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims description 6
- 239000000155 melt Substances 0.000 claims description 6
- 239000002610 basifying agent Substances 0.000 claims description 4
- 238000002425 crystallisation Methods 0.000 claims description 4
- 230000008025 crystallization Effects 0.000 claims description 4
- 238000004519 manufacturing process Methods 0.000 claims description 4
- 239000012530 fluid Substances 0.000 claims description 3
- 239000003795 chemical substances by application Substances 0.000 claims description 2
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 claims description 2
- 230000001419 dependent effect Effects 0.000 claims 2
- 101100283604 Caenorhabditis elegans pigk-1 gene Proteins 0.000 claims 1
- 239000000463 material Substances 0.000 claims 1
- 229940058023 trisodium citrate anhydrous Drugs 0.000 claims 1
- 239000002245 particle Substances 0.000 description 5
- 238000000634 powder X-ray diffraction Methods 0.000 description 2
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 238000000113 differential scanning calorimetry Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940088679 drug related substance Drugs 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000007791 liquid phase Substances 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 239000000320 mechanical mixture Substances 0.000 description 1
- 239000003595 mist Substances 0.000 description 1
- 230000002572 peristaltic effect Effects 0.000 description 1
- 239000012071 phase Substances 0.000 description 1
- 230000007928 solubilization Effects 0.000 description 1
- 238000005063 solubilization Methods 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 238000002076 thermal analysis method Methods 0.000 description 1
- 238000009827 uniform distribution Methods 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462052238P | 2014-09-18 | 2014-09-18 | |
| US62/052,238 | 2014-09-18 | ||
| PCT/US2015/051068 WO2016044796A1 (en) | 2014-09-18 | 2015-09-18 | Eutectic formulations of cyclobenzaprine hydrochloride |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018173466A Division JP6717902B6 (ja) | 2014-09-18 | 2018-09-18 | シクロベンザプリン塩酸塩の共融製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2017532374A JP2017532374A (ja) | 2017-11-02 |
| JP2017532374A5 true JP2017532374A5 (enExample) | 2018-11-01 |
| JP6614724B2 JP6614724B2 (ja) | 2019-12-04 |
Family
ID=55533932
Family Applications (6)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017535609A Active JP6614724B2 (ja) | 2014-09-18 | 2015-09-18 | シクロベンザプリン塩酸塩の共融製剤 |
| JP2018173466A Active JP6717902B6 (ja) | 2014-09-18 | 2018-09-18 | シクロベンザプリン塩酸塩の共融製剤 |
| JP2019236602A Withdrawn JP2020059757A (ja) | 2014-09-18 | 2019-12-26 | シクロベンザプリン塩酸塩の共融製剤 |
| JP2021169539A Withdrawn JP2022001605A (ja) | 2014-09-18 | 2021-10-15 | シクロベンザプリン塩酸塩の共融製剤 |
| JP2023116057A Withdrawn JP2023126486A (ja) | 2014-09-18 | 2023-07-14 | シクロベンザプリン塩酸塩の共融製剤 |
| JP2025076812A Pending JP2025107355A (ja) | 2014-09-18 | 2025-05-02 | シクロベンザプリン塩酸塩の共融製剤 |
Family Applications After (5)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018173466A Active JP6717902B6 (ja) | 2014-09-18 | 2018-09-18 | シクロベンザプリン塩酸塩の共融製剤 |
| JP2019236602A Withdrawn JP2020059757A (ja) | 2014-09-18 | 2019-12-26 | シクロベンザプリン塩酸塩の共融製剤 |
| JP2021169539A Withdrawn JP2022001605A (ja) | 2014-09-18 | 2021-10-15 | シクロベンザプリン塩酸塩の共融製剤 |
| JP2023116057A Withdrawn JP2023126486A (ja) | 2014-09-18 | 2023-07-14 | シクロベンザプリン塩酸塩の共融製剤 |
| JP2025076812A Pending JP2025107355A (ja) | 2014-09-18 | 2025-05-02 | シクロベンザプリン塩酸塩の共融製剤 |
Country Status (13)
| Country | Link |
|---|---|
| US (2) | US10357465B2 (enExample) |
| EP (1) | EP3193854A4 (enExample) |
| JP (6) | JP6614724B2 (enExample) |
| CN (2) | CN107072968B (enExample) |
| AU (2) | AU2015317336B2 (enExample) |
| BR (1) | BR112017005231A2 (enExample) |
| CA (1) | CA2961822A1 (enExample) |
| IL (2) | IL251218B (enExample) |
| MX (1) | MX387402B (enExample) |
| MY (1) | MY186047A (enExample) |
| SG (2) | SG11201701995PA (enExample) |
| WO (1) | WO2016044796A1 (enExample) |
| ZA (1) | ZA201701637B (enExample) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HUE037281T2 (hu) | 2009-11-20 | 2018-08-28 | Tonix Pharma Holdings Ltd | Eljárás és készítmény poszt-traumás stressz rendellenesség tüneteinek kezelésére ciklobenzaprin alkalmazásával |
| US20110319389A1 (en) | 2010-06-24 | 2011-12-29 | Tonix Pharmaceuticals, Inc. | Methods and compositions for treating fatigue associated with disordered sleep using very low dose cyclobenzaprine |
| US11998516B2 (en) | 2011-03-07 | 2024-06-04 | Tonix Pharma Holdings Limited | Methods and compositions for treating depression using cyclobenzaprine |
| US9636408B2 (en) | 2013-03-15 | 2017-05-02 | Tonix Pharma Holdings Limited | Eutectic formulations of cyclobenzaprine hydrochloride and amitriptyline hydrochloride |
| CA2961822A1 (en) * | 2014-09-18 | 2016-03-24 | Tonix Pharma Holdings Limited | Eutectic formulations of cyclobenzaprine hydrochloride |
| BR112020011345A2 (pt) * | 2017-12-11 | 2020-11-17 | Tonix Pharma Holdings Limited | tratamento com ciclobenzaprina para agitação, psicose e declínio cognitivo na demência e condições neurodegenerativas |
| CA3109258A1 (en) * | 2018-08-20 | 2020-02-27 | Tonix Pharma Holdings Limited | Methods of treating acute stress disorder and posttraumatic stress disorder |
| NL2023661B1 (en) * | 2019-08-19 | 2021-04-21 | Seranovo Holding B V | Pharmaceutical Eutectic Salt Formulation |
| CA3179754A1 (en) | 2020-04-08 | 2021-10-14 | Tonix Pharmaceuticals Holding Corp. | Cyclobenzaprine treatment for sexual dysfunction |
| AU2021382668A1 (en) * | 2020-11-20 | 2023-06-22 | Tonix Pharmaceuticals Holding Corp. | Cyclobenzaprine treatment for alcohol use disorder |
| EP4255407A1 (en) * | 2020-12-07 | 2023-10-11 | Tonix Pharmaceuticals Holding Corp. | Cyclobenzaprine treatment for fibromyalgia |
| US20240415789A1 (en) * | 2021-10-06 | 2024-12-19 | Tonix Pharmaceuticals Holding Corp. | Cyclobenzaprine for treatment or prevention of sexual dysfunction associated with mental health conditions in female patients |
| EP4543427A1 (en) | 2022-06-21 | 2025-04-30 | Tonix Pharmaceuticals Holding Corp. | Cyclobenzaprine treatment for post-acute sequelae of (sars)-cov-2 infection (pasc) |
| WO2025160302A1 (en) | 2024-01-25 | 2025-07-31 | Tonix Pharmaceuticals Holding Corp. | Cyclobenzaprine treatment for acute stress reaction or acute stress disorder |
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| US5120548A (en) | 1989-11-07 | 1992-06-09 | Merck & Co., Inc. | Swelling modulated polymeric drug delivery device |
| US5733566A (en) | 1990-05-15 | 1998-03-31 | Alkermes Controlled Therapeutics Inc. Ii | Controlled release of antiparasitic agents in animals |
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| SG47101A1 (en) | 1992-07-31 | 1998-03-20 | Us Bioscience | Crystalline amifostine compositions and methods for the preparation and use of same |
| US5591767A (en) | 1993-01-25 | 1997-01-07 | Pharmetrix Corporation | Liquid reservoir transdermal patch for the administration of ketorolac |
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| HUE037281T2 (hu) | 2009-11-20 | 2018-08-28 | Tonix Pharma Holdings Ltd | Eljárás és készítmény poszt-traumás stressz rendellenesség tüneteinek kezelésére ciklobenzaprin alkalmazásával |
| US20110319389A1 (en) | 2010-06-24 | 2011-12-29 | Tonix Pharmaceuticals, Inc. | Methods and compositions for treating fatigue associated with disordered sleep using very low dose cyclobenzaprine |
| JP6355921B2 (ja) | 2010-09-01 | 2018-07-11 | トニックス ファーマスーティカルズ, インコーポレイテッドTONIX Pharmaceuticals, Inc. | コカイン嗜癖の治療 |
| US11998516B2 (en) * | 2011-03-07 | 2024-06-04 | Tonix Pharma Holdings Limited | Methods and compositions for treating depression using cyclobenzaprine |
| SI2861223T1 (sl) * | 2012-06-15 | 2023-01-31 | Tonix Pharma Holdings Limited | Sestavki in postopki za transmukozalno absorpcijo |
| US9636408B2 (en) * | 2013-03-15 | 2017-05-02 | Tonix Pharma Holdings Limited | Eutectic formulations of cyclobenzaprine hydrochloride and amitriptyline hydrochloride |
| CA2961822A1 (en) | 2014-09-18 | 2016-03-24 | Tonix Pharma Holdings Limited | Eutectic formulations of cyclobenzaprine hydrochloride |
-
2015
- 2015-09-18 CA CA2961822A patent/CA2961822A1/en active Pending
- 2015-09-18 BR BR112017005231A patent/BR112017005231A2/pt not_active Application Discontinuation
- 2015-09-18 US US15/511,287 patent/US10357465B2/en active Active
- 2015-09-18 MY MYPI2017700889A patent/MY186047A/en unknown
- 2015-09-18 MX MX2017003644A patent/MX387402B/es unknown
- 2015-09-18 JP JP2017535609A patent/JP6614724B2/ja active Active
- 2015-09-18 WO PCT/US2015/051068 patent/WO2016044796A1/en not_active Ceased
- 2015-09-18 CN CN201580050140.2A patent/CN107072968B/zh active Active
- 2015-09-18 SG SG11201701995PA patent/SG11201701995PA/en unknown
- 2015-09-18 AU AU2015317336A patent/AU2015317336B2/en active Active
- 2015-09-18 CN CN202011576351.9A patent/CN112618494B/zh active Active
- 2015-09-18 EP EP15841528.1A patent/EP3193854A4/en active Pending
- 2015-09-18 SG SG10201902203VA patent/SG10201902203VA/en unknown
-
2017
- 2017-03-07 ZA ZA2017/01637A patent/ZA201701637B/en unknown
- 2017-03-16 IL IL251218A patent/IL251218B/en active IP Right Grant
-
2018
- 2018-09-18 JP JP2018173466A patent/JP6717902B6/ja active Active
-
2019
- 2019-07-22 US US16/518,338 patent/US11026898B2/en active Active
- 2019-12-26 JP JP2019236602A patent/JP2020059757A/ja not_active Withdrawn
-
2020
- 2020-10-05 IL IL277814A patent/IL277814B/en unknown
- 2020-12-17 AU AU2020289838A patent/AU2020289838B2/en active Active
-
2021
- 2021-10-15 JP JP2021169539A patent/JP2022001605A/ja not_active Withdrawn
-
2023
- 2023-07-14 JP JP2023116057A patent/JP2023126486A/ja not_active Withdrawn
-
2025
- 2025-05-02 JP JP2025076812A patent/JP2025107355A/ja active Pending
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