JP2016531850A5 - - Google Patents
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- Publication number
- JP2016531850A5 JP2016531850A5 JP2016516520A JP2016516520A JP2016531850A5 JP 2016531850 A5 JP2016531850 A5 JP 2016531850A5 JP 2016516520 A JP2016516520 A JP 2016516520A JP 2016516520 A JP2016516520 A JP 2016516520A JP 2016531850 A5 JP2016531850 A5 JP 2016531850A5
- Authority
- JP
- Japan
- Prior art keywords
- powder formulation
- dhe
- intranasal powder
- present
- auc
- 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
- 238000009472 formulation Methods 0.000 claims description 87
- 239000000203 mixture Substances 0.000 claims description 87
- 239000000843 powder Substances 0.000 claims description 81
- 229960004704 dihydroergotamine Drugs 0.000 claims description 56
- HESHRHUZIWVEAJ-JGRZULCMSA-N dihydroergotamine Chemical compound C([C@H]1C(=O)N2CCC[C@H]2[C@]2(O)O[C@@](C(N21)=O)(C)NC(=O)[C@H]1CN([C@H]2[C@@H](C3=CC=CC4=NC=C([C]34)C2)C1)C)C1=CC=CC=C1 HESHRHUZIWVEAJ-JGRZULCMSA-N 0.000 claims description 56
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 18
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 18
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 18
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 18
- 239000002245 particle Substances 0.000 claims description 11
- 150000003839 salts Chemical class 0.000 claims description 8
- 206010019233 Headaches Diseases 0.000 claims description 5
- 231100000869 headache Toxicity 0.000 claims description 5
- 208000019695 Migraine disease Diseases 0.000 claims description 4
- 206010027599 migraine Diseases 0.000 claims description 4
- 208000000060 Migraine with aura Diseases 0.000 claims 1
- 229960000807 dihydroergotamine mesylate Drugs 0.000 claims 1
- ADYPXRFPBQGGAH-UMYZUSPBSA-N dihydroergotamine mesylate Chemical compound CS(O)(=O)=O.C([C@H]1C(=O)N2CCC[C@H]2[C@]2(O)O[C@@](C(N21)=O)(C)NC(=O)[C@H]1CN([C@H]2[C@@H](C=3C=CC=C4NC=C(C=34)C2)C1)C)C1=CC=CC=C1 ADYPXRFPBQGGAH-UMYZUSPBSA-N 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 206010052787 migraine without aura Diseases 0.000 claims 1
- 238000000034 method Methods 0.000 description 56
- 241000282693 Cercopithecidae Species 0.000 description 12
- 241000282567 Macaca fascicularis Species 0.000 description 12
- 241000288906 Primates Species 0.000 description 12
- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 description 11
- 229960001948 caffeine Drugs 0.000 description 6
- LPHGQDQBBGAPDZ-UHFFFAOYSA-N Isocaffeine Natural products CN1C(=O)N(C)C(=O)C2=C1N(C)C=N2 LPHGQDQBBGAPDZ-UHFFFAOYSA-N 0.000 description 5
- VJEONQKOZGKCAK-UHFFFAOYSA-N caffeine Natural products CN1C(=O)N(C)C(=O)C2=C1C=CN2C VJEONQKOZGKCAK-UHFFFAOYSA-N 0.000 description 5
- 239000001506 calcium phosphate Substances 0.000 description 3
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical group [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 3
- 229940078499 tricalcium phosphate Drugs 0.000 description 3
- 229910000391 tricalcium phosphate Inorganic materials 0.000 description 3
- 235000019731 tricalcium phosphate Nutrition 0.000 description 3
- QUNWUDVFRNGTCO-UHFFFAOYSA-N 1,7-dimethylxanthine Chemical compound N1C(=O)N(C)C(=O)C2=C1N=CN2C QUNWUDVFRNGTCO-UHFFFAOYSA-N 0.000 description 2
- LRFVTYWOQMYALW-UHFFFAOYSA-N 9H-xanthine Chemical compound O=C1NC(=O)NC2=C1NC=N2 LRFVTYWOQMYALW-UHFFFAOYSA-N 0.000 description 2
- 235000010980 cellulose Nutrition 0.000 description 2
- 229920002678 cellulose Polymers 0.000 description 2
- 239000001913 cellulose Substances 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 239000013081 microcrystal Substances 0.000 description 2
- YAPQBXQYLJRXSA-UHFFFAOYSA-N theobromine Chemical compound CN1C(=O)NC(=O)C2=C1N=CN2C YAPQBXQYLJRXSA-UHFFFAOYSA-N 0.000 description 2
- ZFXYFBGIUFBOJW-UHFFFAOYSA-N theophylline Chemical compound O=C1N(C)C(=O)N(C)C2=C1NC=N2 ZFXYFBGIUFBOJW-UHFFFAOYSA-N 0.000 description 2
- 229940100578 Acetylcholinesterase inhibitor Drugs 0.000 description 1
- AFVFQIVMOAPDHO-UHFFFAOYSA-N Methanesulfonic acid Chemical compound CS(O)(=O)=O AFVFQIVMOAPDHO-UHFFFAOYSA-N 0.000 description 1
- 229940099471 Phosphodiesterase inhibitor Drugs 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 229940121359 adenosine receptor antagonist Drugs 0.000 description 1
- 239000000544 cholinesterase inhibitor Substances 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000002571 phosphodiesterase inhibitor Substances 0.000 description 1
- 239000000296 purinergic P1 receptor antagonist Substances 0.000 description 1
- 229960004559 theobromine Drugs 0.000 description 1
- 229960000278 theophylline Drugs 0.000 description 1
- 229940124549 vasodilator Drugs 0.000 description 1
- 239000003071 vasodilator agent Substances 0.000 description 1
- 229940075420 xanthine Drugs 0.000 description 1
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2019162995A JP6902583B2 (ja) | 2013-09-24 | 2019-09-06 | 頭痛治療用の鼻腔内dhe |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361881947P | 2013-09-24 | 2013-09-24 | |
| US61/881,947 | 2013-09-24 | ||
| PCT/IB2014/002706 WO2015044782A2 (en) | 2013-09-24 | 2014-09-24 | Intranasal dhe for the treatment of headache |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019162995A Division JP6902583B2 (ja) | 2013-09-24 | 2019-09-06 | 頭痛治療用の鼻腔内dhe |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2016531850A JP2016531850A (ja) | 2016-10-13 |
| JP2016531850A5 true JP2016531850A5 (enExample) | 2017-10-26 |
Family
ID=52424045
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016516520A Pending JP2016531850A (ja) | 2013-09-24 | 2014-09-24 | 頭痛治療用の鼻腔内dhe |
| JP2019162995A Active JP6902583B2 (ja) | 2013-09-24 | 2019-09-06 | 頭痛治療用の鼻腔内dhe |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019162995A Active JP6902583B2 (ja) | 2013-09-24 | 2019-09-06 | 頭痛治療用の鼻腔内dhe |
Country Status (6)
| Country | Link |
|---|---|
| US (5) | US20160228433A1 (enExample) |
| EP (2) | EP3049059B1 (enExample) |
| JP (2) | JP2016531850A (enExample) |
| DK (1) | DK3049059T3 (enExample) |
| ES (1) | ES2904570T3 (enExample) |
| WO (1) | WO2015044782A2 (enExample) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101980738A (zh) | 2008-02-07 | 2011-02-23 | 华盛顿大学 | 圆周气雾设备 |
| EP2680913B1 (en) | 2011-03-03 | 2020-05-06 | Impel NeuroPharma Inc. | Nasal drug delivery device |
| CN107376071B (zh) | 2011-05-09 | 2021-07-09 | 英倍尔药业股份有限公司 | 用于将化合物递送到使用者的上部嗅觉区的喷嘴 |
| HK1222358A1 (zh) | 2013-04-28 | 2017-06-30 | Impel Neuropharma Inc. | 医用单位剂量容器 |
| EP3049059B1 (en) | 2013-09-24 | 2021-11-03 | Satsuma Pharmaceuticals, Inc. | Intranasal dhe formulation for the treatment of headache |
| EP3341059B1 (en) | 2015-09-10 | 2022-03-02 | Impel NeuroPharma Inc. | In-line nasal delivery device |
| CA3030359A1 (en) | 2016-08-05 | 2018-02-08 | Shin Nippon Biomedical Laboratories, Ltd. | Intranasal pharmaceutical powder compositions |
| BR112019027508A2 (pt) * | 2017-07-02 | 2020-07-07 | Dr. Reddys Laboratories Limited | formas de dosagem nasal de di-hidroergotamina |
| US11571532B2 (en) | 2017-11-21 | 2023-02-07 | Impel Pharmaceuticals Inc. | Intranasal device with dip tube |
| US11395887B2 (en) | 2017-11-21 | 2022-07-26 | Impel Pharmaceuticals Inc. | Intranasal device with inlet interface |
| EP3735223A4 (en) | 2018-01-05 | 2021-10-13 | Impel Neuropharma Inc. | INTRANASAL ADMINISTRATION OF OLANZAPINE BY A PRECISION OLFACTORY DEVICE |
| BR112020013744A8 (pt) * | 2018-01-05 | 2022-10-18 | Impel Neuropharma Inc | Dispensação intranasal de di-hidroergotamina por dispositivo olfativo de precisão |
| JP2021532098A (ja) | 2018-07-19 | 2021-11-25 | インペル ニューロファーマ インコーポレイテッド | パーキンソン病の治療のためのレボドパおよびドーパデカルボキシラーゼ阻害剤の呼吸管路送達 |
| CA3122396A1 (en) | 2018-12-11 | 2020-06-18 | Satsuma Pharmaceuticals, Inc. | Compositions, devices, and methods for treating or preventing headaches |
| CN113473967B (zh) | 2019-01-03 | 2022-09-09 | 英倍尔制药公司 | 经鼻药物递送装置 |
| AU2020277313A1 (en) | 2019-05-17 | 2022-01-20 | Impel Pharmaceuticals Inc. | Single-use nasal delivery device |
| IL324950A (en) * | 2023-05-31 | 2026-01-01 | Shin Nippon Biomedical Laboratories Ltd | Compositions for enhanced mucosal penetration |
Family Cites Families (42)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2750090A1 (de) | 1976-11-19 | 1978-06-01 | Sandoz Ag | Neue verabreichungsformen fuer organische verbindungen |
| US5169849A (en) * | 1982-02-01 | 1992-12-08 | Sandoz Ltd. | Nasal pharmaceutical compositions |
| JPS59163313A (ja) * | 1983-03-09 | 1984-09-14 | Teijin Ltd | 経鼻投与用ペプチドホルモン類組成物 |
| DE69434304T2 (de) * | 1993-03-26 | 2005-12-29 | Merkus, Franciscus Wilhelmus H.M. | Pharmazeutische Zusammensetzungen zur intranasalen Verabreichung von Dihydroergotamin |
| JP3197221B2 (ja) * | 1996-02-27 | 2001-08-13 | 帝人株式会社 | 吸収性が改善された粉末状経鼻投与組成物 |
| SE9803770D0 (sv) | 1998-11-05 | 1998-11-05 | Astra Ab | Dry powder pharmaceutical formulation |
| AU7685200A (en) * | 1999-10-12 | 2001-04-23 | Kaken Pharmaceutical Co., Ltd. | Powdery inhalational preparations and process for producing the same |
| EP1397173A1 (en) * | 2001-06-20 | 2004-03-17 | Nektar Therapeutics | Powder aerosolization apparatus and method |
| MXPA03005980A (es) * | 2001-07-05 | 2003-09-10 | Translational Res Ltd | Composiciones para administracion nasal de insulina. |
| US20030044458A1 (en) | 2001-08-06 | 2003-03-06 | Curtis Wright | Oral dosage form comprising a therapeutic agent and an adverse-effect agent |
| FR2834212B1 (fr) * | 2001-12-27 | 2004-07-09 | Besins Int Belgique | Utilisation d'une poudre a liberation immediate dans des compositions pharmaceutiques et nutraceutiques |
| JP4212019B2 (ja) * | 2002-01-09 | 2009-01-21 | Translational Research 株式会社 | 薬物の経鼻投与用組成物 |
| GB0228826D0 (en) * | 2002-12-11 | 2003-01-15 | Okpala Joseph | Hair technology in creating particles with improved delivery capabilities |
| US7638138B2 (en) * | 2003-02-21 | 2009-12-29 | Translational Research, Ltd. | Compositions for nasal administration of pharmaceuticals |
| GB0304636D0 (en) * | 2003-02-28 | 2003-04-02 | Britannia Pharmaceuticals Ltd | Pharmaceutical composition for nasal delivery |
| EP1663159A4 (en) | 2003-09-10 | 2010-06-09 | Map Pharmaceuticals Inc | AEROSOL FORMULATIONS FOR THE DELIVERY OF DIHYDROERGOTAMINE TO THE SYSTEMIC CIRCULATION BY PULMONARY INHALATION |
| WO2006016530A1 (ja) * | 2004-08-10 | 2006-02-16 | Translational Research, Ltd. | 速効性でかつ高い吸収性を可能とする経鼻投与用組成物 |
| JP5694643B2 (ja) * | 2005-08-05 | 2015-04-01 | スリーエム イノベイティブ プロパティズ カンパニー | 改善された流動性を示す組成物 |
| WO2007066646A1 (ja) * | 2005-12-06 | 2007-06-14 | Asahi Kasei Chemicals Corporation | 高速直接打錠による錠剤の製造方法 |
| ES2652415T3 (es) * | 2006-12-26 | 2018-02-02 | Shin Nippon Biomedical Laboratories, Ltd. | Preparación para aplicación transnasal |
| PL2425820T3 (pl) | 2007-02-11 | 2015-08-31 | Map Pharmaceuticals Inc | Sposób terapeutycznego stosowania dhe w celu umożliwienia szybkiego złagodzenia migreny przy jednoczesnym zminimalizowaniu profilu działań niepożądanych |
| JP2009076785A (ja) * | 2007-09-21 | 2009-04-09 | Panasonic Corp | 半導体装置の製造方法 |
| US20110082150A1 (en) | 2008-02-11 | 2011-04-07 | Robert Owen Cook | Headache pre-emption by dihydroergotamine treatment during headache Precursor events |
| US9101539B2 (en) * | 2009-05-15 | 2015-08-11 | Shin Nippon Biomedical Laboratories, Ltd. | Intranasal pharmaceutical compositions with improved pharmacokinetics |
| US20110171141A1 (en) * | 2009-06-26 | 2011-07-14 | Kellerman Donald J | Administration of dihydroergotamine mesylate particles using a metered dose inhaler |
| US8827946B2 (en) | 2009-07-31 | 2014-09-09 | Shin Nippon Biomedical Laboratories, Ltd. | Intranasal granisetron and nasal applicator |
| SG181896A1 (en) | 2009-12-23 | 2012-07-30 | Map Pharmaceuticals Inc | Novel ergoline analogs |
| EP2689785B1 (en) * | 2010-04-15 | 2021-05-19 | Shin Nippon Biomedical Laboratories, Ltd. | Method for generating dry vaccine powder formulation for inranasal delivery |
| WO2011163600A2 (en) * | 2010-06-25 | 2011-12-29 | Apt Pharmaceuticals, Inc. | Tacrolimus compositions for aerosol administration |
| ES2659761T3 (es) | 2011-01-31 | 2018-03-19 | Shin Nippon Biomedical Laboratories, Ltd. | Dispositivos de administración intranasal |
| EP2680913B1 (en) | 2011-03-03 | 2020-05-06 | Impel NeuroPharma Inc. | Nasal drug delivery device |
| EP2787970B1 (en) * | 2011-12-11 | 2018-04-11 | Recro Pharma, Inc. | Intranasal dexmedetomidine compositions and methods of use thereof |
| US20140179705A1 (en) | 2012-12-21 | 2014-06-26 | Map Pharmaceuticals, Inc. | 8'-hydroxy-dihydroergotamine compounds and compositions |
| EP2935280A4 (en) | 2012-12-21 | 2016-05-25 | Map Pharmaceuticals Inc | 8'-HYDROXY-DIHYDROERGOTAMINE COMPOUNDS AND COMPOSITIONS |
| EP3049059B1 (en) | 2013-09-24 | 2021-11-03 | Satsuma Pharmaceuticals, Inc. | Intranasal dhe formulation for the treatment of headache |
| US9561177B2 (en) | 2014-03-14 | 2017-02-07 | Adapt Pharma Limited | Nasal drug products and methods of their use |
| CA3030359A1 (en) | 2016-08-05 | 2018-02-08 | Shin Nippon Biomedical Laboratories, Ltd. | Intranasal pharmaceutical powder compositions |
| JP7523879B2 (ja) | 2016-10-31 | 2024-07-29 | エスエス製薬株式会社 | 医薬組成物 |
| BR112019027508A2 (pt) | 2017-07-02 | 2020-07-07 | Dr. Reddys Laboratories Limited | formas de dosagem nasal de di-hidroergotamina |
| US11744967B2 (en) | 2017-09-26 | 2023-09-05 | Shin Nippon Biomedical Laboratories, Ltd. | Intranasal delivery devices |
| BR112020013744A8 (pt) | 2018-01-05 | 2022-10-18 | Impel Neuropharma Inc | Dispensação intranasal de di-hidroergotamina por dispositivo olfativo de precisão |
| CA3122396A1 (en) | 2018-12-11 | 2020-06-18 | Satsuma Pharmaceuticals, Inc. | Compositions, devices, and methods for treating or preventing headaches |
-
2014
- 2014-09-24 EP EP14830861.2A patent/EP3049059B1/en active Active
- 2014-09-24 JP JP2016516520A patent/JP2016531850A/ja active Pending
- 2014-09-24 DK DK14830861.2T patent/DK3049059T3/da active
- 2014-09-24 EP EP21205407.6A patent/EP4008307A1/en active Pending
- 2014-09-24 US US15/023,206 patent/US20160228433A1/en not_active Abandoned
- 2014-09-24 WO PCT/IB2014/002706 patent/WO2015044782A2/en not_active Ceased
- 2014-09-24 ES ES14830861T patent/ES2904570T3/es active Active
-
2019
- 2019-05-16 US US16/414,350 patent/US20190275036A1/en not_active Abandoned
- 2019-09-06 JP JP2019162995A patent/JP6902583B2/ja active Active
-
2020
- 2020-02-14 US US16/791,431 patent/US20200179379A1/en not_active Abandoned
-
2022
- 2022-06-07 US US17/834,583 patent/US12594273B2/en active Active
-
2023
- 2023-10-02 US US18/479,335 patent/US20240108619A1/en active Pending
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