JP2015522624A5 - - Google Patents
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- Publication number
- JP2015522624A5 JP2015522624A5 JP2015523309A JP2015523309A JP2015522624A5 JP 2015522624 A5 JP2015522624 A5 JP 2015522624A5 JP 2015523309 A JP2015523309 A JP 2015523309A JP 2015523309 A JP2015523309 A JP 2015523309A JP 2015522624 A5 JP2015522624 A5 JP 2015522624A5
- Authority
- JP
- Japan
- Prior art keywords
- solution
- atomoxetine
- pharmaceutical composition
- range
- composition according
- 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
- 239000000243 solution Substances 0.000 claims description 86
- 229960002430 atomoxetine Drugs 0.000 claims description 72
- 239000000796 flavoring agent Substances 0.000 claims description 49
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 40
- 235000019634 flavors Nutrition 0.000 claims description 39
- 239000008194 pharmaceutical composition Substances 0.000 claims description 35
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 31
- 235000011034 Rubus glaucus Nutrition 0.000 claims description 25
- 235000009122 Rubus idaeus Nutrition 0.000 claims description 25
- 240000007651 Rubus glaucus Species 0.000 claims description 24
- LUCXVPAZUDVVBT-UNTBIKODSA-N atomoxetine hydrochloride Chemical compound Cl.O([C@H](CCNC)C=1C=CC=CC=1)C1=CC=CC=C1C LUCXVPAZUDVVBT-UNTBIKODSA-N 0.000 claims description 24
- 238000003756 stirring Methods 0.000 claims description 23
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 20
- 239000007864 aqueous solution Substances 0.000 claims description 20
- 229960002828 atomoxetine hydrochloride Drugs 0.000 claims description 16
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 15
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims description 15
- 239000004299 sodium benzoate Substances 0.000 claims description 15
- 235000010234 sodium benzoate Nutrition 0.000 claims description 15
- OOSZCNKVJAVHJI-UHFFFAOYSA-N 1-[(4-fluorophenyl)methyl]piperazine Chemical compound C1=CC(F)=CC=C1CN1CCNCC1 OOSZCNKVJAVHJI-UHFFFAOYSA-N 0.000 claims description 14
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 14
- 239000004376 Sucralose Substances 0.000 claims description 14
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 14
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 14
- 239000008213 purified water Substances 0.000 claims description 14
- 229940074545 sodium dihydrogen phosphate dihydrate Drugs 0.000 claims description 14
- 239000000600 sorbitol Substances 0.000 claims description 14
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 claims description 14
- 235000019408 sucralose Nutrition 0.000 claims description 14
- 239000000811 xylitol Substances 0.000 claims description 14
- 235000010447 xylitol Nutrition 0.000 claims description 14
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 14
- 229960002675 xylitol Drugs 0.000 claims description 14
- 229960003885 sodium benzoate Drugs 0.000 claims description 13
- 238000000034 method Methods 0.000 claims description 12
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 10
- 235000013355 food flavoring agent Nutrition 0.000 claims description 10
- 229960004838 phosphoric acid Drugs 0.000 claims description 10
- 229960002920 sorbitol Drugs 0.000 claims description 10
- 239000003814 drug Substances 0.000 claims description 8
- 208000006096 Attention Deficit Disorder with Hyperactivity Diseases 0.000 claims description 7
- 235000003599 food sweetener Nutrition 0.000 claims description 7
- 239000003765 sweetening agent Substances 0.000 claims description 7
- 208000036864 Attention deficit/hyperactivity disease Diseases 0.000 claims description 5
- 208000015802 attention deficit-hyperactivity disease Diseases 0.000 claims description 5
- 238000004519 manufacturing process Methods 0.000 claims description 4
- 238000002156 mixing Methods 0.000 claims description 4
- 229940100688 oral solution Drugs 0.000 claims 1
- VHGCDTVCOLNTBX-QGZVFWFLSA-N atomoxetine Chemical compound O([C@H](CCNC)C=1C=CC=CC=1)C1=CC=CC=C1C VHGCDTVCOLNTBX-QGZVFWFLSA-N 0.000 description 64
- 239000000203 mixture Substances 0.000 description 13
- 235000019658 bitter taste Nutrition 0.000 description 10
- 238000009472 formulation Methods 0.000 description 7
- 235000019640 taste Nutrition 0.000 description 7
- 229940079593 drug Drugs 0.000 description 6
- 239000007909 solid dosage form Substances 0.000 description 5
- 238000007792 addition Methods 0.000 description 4
- 238000004458 analytical method Methods 0.000 description 4
- 238000013459 approach Methods 0.000 description 3
- 239000002775 capsule Substances 0.000 description 3
- 239000006071 cream Substances 0.000 description 3
- 239000002552 dosage form Substances 0.000 description 3
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 description 2
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 description 2
- 235000006679 Mentha X verticillata Nutrition 0.000 description 2
- 235000002899 Mentha suaveolens Nutrition 0.000 description 2
- 235000001636 Mentha x rotundifolia Nutrition 0.000 description 2
- 239000008297 liquid dosage form Substances 0.000 description 2
- 229940041616 menthol Drugs 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 230000009747 swallowing Effects 0.000 description 2
- 206010013911 Dysgeusia Diseases 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 244000235659 Rubus idaeus Species 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 235000013361 beverage Nutrition 0.000 description 1
- 230000000595 bitter masking effect Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 239000007910 chewable tablet Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000013270 controlled release Methods 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 239000012458 free base Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 239000012456 homogeneous solution Substances 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000000873 masking effect Effects 0.000 description 1
- VHGCDTVCOLNTBX-UHFFFAOYSA-N n-methyl-3-(2-methylphenoxy)-3-phenylpropan-1-amine Chemical compound C=1C=CC=CC=1C(CCNC)OC1=CC=CC=C1C VHGCDTVCOLNTBX-UHFFFAOYSA-N 0.000 description 1
- 239000002767 noradrenalin uptake inhibitor Substances 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- -1 polypropylene Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- BBMHARZCALWXSL-UHFFFAOYSA-M sodium dihydrogenphosphate monohydrate Chemical compound O.[Na+].OP(O)([O-])=O BBMHARZCALWXSL-UHFFFAOYSA-M 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 239000008371 vanilla flavor Substances 0.000 description 1
- 239000001993 wax Substances 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361901577P | 2013-11-08 | 2013-11-08 | |
| US61/901,577 | 2013-11-08 | ||
| PCT/US2013/076435 WO2014204513A1 (en) | 2013-11-08 | 2013-12-19 | Atomoxetine solution |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2015522624A JP2015522624A (ja) | 2015-08-06 |
| JP2015522624A5 true JP2015522624A5 (enExample) | 2016-02-18 |
| JP5973073B2 JP5973073B2 (ja) | 2016-08-23 |
Family
ID=49920679
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015523309A Active JP5973073B2 (ja) | 2013-11-08 | 2013-12-19 | アトモキセチン溶液 |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US9326935B2 (enExample) |
| EP (1) | EP2838510B1 (enExample) |
| JP (1) | JP5973073B2 (enExample) |
| CN (1) | CN105705135A (enExample) |
| CY (1) | CY1118100T1 (enExample) |
| DK (1) | DK2838510T3 (enExample) |
| ES (1) | ES2605495T3 (enExample) |
| HU (1) | HUE032205T2 (enExample) |
| IL (1) | IL244878A (enExample) |
| MX (1) | MX365663B (enExample) |
| PL (1) | PL2838510T3 (enExample) |
| PT (1) | PT2838510T (enExample) |
| SI (1) | SI2838510T1 (enExample) |
| TW (1) | TWI583402B (enExample) |
| WO (1) | WO2014204513A1 (enExample) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105726473A (zh) * | 2016-03-31 | 2016-07-06 | 北京万全德众医药生物技术有限公司 | 托莫西汀或其可药用盐口服溶液及其制备方法 |
| CN106727291B (zh) * | 2016-12-06 | 2020-02-11 | 山东达因海洋生物制药股份有限公司 | 一种盐酸托莫西汀口服溶液及其制备方法 |
| US9855228B1 (en) * | 2016-12-14 | 2018-01-02 | Taho Pharmaceuticals Ltd. | Oral solution comprising atomoxetine hydrochloride and methods thereof |
| CN111437247A (zh) * | 2019-01-17 | 2020-07-24 | 北京万全德众医药生物技术有限公司 | 一种托莫西汀口服液的制备方法 |
| CN112438949A (zh) * | 2019-09-05 | 2021-03-05 | 北京兴源联合医药科技有限公司 | 一种含钙补充剂的盐酸托莫西汀口服液及其制备方法 |
| CN112451476A (zh) * | 2019-09-09 | 2021-03-09 | 北京兴源联合医药科技有限公司 | 一种盐酸托莫西汀口服液及其制备方法 |
| CN111956607A (zh) * | 2020-09-25 | 2020-11-20 | 健民药业集团股份有限公司 | 盐酸托莫西汀口服溶液及其制备方法 |
Family Cites Families (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NZ198953A (en) * | 1980-11-14 | 1984-10-19 | Lilly Co Eli | (-)-n-methyl-3-(2-methylphenoxy)-3-phenylpropylamine,its salts and pharmaceutical formulations |
| US5658590A (en) | 1995-01-11 | 1997-08-19 | Eli Lilly And Company | Treatment of attention-deficit/hyperactivity disorder |
| CA2400571A1 (en) * | 2000-03-07 | 2001-09-13 | Eli Lilly And Company | Treatment of psoriasis |
| US20040033228A1 (en) * | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
| US20050096311A1 (en) | 2003-10-30 | 2005-05-05 | Cns Response | Compositions and methods for treatment of nervous system disorders |
| ES2390879T3 (es) * | 2003-12-31 | 2012-11-19 | Actavis Group Ptc Ehf. | Formulaciones de atomoxetina |
| CA2600609A1 (en) * | 2005-04-05 | 2006-10-12 | Teva Pharmaceutical Fine Chemicals S.R.L. | Stable atomoxetine hydrochloride, a process for the preparation thereof, and an analytical control of its stability |
| CN101155775A (zh) * | 2005-04-05 | 2008-04-02 | 特瓦药物精化学品股份有限公司 | 稳定的阿托莫西汀盐酸盐、其制备方法，以及其稳定性分析控制 |
| US20070134277A1 (en) * | 2005-12-09 | 2007-06-14 | Children's Medical Center Corporation | Pharmaceutical formulation for sulfur-containing drugs in liquid dosage forms |
| WO2007103687A2 (en) | 2006-03-01 | 2007-09-13 | Tristrata, Inc. | Composition and method for topical treatment of tar-responsive dermatological disorders |
| US20080031932A1 (en) | 2006-08-04 | 2008-02-07 | Watson Laboratories, Inc. | Transdermal atomoxetine formulations and associated methods |
| US20080066739A1 (en) | 2006-09-20 | 2008-03-20 | Lemahieu Edward | Methods and systems of delivering medication via inhalation |
| US20080145318A1 (en) | 2006-12-13 | 2008-06-19 | Midha Kamal K | Atomoxetine formulations and associated methods |
| US9629920B2 (en) * | 2009-12-18 | 2017-04-25 | Exodos Life Sciences Limited Partnership | Methods and compositions for stable liquid drug formulations |
| WO2011123695A1 (en) | 2010-03-31 | 2011-10-06 | Abela Pharmaceuticals, Inc. | Dimethy sulfoxxide (dmso) formulations for treating autism |
| JP6336902B2 (ja) | 2011-06-22 | 2018-06-06 | ビョーメ バイオサイエンシズ ピーブイティー．リミテッド | コンジュゲートベースの抗真菌性および抗菌性プロドラッグ |
| US9040082B2 (en) | 2011-06-24 | 2015-05-26 | K-Pax Pharmaceuticals, Inc. | Compositions and methods for treatment of chronic fatigue |
| US20120128683A1 (en) | 2011-11-22 | 2012-05-24 | Shantha Totada R | Autism treatment |
-
2013
- 2013-12-19 JP JP2015523309A patent/JP5973073B2/ja active Active
- 2013-12-19 MX MX2016005998A patent/MX365663B/es active IP Right Grant
- 2013-12-19 ES ES13818182.1T patent/ES2605495T3/es active Active
- 2013-12-19 CN CN201380080783.2A patent/CN105705135A/zh active Pending
- 2013-12-19 EP EP13818182.1A patent/EP2838510B1/en not_active Revoked
- 2013-12-19 DK DK13818182.1T patent/DK2838510T3/en active
- 2013-12-19 HU HUE13818182A patent/HUE032205T2/en unknown
- 2013-12-19 SI SI201330306A patent/SI2838510T1/sl unknown
- 2013-12-19 WO PCT/US2013/076435 patent/WO2014204513A1/en not_active Ceased
- 2013-12-19 PL PL13818182T patent/PL2838510T3/pl unknown
- 2013-12-19 US US14/134,183 patent/US9326935B2/en active Active
- 2013-12-19 PT PT138181821T patent/PT2838510T/pt unknown
-
2014
- 2014-01-10 TW TW103101018A patent/TWI583402B/zh active
-
2016
- 2016-04-04 IL IL244878A patent/IL244878A/en active IP Right Grant
- 2016-10-13 CY CY20161101032T patent/CY1118100T1/el unknown
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