DK2838510T3 - Atomoxetine solution - Google Patents
Atomoxetine solution Download PDFInfo
- Publication number
- DK2838510T3 DK2838510T3 DK13818182.1T DK13818182T DK2838510T3 DK 2838510 T3 DK2838510 T3 DK 2838510T3 DK 13818182 T DK13818182 T DK 13818182T DK 2838510 T3 DK2838510 T3 DK 2838510T3
- Authority
- DK
- Denmark
- Prior art keywords
- solution
- atomoxetine
- range
- flavor
- pharmaceutical composition
- Prior art date
Links
- 229960002430 atomoxetine Drugs 0.000 title claims description 65
- VHGCDTVCOLNTBX-QGZVFWFLSA-N atomoxetine Chemical compound O([C@H](CCNC)C=1C=CC=CC=1)C1=CC=CC=C1C VHGCDTVCOLNTBX-QGZVFWFLSA-N 0.000 title description 58
- 239000000243 solution Substances 0.000 claims description 85
- 239000000796 flavoring agent Substances 0.000 claims description 49
- 235000019634 flavors Nutrition 0.000 claims description 40
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 36
- 238000003756 stirring Methods 0.000 claims description 26
- 239000008194 pharmaceutical composition Substances 0.000 claims description 25
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 25
- 239000007864 aqueous solution Substances 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
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 18
- 229960002828 atomoxetine hydrochloride Drugs 0.000 claims description 16
- 238000000034 method Methods 0.000 claims description 13
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims description 13
- 239000004299 sodium benzoate Substances 0.000 claims description 13
- 235000010234 sodium benzoate Nutrition 0.000 claims description 13
- OOSZCNKVJAVHJI-UHFFFAOYSA-N 1-[(4-fluorophenyl)methyl]piperazine Chemical compound C1=CC(F)=CC=C1CN1CCNCC1 OOSZCNKVJAVHJI-UHFFFAOYSA-N 0.000 claims description 12
- 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 12
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 12
- 239000004376 Sucralose Substances 0.000 claims description 12
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 12
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 12
- 239000008213 purified water Substances 0.000 claims description 12
- 229940074545 sodium dihydrogen phosphate dihydrate Drugs 0.000 claims description 12
- 239000000600 sorbitol Substances 0.000 claims description 12
- 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 12
- 235000019408 sucralose Nutrition 0.000 claims description 12
- 239000000811 xylitol Substances 0.000 claims description 12
- 235000010447 xylitol Nutrition 0.000 claims description 12
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 12
- 229960002675 xylitol Drugs 0.000 claims description 12
- 229960003885 sodium benzoate Drugs 0.000 claims description 11
- 235000013355 food flavoring agent Nutrition 0.000 claims description 9
- 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 8
- 229960004838 phosphoric acid Drugs 0.000 claims description 8
- 229960002920 sorbitol Drugs 0.000 claims description 8
- 235000019640 taste Nutrition 0.000 claims description 8
- 235000003599 food sweetener Nutrition 0.000 claims description 4
- 239000003765 sweetening agent Substances 0.000 claims description 4
- 238000002360 preparation method Methods 0.000 claims 1
- 238000009472 formulation Methods 0.000 description 9
- 239000000203 mixture Substances 0.000 description 9
- 235000019658 bitter taste Nutrition 0.000 description 7
- 239000003814 drug Substances 0.000 description 6
- 208000006096 Attention Deficit Disorder with Hyperactivity Diseases 0.000 description 5
- 229940079593 drug Drugs 0.000 description 5
- 239000007909 solid dosage form Substances 0.000 description 5
- 208000036864 Attention deficit/hyperactivity disease Diseases 0.000 description 4
- 235000011034 Rubus glaucus Nutrition 0.000 description 4
- 244000235659 Rubus idaeus Species 0.000 description 4
- 235000009122 Rubus idaeus Nutrition 0.000 description 4
- 208000015802 attention deficit-hyperactivity disease Diseases 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
- 230000000873 masking effect Effects 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
- 239000012456 homogeneous solution Substances 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000004519 manufacturing process Methods 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
- 206010013911 Dysgeusia Diseases 0.000 description 1
- 241000167880 Hirundinidae Species 0.000 description 1
- 239000004743 Polypropylene Substances 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
- 239000004615 ingredient Substances 0.000 description 1
- 239000012669 liquid formulation Substances 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
- 229940100688 oral solution Drugs 0.000 description 1
- 239000008177 pharmaceutical agent Substances 0.000 description 1
- 239000000546 pharmaceutical excipient 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
- 230000003389 potentiating effect Effects 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 229940012488 strattera Drugs 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 239000008371 vanilla flavor Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/20—Hypnotics; Sedatives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
Landscapes
- Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Neurosurgery (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Psychiatry (AREA)
- Hospice & Palliative Care (AREA)
- Anesthesiology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361901577P | 2013-11-08 | 2013-11-08 | |
| PCT/US2013/076435 WO2014204513A1 (en) | 2013-11-08 | 2013-12-19 | Atomoxetine solution |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2838510T3 true DK2838510T3 (en) | 2016-12-19 |
Family
ID=49920679
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK13818182.1T DK2838510T3 (en) | 2013-11-08 | 2013-12-19 | Atomoxetine solution |
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
Also Published As
| Publication number | Publication date |
|---|---|
| IL244878A0 (en) | 2016-05-31 |
| TWI583402B (zh) | 2017-05-21 |
| MX365663B (es) | 2019-06-10 |
| WO2014204513A1 (en) | 2014-12-24 |
| TW201431567A (zh) | 2014-08-16 |
| US20150133562A1 (en) | 2015-05-14 |
| PT2838510T (pt) | 2016-11-23 |
| CN105705135A (zh) | 2016-06-22 |
| CY1118100T1 (el) | 2017-06-28 |
| US9326935B2 (en) | 2016-05-03 |
| IL244878A (en) | 2017-04-30 |
| ES2605495T3 (es) | 2017-03-14 |
| JP5973073B2 (ja) | 2016-08-23 |
| SI2838510T1 (sl) | 2016-11-30 |
| JP2015522624A (ja) | 2015-08-06 |
| HUE032205T2 (en) | 2017-09-28 |
| PL2838510T3 (pl) | 2017-09-29 |
| MX2016005998A (es) | 2016-07-18 |
| EP2838510B1 (en) | 2016-09-21 |
| EP2838510A1 (en) | 2015-02-25 |
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