DK2838510T3 - Atomoxetin-opløsning - Google Patents

Atomoxetin-opløsning Download PDF

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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
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DK
Denmark
Prior art keywords
solution
atomoxetine
range
flavor
pharmaceutical composition
Prior art date
Application number
DK13818182.1T
Other languages
English (en)
Inventor
Matthew S Mermey
Arup Kumar Roy
Original Assignee
Lilly Co Eli
Priority date (The priority date 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 date listed.)
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=49920679&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2838510(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
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Publication of DK2838510T3 publication Critical patent/DK2838510T3/da

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; Sedatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions

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  • 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)
  • Neurology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Physiology (AREA)
  • Nutrition Science (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)

Claims (9)

1. Farmaceutisk sammensætning omfattende atomoxetin, vand, et smagsstof, som er F-9999 PFC Kunstig Hindbær CA Smag, og et sødemiddel, hvor den farmaceutiske sammensætning foreligger i form af en oral vandig opløsning, og pH-værdien af den orale vandige opløsning ligger i området fra 2,0 til 6,0, og hvor koncentrationen af atomoxetin ligger i området fra 1,0 til 10 mg/ml_, og koncentrationen af F-9999 PFC Kunstig Hindbær CA Smag ligger i området 1,0-30 mg/mL.
2. Farmaceutisk sammensætning ifølge krav 1, omfattende atomoxetin, vand, natriumbenzoat, natriumdihydrogenphosphatdihydrat, phosphorsyre, sorbitol, xylitol, F-9999 PFC Kunstig Hindbær CA Smag, og sucralose, hvor pH-vær-dien af den orale vandige opløsning ligger i området fra 3,0 til 5,0.
3. Farmaceutisk sammensætning ifølge et af kravene 1 til 2, hvor atomoxetin er atomoxetinhydrochlorid.
4. Farmaceutisk sammensætning ifølge et af kravene 1 til 3, hvor koncentrationen af atomoxetin ligger i området 3 til 6 mg/mL.
5. Farmaceutisk sammensætning ifølge et af kravene 1 til 4, hvor pH-værdien af den orale vandige opløsning ligger i området 3,7 til 4,3.
6. Fremgangsmåde til fremstilling af en farmaceutisk sammensætning af en oral vandig opløsning omfattende at kombinere atomoxetin, vand, natriumbenzoat, natriumdihydrogenphosphatdihydrat, phosphorsyre, sorbitol, xylitol, F-9999 PFC Kunstig Hindbær CA Smag, og sucralose, hvor pH-værdien af opløsningen ligger i området 3,7-4,3, og hvor koncentrationen af atomoxetin ligger i området fra 1,0 til 10 mg/mL, og koncentrationen af F-9999 PFC Kunstig Hindbær CA Smag ligger i området 1,0-30 mg/mL.
7. Farmaceutisk sammensætning ifølge krav 6, hvor atomoxetin er atomoxetinhydrochlorid.
8. Fremgangsmåde ifølge krav 7, omfattende følgende trin: (a) . at tilsætte atomoxetinhydrochlorid, natriumbenzoat og natriumdihydro-genphosphatdihydrat til oprenset vand, og omrøre, indtil der dannes en opløsning; (b) . at tilsætte phosphorsyre fortyndet i oprenset vand til opløsningen dannet i trin (a), og omrore, indtil der dannes en opløsning; (b). at tilsætte sorbitol til opløsningen dannet i trin (b), og omrøre, indtil der dannes en opløsning; (b). at tilsætte xylitol til opløsningen dannet i trin (c), og omrore, indtil der dannes en opløsning; (e). at tilsætte smagsstof F-9999 PFC Kunstig Hindbær CA Smag til opløsningen dannet i trin (d), og omrøre, indtil der dannes en opløsning; (b). at tilsætte sucralose til opløsningen dannet i trin (e), og omrore, indtil der dannes en opløsning; (g) , at indstille pH-værdien af opløsningen dannet i trin (f) til 3,7 til 4,3 med vandig phosphorsyreopløsning og/eller vandig natriumhydroxidopløsning; og (h) . at tilsætte oprenset vand til opløsningen dannet i trin (g) for at opnå ato-moxetinhydrochloridkoncentrationen i området fra 3,0 til 6,0 mg/mL.
9. Farmaceutisk sammensætning, som fremstilles ved fremgangsmåden ifølge et af kravene 6 til 8.
DK13818182.1T 2013-11-08 2013-12-19 Atomoxetin-opløsning DK2838510T3 (da)

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 (da) 2016-12-19

Family

ID=49920679

Family Applications (1)

Application Number Title Priority Date Filing Date
DK13818182.1T DK2838510T3 (da) 2013-11-08 2013-12-19 Atomoxetin-opløsning

Country Status (15)

Country Link
US (1) US9326935B2 (da)
EP (1) EP2838510B1 (da)
JP (1) JP5973073B2 (da)
CN (1) CN105705135A (da)
CY (1) CY1118100T1 (da)
DK (1) DK2838510T3 (da)
ES (1) ES2605495T3 (da)
HU (1) HUE032205T2 (da)
IL (1) IL244878A (da)
MX (1) MX365663B (da)
PL (1) PL2838510T3 (da)
PT (1) PT2838510T (da)
SI (1) SI2838510T1 (da)
TW (1) TWI583402B (da)
WO (1) WO2014204513A1 (da)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
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
CN115869253A (zh) * 2021-09-28 2023-03-31 郑州深蓝海生物医药科技有限公司 一种盐酸托莫西汀口服溶液及其制备方法

Family Cites Families (18)

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PL233786A1 (da) * 1980-11-14 1982-05-24 Lilly Co Eli
US5658590A (en) 1995-01-11 1997-08-19 Eli Lilly And Company Treatment of attention-deficit/hyperactivity disorder
JP2003525899A (ja) * 2000-03-07 2003-09-02 イーライ・リリー・アンド・カンパニー 乾癬の治療
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
AU2004312059A1 (en) * 2003-12-31 2005-07-21 Actavis Group Hf Atomoxetine formulations
MX2007010268A (es) * 2005-04-05 2008-02-19 Teva Pharm Fine Chemicals Srl Clorhidrato de atomoxetina estable, un proceso para la preparacion del mismo, y un control analitico de su estabilidad.
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US20120128683A1 (en) 2011-11-22 2012-05-24 Shantha Totada R Autism treatment

Also Published As

Publication number Publication date
IL244878A (en) 2017-04-30
EP2838510A1 (en) 2015-02-25
MX2016005998A (es) 2016-07-18
ES2605495T3 (es) 2017-03-14
HUE032205T2 (en) 2017-09-28
JP5973073B2 (ja) 2016-08-23
CY1118100T1 (el) 2017-06-28
WO2014204513A1 (en) 2014-12-24
MX365663B (es) 2019-06-10
PL2838510T3 (pl) 2017-09-29
US20150133562A1 (en) 2015-05-14
IL244878A0 (en) 2016-05-31
PT2838510T (pt) 2016-11-23
EP2838510B1 (en) 2016-09-21
US9326935B2 (en) 2016-05-03
CN105705135A (zh) 2016-06-22
JP2015522624A (ja) 2015-08-06
SI2838510T1 (sl) 2016-11-30
TW201431567A (zh) 2014-08-16
TWI583402B (zh) 2017-05-21

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