DK2373305T3 - Transdermale farmaceutiske sammensætninger omfattende en serm - Google Patents

Transdermale farmaceutiske sammensætninger omfattende en serm Download PDF

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Publication number
DK2373305T3
DK2373305T3 DK09764869.5T DK09764869T DK2373305T3 DK 2373305 T3 DK2373305 T3 DK 2373305T3 DK 09764869 T DK09764869 T DK 09764869T DK 2373305 T3 DK2373305 T3 DK 2373305T3
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DK
Denmark
Prior art keywords
pharmaceutical composition
composition
transdermal pharmaceutical
breast
transdermal
Prior art date
Application number
DK09764869.5T
Other languages
English (en)
Inventor
Valérie Masini-Eteve
Original Assignee
Besins Healthcare Lu Sarl
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.)
Filing date
Publication date
Application filed by Besins Healthcare Lu Sarl filed Critical Besins Healthcare Lu Sarl
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Publication of DK2373305T3 publication Critical patent/DK2373305T3/da

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Classifications

    • 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
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4523Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4535Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
    • 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
    • A61K9/0041Mammary glands, e.g. breasts, udder; Intramammary administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/30Oestrogens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (9)

1. Transdermal farmaceutisk sammensætning til transdermal indgivelse til en hudoverflade, hvor sammensætningen omfatter: (i) 0,01 til 10 % (v/v), fortrinsvis 2 til 5 % (v/v) endoxifen eller et farmaceutisk acceptabelt salt deraf, (ii) 60 til 80 % (v/v) af mindst en monoalkohol, hvor den mindst ene monoalkohol er udvalgt blandt C2-C4 monoalkoholer, fortrinsvis ethanol eller isopro-panol, (iii) 0,1 til 10 % (v/v) af mindst en penetrationsforstærker, hvor den mindst ene penetrationsforstærker er oliesyre, og forudsat at isopropylmyristat er udelukket, (iv) 0 til 5 % (v/v) af mindst et geleringsmiddel, fortrinsvis polyacrylsyrer, cellulosematerialer eller blandinger deraf, (v) 0,01 til 30 % (v/v) af mindst et befugtningsmiddel, fortrinsvis glycerin, (vi) q.s. 100 % (v/v) vand.
2. Transdermal farmaceutisk sammensætning ifølge krav 1, hvor den mindst ene penetrationsforstærker er en blanding af oliesyre og propylenglycol.
3. Transdermal farmaceutisk sammensætning ifølge krav 1, til anvendelse i en fremgangsmåde til indgivelse af en terapeutisk virksom mængde af endoxifen eller det farmaceutisk acceptable salt deraf til en patient med behov herfor, omfattende at indgive sammensætningen transdermalt på en hudoverflade hos patienten.
4. Transdermal farmaceutisk sammensætning til anvendelse ifølge krav 3, hvor patienten lider af en brystsygdom.
5. Transdermal farmaceutisk sammensætning ifølge krav 3, hvor patienten lider af østrogenforstyrrelse.
6. Transdermal farmaceutisk sammensætning ifølge krav 5, hvor østrogenforstyrrelsen er en brystsygdom udvalgt blandt godartede brystsygdomme, gynækomasti, brystcancer, mastalgi og tilstande, der involverer tæt bryst- væv.
7. Dosispakke, enhedsdosispakke eller flerdosispakke indeholdende en transdermal farmaceutisk sammensætning ifølge krav 1.
8. Dispenser, eventuelt med håndpumpe, indeholdende en transdermal farmaceutisk sammensætning ifølge krav 1.
9. Fremgangsmåde til fremstilling af en transdermal farmaceutisk sammensætning ifølge krav 1, omfattende trinnene til fremstilling af en blanding omfattende: (i) mindst en monoalhohol udvalgt blandt C2-C4-monoalkoholer, (ii) endoxifen eller de farmaceutisk acceptable salte deraf, (iii) en vandig vehikel, (iv) mindst en penetrationsforstærker, hvor den mindst ene penetrationsforstærker er oliesyre, og forudsat at isopropyl-myristat er udelukket, (v) eventuelt mindst et geleringsmiddel, (vi) mindst et befugtningsmiddel.
DK09764869.5T 2008-12-11 2009-12-09 Transdermale farmaceutiske sammensætninger omfattende en serm DK2373305T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US12184808P 2008-12-11 2008-12-11
EP08305924 2008-12-11
PCT/EP2009/066768 WO2010066810A1 (en) 2008-12-11 2009-12-09 Transdermal pharmaceutical compositions comprising a serm

Publications (1)

Publication Number Publication Date
DK2373305T3 true DK2373305T3 (da) 2017-05-15

Family

ID=40521639

Family Applications (2)

Application Number Title Priority Date Filing Date
DK17157911.3T DK3202420T3 (da) 2008-12-11 2009-12-09 Transdermale farmaceutiske sammensætninger omfattende en serm
DK09764869.5T DK2373305T3 (da) 2008-12-11 2009-12-09 Transdermale farmaceutiske sammensætninger omfattende en serm

Family Applications Before (1)

Application Number Title Priority Date Filing Date
DK17157911.3T DK3202420T3 (da) 2008-12-11 2009-12-09 Transdermale farmaceutiske sammensætninger omfattende en serm

Country Status (9)

Country Link
US (2) US20120010245A1 (da)
EP (3) EP3656376A1 (da)
DK (2) DK3202420T3 (da)
ES (1) ES2624557T3 (da)
HU (1) HUE034680T2 (da)
PL (1) PL3202420T3 (da)
PT (1) PT2373305T (da)
SI (2) SI3202420T1 (da)
WO (1) WO2010066810A1 (da)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10080760B2 (en) 2009-10-27 2018-09-25 Besins Healthcare Luxembourg Sarl Transdermal pharmaceutical compositions comprising active agents
WO2015179282A1 (en) * 2014-05-20 2015-11-26 Topokine Therapeutics, Inc. Topical compositions comprising a thiazolidinedione
US10185559B2 (en) * 2014-06-25 2019-01-22 Entit Software Llc Documentation notification
WO2017011623A1 (en) * 2015-07-14 2017-01-19 Atossa Genetics Inc. Transpapillary methods and compositions for treating breast disorders
US20170304232A1 (en) 2016-04-20 2017-10-26 Northwestern University Endoxifen For Local Transdermal Therapy To The Breast
CN111212631A (zh) * 2017-09-11 2020-05-29 阿托莎医疗公司 局部用组合物和治疗方法
TWI793165B (zh) 2017-09-11 2023-02-21 美商阿托薩醫療公司 製造及使用因多昔芬(endoxifen)之方法
MX2022000203A (es) 2019-07-03 2022-03-22 Atossa Therapeutics Inc Composiciones de liberacion sostenida de endoxifeno.
GB2608397B (en) * 2021-06-29 2025-04-09 Chaitowitz Ilan Gynecomastia treatment

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DE4407742C1 (de) * 1994-03-08 1995-06-22 Hexal Pharma Gmbh Transdermales System in Form eines Pflasters mit einem Tamoxifen-Derivat
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Also Published As

Publication number Publication date
WO2010066810A8 (en) 2010-10-21
WO2010066810A1 (en) 2010-06-17
HUE034680T2 (en) 2018-02-28
PL3202420T3 (pl) 2020-07-13
EP3202420A1 (en) 2017-08-09
SI2373305T1 (sl) 2017-09-29
DK3202420T3 (da) 2020-04-06
ES2624557T3 (es) 2017-07-14
PT2373305T (pt) 2017-06-14
EP3202420B1 (en) 2020-03-04
US20190380948A1 (en) 2019-12-19
EP3656376A1 (en) 2020-05-27
EP2373305A1 (en) 2011-10-12
EP2373305B1 (en) 2017-03-15
US20120010245A1 (en) 2012-01-12
SI3202420T1 (sl) 2020-08-31

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