DK2645993T3 - Farmaceutiske cremesammensætninger, der omfatter oxymetazolin - Google Patents

Farmaceutiske cremesammensætninger, der omfatter oxymetazolin Download PDF

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Publication number
DK2645993T3
DK2645993T3 DK11794911.5T DK11794911T DK2645993T3 DK 2645993 T3 DK2645993 T3 DK 2645993T3 DK 11794911 T DK11794911 T DK 11794911T DK 2645993 T3 DK2645993 T3 DK 2645993T3
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DK
Denmark
Prior art keywords
cream
oxymetazoline
skin
weight
amount
Prior art date
Application number
DK11794911.5T
Other languages
English (en)
Inventor
Stuart D Shanler
Christopher Powala
Luis Rios
Original Assignee
Allergan Inc
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Publication date
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Publication of DK2645993T3 publication Critical patent/DK2645993T3/da

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4174—Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system

Claims (13)

1. Farmaceutisk sammensætning, der omfatter oxymetazolin, cetostearylalkohol, polyethylenglycol 6 (PEG-6)-stearat, polyethylenglycol 32 (PEG-32)-stearat og glycolstearat, hvor sammensætningen er en creme, med det forbehold at cremen ikke har følgende sammensætning:
2. Farmaceutisk sammensætning, der omfatter oxymetazolin, cetostearylalkohol, polyethylenglycol 6 (PEG-6)-stearat, polyethylenglycol 32 (PEG-32)-stearat og glycolstearat, hvor sammensætningen er en creme, og hvor oxymetazolin er den eneste aktive farmaceutiske bestanddel i formuleringen.
3. Farmaceutisk sammensætning ifølge krav 1 eller 2, hvor oxymetazolinen forekommer i en mængde på fra 0,0075 til 5 vægtprocent.
4. Farmaceutisk sammensætning ifølge krav 1 eller 2, der indeholder en emulgator i en mængde på fra 1 % til 30 vægtprocent.
5. Farmaceutisk sammensætning ifølge krav 1 eller 2, der indeholder et blødgøringsmiddel i en mængde på fra 1 til 50 vægtprocent.
6. Farmaceutisk sammensætning ifølge krav 1 eller 2, der indeholder en emulgator og et blødgøringsmiddel i et forhold på fra 0,7:1 til 1,8:1, hvor blødgøringsmidlet er valgt blandt fedtsyreestere, fedtalkoholer eller kombinationer deraf.
7. Farmaceutisk sammensætning ifølge krav 1 eller 2, som endvidere omfatter et tilsætningsstof, der er valgt fra gruppen bestående af konserveringsmidler, emulsionsstabilisatorer, pH-justeringsmidler, chelate ringsmid ler, viskositetsmodificerende midler, antioxidanter, overfladeaktive midler, blødgøringsmidler, opakiseringsmidler, hudkonditioneringsmidler, buffere og kombinationer deraf, hvor blødgøringsmidlet er valgt blandt fedtsyreestere, fedtalkoholer eller kombinationer deraf.
8. Farmaceutisk sammensætning ifølge krav 1, hvor sammensætningen yderligere omfatter et topisk aktivt farmaceutisk middel, der er valgt fra gruppen bestående af et antimykobakterielt middel, et anti-rosacea-middel og en blanding deraf.
9. Farmaceutisk sammensætning ifølge krav 1 eller 2, hvor sammensætningen omfatter en pH-værdi fra 2,0 til 7,0 ved stuetemperatur.
10. Farmaceutisk sammensætning ifølge krav 1 eller 2, hvor pH-værdien er uændret efter 4 ugers opbevaring ved 25 °C/60 % RH, 30 °C/75 % RH eller 40 °C/75 % RH.
11. Farmaceutisk sammensætning ifølge krav 1 eller 2, hvor pH-værdien er uændret efter 1 uges opbevaring ved 60 °C.
12. Farmaceutisk sammensætning ifølge krav 1, som endvidere omfatter en vasokonstriktor.
13. Farmaceutisk sammensætning ifølge krav 1 eller 2, som endvidere omfatter én eller flere komponenter, der er valgt blandt: ét eller flere konserveringsmidler i en mængde på fra 0,01 til 5 vægtprocent af den farmaceutiske sammensætning; ét eller flere chelateringsmidler i en mængde på fra 0,001 til 2 vægtprocent af den farmaceutiske sammensætning; ét eller flere viskositetsmodificerende midler i en mængde på fra 0,5 til 30 vægtprocent af den farmaceutiske sammensætning; én eller flere antioxidanter i en mængde på fra 0,01 til 3 vægtprocent af den farmaceutiske sammensætning; ét eller flere overfladeaktive midler i en mængde på fra 0,1 til 50 vægtprocent af den farmaceutiske sammensætning; ét eller flere opakiseringsmidler i en mængde på fra 0,01 til 20 vægtprocent af den farmaceutiske sammensætning; ét eller flere hudkonditioneringsmidler i en mængde på fra 1 til 50 vægtprocent af den farmaceutiske sammensætning; én eller flere pH-regulatorer i en mængde, som er tilstrækkelig til at tilvejebringe en pH-værdi på fra 2,5 til 7,0 for den farmaceutiske sammensætning; og kombinationer deraf.
DK11794911.5T 2010-12-03 2011-12-01 Farmaceutiske cremesammensætninger, der omfatter oxymetazolin DK2645993T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US41969710P 2010-12-03 2010-12-03
US41969310P 2010-12-03 2010-12-03
PCT/US2011/062936 WO2012075319A2 (en) 2010-12-03 2011-12-01 Pharmaceutical cream compositions and methods of use

Publications (1)

Publication Number Publication Date
DK2645993T3 true DK2645993T3 (da) 2017-02-13

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DK11794911.5T DK2645993T3 (da) 2010-12-03 2011-12-01 Farmaceutiske cremesammensætninger, der omfatter oxymetazolin

Country Status (12)

Country Link
US (3) US8883838B2 (da)
EP (2) EP2645993B1 (da)
JP (1) JP6030067B2 (da)
AU (3) AU2011336449B2 (da)
CA (1) CA2819633C (da)
DK (1) DK2645993T3 (da)
ES (2) ES2618907T3 (da)
HK (1) HK1190307A1 (da)
PL (1) PL2645993T3 (da)
PT (1) PT2645993T (da)
TW (1) TWI533893B (da)
WO (1) WO2012075319A2 (da)

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Also Published As

Publication number Publication date
EP2645993A2 (en) 2013-10-09
TW201242618A (en) 2012-11-01
JP2014505026A (ja) 2014-02-27
CA2819633C (en) 2019-04-23
AU2016238909A1 (en) 2016-10-27
WO2012075319A3 (en) 2012-07-19
US20200188517A1 (en) 2020-06-18
US20120149748A1 (en) 2012-06-14
EP3181121B1 (en) 2020-10-28
US20150045403A1 (en) 2015-02-12
AU2011336449B2 (en) 2016-07-07
EP3181121A1 (en) 2017-06-21
WO2012075319A2 (en) 2012-06-07
PL2645993T3 (pl) 2017-07-31
CA2819633A1 (en) 2012-06-07
JP6030067B2 (ja) 2016-11-24
TWI533893B (zh) 2016-05-21
US8883838B2 (en) 2014-11-11
ES2843696T3 (es) 2021-07-20
EP2645993B1 (en) 2016-11-02
AU2018229508B2 (en) 2020-06-25
AU2018229508A1 (en) 2018-10-04
AU2011336449A1 (en) 2013-07-11
HK1190307A1 (zh) 2014-07-04
PT2645993T (pt) 2017-03-03
ES2618907T3 (es) 2017-06-22

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