DK2450041T3 - Forbedret testosterongel til anvendelse i behandlingen af hypogonadisme - Google Patents
Forbedret testosterongel til anvendelse i behandlingen af hypogonadisme Download PDFInfo
- Publication number
- DK2450041T3 DK2450041T3 DK11181638.5T DK11181638T DK2450041T3 DK 2450041 T3 DK2450041 T3 DK 2450041T3 DK 11181638 T DK11181638 T DK 11181638T DK 2450041 T3 DK2450041 T3 DK 2450041T3
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- testosterone
- formulation
- gel
- skin
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- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
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- 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
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- 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
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- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
- A61P5/26—Androgens
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Claims (9)
1. Testosterongelsformulering bestående af: i. fra 1,50 til 1,70 % (w/w) testosteron; ii. fra 0,6 til 1,2 % (w/w) isopropylmyristat; iii. fra 60 til 80 % (w/w) af en alkohol valgt fra gruppen bestående af ethanol og isopropanol; iv. en tilstrækkelig mængde af fortykkelsesmiddel til at give sammensætningen en viskositet der overstiger 9000 cps; og v. vand; til anvendelse i behandling af hypogonadisme hos et individ ved perkutan administration.
2. Testosterongelsformuleringen til anvendelse ifølge krav 1, hvor nævnte formulering omfatter: i. fra 1,50 % til 1,70 % (w/w) testosteron; ii. fra 0,6 % til 1,2 % (w/w) isopropylmyristat; iii. fra 67 % til 74 % (w/w) afen alkohol valgt fra gruppen bestående af ethanol og isopropanol; iv. en tilstrækkelig mængde af fortykkelsesmiddel til at give sammensætningen en viskositet der overstiger 9000 cps; og v. vand.
3. Testosterongelsformuleringen til anvendelse ifølge krav 1 eller 2, hvor sammensætningen er opnåelig ved at kombinere: i. 1,62 % (w/w) testosteron; ii. 1,00 % (w/w) isopropylmyristat; iii. 73,5 % (w/w) alkohol (95 % v/v)* iv. 1,00 % (w/w) carbopol® 980; v. 7,00 % (w/w) 0,1 N natriumhydroxid; og vi. 15,9 % (w/w) oprenset vand *svarende til omkring 68,1 % absolut alkohol i formuleringen.
4. Testosterongelsformuleringen til anvendelse ifølge krav 1 eller 2, hvor sammensætningen omfatter omkring 1,62 % (w/w) testosteron.
5. Testosterongelsformuleringen til anvendelse ifølge krav 1 eller 2, hvor fortykkelsesmidlet er en neutraliseret carbomer.
6. Testosterongelsformuleringen til anvendelse ifølge krav 1 eller 2, hvor sammensætningen har en viskositet på 13000 cps til 33000 cps.
7. Testosterongelsformuleringen til anvendelse ifølge et hvilket som helst af de foregående krav, hvor individet har en serumtestosteronkoncentration før behandling på mindre end 300 ng/dl.
8. Testosterongelsformuleringen til anvendelse ifølge et hvilket som helst af de foregående krav, hvor en terapeutisk effektiv dosis af sammensætningen administreres en, to eller tre gange om dagen i mindst omkring 7 dage.
9. Fremgangsmåde til at opnå en testosterongelsformulering ved at kombinere: i. 1,62 % (w/w) testosteron; ii. 1,00 % (w/w) isopropylmyristat; iii. 73,5 % (w/w) alkohol (95% v/v)* iv. 1,00 % (w/w) carbopol® 980; v. 7,00 % (w/w) 0,1 N natriumhydroxid; og vi. 15,9 % (w/w) oprenset vand *svarende til omkring 68,1 % absolut alkohol i formuleringen.
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| EP06836341A EP1937276B1 (en) | 2005-10-12 | 2006-10-12 | Improved testosterone gel and method of use |
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| DK11181638.5T DK2450041T3 (da) | 2005-10-12 | 2006-10-12 | Forbedret testosterongel til anvendelse i behandlingen af hypogonadisme |
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| DK06836341.5T DK1937276T3 (da) | 2005-10-12 | 2006-10-12 | Forbedret testosterongel og fremgangsmåde til anvendelse deraf |
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