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DK2450041T3 - Forbedret testosterongel til anvendelse i behandlingen af hypogonadisme - Google Patents

Forbedret testosterongel til anvendelse i behandlingen af hypogonadisme Download PDF

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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
Authority
DK
Denmark
Prior art keywords
testosterone
formulation
gel
skin
dose
Prior art date
Application number
DK11181638.5T
Other languages
English (en)
Inventor
Ramana Malladi
Jodi Miller
Original Assignee
Unimed Pharmaceuticals Llc
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=37943593&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2450041(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Unimed Pharmaceuticals Llc, Besins Healthcare Lu Sarl filed Critical Unimed Pharmaceuticals Llc
Application granted granted Critical
Publication of DK2450041T3 publication Critical patent/DK2450041T3/da

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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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • 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
    • 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
    • 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
    • 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
    • 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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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

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.
DK11181638.5T 2005-10-12 2006-10-12 Forbedret testosterongel til anvendelse i behandlingen af hypogonadisme DK2450041T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US72527605P 2005-10-12 2005-10-12
EP06836341A EP1937276B1 (en) 2005-10-12 2006-10-12 Improved testosterone gel and method of use

Publications (1)

Publication Number Publication Date
DK2450041T3 true DK2450041T3 (da) 2018-11-19

Family

ID=37943593

Family Applications (3)

Application Number Title Priority Date Filing Date
DK06836341.5T DK1937276T3 (da) 2005-10-12 2006-10-12 Forbedret testosterongel og fremgangsmåde til anvendelse deraf
DK18195634.3T DK3456329T3 (da) 2005-10-12 2006-10-12 Forbedret testosteron-gel og fremgangsmåde til brug
DK11181638.5T DK2450041T3 (da) 2005-10-12 2006-10-12 Forbedret testosterongel til anvendelse i behandlingen af hypogonadisme

Family Applications Before (2)

Application Number Title Priority Date Filing Date
DK06836341.5T DK1937276T3 (da) 2005-10-12 2006-10-12 Forbedret testosterongel og fremgangsmåde til anvendelse deraf
DK18195634.3T DK3456329T3 (da) 2005-10-12 2006-10-12 Forbedret testosteron-gel og fremgangsmåde til brug

Country Status (31)

Country Link
US (11) US20070237822A1 (da)
EP (4) EP2450041B1 (da)
JP (2) JP5584415B2 (da)
KR (1) KR101342357B1 (da)
CN (1) CN101287470B (da)
AU (1) AU2006299833B2 (da)
BR (1) BRPI0617294B8 (da)
CA (1) CA2624788C (da)
CY (1) CY1120904T1 (da)
DK (3) DK1937276T3 (da)
EA (1) EA012754B1 (da)
EC (1) ECSP088363A (da)
ES (2) ES2693745T3 (da)
FI (1) FI3456329T3 (da)
GE (1) GEP20125432B (da)
HK (1) HK1117417A1 (da)
HR (1) HRP20130071T1 (da)
IL (1) IL190522A (da)
LT (1) LT2450041T (da)
MA (1) MA29941B1 (da)
NO (2) NO346660B1 (da)
NZ (1) NZ567056A (da)
PL (2) PL1937276T3 (da)
PT (3) PT2450041T (da)
RS (1) RS52671B (da)
SI (2) SI1937276T1 (da)
TN (1) TNSN08167A1 (da)
TR (1) TR201815853T4 (da)
UA (1) UA87627C2 (da)
WO (1) WO2007044976A2 (da)
ZA (1) ZA200803087B (da)

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EP1634583A1 (en) * 2004-09-09 2006-03-15 Laboratoires Besins International Testosterone gels comprising propylene glycol as penetration enhancer
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CN107949389A (zh) * 2015-09-30 2018-04-20 富士胶片株式会社 经皮吸收用组合物
JP6838952B2 (ja) * 2016-12-07 2021-03-03 川崎重工業株式会社 ロボット及びロボットに使用される袋体

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