AU2005221403B8 - Stabilised supersaturated solid solutions of steroidal drugs - Google Patents

Stabilised supersaturated solid solutions of steroidal drugs Download PDF

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Publication number
AU2005221403B8
AU2005221403B8 AU2005221403A AU2005221403A AU2005221403B8 AU 2005221403 B8 AU2005221403 B8 AU 2005221403B8 AU 2005221403 A AU2005221403 A AU 2005221403A AU 2005221403 A AU2005221403 A AU 2005221403A AU 2005221403 B8 AU2005221403 B8 AU 2005221403B8
Authority
AU
Australia
Prior art keywords
solvent
steroidal molecule
steroidal
composition
molecule
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
AU2005221403A
Other languages
English (en)
Other versions
AU2005221403B2 (en
AU2005221403A1 (en
Inventor
Adrian Funke
Ralph Lipp
Torsten Wagner
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer Pharma AG
Original Assignee
Bayer Schering Pharma AG
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=34928105&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2005221403(B8) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bayer Schering Pharma AG filed Critical Bayer Schering Pharma AG
Publication of AU2005221403A1 publication Critical patent/AU2005221403A1/en
Assigned to BAYER SCHERING PHARMA AKTIENGESELLSCHAFT reassignment BAYER SCHERING PHARMA AKTIENGESELLSCHAFT Alteration of Name(s) of Applicant(s) under S113 Assignors: SCHERING AKTIENGESELLSCHAFT
Application granted granted Critical
Publication of AU2005221403B2 publication Critical patent/AU2005221403B2/en
Publication of AU2005221403B8 publication Critical patent/AU2005221403B8/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A61K31/585Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin containing lactone rings, e.g. oxandrolone, bufalin
    • 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
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/143Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • 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
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/38Drugs for disorders of the endocrine system of the suprarenal hormones

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
AU2005221403A 2004-03-10 2005-03-10 Stabilised supersaturated solid solutions of steroidal drugs Ceased AU2005221403B8 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US55133004P 2004-03-10 2004-03-10
US60/551,330 2004-03-10
EP04075714 2004-03-10
EP04075714.8 2004-03-10
PCT/IB2005/000748 WO2005087199A2 (en) 2004-03-10 2005-03-10 Stabilised supersaturated solid solutions of steroidal drugs

Publications (3)

Publication Number Publication Date
AU2005221403A1 AU2005221403A1 (en) 2005-09-22
AU2005221403B2 AU2005221403B2 (en) 2009-12-10
AU2005221403B8 true AU2005221403B8 (en) 2010-01-07

Family

ID=34928105

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2005221403A Ceased AU2005221403B8 (en) 2004-03-10 2005-03-10 Stabilised supersaturated solid solutions of steroidal drugs

Country Status (32)

Country Link
US (1) US8715735B2 (https=)
EP (2) EP2087883B1 (https=)
JP (1) JP5006185B2 (https=)
KR (1) KR101210695B1 (https=)
CN (1) CN1984644B (https=)
AR (1) AR048500A1 (https=)
AT (1) ATE442131T1 (https=)
AU (1) AU2005221403B8 (https=)
BR (1) BRPI0507342A (https=)
CA (1) CA2558582C (https=)
CR (1) CR8630A (https=)
DE (1) DE602005016551D1 (https=)
DK (1) DK1765290T3 (https=)
EA (1) EA012746B1 (https=)
EC (1) ECSP066902A (https=)
ES (2) ES2390406T3 (https=)
GT (1) GT200500045A (https=)
HR (1) HRP20090614T1 (https=)
IL (1) IL177894A0 (https=)
MY (1) MY142989A (https=)
NO (1) NO20064473L (https=)
NZ (1) NZ549793A (https=)
PA (1) PA8626101A1 (https=)
PE (1) PE20060016A1 (https=)
PL (1) PL1765290T3 (https=)
PT (1) PT1765290E (https=)
RS (1) RS51076B (https=)
SI (1) SI1765290T1 (https=)
SV (1) SV2005002044A (https=)
TW (1) TWI345986B (https=)
UY (1) UY28803A1 (https=)
WO (1) WO2005087199A2 (https=)

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US10806740B2 (en) 2012-06-18 2020-10-20 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
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US10471072B2 (en) 2012-12-21 2019-11-12 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
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US11246875B2 (en) 2012-12-21 2022-02-15 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
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Also Published As

Publication number Publication date
CR8630A (es) 2007-06-06
EP1765290B1 (en) 2009-09-09
EP2087883B1 (en) 2012-07-25
PL1765290T3 (pl) 2010-02-26
ES2332229T3 (es) 2010-01-29
ATE442131T1 (de) 2009-09-15
NZ549793A (en) 2010-06-25
IL177894A0 (en) 2006-12-31
WO2005087199A3 (en) 2009-01-15
CA2558582C (en) 2013-07-16
HK1103660A1 (en) 2007-12-28
WO2005087199A8 (en) 2007-03-29
EP2087883A1 (en) 2009-08-12
MY142989A (en) 2011-02-14
TW200600116A (en) 2006-01-01
AU2005221403B2 (en) 2009-12-10
TWI345986B (en) 2011-08-01
WO2005087199A2 (en) 2005-09-22
JP2007528389A (ja) 2007-10-11
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