PT1591121E - Processo para preparar produtos de hormona esteróide compreendendo um agente estabilizante na forma não cristalina - Google Patents

Processo para preparar produtos de hormona esteróide compreendendo um agente estabilizante na forma não cristalina Download PDF

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Publication number
PT1591121E
PT1591121E PT05076805T PT05076805T PT1591121E PT 1591121 E PT1591121 E PT 1591121E PT 05076805 T PT05076805 T PT 05076805T PT 05076805 T PT05076805 T PT 05076805T PT 1591121 E PT1591121 E PT 1591121E
Authority
PT
Portugal
Prior art keywords
crystalline form
steroid hormone
products
stabilizing agent
hormone
Prior art date
Application number
PT05076805T
Other languages
English (en)
Inventor
Thomas Schultz
Bradley A Clark
Angela Falzone
Original Assignee
Ortho Mcneil Janssen Pharm
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 Ortho Mcneil Janssen Pharm filed Critical Ortho Mcneil Janssen Pharm
Publication of PT1591121E publication Critical patent/PT1591121E/pt

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Classifications

    • 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
    • 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
    • A61K31/567Compounds 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 position 17 alpha, e.g. mestranol, norethandrolone
    • 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
    • A61K31/565Compounds 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
    • A61K31/568Compounds 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
    • A61K31/569Compounds 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 substituted in position 17 alpha, e.g. ethisterone
    • 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
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • 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
    • A61K31/575Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • 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
    • A61K9/145Intimate 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 organic compounds
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/18Feminine contraceptives
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
PT05076805T 2000-12-14 2001-12-13 Processo para preparar produtos de hormona esteróide compreendendo um agente estabilizante na forma não cristalina PT1591121E (pt)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US25566900P 2000-12-14 2000-12-14

Publications (1)

Publication Number Publication Date
PT1591121E true PT1591121E (pt) 2009-07-20

Family

ID=22969374

Family Applications (1)

Application Number Title Priority Date Filing Date
PT05076805T PT1591121E (pt) 2000-12-14 2001-12-13 Processo para preparar produtos de hormona esteróide compreendendo um agente estabilizante na forma não cristalina

Country Status (31)

Country Link
US (4) US7867990B2 (pt)
EP (2) EP1591121B1 (pt)
KR (1) KR100899032B1 (pt)
CN (1) CN1290507C (pt)
AT (2) ATE307591T1 (pt)
AU (2) AU2002227421B2 (pt)
BG (1) BG66178B1 (pt)
BR (1) BRPI0116793B8 (pt)
CA (1) CA2431521E (pt)
CR (1) CR7022A (pt)
CY (1) CY1109404T1 (pt)
CZ (1) CZ306435B6 (pt)
DE (2) DE60139087D1 (pt)
DK (2) DK1361881T3 (pt)
EC (1) ECSP034654A (pt)
EE (1) EE05358B1 (pt)
ES (2) ES2327538T3 (pt)
HK (2) HK1057174A1 (pt)
HU (1) HU230400B1 (pt)
IL (2) IL156423A0 (pt)
ME (1) ME00339B (pt)
MX (1) MXPA03005339A (pt)
NO (2) NO334341B1 (pt)
NZ (1) NZ526517A (pt)
PT (1) PT1591121E (pt)
RS (1) RS50414B (pt)
RU (1) RU2286155C2 (pt)
SK (1) SK288222B6 (pt)
UA (1) UA77404C2 (pt)
WO (1) WO2002047693A2 (pt)
ZA (1) ZA200305342B (pt)

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EP2172190A1 (en) * 2008-10-02 2010-04-07 Laboratorios Liconsa, S.A. Inhalable particles comprising tiotropium
US10987361B2 (en) 2010-02-08 2021-04-27 Shenzhen Evergreen Therapeutics Co., Ltd. Treating auto-immune and auto-inflammatory diseases
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EP2533799B8 (en) * 2010-02-08 2019-12-25 Shenzhen Evergreen Therapeutics Co., Ltd. Methods for the use of progestogen as a glucocorticoid sensitizer
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US9301920B2 (en) 2012-06-18 2016-04-05 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
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CN102793929B (zh) * 2012-09-07 2013-12-11 上海奥科达生物医药科技有限公司 一种制备稳定非晶态药物制剂的方法
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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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US11266661B2 (en) 2012-12-21 2022-03-08 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US11246875B2 (en) 2012-12-21 2022-02-15 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10568891B2 (en) 2012-12-21 2020-02-25 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
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US10328087B2 (en) 2015-07-23 2019-06-25 Therapeuticsmd, Inc. Formulations for solubilizing hormones
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Also Published As

Publication number Publication date
CA2431521E (en) 2013-04-16
IL156423A (en) 2010-04-29
EP1361881B1 (en) 2005-10-26
KR100899032B1 (ko) 2009-05-21
ECSP034654A (es) 2003-07-25
NO334341B1 (no) 2014-02-10
MXPA03005339A (es) 2004-03-26
DE60114467T2 (de) 2006-07-20
BR0116793A (pt) 2004-01-27
BRPI0116793B8 (pt) 2021-05-25
BG66178B1 (bg) 2011-11-30
CR7022A (es) 2009-02-23
WO2002047693A3 (en) 2002-11-07
AU2742102A (en) 2002-06-24
US20110046095A1 (en) 2011-02-24
ES2253451T3 (es) 2006-06-01
US20020173669A1 (en) 2002-11-21
ZA200305342B (en) 2004-10-11
DK1591121T3 (da) 2009-10-05
CZ20031896A3 (en) 2004-03-17
CA2431521A1 (en) 2002-06-20
ATE307591T1 (de) 2005-11-15
ES2327538T3 (es) 2009-10-30
BG107958A (bg) 2004-11-30
HUP0400646A3 (en) 2012-08-28
NO20032708L (no) 2003-07-04
NZ526517A (en) 2005-09-30
ATE434439T1 (de) 2009-07-15
EE05358B1 (et) 2010-12-15
MEP48808A (en) 2011-02-10
IL156423A0 (en) 2004-01-04
NO20032708D0 (no) 2003-06-13
ME00339B (me) 2011-05-10
UA77404C2 (en) 2006-12-15
YU47903A (sh) 2006-08-17
RU2003121240A (ru) 2005-02-10
RS50414B (sr) 2009-12-31
EP1591121B1 (en) 2009-06-24
AU2002227421B2 (en) 2007-08-23
US7867990B2 (en) 2011-01-11
SK288222B6 (sk) 2014-09-04
HK1083457A1 (en) 2006-07-07
KR20030061856A (ko) 2003-07-22
US20140309204A1 (en) 2014-10-16
SK8802003A3 (en) 2004-04-06
HK1057174A1 (en) 2004-03-19
CN1290507C (zh) 2006-12-20
DE60114467D1 (de) 2005-12-01
BRPI0116793B1 (pt) 2015-06-23
DK1361881T3 (da) 2006-02-20
CA2431521C (en) 2010-03-16
WO2002047693A2 (en) 2002-06-20
DE60139087D1 (de) 2009-08-06
HU230400B1 (hu) 2016-04-28
HUP0400646A2 (hu) 2004-06-28
US20110046099A1 (en) 2011-02-24
EP1361881A2 (en) 2003-11-19
EP1591121A1 (en) 2005-11-02
CZ306435B6 (cs) 2017-01-25
CY1109404T1 (el) 2014-07-02
NO20131334L (no) 2003-07-04
EE200300229A (et) 2003-08-15
CN1489468A (zh) 2004-04-14
RU2286155C2 (ru) 2006-10-27

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