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DE60139087D1 - Verfahren zu Herstellung von Zubereitungen enthaltend einen Steroidhormon und ein Stabilisierungsmittel in nicht-kristallinen Form - Google Patents

Verfahren zu Herstellung von Zubereitungen enthaltend einen Steroidhormon und ein Stabilisierungsmittel in nicht-kristallinen Form

Info

Publication number
DE60139087D1
DE60139087D1 DE60139087T DE60139087T DE60139087D1 DE 60139087 D1 DE60139087 D1 DE 60139087D1 DE 60139087 T DE60139087 T DE 60139087T DE 60139087 T DE60139087 T DE 60139087T DE 60139087 D1 DE60139087 D1 DE 60139087D1
Authority
DE
Germany
Prior art keywords
crystalline form
steroid hormone
hormone
preparation
excipient
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.)
Expired - Lifetime
Application number
DE60139087T
Other languages
English (en)
Inventor
Thomas Schultz
Bradley A Clark
Angela Falzone
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.)
Janssen Pharmaceuticals Inc
Original Assignee
Ortho McNeil Janssen Pharmaceuticals Inc
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 Pharmaceuticals Inc filed Critical Ortho McNeil Janssen Pharmaceuticals Inc
Application granted granted Critical
Publication of DE60139087D1 publication Critical patent/DE60139087D1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

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
    • 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
    • A61K31/567—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 position 17 alpha, e.g. mestranol, norethandrolone
    • 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
    • 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
    • A61K31/569—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 substituted in position 17 alpha, e.g. ethisterone
    • 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
    • A61K31/57—Compounds 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
    • 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
    • A61K31/575—Compounds 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
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate 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
    • A61K9/145—Intimate 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
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/18—Feminine contraceptives
    • 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
    • A61P5/30—Oestrogens

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)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Reproductive Health (AREA)
  • Diabetes (AREA)
  • Gynecology & Obstetrics (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)
DE60139087T 2000-12-14 2001-12-13 Verfahren zu Herstellung von Zubereitungen enthaltend einen Steroidhormon und ein Stabilisierungsmittel in nicht-kristallinen Form Expired - Lifetime DE60139087D1 (de)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
DE60139087D1 true DE60139087D1 (de) 2009-08-06

Family

ID=22969374

Family Applications (2)

Application Number Title Priority Date Filing Date
DE60139087T Expired - Lifetime DE60139087D1 (de) 2000-12-14 2001-12-13 Verfahren zu Herstellung von Zubereitungen enthaltend einen Steroidhormon und ein Stabilisierungsmittel in nicht-kristallinen Form
DE60114467T Expired - Lifetime DE60114467T2 (de) 2000-12-14 2001-12-13 Zubereitungen enthaltend ein steroidhormon und ein stabilisierungsmittel in nicht-kristalliner form

Family Applications After (1)

Application Number Title Priority Date Filing Date
DE60114467T Expired - Lifetime DE60114467T2 (de) 2000-12-14 2001-12-13 Zubereitungen enthaltend ein steroidhormon und ein stabilisierungsmittel in nicht-kristalliner form

Country Status (31)

Country Link
US (4) US7867990B2 (de)
EP (2) EP1591121B1 (de)
KR (1) KR100899032B1 (de)
CN (1) CN1290507C (de)
AT (2) ATE434439T1 (de)
AU (2) AU2002227421B2 (de)
BG (1) BG66178B1 (de)
BR (1) BRPI0116793B8 (de)
CA (1) CA2431521E (de)
CR (1) CR7022A (de)
CY (1) CY1109404T1 (de)
CZ (1) CZ306435B6 (de)
DE (2) DE60139087D1 (de)
DK (2) DK1591121T3 (de)
EC (1) ECSP034654A (de)
EE (1) EE05358B1 (de)
ES (2) ES2253451T3 (de)
HK (2) HK1057174A1 (de)
HU (1) HU230400B1 (de)
IL (2) IL156423A0 (de)
ME (1) ME00339B (de)
MX (1) MXPA03005339A (de)
NO (2) NO334341B1 (de)
NZ (1) NZ526517A (de)
PT (1) PT1591121E (de)
RS (1) RS50414B (de)
RU (1) RU2286155C2 (de)
SK (1) SK288222B6 (de)
UA (1) UA77404C2 (de)
WO (1) WO2002047693A2 (de)
ZA (1) ZA200305342B (de)

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US7858607B2 (en) * 2003-03-14 2010-12-28 Mamchur Stephen A System for use by compounding pharmacists to produce hormone replacement medicine customized for each consumer
JP4956185B2 (ja) * 2003-06-13 2012-06-20 スケンディ ファイナンス リミテッド 避妊及びホルモン補充療法用の調合製剤
TWI428271B (zh) 2004-06-09 2014-03-01 Smithkline Beecham Corp 生產藥物之裝置及方法
US8101244B2 (en) 2004-06-09 2012-01-24 Smithkline Beecham Corporation Apparatus and method for producing or processing a product or sample
EP1625849A1 (de) * 2004-08-09 2006-02-15 Liconsa, Liberacion Controlada de Sustancias Activas, S.A. Pharmazeutische Zubereitung enthaltend Drospirenon und Ethinylestradiol
US8486926B2 (en) * 2006-11-17 2013-07-16 Harbor Therapeutics, Inc. Steroid tetrol solid state forms
CN103467554A (zh) * 2008-02-05 2013-12-25 哈博生物科学公司 药学固体形式
AU2009231589B2 (en) 2008-04-03 2013-11-07 Neurmedix, Inc. Solid state forms of a pharmaceutical
EP2172190A1 (de) * 2008-10-02 2010-04-07 Laboratorios Liconsa, S.A. Inhalierbare Partikel mit Tiotropium
WO2011097571A2 (en) * 2010-02-08 2011-08-11 Prairie Pharmaceuticals, Llc Methods for the use of progestogen as a glucocorticoid sensitizer
US10993879B2 (en) 2010-02-08 2021-05-04 Shenzhen Evergreen Therapeutics Co., Ltd. Pulmonary delivery of progestogen
US10987361B2 (en) 2010-02-08 2021-04-27 Shenzhen Evergreen Therapeutics Co., Ltd. Treating auto-immune and auto-inflammatory diseases
HUE055562T2 (hu) 2011-11-23 2021-11-29 Therapeuticsmd Inc Természetes kombinációjú hormon helyettesítõ kiszerelések, és terápiák ezekkel
US9301920B2 (en) 2012-06-18 2016-04-05 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US20150196640A1 (en) 2012-06-18 2015-07-16 Therapeuticsmd, Inc. Progesterone formulations having a desirable pk profile
US10806740B2 (en) 2012-06-18 2020-10-20 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US10806697B2 (en) 2012-12-21 2020-10-20 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US20130338122A1 (en) 2012-06-18 2013-12-19 Therapeuticsmd, Inc. Transdermal hormone replacement therapies
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
US10537581B2 (en) 2012-12-21 2020-01-21 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US11266661B2 (en) 2012-12-21 2022-03-08 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10471072B2 (en) 2012-12-21 2019-11-12 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
US9180091B2 (en) 2012-12-21 2015-11-10 Therapeuticsmd, Inc. Soluble estradiol capsule for vaginal insertion
CA2947767A1 (en) 2014-05-22 2015-11-26 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US10328087B2 (en) 2015-07-23 2019-06-25 Therapeuticsmd, Inc. Formulations for solubilizing hormones
BR112018070199A2 (pt) 2016-04-01 2019-01-29 Therapeuticsmd Inc composição farmacêutica de hormônio esteroide
US10286077B2 (en) 2016-04-01 2019-05-14 Therapeuticsmd, Inc. Steroid hormone compositions in medium chain oils
US20200129438A1 (en) * 2018-10-31 2020-04-30 Edenbridge Pharmaceuticals, LLC Finished pharmaceutical dosage form comprising a low dose/high potency active pharmaceutical ingredient and one or more excipients
US11633405B2 (en) 2020-02-07 2023-04-25 Therapeuticsmd, Inc. Steroid hormone pharmaceutical formulations

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Also Published As

Publication number Publication date
NO334341B1 (no) 2014-02-10
HU230400B1 (hu) 2016-04-28
WO2002047693A3 (en) 2002-11-07
NO20032708L (no) 2003-07-04
AU2002227421B2 (en) 2007-08-23
ME00339B (me) 2011-05-10
CR7022A (es) 2009-02-23
MEP48808A (en) 2011-02-10
DK1591121T3 (da) 2009-10-05
ZA200305342B (en) 2004-10-11
KR20030061856A (ko) 2003-07-22
HK1083457A1 (en) 2006-07-07
RU2286155C2 (ru) 2006-10-27
CN1290507C (zh) 2006-12-20
EP1591121A1 (de) 2005-11-02
RS50414B (sr) 2009-12-31
CA2431521A1 (en) 2002-06-20
HUP0400646A2 (hu) 2004-06-28
NZ526517A (en) 2005-09-30
ECSP034654A (es) 2003-07-25
WO2002047693A2 (en) 2002-06-20
ES2253451T3 (es) 2006-06-01
HK1057174A1 (en) 2004-03-19
CZ20031896A3 (en) 2004-03-17
US7867990B2 (en) 2011-01-11
US20020173669A1 (en) 2002-11-21
ATE434439T1 (de) 2009-07-15
SK8802003A3 (en) 2004-04-06
CZ306435B6 (cs) 2017-01-25
ATE307591T1 (de) 2005-11-15
IL156423A0 (en) 2004-01-04
EE200300229A (et) 2003-08-15
NO20032708D0 (no) 2003-06-13
NO20131334L (no) 2003-07-04
DE60114467T2 (de) 2006-07-20
EP1591121B1 (de) 2009-06-24
RU2003121240A (ru) 2005-02-10
EE05358B1 (et) 2010-12-15
US20110046095A1 (en) 2011-02-24
BG66178B1 (bg) 2011-11-30
UA77404C2 (en) 2006-12-15
HUP0400646A3 (en) 2012-08-28
AU2742102A (en) 2002-06-24
BRPI0116793B1 (pt) 2015-06-23
CA2431521C (en) 2010-03-16
DK1361881T3 (da) 2006-02-20
US20140309204A1 (en) 2014-10-16
MXPA03005339A (es) 2004-03-26
CN1489468A (zh) 2004-04-14
EP1361881A2 (de) 2003-11-19
BR0116793A (pt) 2004-01-27
KR100899032B1 (ko) 2009-05-21
US20110046099A1 (en) 2011-02-24
SK288222B6 (sk) 2014-09-04
DE60114467D1 (de) 2005-12-01
IL156423A (en) 2010-04-29
CA2431521E (en) 2013-04-16
YU47903A (sh) 2006-08-17
BRPI0116793B8 (pt) 2021-05-25
PT1591121E (pt) 2009-07-20
CY1109404T1 (el) 2014-07-02
BG107958A (bg) 2004-11-30
EP1361881B1 (de) 2005-10-26
ES2327538T3 (es) 2009-10-30

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