EE05358B1 - Steroidhormoonprodukt ja selle valmistamismeetod - Google Patents

Steroidhormoonprodukt ja selle valmistamismeetod

Info

Publication number
EE05358B1
EE05358B1 EEP200300229A EEP200300229A EE05358B1 EE 05358 B1 EE05358 B1 EE 05358B1 EE P200300229 A EEP200300229 A EE P200300229A EE P200300229 A EEP200300229 A EE P200300229A EE 05358 B1 EE05358 B1 EE 05358B1
Authority
EE
Estonia
Prior art keywords
hormone
excipient
steroid hormone
products
preparation
Prior art date
Application number
EEP200300229A
Other languages
English (en)
Estonian (et)
Inventor
Schultz Thomas
A. Clark Bradley
Falzone Angela
Original Assignee
Ortho-Mcneil Pharmaceutical, 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 Pharmaceutical, Inc. filed Critical Ortho-Mcneil Pharmaceutical, Inc.
Publication of EE200300229A publication Critical patent/EE200300229A/xx
Publication of EE05358B1 publication Critical patent/EE05358B1/xx

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)
EEP200300229A 2000-12-14 2001-12-13 Steroidhormoonprodukt ja selle valmistamismeetod EE05358B1 (et)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US25566900P 2000-12-14 2000-12-14
PCT/US2001/048862 WO2002047693A2 (en) 2000-12-14 2001-12-13 Steroid hormone products comprising a stabilizing agent in non-crystalline form

Publications (2)

Publication Number Publication Date
EE200300229A EE200300229A (et) 2003-08-15
EE05358B1 true EE05358B1 (et) 2010-12-15

Family

ID=22969374

Family Applications (1)

Application Number Title Priority Date Filing Date
EEP200300229A EE05358B1 (et) 2000-12-14 2001-12-13 Steroidhormoonprodukt ja selle valmistamismeetod

Country Status (31)

Country Link
US (4) US7867990B2 (bg)
EP (2) EP1361881B1 (bg)
KR (1) KR100899032B1 (bg)
CN (1) CN1290507C (bg)
AT (2) ATE434439T1 (bg)
AU (2) AU2002227421B2 (bg)
BG (1) BG66178B1 (bg)
BR (1) BRPI0116793B8 (bg)
CA (1) CA2431521E (bg)
CR (1) CR7022A (bg)
CY (1) CY1109404T1 (bg)
CZ (1) CZ306435B6 (bg)
DE (2) DE60114467T2 (bg)
DK (2) DK1361881T3 (bg)
EC (1) ECSP034654A (bg)
EE (1) EE05358B1 (bg)
ES (2) ES2253451T3 (bg)
HK (2) HK1057174A1 (bg)
HU (1) HU230400B1 (bg)
IL (2) IL156423A0 (bg)
ME (1) ME00339B (bg)
MX (1) MXPA03005339A (bg)
NO (2) NO334341B1 (bg)
NZ (1) NZ526517A (bg)
PT (1) PT1591121E (bg)
RS (1) RS50414B (bg)
RU (1) RU2286155C2 (bg)
SK (1) SK288222B6 (bg)
UA (1) UA77404C2 (bg)
WO (1) WO2002047693A2 (bg)
ZA (1) ZA200305342B (bg)

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US20020132801A1 (en) * 2001-01-11 2002-09-19 Schering Aktiengesellschaft Drospirenone for hormone replacement therapy
ES2253451T3 (es) * 2000-12-14 2006-06-01 Ortho-Mcneil Pharmaceutical, Inc. Productos a base de hormona esteroide y sus procedimientos de fabricacion.
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
PL1820494T3 (pl) * 2003-06-13 2010-07-30 Skendi Finance Ltd Mikrocząstki składające się z estradiolu i cholesterolu
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 (en) * 2004-08-09 2006-02-15 Liconsa, Liberacion Controlada de Sustancias Activas, S.A. Pharmaceutical composition comprising drospirenone and ethynylestradiol
US8486926B2 (en) * 2006-11-17 2013-07-16 Harbor Therapeutics, Inc. Steroid tetrol solid state forms
EA018974B9 (ru) * 2008-02-05 2014-04-30 Харбор Терапьютикс, Инк. Твердые лекарственные формы
AU2009231589B2 (en) 2008-04-03 2013-11-07 Neurmedix, Inc. Solid state forms of a pharmaceutical
EP2172190A1 (en) * 2008-10-02 2010-04-07 Laboratorios Liconsa, S.A. Inhalable particles comprising tiotropium
US10993879B2 (en) 2010-02-08 2021-05-04 Shenzhen Evergreen Therapeutics Co., Ltd. Pulmonary delivery of progestogen
WO2011097571A2 (en) * 2010-02-08 2011-08-11 Prairie Pharmaceuticals, Llc Methods for the use of progestogen as a glucocorticoid sensitizer
US10987361B2 (en) 2010-02-08 2021-04-27 Shenzhen Evergreen Therapeutics Co., Ltd. Treating auto-immune and auto-inflammatory diseases
LT2782584T (lt) 2011-11-23 2021-09-10 Therapeuticsmd, Inc. Natūralios kombinuotos pakaitinės hormonų terapijos kompozicijos ir gydymas
US9301920B2 (en) 2012-06-18 2016-04-05 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
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
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
US10568891B2 (en) 2012-12-21 2020-02-25 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
US11266661B2 (en) 2012-12-21 2022-03-08 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
US11246875B2 (en) 2012-12-21 2022-02-15 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
AU2015264003A1 (en) 2014-05-22 2016-11-17 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US10328087B2 (en) 2015-07-23 2019-06-25 Therapeuticsmd, Inc. Formulations for solubilizing hormones
US10286077B2 (en) 2016-04-01 2019-05-14 Therapeuticsmd, Inc. Steroid hormone compositions in medium chain oils
WO2017173071A1 (en) 2016-04-01 2017-10-05 Therapeuticsmd, Inc. Steroid hormone pharmaceutical composition
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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ES2253451T3 (es) * 2000-12-14 2006-06-01 Ortho-Mcneil Pharmaceutical, Inc. Productos a base de hormona esteroide y sus procedimientos de fabricacion.

Also Published As

Publication number Publication date
NO20032708D0 (no) 2003-06-13
BRPI0116793B1 (pt) 2015-06-23
US20110046095A1 (en) 2011-02-24
UA77404C2 (en) 2006-12-15
ECSP034654A (es) 2003-07-25
DE60114467T2 (de) 2006-07-20
ES2253451T3 (es) 2006-06-01
CY1109404T1 (el) 2014-07-02
ATE307591T1 (de) 2005-11-15
PT1591121E (pt) 2009-07-20
EP1591121A1 (en) 2005-11-02
US20140309204A1 (en) 2014-10-16
DK1361881T3 (da) 2006-02-20
WO2002047693A2 (en) 2002-06-20
CZ20031896A3 (en) 2004-03-17
SK288222B6 (sk) 2014-09-04
CZ306435B6 (cs) 2017-01-25
EE200300229A (et) 2003-08-15
NO334341B1 (no) 2014-02-10
SK8802003A3 (en) 2004-04-06
US20110046099A1 (en) 2011-02-24
RU2286155C2 (ru) 2006-10-27
CA2431521E (en) 2013-04-16
CR7022A (es) 2009-02-23
HK1083457A1 (en) 2006-07-07
CN1290507C (zh) 2006-12-20
DE60114467D1 (de) 2005-12-01
HU230400B1 (hu) 2016-04-28
BR0116793A (pt) 2004-01-27
ZA200305342B (en) 2004-10-11
MEP48808A (en) 2011-02-10
EP1361881A2 (en) 2003-11-19
BG66178B1 (bg) 2011-11-30
BRPI0116793B8 (pt) 2021-05-25
NO20032708L (no) 2003-07-04
IL156423A0 (en) 2004-01-04
CA2431521A1 (en) 2002-06-20
EP1591121B1 (en) 2009-06-24
US20020173669A1 (en) 2002-11-21
KR100899032B1 (ko) 2009-05-21
IL156423A (en) 2010-04-29
DE60139087D1 (de) 2009-08-06
HUP0400646A3 (en) 2012-08-28
EP1361881B1 (en) 2005-10-26
US7867990B2 (en) 2011-01-11
DK1591121T3 (da) 2009-10-05
RS50414B (sr) 2009-12-31
HUP0400646A2 (hu) 2004-06-28
ME00339B (me) 2011-05-10
BG107958A (bg) 2004-11-30
CN1489468A (zh) 2004-04-14
AU2742102A (en) 2002-06-24
NO20131334L (no) 2003-07-04
KR20030061856A (ko) 2003-07-22
ES2327538T3 (es) 2009-10-30
NZ526517A (en) 2005-09-30
MXPA03005339A (es) 2004-03-26
RU2003121240A (ru) 2005-02-10
HK1057174A1 (en) 2004-03-19
YU47903A (sh) 2006-08-17
ATE434439T1 (de) 2009-07-15
WO2002047693A3 (en) 2002-11-07
AU2002227421B2 (en) 2007-08-23
CA2431521C (en) 2010-03-16

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