UA77404C2 - Norgestimate-based steroid hormone product and method for its manufacture - Google Patents

Norgestimate-based steroid hormone product and method for its manufacture Download PDF

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Publication number
UA77404C2
UA77404C2 UA2003065552A UA2003065552A UA77404C2 UA 77404 C2 UA77404 C2 UA 77404C2 UA 2003065552 A UA2003065552 A UA 2003065552A UA 2003065552 A UA2003065552 A UA 2003065552A UA 77404 C2 UA77404 C2 UA 77404C2
Authority
UA
Ukraine
Prior art keywords
norgestimate
lactose
crystalline
mixture
steroid
Prior art date
Application number
UA2003065552A
Other languages
English (en)
Ukrainian (uk)
Original Assignee
Ortho Mcneil Pharm 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 Pharm Inc filed Critical Ortho Mcneil Pharm Inc
Publication of UA77404C2 publication Critical patent/UA77404C2/uk

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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)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (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)
UA2003065552A 2000-12-14 2001-12-13 Norgestimate-based steroid hormone product and method for its manufacture UA77404C2 (en)

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 (1)

Publication Number Publication Date
UA77404C2 true UA77404C2 (en) 2006-12-15

Family

ID=22969374

Family Applications (1)

Application Number Title Priority Date Filing Date
UA2003065552A UA77404C2 (en) 2000-12-14 2001-12-13 Norgestimate-based steroid hormone product and method for its manufacture

Country Status (31)

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

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ES2327538T3 (es) * 2000-12-14 2009-10-30 Ortho-Mcneil-Janssen Pharmaceuticals, Inc. Proceso para preparar productos de hormona esteroidea que comprenden un agente estabilizante en forma no cristalina.
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
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TWI547431B (zh) 2004-06-09 2016-09-01 史密斯克萊美占公司 生產藥物之裝置及方法
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EP2249838A4 (en) * 2008-02-05 2012-05-02 Harbor Biosciences Inc PHARMACEUTICAL FORMS IN SOLID STATE
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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
US10993879B2 (en) 2010-02-08 2021-05-04 Shenzhen Evergreen Therapeutics Co., Ltd. Pulmonary delivery of progestogen
EP2533799B8 (en) * 2010-02-08 2019-12-25 Shenzhen Evergreen Therapeutics Co., Ltd. Methods for the use of progestogen as a glucocorticoid sensitizer
ES2885523T3 (es) 2011-11-23 2021-12-14 Therapeuticsmd Inc Formulaciones y terapias de reposición hormonal de combinación naturales
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
US9180091B2 (en) 2012-12-21 2015-11-10 Therapeuticsmd, Inc. Soluble estradiol capsule for vaginal insertion
US10471072B2 (en) 2012-12-21 2019-11-12 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
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
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
RU2016143081A (ru) 2014-05-22 2018-06-26 Терапьютиксмд, Инк. Натуральные комбинированные гормонозаместительные составы и терапии
US10328087B2 (en) 2015-07-23 2019-06-25 Therapeuticsmd, Inc. Formulations for solubilizing hormones
US9931349B2 (en) 2016-04-01 2018-04-03 Therapeuticsmd, Inc. Steroid hormone pharmaceutical composition
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
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
PT1591121E (pt) 2009-07-20
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
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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