ME00339B - Proizvodi steroidnih hormona i postupci za njihovo dobijanje - Google Patents

Proizvodi steroidnih hormona i postupci za njihovo dobijanje

Info

Publication number
ME00339B
ME00339B MEP-2008-488A MEP48808A ME00339B ME 00339 B ME00339 B ME 00339B ME P48808 A MEP48808 A ME P48808A ME 00339 B ME00339 B ME 00339B
Authority
ME
Montenegro
Prior art keywords
crystalline form
products
stabilizing agent
steroid hormone
hormone products
Prior art date
Application number
MEP-2008-488A
Other languages
English (en)
French (fr)
Inventor
Thomas Schultz
Bradley A Clark
Angela Falzone
Original Assignee
Ortho Mcneil Janssenn 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 Janssenn Pharmaceutical Inc filed Critical Ortho Mcneil Janssenn Pharmaceutical Inc
Publication of MEP48808A publication Critical patent/MEP48808A/xx
Publication of ME00339B publication Critical patent/ME00339B/me

Links

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)
  • 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)

Abstract

Prikazani pronalazak se odnosi na proizvode stereoidnih hormona, kao što su oralna kontraceptivna sredstva, koji uključujući bar jedan aktivni steroidni sastojak pomešan sa ekscipijentom i imaju poboljšane osobine rastvaranja i brzine oslobađanja. Pronalazak se dalje odnosi na postupak za pripremanje takvih proizvoda stereoidnih hormona, gde je smeša hormona i ekscipijenta podvrgnuta dovoljnoj mehaničkoj energiji da bi se dobila mešavima praha u kojoj hormon je stabilizovan sa ekscipijentom u suštinski ne kristalnom obliku.
MEP-2008-488A 2000-12-14 2001-12-13 Proizvodi steroidnih hormona i postupci za njihovo dobijanje ME00339B (me)

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
MEP48808A MEP48808A (en) 2011-02-10
ME00339B true ME00339B (me) 2011-05-10

Family

ID=22969374

Family Applications (1)

Application Number Title Priority Date Filing Date
MEP-2008-488A ME00339B (me) 2000-12-14 2001-12-13 Proizvodi steroidnih hormona i postupci za njihovo dobijanje

Country Status (31)

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

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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
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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
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
EE05358B1 (et) 2010-12-15
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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