BRPI0116793B8 - produtos de hormônio de esteróide e métodos para prepará-los - Google Patents

produtos de hormônio de esteróide e métodos para prepará-los

Info

Publication number
BRPI0116793B8
BRPI0116793B8 BRPI0116793A BR0116793A BRPI0116793B8 BR PI0116793 B8 BRPI0116793 B8 BR PI0116793B8 BR PI0116793 A BRPI0116793 A BR PI0116793A BR 0116793 A BR0116793 A BR 0116793A BR PI0116793 B8 BRPI0116793 B8 BR PI0116793B8
Authority
BR
Brazil
Prior art keywords
methods
products
hormone
excipient
steroid hormone
Prior art date
Application number
BRPI0116793A
Other languages
English (en)
Other versions
BRPI0116793B1 (pt
BR0116793A (pt
Inventor
Falzone Angela
A Clark Bradley
Schultz Thomas
Original Assignee
Johnson & Johnson
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 Johnson & Johnson, Ortho Mcneil Pharm Inc filed Critical Johnson & Johnson
Publication of BR0116793A publication Critical patent/BR0116793A/pt
Publication of BRPI0116793B1 publication Critical patent/BRPI0116793B1/pt
Publication of BRPI0116793B8 publication Critical patent/BRPI0116793B8/pt

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
    • 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
    • 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)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Reproductive Health (AREA)
  • Biophysics (AREA)
  • Molecular Biology (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

"produtos de hormônio de esteróide e métodos para prepará-los". a presente invenção refere-se a produtos de hormônio de esteróide, tal como os produtos contraceptivos orais, incluindo pelo menos um ingrediente ativo de esteróide misturado com um excipiente e tendo propriedades de dissolução e taxa de liberação melhoradas. a invenção também refere-se a métodos de preparação de tais produtos de hormônio de esteróide, nos quais uma mistura do hormônio e o excipiente é submetida à suficiente energia mecânica para formar uma mistura de pó, na qual o hormônio é estabilizado pelo excipiente de forma substancialmente não-cristalina.
BRPI0116793A 2000-12-14 2001-12-13 produtos de hormônio de esteróide e métodos para prepará-los BRPI0116793B8 (pt)

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 (3)

Publication Number Publication Date
BR0116793A BR0116793A (pt) 2004-01-27
BRPI0116793B1 BRPI0116793B1 (pt) 2015-06-23
BRPI0116793B8 true BRPI0116793B8 (pt) 2021-05-25

Family

ID=22969374

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0116793A BRPI0116793B8 (pt) 2000-12-14 2001-12-13 produtos de hormônio de esteróide e métodos para prepará-los

Country Status (30)

Country Link
US (4) US7867990B2 (pt)
EP (2) EP1591121B1 (pt)
KR (1) KR100899032B1 (pt)
CN (1) CN1290507C (pt)
AT (2) ATE307591T1 (pt)
AU (2) AU2742102A (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) DE60114467T2 (pt)
DK (2) DK1591121T3 (pt)
EC (1) ECSP034654A (pt)
EE (1) EE05358B1 (pt)
ES (2) ES2253451T3 (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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Also Published As

Publication number Publication date
NO20131334L (no) 2003-07-04
MXPA03005339A (es) 2004-03-26
IL156423A (en) 2010-04-29
KR100899032B1 (ko) 2009-05-21
PT1591121E (pt) 2009-07-20
ATE434439T1 (de) 2009-07-15
RS50414B (sr) 2009-12-31
NO20032708L (no) 2003-07-04
HUP0400646A2 (hu) 2004-06-28
IL156423A0 (en) 2004-01-04
UA77404C2 (en) 2006-12-15
HK1057174A1 (en) 2004-03-19
DE60139087D1 (de) 2009-08-06
HUP0400646A3 (en) 2012-08-28
CY1109404T1 (el) 2014-07-02
DK1591121T3 (da) 2009-10-05
US20110046099A1 (en) 2011-02-24
CR7022A (es) 2009-02-23
EP1361881A2 (en) 2003-11-19
ES2327538T3 (es) 2009-10-30
ZA200305342B (en) 2004-10-11
EP1361881B1 (en) 2005-10-26
HU230400B1 (hu) 2016-04-28
CN1489468A (zh) 2004-04-14
NO334341B1 (no) 2014-02-10
SK288222B6 (sk) 2014-09-04
AU2002227421B2 (en) 2007-08-23
US20110046095A1 (en) 2011-02-24
WO2002047693A3 (en) 2002-11-07
BG107958A (bg) 2004-11-30
NZ526517A (en) 2005-09-30
BRPI0116793B1 (pt) 2015-06-23
YU47903A (sh) 2006-08-17
EE05358B1 (et) 2010-12-15
BG66178B1 (bg) 2011-11-30
KR20030061856A (ko) 2003-07-22
US20140309204A1 (en) 2014-10-16
CA2431521A1 (en) 2002-06-20
MEP48808A (en) 2011-02-10
SK8802003A3 (en) 2004-04-06
DE60114467T2 (de) 2006-07-20
CZ306435B6 (cs) 2017-01-25
RU2003121240A (ru) 2005-02-10
ATE307591T1 (de) 2005-11-15
HK1083457A1 (en) 2006-07-07
AU2742102A (en) 2002-06-24
EE200300229A (et) 2003-08-15
CA2431521C (en) 2010-03-16
EP1591121A1 (en) 2005-11-02
DK1361881T3 (da) 2006-02-20
WO2002047693A2 (en) 2002-06-20
ECSP034654A (es) 2003-07-25
CN1290507C (zh) 2006-12-20
DE60114467D1 (de) 2005-12-01
RU2286155C2 (ru) 2006-10-27
US7867990B2 (en) 2011-01-11
ES2253451T3 (es) 2006-06-01
EP1591121B1 (en) 2009-06-24
US20020173669A1 (en) 2002-11-21
NO20032708D0 (no) 2003-06-13
BR0116793A (pt) 2004-01-27
ME00339B (me) 2011-05-10
CZ20031896A3 (en) 2004-03-17
CA2431521E (en) 2013-04-16

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