DK1848406T3 - Solid, penal formulation for contraception containing dienogest and ethynyl estradiol - Google Patents

Solid, penal formulation for contraception containing dienogest and ethynyl estradiol

Info

Publication number
DK1848406T3
DK1848406T3 DK06706961T DK06706961T DK1848406T3 DK 1848406 T3 DK1848406 T3 DK 1848406T3 DK 06706961 T DK06706961 T DK 06706961T DK 06706961 T DK06706961 T DK 06706961T DK 1848406 T3 DK1848406 T3 DK 1848406T3
Authority
DK
Denmark
Prior art keywords
dienogest
solid
penal
formulation
ethinyl estradiol
Prior art date
Application number
DK06706961T
Other languages
Danish (da)
Inventor
Sabine Fricke
Hagen Gerecke
Ralf Ladwig
Alexander Buske
Harald Raethe
Original Assignee
Jenapharm Gmbh
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
Priority claimed from EP05003179A external-priority patent/EP1690543A1/en
Priority claimed from EP05003181A external-priority patent/EP1690529A1/en
Application filed by Jenapharm Gmbh filed Critical Jenapharm Gmbh
Application granted granted Critical
Publication of DK1848406T3 publication Critical patent/DK1848406T3/en

Links

Classifications

    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K31/567—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
    • A61K31/57—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (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)
  • Reproductive Health (AREA)
  • Endocrinology (AREA)
  • Organic Chemistry (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

Disclosed is a solid peroral contraceptive drug containing 17a-cyanomethyI-17-ß-hydroxyestra-4,9-dien-3on (dienogest) at a daily dose that is equal to or smaller than 2.0 mg as one active component and 17a-ethinyl estradiol (ethinyl estradiol) at a daily dose of less than 0.03 mg as another active component along with one or several pharmaceutically acceptable carriers. The dienogest is proportionately released in at least two phases while the ethinyl estradiol is released at the same time as the first phase of the dienogest.
DK06706961T 2005-02-15 2006-02-15 Solid, penal formulation for contraception containing dienogest and ethynyl estradiol DK1848406T3 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP05003179A EP1690543A1 (en) 2005-02-15 2005-02-15 Pharmaceutical composition for contraception
EP05003181A EP1690529A1 (en) 2005-02-15 2005-02-15 Peroral solid dosage form for contraception comprising Dienogest and Ethinylestradiol
PCT/EP2006/001358 WO2006087177A2 (en) 2005-02-15 2006-02-15 Solid peroral contraceptive drug

Publications (1)

Publication Number Publication Date
DK1848406T3 true DK1848406T3 (en) 2008-09-15

Family

ID=37951746

Family Applications (1)

Application Number Title Priority Date Filing Date
DK06706961T DK1848406T3 (en) 2005-02-15 2006-02-15 Solid, penal formulation for contraception containing dienogest and ethynyl estradiol

Country Status (20)

Country Link
EP (1) EP1848406B1 (en)
JP (1) JP2008527019A (en)
KR (1) KR20070087141A (en)
AT (1) ATE395047T1 (en)
AU (1) AU2006215822B2 (en)
BR (1) BRPI0606297A2 (en)
CA (1) CA2594939A1 (en)
CY (1) CY1108265T1 (en)
DE (1) DE502006000771D1 (en)
DK (1) DK1848406T3 (en)
EA (1) EA200701389A1 (en)
ES (1) ES2310907T3 (en)
HR (1) HRP20080394T3 (en)
IL (1) IL184257A0 (en)
NO (1) NO20072893L (en)
PL (1) PL1848406T3 (en)
PT (1) PT1848406E (en)
RS (1) RS50597B (en)
SI (1) SI1848406T1 (en)
WO (1) WO2006087177A2 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2020235A1 (en) * 2007-07-31 2009-02-04 Bayer Schering Pharma AG Method for manufacturing a single-phase pharmaceutical preparation for oral treatment to regulate blood pressure
JP2010529063A (en) * 2007-07-31 2010-08-26 バイエル・シエーリング・ファーマ アクチエンゲゼルシャフト Single-phase pharmaceutical complex preparations (dienogest and ethinylestradiol) for oral therapy for the regulation of blood pressure
JP6759478B2 (en) * 2019-02-13 2020-09-23 富士製薬工業株式会社 Oral solid composition, a method for producing the same, and an oral tablet obtained by the method for producing the oral solid composition.
EP3954364A1 (en) 2020-08-14 2022-02-16 Chemo Research, S.L. New modified release oral contraceptive composition

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19525017A1 (en) * 1995-06-28 1997-01-02 Schering Ag Pharmaceutical combination preparation, kit and method for hormonal contraception
EP0956024B1 (en) * 1996-07-26 2004-07-21 Wyeth Monophasic oral contraceptive method and kit comprising a combination of progestin and estrogen

Also Published As

Publication number Publication date
SI1848406T1 (en) 2008-10-31
NO20072893L (en) 2007-09-12
WO2006087177A3 (en) 2007-08-30
RS50597B (en) 2010-05-07
EP1848406B1 (en) 2008-05-14
PL1848406T3 (en) 2009-06-30
WO2006087177B1 (en) 2007-10-11
CA2594939A1 (en) 2006-08-24
ES2310907T3 (en) 2009-01-16
PT1848406E (en) 2008-08-21
JP2008527019A (en) 2008-07-24
BRPI0606297A2 (en) 2009-06-09
DE502006000771D1 (en) 2008-06-26
AU2006215822A1 (en) 2006-08-24
ATE395047T1 (en) 2008-05-15
KR20070087141A (en) 2007-08-27
WO2006087177A2 (en) 2006-08-24
WO2006087177A8 (en) 2007-05-24
IL184257A0 (en) 2007-10-31
EP1848406A2 (en) 2007-10-31
HRP20080394T3 (en) 2008-11-30
AU2006215822B2 (en) 2008-09-04
CY1108265T1 (en) 2014-02-12
EA200701389A1 (en) 2008-02-28

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