RS50262B2 - Farmaceutska kombinacija etinilestradiola i drospirenona za primenu kao kontraceptivnog sredstva - Google Patents

Farmaceutska kombinacija etinilestradiola i drospirenona za primenu kao kontraceptivnog sredstva

Info

Publication number
RS50262B2
RS50262B2 RS14502A RSP20020145A RS50262B2 RS 50262 B2 RS50262 B2 RS 50262B2 RS 14502 A RS14502 A RS 14502A RS P20020145 A RSP20020145 A RS P20020145A RS 50262 B2 RS50262 B2 RS 50262B2
Authority
RS
Serbia
Prior art keywords
drospirenone
active agent
ethinylestradiol
administration
composition
Prior art date
Application number
RS14502A
Other languages
English (en)
Inventor
Wolfgang Heil
Jürgen HILMAN
Ralph Lipp
Renate Heithecker
Original Assignee
Bayer Pharma AG
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26153359&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=RS50262(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bayer Pharma AG filed Critical Bayer Pharma AG
Publication of RS50262B2 publication Critical patent/RS50262B2/sr

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
    • 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
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A61K31/585—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin containing lactone rings, e.g. oxandrolone, bufalin
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/10—Anti-acne agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • 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
    • A61P5/28—Antiandrogens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/10—Antioedematous agents; Diuretics
    • 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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Reproductive Health (AREA)
  • Dermatology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Farmaceutska kompozicija koja sadrži, kao prvo aktivno sredstvo. 6β.7β; 15β,16β-dimetilen-3-okso-17α-pregn-4-en-21,17-karbolakton (drospirenon) u količini koja odgovara jednoj dnevnoj dozi, nakom davanja kompozicije, od oko 2 mg do oko 4 mg, i, kao drugo aktivno sredstvo, 17α-etinilestradiol (etinilestra-diol) u količini koja odgovara dnevnoj dozi od oko 0,01 mg do oko 0,05 mg, zajedno sa jednim ili više farmaceutski prihvatljivih nosača ili neutralnih dodataka. Kod jednog posebnog izvođenja, kompozicija se sastoji od više odvojeno pakovanih i pojedinačno odvojivih dnevnih doznih jedinica postavljenih u jednu jedinicu pakovanja i namenjenih za oralno davanje u trajanju od najmanje 21 dan zaredom, pri čemu pomenute dnevne dozne jedinice sadrže svaka jednu kombinaciju drospirenona i etinilestradiola. Kompozicija može dalje sadržati 7 ili manje dnevnih doznih jedinica koje ne sadrže nikakvo aktivno sredstvo ili sadrže sam etinilestradiol.

Claims (2)

PATENTNI ZAHTEVI
1. Tableta, što sadrži, kao prvo aktivno sredstvo drospirenon u količini koja odgovara dnevnoj dozi, pri davanju tablete, od 3 mg, i kao drugo aktivno sredstvo, etinilestradiol u količini koja odgovara dnevnoj dozi od oko 0,015 mg do 0,03 mg, zajedno sa jednim ili više farmaceutski prihvatljivih nosača ili inertnih punilaca naznačena time što se bar 70% navedenog drospirenona rastvori iz navedene tablete koja sadrži 3 mg drospirenona za 30 minuta, kako je to utvrđeno putem USP XXIII Paddle Method II upotrebom 900 ml vode na 37°C kao medijuma rastvaranja i pri brzini mešanja od 50 obrtaja u minuti.
2. Tableta prema zahtevu 1, naznačena time, što je etinilestradiol u mikronizovanom obliku.
RS14502A 1999-08-31 2000-08-31 Farmaceutska kombinacija etinilestradiola i drospirenona za primenu kao kontraceptivnog sredstva RS50262B2 (sr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US38627499A 1999-08-31 1999-08-31
EP99202826 1999-08-31
PCT/IB2000/001213 WO2001015701A1 (en) 1999-08-31 2000-08-31 Pharmaceutical combination of ethinylestradiol and drospirenone for use as a contraceptive

Publications (1)

Publication Number Publication Date
RS50262B2 true RS50262B2 (sr) 2018-10-31

Family

ID=26153359

Family Applications (3)

Application Number Title Priority Date Filing Date
YU14502A RS50262B (sr) 1999-08-31 2000-08-31 Farmaceutska kombinacija etinilestradiola i drospirenona za primenu kao kontraceptivnog sredstva
RS14502A RS50262B2 (sr) 1999-08-31 2000-08-31 Farmaceutska kombinacija etinilestradiola i drospirenona za primenu kao kontraceptivnog sredstva
RSP-2009/0134A RS20090134A (sr) 1999-08-31 2000-08-31 Farmaceutska kombinacija etinilestradiola i drospirenona za primenu kao kontraceptivnog sredstva

Family Applications Before (1)

Application Number Title Priority Date Filing Date
YU14502A RS50262B (sr) 1999-08-31 2000-08-31 Farmaceutska kombinacija etinilestradiola i drospirenona za primenu kao kontraceptivnog sredstva

Family Applications After (1)

Application Number Title Priority Date Filing Date
RSP-2009/0134A RS20090134A (sr) 1999-08-31 2000-08-31 Farmaceutska kombinacija etinilestradiola i drospirenona za primenu kao kontraceptivnog sredstva

Country Status (26)

Country Link
EP (4) EP2044941A1 (sr)
JP (2) JP4354667B2 (sr)
KR (2) KR101019361B1 (sr)
AT (3) ATE254464T1 (sr)
AU (4) AU780330B2 (sr)
BG (1) BG66114B1 (sr)
BR (1) BR0014159A (sr)
CY (3) CY1108990T1 (sr)
CZ (1) CZ300514B6 (sr)
DE (5) DE60042089D1 (sr)
DK (3) DK1214076T3 (sr)
EE (1) EE05128B1 (sr)
ES (3) ES2211580T3 (sr)
HK (1) HK1047247B (sr)
HR (1) HRP20070188B1 (sr)
HU (1) HU227207B1 (sr)
IL (1) IL148339A0 (sr)
ME (2) MEP36008A (sr)
NO (1) NO326860B1 (sr)
NZ (1) NZ517845A (sr)
PL (1) PL199028B1 (sr)
PT (3) PT1214076E (sr)
RS (3) RS50262B (sr)
SI (3) SI1214076T1 (sr)
TW (1) TWI276436B (sr)
WO (1) WO2001015701A1 (sr)

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Also Published As

Publication number Publication date
HK1047247A1 (en) 2003-02-14
PT1598069E (pt) 2009-07-20
HK1082432A1 (en) 2006-06-09
TWI276436B (en) 2007-03-21
CY1108990T1 (el) 2014-02-12
JP4354667B2 (ja) 2009-10-28
HU227207B1 (en) 2010-11-29
DE60006692D1 (de) 2003-12-24
SI1214076T1 (en) 2004-06-30
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EP1214076B1 (en) 2003-11-19

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