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CO5200771A1 - A PHARMACEUTICAL COMPOSITION TO BE USED AS AN CONTRACEPTIVE AGENT - Google Patents

A PHARMACEUTICAL COMPOSITION TO BE USED AS AN CONTRACEPTIVE AGENT

Info

Publication number
CO5200771A1
CO5200771A1 CO00065489A CO00065489A CO5200771A1 CO 5200771 A1 CO5200771 A1 CO 5200771A1 CO 00065489 A CO00065489 A CO 00065489A CO 00065489 A CO00065489 A CO 00065489A CO 5200771 A1 CO5200771 A1 CO 5200771A1
Authority
CO
Colombia
Prior art keywords
amount
drospirenone
dosage units
daily dosage
mammal
Prior art date
Application number
CO00065489A
Other languages
Spanish (es)
Inventor
Wolfgang Heil
Jurgen Hilmann
Ralph Lipp
Heithecker Renate
Original Assignee
Bayer Schering 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=8240592&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CO5200771(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bayer Schering Pharma Ag filed Critical Bayer Schering Pharma Ag
Publication of CO5200771A1 publication Critical patent/CO5200771A1/en

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
    • 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
    • A61K31/57Compounds 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
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A61K31/585Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Una composición farmacéutica, caracterizada por comprender, como un primer agente activo, 6b, 7b; 15b, 16b-dimetilen-3-oxo-17a-pregn-4-en-21, 17 -carbolactona (drospirenona) en una cantidad correspondiente a una dosis diaria, a ser administrada con la composición, de desde aproximadamente 2 mg a aproximadamente 4 mg, y, como un segundo agente activo, 17a-etinilestradiol (etinilestradiol) en una cantidad correspondiente a una dosis diaria de desde aproximadamente 0,01 mg a aproximadamente 0,05 mg, conjuntamente con uno o más soportes o excipientes farmacéuticamente aceptables.Una preparación farmacéutica, caracterizada por consistir de un número de unidades de dosificación diaria colocadas en una unidad de empaque, empaquetadas separadamente y separables individualmente, y provistas para la administración oral durante un periodo de 21 días consecutivos, comprendiendo dichas unidades de dosificación diaria una combinación de drospirenona en una cantidad de desde aproximadamente 2 mg a aproximadamente 4 mg y etinilestradiol en una cantidad de desde aproximadamente 0,01 a aproximadamente 0,05 mg.Una preparación farmacéutica caracterizada por consistir de un número de unidades de dosificación diaria colocadas en una unidad de empaque, empaquetadas separadamente y separables individualmente y provistas para la administración oral durante un período de al menos 28 días consecutivos, en donde al menos 21 de dichas unidades de dosificación diaria comprenden una combinación da drospirenona en una cantidad de desde aproximadamente 2 mg a aproximadamente 4 mg y etinilestradiol en una cantidad de desde aproximadamente 0,01 a aproximadamente 0,05 mg, y en donde 7 ó menos de dichas unidades de dosificación diaria contienen sólo etinilestradiol en una cantidad de desde aproximadamente 0,01 a aproximadamente 0,05 mg.Un método para inhibir ovulación en un mamífero, en particular en un humano, caracterizado por comprender administrar, a dicho mamífero, drospirenona en una cantidad en la gama de desde aproximadamente 2 mg a aproximadamente 4 mg por día, conjuntamente con etinilestradiol en una cantidad de desde aproximadamente 0,01 mg a aproximadamente 0,05 mg por día, siendo dichas cantidades efectivas para inhibir ovulación en dicho mamífero.Un método para promover una disolución rápida de drospirenona de una forma de dosificación unitaria para administración oral, estando el método caracterizado por comprender proveer drospirenona, en dicha forma de dosificación unitaria, en forma micronizada, o pulverizada desde una solución sobre las partículas de un soporte inerte mezclado con uno o más excipientes farmacéuticamente aceptables que promueven la disolución de la drospirenona.A pharmaceutical composition, characterized by comprising, as a first active agent, 6b, 7b; 15b, 16b-dimethylene-3-oxo-17a-pregn-4-en-21, 17 -carbolactone (drospirenone) in an amount corresponding to a daily dose, to be administered with the composition, from about 2 mg to about 4 mg, and, as a second active agent, 17a-ethynyl estradiol (ethynyl estradiol) in an amount corresponding to a daily dose of from about 0.01 mg to about 0.05 mg, together with one or more pharmaceutically acceptable carriers or excipients. pharmaceutical preparation, characterized in that it consists of a number of daily dosage units placed in a packaging unit, packaged separately and individually separable, and provided for oral administration for a period of 21 consecutive days, said daily dosage units comprising a combination of drospirenone in an amount from about 2 mg to about 4 mg and ethinyl estradiol in an amount from about 0.01 to ap approximately 0.05 mg. A pharmaceutical preparation characterized by consisting of a number of daily dosage units placed in a packaging unit, packaged separately and individually separable and provided for oral administration for a period of at least 28 consecutive days, wherein at least 21 of said daily dosage units comprise a combination of drospirenone in an amount of from about 2 mg to about 4 mg and ethinyl estradiol in an amount of from about 0.01 to about 0.05 mg, and wherein 7 or less of said daily dosage units contain only ethinylestradiol in an amount of from about 0.01 to about 0.05 mg. A method for inhibiting ovulation in a mammal, in particular in a human, characterized by comprising administering, to said mammal, drospirenone. in an amount in the range of from about 2 mg to about 4 mg per day, together with ethinyl estradiol in an amount of from about 0.01 mg to about 0.05 mg per day, said amounts being effective in inhibiting ovulation in said mammal, a method of promoting a rapid dissolution of drospirenone from a unit dosage form for administration. orally, the method being characterized by comprising providing drospirenone, in said unit dosage form, in micronized form, or sprayed from a solution on the particles of an inert support mixed with one or more pharmaceutically acceptable excipients that promote the dissolution of drospirenone.

CO00065489A 1999-08-31 2000-08-31 A PHARMACEUTICAL COMPOSITION TO BE USED AS AN CONTRACEPTIVE AGENT CO5200771A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP99202826 1999-08-31

Publications (1)

Publication Number Publication Date
CO5200771A1 true CO5200771A1 (en) 2002-09-27

Family

ID=8240592

Family Applications (1)

Application Number Title Priority Date Filing Date
CO00065489A CO5200771A1 (en) 1999-08-31 2000-08-31 A PHARMACEUTICAL COMPOSITION TO BE USED AS AN CONTRACEPTIVE AGENT

Country Status (6)

Country Link
CN (1) CN1879632A (en)
AR (2) AR025443A1 (en)
CO (1) CO5200771A1 (en)
EC (1) ECSP003721A (en)
PE (1) PE20010665A1 (en)
ZA (2) ZA200201668B (en)

Also Published As

Publication number Publication date
AR025443A1 (en) 2002-11-27
ZA200201668B (en) 2004-06-24
ECSP003721A (en) 2002-05-23
AR043470A2 (en) 2005-07-27
PE20010665A1 (en) 2001-06-19
CN1879632A (en) 2006-12-20
ZA200404083B (en) 2006-02-22

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Legal Events

Date Code Title Description
FC Application refused