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1. WO2006120035 - PHARMACEUTICAL COMPOSITION CONTAINING GESTAGENS AND/OR ESTROGENS AND 5-METHYL-(6S)-TETRAHYDROFOLATE

Publication Number WO/2006/120035
Publication Date 16.11.2006
International Application No. PCT/EP2006/004858
International Filing Date 15.05.2006
Chapter 2 Demand Filed 13.03.2007
IPC
A61K 31/519 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
495having six-membered rings with two nitrogen atoms as the only ring hetero atoms, e.g. piperazine
505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
519ortho- or peri-condensed with heterocyclic rings
A61K 31/135 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
13Amines, e.g. amantadine
135having aromatic rings, e.g. methadone
A61K 31/7028 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
70Carbohydrates; Sugars; Derivatives thereof
7028Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
A61K 31/00 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
A61K 31/565 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopentahydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
565not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
A61K 31/57 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopentahydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
57substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane, progesterone
CPC
A61K 31/135
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
13Amines
135having aromatic rings ; , e.g. ketamine, nortriptyline
A61K 31/4415
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
435having six-membered rings with one nitrogen as the only ring hetero atom
44Non condensed pyridines; Hydrogenated derivatives thereof
4415Pyridoxine, i.e. Vitamin B6
A61K 31/519
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
495having six-membered rings with two ; or more; nitrogen atoms as the only ring heteroatoms, e.g. piperazine ; or tetrazines
505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
519ortho- or peri-condensed with heterocyclic rings
A61K 31/525
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
495having six-membered rings with two ; or more; nitrogen atoms as the only ring heteroatoms, e.g. piperazine ; or tetrazines
505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
519ortho- or peri-condensed with heterocyclic rings
525Isoalloxazines, e.g. riboflavins, vitamin B2
A61K 31/56
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
A61K 31/565
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
565not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
Applicants
  • BAYER SCHERING PHARMA AKTIENGESELLSCHAFT [DE]/[DE] (AllExceptUS)
  • MERCK EPROVA AG [CH]/[CH] (AllExceptUS)
  • STROTHMANN, Kai [DE]/[DE] (UsOnly)
  • SMITH, Gavin, Welch [GB]/[DE] (UsOnly)
  • KING, Kristina [DE]/[DE] (UsOnly)
  • MOSER, Rudolf [CH]/[CH] (UsOnly)
  • PIETRZIK, Klaus [DE]/[DE] (UsOnly)
Inventors
  • STROTHMANN, Kai
  • SMITH, Gavin, Welch
  • KING, Kristina
  • MOSER, Rudolf
  • PIETRZIK, Klaus
Agents
  • BAYER SCHERING PHARMA AKTIENGESELLSCHAFT
Priority Data
10 2005 023 301.513.05.2005DE
10 2006 016 285.403.04.2006DE
Publication Language German (de)
Filing Language German (DE)
Designated States
Title
(DE) PHARMAZEUTISCHE ZUSAMMENSETZUNG ENTHALTEND GESTAGENE UND/ODER ESTROGENE UND 5-METHYL-(6S)-TETRAHYDROFOLAT
(EN) PHARMACEUTICAL COMPOSITION CONTAINING GESTAGENS AND/OR ESTROGENS AND 5-METHYL-(6S)-TETRAHYDROFOLATE
(FR) COMPOSITION PHARMACEUTIQUE CONTENANT DES GESTAGENES ET/OU DES OESTROGENES ET DU 5-METHYL-(6S)-TETRAHYDROFOLATE
Abstract
(DE) Die vorliegende Erfindung betrifft eine pharmazeutische Zusammensetzung, die Gestagene, vorzugsweise Drospirenon, Estrogene, vorzugsweise Ethinylestradiol und 5-Methyl-(6S)-tetrahydrofolat enthält, als orales Kontrazeptivum eingesetzt werden kann und dabei folatmangelbedingten Erkrankungen der Konsumentinnen, insbesondere Herz-Kreislauferkrankungen und nach Konzeption des Embryos, angeborenen folatmangelbedingten Fehlbildungen wie zum Beispiel Neuralrohrdefekten, Ventrikelklappendefekten, Urogenitaldefekten, sowie Lippen-, Kiefer- und Gaumenspalten vorbeugt, ohne die Symptome eines Vitamin-B12-Mangels zu maskieren, und gleichzeitig auch im Falle eines homo- bzw. heterozygot vorliegenden Polymorphismus der Methylentetrahydrofolatreduktase die uneingeschränkte Verwendbarkeit der Folatkomponente 5-Methyl-(6S)-tetrahydrofolat durch den Organismus und damit deren biologische Aktivität zur Vermeidung von obengenannten angeborenen folatmangelbedingten Fehlbildüngen erleichtert. Darüber hinaus wird nach Absetzen des Kontrazeptivums eine länger andauernde Schutzwirkung aufrechterhalten.
(EN) The invention relates to a pharmaceutical composition which contains gestagens, preferably drospirenone, estrogens, preferably ethinylestradiol, and 5-methyl-(6S)-tetrahydrofolate, can be used as an oral contraceptive, and prevents diseases of the consumer caused by folate deficiency, especially cardiovascular diseases, as well as congenital defects caused by folate deficiency after conceiving the embryo, such as neural tube defects, defects of the ventricular valve, urogenital defects, and cheilognathopalatoschisis, without masking the symptoms of vitamin B12 deficiency while facilitating unrestricted usability of the folate component 5-methyl-(6S)-tetrahydrofolate by the organism and thus the biological activity thereof in order to prevent said congenital defects caused by folate deficiency in case of a homozygous or heterozygous methylenetetrahydrofolate reductase polymorphism. In addition, an extended protective effect is maintained after discontinuing the contraceptive.
(FR) La présente invention concerne une composition pharmaceutique contenant des gestagènes, de préférence de la drospirénone, des oestrogènes, de préférence de l'éthinylestradiol et du 5-méthyl-(6S)-tétrahydrofolate, qui peut être utilisée comme contraceptif oral et qui peut ainsi prévenir des maladies induites par un déficit en folate chez des consommatrices, en particulier des maladies cardio-vasculaires et, après la conception de l'embryon, des malformations congénitales induites par un déficit en folate, telles que des anomalies du tube neural, des anomalies des ventricules, des anomalies urogénitales, ainsi que des becs-de-lièvre, sans masquer les symptômes d'un déficit en vitamine B12. En cas d'un polymorphisme homozygote ou hétérozygote de la méthylène tétrahydrofolate réductase, cette composition facilite la capacité d'utilisation illimitée des composants de folate 5-méthyl-(6S)-tétrahydrofolate par l'organisme et ainsi leur activité biologique, afin d'éviter les malformations congénitales induites par un déficit en folate susmentionnées. Après arrêt du contraceptif, une action protectrice persistant plus longtemps est maintenue.
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