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DK2272505T3 - Tabletter indeholdende vardenafil hydrochlorid trihydrat - Google Patents

Tabletter indeholdende vardenafil hydrochlorid trihydrat Download PDF

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Publication number
DK2272505T3
DK2272505T3 DK10183693.0T DK10183693T DK2272505T3 DK 2272505 T3 DK2272505 T3 DK 2272505T3 DK 10183693 T DK10183693 T DK 10183693T DK 2272505 T3 DK2272505 T3 DK 2272505T3
Authority
DK
Denmark
Prior art keywords
trihydrate
vardenafil
tablets
coated tablets
vardenafil hydrochloride
Prior art date
Application number
DK10183693.0T
Other languages
English (en)
Inventor
Peter Serno
Alfons Grunenberg
Andreas Ohm
Rainer Bellinghausen
Elmer Volters
Jan-Olav Henck
Original Assignee
Bayer Ip 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=29796385&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2272505(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bayer Ip Gmbh filed Critical Bayer Ip Gmbh
Application granted granted Critical
Publication of DK2272505T3 publication Critical patent/DK2272505T3/da

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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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/53—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
    • 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
    • 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
    • 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
    • A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D487/00—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00
    • C07D487/02—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00 in which the condensed system contains two hetero rings
    • C07D487/04—Ortho-condensed systems
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/2893—Tablet coating processes
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Reproductive Health (AREA)
  • Endocrinology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gynecology & Obstetrics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)

Claims (9)

1. Fremgangsmåde til fremstilling at overtrukne tabletter indeholdende vardenafil hydrochlorid med et trihydrat-indhold på i det mindste 90 mol-% i fast form, kendetegnet ved, at a) der ved fremstillingen af de overtrukne tabletter anvendes vardenafil hydrochlorid med vilkårligt vandindhold, og b) vardenafil hydrochlorid i slutproduktet omdannes til trihydratformen, idet slutproduktet bringes i kontakt med fugtet gas, til der har dannet sig i det mindste 90 mol-% trihydrat.
2. Fremgangsmåde ifølge krav 1, kendetegnet ved, at omdannelsen til trihydratformen sker med fugtet gas i en periode på få minutter op til flere dage.
3. Fremgangsmåde ifølge krav 1, kendetegnet ved, at omdannelsen til trihydratformen sker med fugtet gas i en periode på 0,5 timer til 12 timer.
4. Fremgangsmåde ifølge krav 1, kendetegnet ved, at omdannelsen til trihydratformen sker i farmaceutisk gængse blisterpakninger med fugtet gas i en periode på 1 dag op til 6 måneder.
5. Fremgangsmåde ifølge i det mindste et af kravene 1 til 4, kendetegnet ved, at omdannelsen til trihydratformen sker med luft med en relativ fugtighed på 35% til 100%.
6. Fremgangsmåde ifølge i det mindste et af kravene 1 til 4, kendetegnet ved, at omdannelsen til trihydratformen sker med luft med en relativ fugtighed på 50% til 99%.
7. Overtrukne tabletter opnåelige ifølge fremgangsmåden ifølge i det mindste et af kravene 1 til 6, indeholdende vardenafil hydrochlorid trihydrat på op til 0,1-70 vægt-%, et sprængmiddel på op til 0,1-10 vægt-%, et smøremiddel på op til 0,1-2 vægt-% og i givet fald yderligere hjælpemidler samt et fyldmiddel som resterende bestanddele.
8. Overtrukne tabletter ifølge krav 7, indeholdende mikrokrystallin cellulose som fyldmiddel, crospovidone som sprængmiddel og magnesiumstearat som smøremiddel.
9. Overtrukne tabletter ifølge krav 7 eller 8 til behandling af erektil dysfunktion.
DK10183693.0T 2002-07-16 2003-07-03 Tabletter indeholdende vardenafil hydrochlorid trihydrat DK2272505T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10232113A DE10232113A1 (de) 2002-07-16 2002-07-16 Vardenafil Hydrochlorid Trihydrat enthaltende Arzneimittel
EP03763695A EP1523303B1 (de) 2002-07-16 2003-07-03 Vardenafil hydrochlorid trihydrat enthaltende arzneimittel und deren herstellungsverfahren

Publications (1)

Publication Number Publication Date
DK2272505T3 true DK2272505T3 (da) 2017-01-23

Family

ID=29796385

Family Applications (2)

Application Number Title Priority Date Filing Date
DK10183693.0T DK2272505T3 (da) 2002-07-16 2003-07-03 Tabletter indeholdende vardenafil hydrochlorid trihydrat
DK03763695.8T DK1523303T3 (da) 2002-07-16 2003-07-03 Lægemidler indeholdende vardenafil hydrochlorid trihydrat og deres fremstillingsmåder

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK03763695.8T DK1523303T3 (da) 2002-07-16 2003-07-03 Lægemidler indeholdende vardenafil hydrochlorid trihydrat og deres fremstillingsmåder

Country Status (32)

Country Link
US (2) US8273876B2 (da)
EP (2) EP1523303B1 (da)
JP (2) JP5173113B2 (da)
KR (2) KR20100137572A (da)
CN (2) CN1681481B (da)
AT (1) ATE538777T1 (da)
AU (1) AU2003249942B2 (da)
BR (1) BRPI0305559B8 (da)
CA (2) CA2492747C (da)
CU (1) CU23473B7 (da)
CY (2) CY1112460T1 (da)
DE (1) DE10232113A1 (da)
DK (2) DK2272505T3 (da)
EC (1) ECSP055541A (da)
ES (2) ES2609593T3 (da)
HK (1) HK1084019A1 (da)
HR (3) HRP20050143B1 (da)
HU (1) HUE032362T2 (da)
IL (2) IL166162A (da)
LT (1) LT2272505T (da)
MA (1) MA27320A1 (da)
MX (1) MXPA05000554A (da)
NO (2) NO335434B1 (da)
NZ (1) NZ537698A (da)
PH (1) PH12012501171A1 (da)
PL (1) PL223341B1 (da)
PT (2) PT2272505T (da)
RU (1) RU2349306C2 (da)
SI (2) SI1523303T1 (da)
UA (1) UA85542C2 (da)
WO (1) WO2004006894A1 (da)
ZA (1) ZA200500268B (da)

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