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DK200001170A - Farmaceutiske sammensætninger - Google Patents

Farmaceutiske sammensætninger Download PDF

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Publication number
DK200001170A
DK200001170A DK200001170A DKPA200001170A DK200001170A DK 200001170 A DK200001170 A DK 200001170A DK 200001170 A DK200001170 A DK 200001170A DK PA200001170 A DKPA200001170 A DK PA200001170A DK 200001170 A DK200001170 A DK 200001170A
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DK
Denmark
Prior art keywords
pharmaceutical composition
tribasic
phosphate
salt
dihydroxyhept
Prior art date
Application number
DK200001170A
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English (en)
Inventor
Creekmore Joseph Richard
Wiggins Norman Alfred
Original Assignee
Astrazeneca Ab
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.)
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Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=9884259&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK200001170(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Astrazeneca Ab filed Critical Astrazeneca Ab
Publication of DK200001170A publication Critical patent/DK200001170A/da

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    • 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
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2813—Inorganic compounds
    • 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
    • A61K9/282—Organic compounds, e.g. fats
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • 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
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Molecular Biology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Cardiology (AREA)
  • Emergency Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Description

PATENTKRAV 1. Farmaceutisk sammensætning omfattende (E)-7-[4-(4-fluorphenyl)-6-isopropyl-2-[methyl(methylsulfonyl)annno]pyrimidin-5-yl]-(3R, 5S)-3,5-dihydroxyhept-6-ensyre eller et farmaceutisk acceptabelt salt deraf som den aktive bestanddel og et tribasisk phosphatsalt, hvori kationen er multivalent. 2. Farmaceutisk sammensætning ifølge krav 1, hvori det tribasiske phosphatsalt, hvori kationen er multivalent, er valgt blandt tribasisk calciumphosphat, tribasisk magne-siumphosphat og tribasisk aluminiumphosphat. 3. Farmaceutisk sammensætning ifølge krav 1 eller 2, hvori det tribasiske phosphatsalt, hvori kationen er multivalent, er tribasisk calciumphosphat. 4. Farmaceutisk sammensætning ifølge ethvert af kravene 1-3, hvori forholdet mellem tribasisk phosphatsalt og aktiv bestanddel er i området fra 1:80 til 50:1 på vægtbasis. 5. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, som yderligere omfatter et eller flere fyldstoffer, bindemidler, desintegreringsmidler eller smøremidler. 6. Farmaceutisk sammensætning til oral administration omfattende (E)-7-[4-(4-fluorphenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-(3R, 5S)-3,5-dihydroxyhept-6-ensyre eller et farmaceutisk acceptabelt salt deraf som den aktive bestanddel, et eller flere fyldstoffer, et eller flere bindemidler, et eller flere desintegreringsmidler, et eller flere smøremidler og et tribasisk phosphatsalt, hvori kationen er multivalent. 7. Farmaceutisk sammensætning ifølge krav 6, hvori den aktive bestanddel er til stede i en mængde på 1 til 80 vægt% af sammensætningen. 8. Farmaceutisk sammensætning ifølge krav 6 eller 7, hvori det tribasiske phosphatsalt er til stede i en mængde på 1 til 50 vægt% af sammensætningen. 9. Farmaceutisk sammensætning ifølge krav 6, 7 eller 8, hvori fyldstoffet er til stede i en mængde fra 30 til 90 vægt% af sammensætningen. 10. Farmaceutisk sammensætning ifølge ethvert af kravene 6-9, hvori bindemidlet er til stede i en mængde fra 2 til 90 vægt% af sammensætningen. 11. Farmaceutisk sammensætning ifølge ethvert af kravene 6-10, hvori desintegreringsmidlet er til stedet i en mængde fra 2 til 10 vægt% af sammensætningen. 12. Farmaceutisk sammensætning ifølge ethvert af kravene 6-11, hvori smøremidlet er til stede i en mængde fra 0,5 til 3 vægt%. 13. Farmaceutisk sammensætning ifølge krav 6 omfattende (E)-7-[4-(4-fluoiphenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-(3R, 5S)-3,5-dihydroxyhept-6-ensyre eller et farmaceutisk acceptabelt salt deraf som den aktive bestanddel, tribasisk calciumphosphat, mikrokrystallinsk cellulose, lactose, natriumstivelsesglycolat, butyleret hydroxytoluen og magnesiumstearat. 14. Farmaceutisk sammensætning ifølge krav 6 omfattende (E)-7-[4-(4-fluorphenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-(3R, 5S)-3,5-dihydroxyhept-6-ensyre eller et farmaceutisk acceptabelt salt deraf som den aktive bestanddel, tribasisk calciumphosphat, povidon, mikrokrystallinsk cellulose, mannitol, natriumstivelsesglycolat, butyleret hydroxytoluen og magnesiumstearat. 15. Farmaceutisk sammensætning ifølge krav 6 omfattende (E)-7-[4-(4-fluorphenyl)-6-isopropyI-2-[methyl(methyIsulfonyl)amino]pyrimidin-5-yl]-(3R, 5S)-3,5-dihydroxyhept- 6-ensyre eller et farmaceutisk acceptabelt salt deraf som den aktive bestanddel, tribasisk calciumphosphat, crospovidon, mikrokrystallinsk cellulose, lactoseog magnesiumstearat. 16. Farmaceutisk sammensætning ifølge krav 6 omfattende (E)-7-[4-(4-fluorphenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-ylK3R,5S)-3,5-dihydroxyhept-6-ensyre eller et farmaceutisk acceptabelt salt deraf som den aktive bestanddel, tribasisk calciumphosphat, povidon, mikrokrystallinsk cellulose, lactose, natriumstivelsesglycolat, butyleret hydroxytoluen og magnesiumstearat. 17. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvori den aktive bestanddel er calciumsaltet af (E)-7-[4-(4-fluorphenyl)-6-isopropyl-2-[methyl(methyl-sulfonyl)amino]pyrimidin-5-yl] -(3R, 5S)-3,5-dihydroxyhept-6-ensyre. 18. Anvendelse af tribasisk phosphatsalt, hvori kationen er multivalent, til stabilisering af forbindelsen (E)-7- [4-(4-fluorphenyl)-6-isopropyl-2- [methyl(methylsulfonyl)amino] -pyrimidin-5-yl]-(3R, 5S)-3,5-dihydroxyhept-6-ensyre eller et farmaceutisk acceptabelt salt deraf. 19. Anvendelse ifølge krav 18, hvori det tribasiske phosphatsalt, hvori kationen er multivalent, er valgt blandt tribasisk calciumphosphat, tribasisk magnesiumphosphat og tribasisk aluminiumphosphat. 20. Anvendelse ifølge krav 18 eller 19, hvori det tribasiske phosphatsalt, hvori kationen er multivalent, er tribasisk calciumphosphat. 21. Fremgangsmåde til fremstilling af en stabiliseret farmaceutisk sammensætning, som omfatter inkorporering af et tribasisk phosphatsalt, hvori kationen er multivalent, i en farmaceutisk sammensætning indeholdende forbindelsen (E)-7-[4-(4-fluorphenyI)-6-isopropyl-2-[methyl(methylsulfonyl)ammo]pyrimidin-5-yl]-(3R, 5S)-3,5 -dihydroxyhept-6-ensyre eller et farmaceutisk acceptabelt salt deraf.
DK200001170A 2000-01-26 2000-08-04 Farmaceutiske sammensætninger DK200001170A (da)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GBGB0001621.2A GB0001621D0 (en) 2000-01-26 2000-01-26 Pharmaceutical compositions

Publications (1)

Publication Number Publication Date
DK200001170A true DK200001170A (da) 2001-01-27

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ID=9884259

Family Applications (3)

Application Number Title Priority Date Filing Date
DK00953283T DK1223918T3 (da) 2000-01-26 2000-08-04 Farmaceutiske præparater omfattende en HMG-CoA-reductaseinhibitor
DK200001171A DK178242B1 (da) 2000-01-26 2000-08-04 Farmaceutiske sammensætninger
DK200001170A DK200001170A (da) 2000-01-26 2000-08-04 Farmaceutiske sammensætninger

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Application Number Title Priority Date Filing Date
DK00953283T DK1223918T3 (da) 2000-01-26 2000-08-04 Farmaceutiske præparater omfattende en HMG-CoA-reductaseinhibitor
DK200001171A DK178242B1 (da) 2000-01-26 2000-08-04 Farmaceutiske sammensætninger

Country Status (48)

Country Link
US (2) US6548513B1 (da)
EP (6) EP2133070A1 (da)
JP (3) JP4800467B2 (da)
KR (3) KR100388713B1 (da)
CN (3) CN100528161C (da)
AP (2) AP1879A (da)
AR (3) AR023624A1 (da)
AT (3) AT412063B (da)
AU (5) AU2000264559A1 (da)
BE (2) BE1013414A5 (da)
BG (4) BG65234B1 (da)
BR (2) BR0003364A (da)
CA (3) CA2639407C (da)
CH (2) CH691347A5 (da)
CL (1) CL2007001807A1 (da)
CR (3) CR6568A (da)
CZ (3) CZ290167B6 (da)
DE (3) DE60001371T2 (da)
DK (3) DK1223918T3 (da)
EE (3) EE04990B1 (da)
ES (2) ES2155043B1 (da)
FI (3) FI121365B (da)
FR (2) FR2795324B1 (da)
GB (3) GB0001621D0 (da)
HK (4) HK1048950A1 (da)
HR (3) HRP20020632B1 (da)
HU (2) HUP0003111A3 (da)
IL (4) IL147870A (da)
IS (3) IS1940B (da)
IT (2) ITTO20000779A1 (da)
ME (4) MEP33708A (da)
MY (2) MY123650A (da)
NL (2) NL1015858C2 (da)
NO (4) NO327675B1 (da)
NZ (2) NZ519774A (da)
PL (2) PL196808B1 (da)
PT (3) PT1223918E (da)
RS (1) RS50201B (da)
RU (2) RU2264210C2 (da)
SE (2) SE523481C2 (da)
SI (1) SI1223918T1 (da)
SK (2) SK11792000A3 (da)
TR (3) TR200201888T2 (da)
TW (2) TW553749B (da)
UA (2) UA51853C2 (da)
WO (2) WO2001054668A1 (da)
YU (1) YU52902A (da)
ZA (2) ZA200003998B (da)

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