TWI228050B - A pharmaceutical composition for use as HMG CoA reductase inhibitor and the production method thereof - Google Patents

A pharmaceutical composition for use as HMG CoA reductase inhibitor and the production method thereof Download PDF

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Publication number
TWI228050B
TWI228050B TW089115659A TW89115659A TWI228050B TW I228050 B TWI228050 B TW I228050B TW 089115659 A TW089115659 A TW 089115659A TW 89115659 A TW89115659 A TW 89115659A TW I228050 B TWI228050 B TW I228050B
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TW
Taiwan
Prior art keywords
pharmaceutical composition
production method
coa reductase
reductase inhibitor
hmg coa
Prior art date
Application number
TW089115659A
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English (en)
Inventor
Joseph Richard Creekmore
Norman Alfred Wiggins
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Astrazeneca Ab
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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)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (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

A8 B8 C8 D8 1228050 六、申請專利範園 10·如申凊專利範圍第1至4項中任一項之醫藥組合物，其 中該活性成分的含量為該組合物的1至5 〇重量％。 11·如申凊專利範圍第1至4項中任一項之醫藥組合物，其 中该辨機鹽的含量為該組合物的1至5 〇重量％。 12. 如申4專利範圍第9項之醫藥組合物，其中該填料的含 量為該組合物的3 0.至9 0重量％。 13. 如申睛專利範圍第9項之醫藥組合物，其中該黏合劑的 含里為該組合物的2至9 0重量％。 14. 如申凊專利範圍第9項之醫藥組合物，其中該崩解劑的 含里為該組合物的2至1 〇重量％ 〇 15. 如申凊專利範圍第9項之醫藥組合物，其中該潤滑劑的 含量為該組合物的〇 · 5至3重量％。 16. 如申請專利範圍第1至4項任一項之醫藥組合物，其中 該活性成分為（Ε)-7_[4·(4_氟苯基）·6_異丙基-2·[甲基 (甲橫醯基）胺基]嘧啶。5_基」-(311，58)_3,5-二羥基庚-6· 晞酸的#5鹽。 Π·如申請專利範圍第9項之醫藥組合物，其中該活性成分 為（Ε)-7-[4-(4-氟苯基）-6 -異丙基-2-[甲基（甲磺醯基） 胺基]嘧啶-5-基]-(3R55S)-3,5-二羥基庚-6-婦酸的鈣 鹽〇 18·—種製備一種經穩定化的醫藥組合物之方法，其包括將 其中所含陽離子為多價者之無機鹽摻加到一冬有化人 物⑻邻_(4_氟苯基）_6_異丙基+ [甲基（甲^醯基口) 胺基]嘴淀-5-基]侦，58)_3,5_二幾基庚_6_婦酸或其醫 -2-
A BCD 1228050 々、申請專利範圍 藥可接受鹽的醫藥組合物之中，其限制條件為該無機 鹽不是水滑石或合成水滑石。 19. 如申請專利範圍第1 8項之方法，其中該陽離子為多價 者之無機鹽係選自包括偏碎酸鍰銘，三驗價磷酸妈， 三驗價磷酸鎂:和三驗價磷酸銘。 20. 如申請專利範圍第J 8項之方法，其中該其中所含陽離 子為多價者之無機鹽為偏石夕酸鎮銘。 -3- 本紙張尺度適用中國國家標準(CNS) A4規格(210 x 297公釐）
TW089115659A 2000-01-26 2000-08-04 A pharmaceutical composition for use as HMG CoA reductase inhibitor and the production method thereof TWI228050B (en)

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
TWI228050B true TWI228050B (en) 2005-02-21

Family

ID=9884259

Family Applications (2)

Application Number Title Priority Date Filing Date
TW089115660A TW553749B (en) 2000-01-26 2000-08-04 Stable pharmaceutical composition comprising (E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[meteyl(methylsulfonyl)amino]pyrimidin-5-yl]-(3r,5s)-3,5-dihydroxyhept-6-enoic acid and method for producing the same
TW089115659A TWI228050B (en) 2000-01-26 2000-08-04 A pharmaceutical composition for use as HMG CoA reductase inhibitor and the production method thereof

Family Applications Before (1)

Application Number Title Priority Date Filing Date
TW089115660A TW553749B (en) 2000-01-26 2000-08-04 Stable pharmaceutical composition comprising (E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[meteyl(methylsulfonyl)amino]pyrimidin-5-yl]-(3r,5s)-3,5-dihydroxyhept-6-enoic acid and method for producing the same

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US (2) US6548513B1 (zh)
EP (6) EP2266540A1 (zh)
JP (3) JP3267960B2 (zh)
KR (3) KR100698333B1 (zh)
CN (3) CN1149997C (zh)
AP (2) AP1449A (zh)
AR (3) AR025055A1 (zh)
AT (3) ATE232088T1 (zh)
AU (5) AU738074B2 (zh)
BE (2) BE1013414A5 (zh)
BG (4) BG65234B1 (zh)
BR (2) BR0003365A (zh)
CA (3) CA2315141C (zh)
CH (2) CH691347A5 (zh)
CL (1) CL2007001807A1 (zh)
CR (3) CR6568A (zh)
CZ (3) CZ298411B6 (zh)
DE (3) DE10038110B4 (zh)
DK (3) DK1223918T3 (zh)
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ES (2) ES2171123B1 (zh)
FI (3) FI121365B (zh)
FR (2) FR2795324B1 (zh)
GB (3) GB0001621D0 (zh)
HK (6) HK1036935A1 (zh)
HR (3) HRP20020097B1 (zh)
HU (2) HU222578B1 (zh)
IL (4) IL147870A (zh)
IS (3) IS1940B (zh)
IT (2) ITTO20000779A1 (zh)
ME (4) MEP33808A (zh)
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PT (3) PT1223918E (zh)
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RU (2) RU2206324C1 (zh)
SE (2) SE523481C2 (zh)
SI (1) SI1223918T1 (zh)
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TR (3) TR200701171T2 (zh)
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WO (2) WO2001054669A1 (zh)
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