DE4240430A1 - - Google Patents
Info
- Publication number
- DE4240430A1 DE4240430A1 DE4240430A DE4240430A DE4240430A1 DE 4240430 A1 DE4240430 A1 DE 4240430A1 DE 4240430 A DE4240430 A DE 4240430A DE 4240430 A DE4240430 A DE 4240430A DE 4240430 A1 DE4240430 A1 DE 4240430A1
- Authority
- DE
- Germany
- Prior art keywords
- weight
- carbonate
- sodium
- agent
- alkaline medium
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
Links
Classifications
-
- 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
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
-
- 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
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
- A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium 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
- 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
Description
R ein organisches Radikal,
X -CH=CH-, vorzugsweise (E)-CH=CH-, und
M ein physiologisch annehmbares Kation, wie ein Alkalimetallkation oder Ammonium, vorzugsweise Natrium oder Kalium, insbesondere aber Natrium bedeuten,
welche außerordentlich leicht bei pH-Werten unter ungefähr 8 abgebaut werden. Ein Beispiel für eine solche Verbindung umfaßt die Verbindung welche die USAN Bezeichnung Fluvastatin-Natrium (Im folgenden "Fluvastatin") trägt und folgende chemische Bezeichnung hat:
R*,S*-(E)-(+)-7-[3-(4-Fluorphenyl)-1-(1-methylethyl)-1H-indol-2-yl] 3,5-dihydroxy-6-heptenoylsäure-Natriumsalz, (vergleiche Europäische Patentanmeldung EP-A 1 14 027).
R ein organisches Radikal,
X -CH=CH- und
M ein physiologisch annehmbares Kation bedeuten, und
ein alkalisches Medium, welches in der Lage ist, in einer wäßrigen Lösung oder Dispersion des Mittels einen pH-Wert von wenigstens 8 einzustellen.
0,5 bis 60 Gew.-% HMG-CoA Reduktase-Verbindung (z. B. Fluvastatin), 10 bis 55 Gew.-% alkalisches Medium (z. B. Carbonate), und 10 bis 65 Gew.-% Füllstoff (z. B. mikrokristalline Cellulose).
0,5 bis 60 Gew.-% Arzneistoff (z. B. Fluvastatin), 5 bis 40 Gew.-% Calciumcarbonat, 0,5 bis 20 Gew.-% Natriumbicarbonat und 10 bis 65 Gew.-% Füllstoff (z. B. mikrokristalline Cellulose).
0,5 bis 60 Gew.-% (typischerweise 0,5 bis 40 Gew.-%) Arzneistoff (z. B. Fluvastatin), 25 bis 40 Gew.-% Calciumcarbonat, 0,5 bis 10 Gew.-% Natriumbicarbonat und 20 bis 35 Gew.-% mikrokristalline Cellulose sowie gewünschtenfalls zusätzlichen Füllstoff (z. B. vorgelatinierte Stärke) in einer Menge von 15 bis 30 Gew.-%.
0,5 bis 60 Gew.-% Arzneistoff (z. B. Fluvastatin), 5 bis 20 Gew.-% Calciumcarbonat, 5 bis 20 Gew.-% Natriumbicarbonat und 50 bis 65 Gew.-% mikrokristalline Cellulose.
US-PS 47 39 073, und EP-A 1 14 027 (R= Indolyl und Derivate davon); EP-A 3 67 895 (R= Pyrimidinyl und Derivate davon); US-Patente 50 01 255 (R= Indenyl und Derivate davon); 46 13 610 (R= Pyrazolyl und Derivate davon); 48 51 427 (R= Pyrrolyl und Derivate davon); 47 55 606 und 48 08 607 (R= Imidazolyl und Derivate davon); 47 51 235 (R= Indolizinyl und Derivate davon); 49 39 159 (R= Azaindolyl und Derivate davon); 48 22 799 (R= Pyrazolopyridinyl und Derivate davon); 48 04 679 (R= Naphthyl und Derivate davon); 48 76 280 (R= Cyclohexyl und Derivate davon); 48 29 081 (R= Thienyl und Derivate davon); 49 27 851 (R= Furyl und Derivate davon); 45 88 715 (R= Phenylsilyl und Derivate davon); und F.G. Kathawala, Medicinal Research Reviews, Vol. 11 (2), 121-146 (1991).
erythro-(±)-(E)-7-[3-(4-Fluorphenyl)-spiro[cyclopentane-1,1′-1H- inden]-2′-yl]-3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;
3R,5S-(E)-7-[3-(4-Fluorphenyl)-1-(1-methylethyl)-indolizin-2-yl]-3,5-- dihydroxy-6-heptenoylsäure-Natriumsalz;
3R,5S-(E)-7-[3-(4-Fluorphenyl)-1-(methylethyl)-1H-pyrrolo[2,3-b] pyridin-2-yl]-3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;
3R,5S-(E)-7-[4-(4-Fluorphenyl)-2-(1-methylethyl)-chinolin-3-yl]-3,5-- dihydroxy-6-heptenoylsäure-Natriumsalz;
3R,5S-(E)-7-[1-(4-Fluorphenyl)-3-(1-methylethyl)-4-oxo-1,4-dihydroch-inolin- 2-yl]-3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;
3R,5S-(E)-7-[4-(4-Fluorphenyl)-6-(1-methylethyl)-3-methyl-1H-pyrazol-o [3,4-b]pyridin-5-yl]-3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;
3R,5S-(E)-7-[3-(1-Methylethyl)-5,6-diphenyl-pyridazin-4-yl]-3,5- dihydroxy-6-heptenoylsäure-Natriumsalz;
3R,5S-(E)-7-[4-(4-Fluorphenyl)-6-(1-methylethyl)-2-phenyl-pyrimidin-- 5-yl]-3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;
3R,5S-(E)-7-[4-(4-Fluorphenyl)-1-(1-methylethyl)-3-phenyl-2-oxo-2,3-- dihydroimidazol-5-yl]-3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;
3R,5S-(E)-7-[4-(4-Fluorphenyl)-2-(1-methylethyl)-1-oxo-1,2-dihydroch-inolin- 3-yl]-3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;
erythro-(±)-(E)-7-[4-(4-Fluorphenyl)-2-(1-methylethyl)-chinolin-3-yl-]- 3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;
erythro-(±)-(E)-7-[1-(4-Fluorphenyl)-3-(1-methylethyl)-pyrrolo [2,1-a]isochinolin-2-yl]-3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;-
erythro-(±)-(E)-7-[4-Cyclopropyl-6-(4-fluorphenyl)-2-(4-methoxypheny-l)- pyrimidin-5-yl]-3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;
3R,5S-(E)-7-[4-(4-Fluorphenyl)-2,6-dimethylpyrimidin-5-yl]-3,5- dihydroxy-6-heptenoylsäure-Natriumsalz;
3R,5S-(E)-7-[4-(4-Fluorphenyl)-6-methyl-2-phenyl-pyrimidin-5-yl]-3,5-- dihydroxy-6-heptenoylsäure-Natriumsalz;
3R,5S-(E)-7-[4-(3,5-Dimethylphenyl)-6-methyl-2-phenyl-pyrimidin-5-yl-]- 3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;
erythro-(±)-(E)-7-[3,4-bis(4-Fluorphenyl)-6-(1-methylethyl)-pyridazi-n- 5-yl]-3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;
erythro-(±)-(E)-7-[1-(4-Fluorphenyl)-3-(1-methylethyl)-5-phenyl-1H- pyrrol-2-yl]-3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;
erythro-(±)-(E)-9,9-bis(4-Fluorphenyl)-3,5-dihydroxy-8-(1-methyl-1H-- tetrazol-5-yl)-6,8-nonadienoylsäure-Natriumsalz;
erythro-(±)-(E)-3,5-Dihydroxy-9,9-diphenyl-6,8-nonadienoylsäure- Natriumsalz;
erythro-(±)-(E)-7-[4-(4-Fluorphenyl)-1,2-bis(1-methylethyl)-3-phenyl-- pyrrol-2-yl]-3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;
3R,5S-(E)-7-[4,5-bis(4-Fluorphenyl)-2-(1-methylethyl)-1H-imidazol-1-- yl]-3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;
3R,5S-(E)-7-[4-(4-Fluorphenyl)-2,6-bis(1-methylethyl)-5-methoxymethy-l- pyridin-3-yl]-3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;
erythro-(±)-(E)-[4-(4-Fluorphenyl)-2-(1-methylethyl)-6-phenyl-pyridi-n- 3-yl]-3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;
erythro-(±)-(E)-[2-(4-Fluorphenyl)-4,4,6,6-tetramethyl-cyclohexen-1-- yl]-3,5-dihydroxy-6-heptenoylsäure-Natriumsalz;
erythro-(±)-(E)-7-[4-(4-Fluorphenyl)-2-cyclopropyl-chinolin-3-yl]-3,-5- dihydroxy-6-heptenoylsäure-Natriumsalz; und
erythro-(±)-(E)-7-[4-(4-Fluorphenyl)-2-(1-methylethyl)-chinolin-3-yl-]- 3,5-dihydroxy-6-heptenoylsäure-Natriumsalz.
Claims (13)
R ein organisches Radikal,
X -CH=CH- und
M ein physiologisch annehmbares Kation bedeuten,
und ein alkalisches Medium, welches in der Lage ist, in einer wäßrigen Lösung oder Dispersion des Mittels einen pH-Wert von wenigstens 8 einzustellen.
0,5 bis 60 Gew.-% Fluvastatin-Natrium,
25 bis 40 Gew.-% Calciumcarbonat,
0,5 bis 10 Gew.-% Natriumbicarbonat und
20 bis 35 Gew.-% mikrokristalline Cellulose enthält.
0,5 bis 60 Gew.-% Fluvastatin-Natrium,
5 bis 20 Gew.-% Calciumcarbonat,
5 bis 20 Gew.-% Natriumbicarbonat und
50 bis 65 Gew.-% mikrokristalline Cellulose.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE4245089A DE4245089B4 (de) | 1991-12-12 | 1992-12-02 | Stabilisiertes pharmazeutisches Mittel, enthaltend einen HMG-CoA-Reduktase-Inhibitor als Wirkstoff |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US80566791A | 1991-12-12 | 1991-12-12 | |
US07/805,667 | 1991-12-12 | ||
DE4245089A DE4245089B4 (de) | 1991-12-12 | 1992-12-02 | Stabilisiertes pharmazeutisches Mittel, enthaltend einen HMG-CoA-Reduktase-Inhibitor als Wirkstoff |
CN93100650A CN1041794C (zh) | 1991-12-12 | 1993-01-30 | 含有一种β-羟基-β-甲基戊二酸单酰辅酶A还原酶抑制剂的稳定的药物组合物 |
Publications (2)
Publication Number | Publication Date |
---|---|
DE4240430A1 true DE4240430A1 (de) | 1993-06-17 |
DE4240430B4 DE4240430B4 (de) | 2007-12-27 |
Family
ID=36808687
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DE4240430A Expired - Lifetime DE4240430B4 (de) | 1991-12-12 | 1992-12-02 | Stabilisiertes pharmazeutisches Mittel, enthaltend einen HMG-CoA-Reduktase-Inhibitor Wirkstoff |
Country Status (31)
Country | Link |
---|---|
US (1) | US5356896A (de) |
EP (1) | EP0547000B1 (de) |
JP (1) | JP2774037B2 (de) |
KR (1) | KR100253824B1 (de) |
CN (1) | CN1041794C (de) |
AT (1) | AT401870B (de) |
AU (1) | AU661075B2 (de) |
CA (1) | CA2085037C (de) |
CH (1) | CH684309A5 (de) |
CY (1) | CY1994A (de) |
CZ (1) | CZ287776B6 (de) |
DE (1) | DE4240430B4 (de) |
DK (1) | DK0547000T3 (de) |
ES (1) | ES2142819T3 (de) |
FI (1) | FI114284B (de) |
FR (1) | FR2684876B1 (de) |
GB (1) | GB2262229B (de) |
GR (1) | GR3032929T3 (de) |
HK (1) | HK25597A (de) |
HU (2) | HU9203780D0 (de) |
IL (1) | IL104041A (de) |
IT (1) | IT1256698B (de) |
LU (1) | LU88201A1 (de) |
MX (1) | MX9207152A (de) |
NO (1) | NO302099B1 (de) |
NZ (1) | NZ245421A (de) |
PT (1) | PT547000E (de) |
RO (1) | RO111542B1 (de) |
RU (1) | RU2121835C1 (de) |
SK (1) | SK281710B6 (de) |
ZA (1) | ZA929642B (de) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE10038110A1 (de) * | 2000-01-26 | 2001-08-23 | Astrazeneca Ab | Pharmazeutische Zusammensetzungen |
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CA2042526A1 (en) * | 1990-06-11 | 1991-12-12 | Adeoye Y. Olukotun | Method for preventing a second heart attack employing an hmg coa reductase inhibitor |
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1992
- 1992-11-30 HU HU9203780A patent/HU9203780D0/hu unknown
- 1992-11-30 HU HU9203780A patent/HU217629B/hu unknown
- 1992-12-02 DE DE4240430A patent/DE4240430B4/de not_active Expired - Lifetime
- 1992-12-04 IT ITRM920870A patent/IT1256698B/it active IP Right Grant
- 1992-12-07 CH CH3751/92A patent/CH684309A5/de not_active IP Right Cessation
- 1992-12-08 PT PT92810962T patent/PT547000E/pt unknown
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- 1992-12-10 FI FI925615A patent/FI114284B/fi not_active IP Right Cessation
- 1992-12-10 JP JP4352222A patent/JP2774037B2/ja not_active Expired - Lifetime
- 1992-12-10 NO NO924768A patent/NO302099B1/no not_active IP Right Cessation
- 1992-12-10 RO RO92-01545A patent/RO111542B1/ro unknown
- 1992-12-10 IL IL10404192A patent/IL104041A/en not_active IP Right Cessation
- 1992-12-10 AU AU30069/92A patent/AU661075B2/en not_active Expired
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- 1992-12-11 AT AT0244992A patent/AT401870B/de not_active IP Right Cessation
- 1992-12-14 FR FR9215142A patent/FR2684876B1/fr not_active Expired - Lifetime
- 1992-12-22 US US07/995,252 patent/US5356896A/en not_active Expired - Lifetime
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1993
- 1993-01-30 CN CN93100650A patent/CN1041794C/zh not_active Expired - Lifetime
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1997
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2000
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE10038110A1 (de) * | 2000-01-26 | 2001-08-23 | Astrazeneca Ab | Pharmazeutische Zusammensetzungen |
DE10038110B4 (de) * | 2000-01-26 | 2006-06-29 | Astrazeneca Ab | Pharmazeutische Zusammensetzungen |
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