PL425975A1 - Złożona kompozycja farmaceutyczna do leczenia dyslipidemii i sposób jej wytwarzania - Google Patents
Złożona kompozycja farmaceutyczna do leczenia dyslipidemii i sposób jej wytwarzaniaInfo
- Publication number
- PL425975A1 PL425975A1 PL425975A PL42597518A PL425975A1 PL 425975 A1 PL425975 A1 PL 425975A1 PL 425975 A PL425975 A PL 425975A PL 42597518 A PL42597518 A PL 42597518A PL 425975 A1 PL425975 A1 PL 425975A1
- Authority
- PL
- Poland
- Prior art keywords
- dyslipidemia
- treatment
- pharmaceutical composition
- lactose
- producing
- Prior art date
Links
- 208000032928 Dyslipidaemia Diseases 0.000 title abstract 2
- 208000017170 Lipid metabolism disease Diseases 0.000 title abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- 238000004519 manufacturing process Methods 0.000 title 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 abstract 3
- 239000008101 lactose Substances 0.000 abstract 3
- 229920000168 Microcrystalline cellulose Polymers 0.000 abstract 2
- ZTHYODDOHIVTJV-UHFFFAOYSA-N Propyl gallate Chemical compound CCCOC(=O)C1=CC(O)=C(O)C(O)=C1 ZTHYODDOHIVTJV-UHFFFAOYSA-N 0.000 abstract 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 abstract 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 abstract 2
- 239000008108 microcrystalline cellulose Substances 0.000 abstract 2
- 229940016286 microcrystalline cellulose Drugs 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- 239000002245 particle Substances 0.000 abstract 2
- 239000004255 Butylated hydroxyanisole Substances 0.000 abstract 1
- 235000005979 Citrus limon Nutrition 0.000 abstract 1
- 244000248349 Citrus limon Species 0.000 abstract 1
- RYMZZMVNJRMUDD-UHFFFAOYSA-N SJ000286063 Natural products C12C(OC(=O)C(C)(C)CC)CC(C)C=C2C=CC(C)C1CCC1CC(O)CC(=O)O1 RYMZZMVNJRMUDD-UHFFFAOYSA-N 0.000 abstract 1
- PNAMDJVUJCJOIX-IUNFJCKHSA-N [(1s,3r,7s,8s,8ar)-8-[2-[(2r,4r)-4-hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] 2,2-dimethylbutanoate;(3r,4s)-1-(4-fluorophenyl)-3-[(3s)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one Chemical compound C([C@H]1[C@@H](C)C=CC2=C[C@H](C)C[C@@H]([C@H]12)OC(=O)C(C)(C)CC)C[C@@H]1C[C@@H](O)CC(=O)O1.N1([C@@H]([C@H](C1=O)CC[C@H](O)C=1C=CC(F)=CC=1)C=1C=CC(O)=CC=1)C1=CC=C(F)C=C1 PNAMDJVUJCJOIX-IUNFJCKHSA-N 0.000 abstract 1
- 239000002253 acid Substances 0.000 abstract 1
- 235000019282 butylated hydroxyanisole Nutrition 0.000 abstract 1
- CZBZUDVBLSSABA-UHFFFAOYSA-N butylated hydroxyanisole Chemical compound COC1=CC=C(O)C(C(C)(C)C)=C1.COC1=CC=C(O)C=C1C(C)(C)C CZBZUDVBLSSABA-UHFFFAOYSA-N 0.000 abstract 1
- 229940043253 butylated hydroxyanisole Drugs 0.000 abstract 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 abstract 1
- OLNTVTPDXPETLC-XPWALMASSA-N ezetimibe Chemical compound N1([C@@H]([C@H](C1=O)CC[C@H](O)C=1C=CC(F)=CC=1)C=1C=CC(O)=CC=1)C1=CC=C(F)C=C1 OLNTVTPDXPETLC-XPWALMASSA-N 0.000 abstract 1
- 229960000815 ezetimibe Drugs 0.000 abstract 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 abstract 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 abstract 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 abstract 1
- 229960003943 hypromellose Drugs 0.000 abstract 1
- 239000000314 lubricant Substances 0.000 abstract 1
- 235000019359 magnesium stearate Nutrition 0.000 abstract 1
- 229940057948 magnesium stearate Drugs 0.000 abstract 1
- 235000010388 propyl gallate Nutrition 0.000 abstract 1
- 239000000473 propyl gallate Substances 0.000 abstract 1
- 229940075579 propyl gallate Drugs 0.000 abstract 1
- RYMZZMVNJRMUDD-HGQWONQESA-N simvastatin Chemical compound C([C@H]1[C@@H](C)C=CC2=C[C@H](C)C[C@@H]([C@H]12)OC(=O)C(C)(C)CC)C[C@@H]1C[C@@H](O)CC(=O)O1 RYMZZMVNJRMUDD-HGQWONQESA-N 0.000 abstract 1
- 229960002855 simvastatin Drugs 0.000 abstract 1
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
- A61K9/14—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
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- 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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
-
- 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
- A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
Landscapes
- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Przedmiotem zgłoszenia jest złożona kompozycja farmaceutyczna do leczenia dyslipidemii zawierająca ezetymib i symwastatynę w farmaceutycznie skutecznych ilościach. Kompozycja ta charakteryzuje się tym, że ma postać tabletki zawierającej ezetymib o rozmiarze cząstek d(0,9) poniżej 10 µm, symwastatynę o rozmiarze cząstek d(0,9) poniżej 15 µm, laktozę, celulozę mikrokrystaliczną, kroskarmelozę sodową, hypromelozę, kwas cytrynowy, butylowany hydroksyanizol, galusan propylu oraz stearynian magnezu jako środek poślizgowy, przy czym laktoza występuje w kompozycji w ilości powyżej 67% oraz stosunek celulozy mikrokrystalicznej do laktozy wynosi od 1:4 do 1:5.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PL425975A PL425975A1 (pl) | 2018-06-19 | 2018-06-19 | Złożona kompozycja farmaceutyczna do leczenia dyslipidemii i sposób jej wytwarzania |
| EP19180471.5A EP3583936A1 (en) | 2018-06-19 | 2019-06-17 | Combined pharmaceutical composition for the treatment of dyslipidemia and method of manufacture thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PL425975A PL425975A1 (pl) | 2018-06-19 | 2018-06-19 | Złożona kompozycja farmaceutyczna do leczenia dyslipidemii i sposób jej wytwarzania |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PL425975A1 true PL425975A1 (pl) | 2020-01-02 |
Family
ID=66912648
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PL425975A PL425975A1 (pl) | 2018-06-19 | 2018-06-19 | Złożona kompozycja farmaceutyczna do leczenia dyslipidemii i sposób jej wytwarzania |
Country Status (2)
| Country | Link |
|---|---|
| EP (1) | EP3583936A1 (pl) |
| PL (1) | PL425975A1 (pl) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115227659B (zh) * | 2022-08-19 | 2023-05-02 | 北京百奥药业有限责任公司 | 一种依折麦布辛伐他汀组合物及其制备方法 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1741427A1 (en) * | 2005-07-06 | 2007-01-10 | KRKA, D.D., Novo Mesto | Pharmaceutical composition comprising simvastatin and ezetimibe |
| EP2368543A1 (en) * | 2010-03-25 | 2011-09-28 | KRKA, tovarna zdravil, d.d., Novo mesto | Method of preparing a granulated pharmaceutical composition comprising simvastatin and/or ezetimibe |
| EP2468258A1 (en) * | 2010-12-22 | 2012-06-27 | LEK Pharmaceuticals d.d. | Process for the preparation of a pharmaceutical composition comprising a low soluble pharmaceutically active ingredient |
| WO2013066279A1 (en) * | 2011-10-13 | 2013-05-10 | Mahmut Bilgic | Solid dosage forms comprising ezetimibe |
-
2018
- 2018-06-19 PL PL425975A patent/PL425975A1/pl unknown
-
2019
- 2019-06-17 EP EP19180471.5A patent/EP3583936A1/en not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| EP3583936A1 (en) | 2019-12-25 |
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