SI2309992T1 - Farmacevtski sestavek, ki vsebuje statin - Google Patents
Farmacevtski sestavek, ki vsebuje statin Download PDFInfo
- Publication number
- SI2309992T1 SI2309992T1 SI200931792T SI200931792T SI2309992T1 SI 2309992 T1 SI2309992 T1 SI 2309992T1 SI 200931792 T SI200931792 T SI 200931792T SI 200931792 T SI200931792 T SI 200931792T SI 2309992 T1 SI2309992 T1 SI 2309992T1
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- SI
- Slovenia
- Prior art keywords
- pharmaceutical composition
- composition according
- less
- moisture content
- pharmaceutically acceptable
- Prior art date
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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
- A61K9/2013—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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—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
- A61K9/28—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
- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (12)
- Farmacevtski sestavek, ki vsebuje statin Patentni zahtevki1. Trden farmacevtski sestavek, ki ga dobimo z mešanjem (a) vsaj ene zdravilne učinkovine, izbrane izmed rosuvastatina in njegovih farmacevtsko sprejemljivih soli, (b) vsaj ene farmacevtsko sprejemljive pomožne snovi z nizko vsebnostjo vlage, ki ima vsebnost vlage manj kot 3,0 ut./ut. %, kjer farmacevtsko sprejemljiva pomožna snov z nizko vsebnostjo vlage vključuje ne-silificirano mikrokristalno celulozo in (c) po izbiri dodatne pomožne snovi in stiskanja dobljene zmesi v odsotnosti topila, kjer sestavek vsebuje vsaj 20 ut./ut. % farmacevtsko sprejemljive pomožne snovi z nizko vsebnostjo vlage in manj kot 0,5 ut./ut. % alkalnih stabilizatoijev.
- 2. Farmacevtski sestavek po zahtevku 1, kjer je zdravilna učinkovina amorfen kalcijev rosuvastatinat.
- 3. Farmacevtski sestavek po zahtevku 1 ali 2, kjer ima zdravilna učinkovina povprečno velikost delcev manj kot 300 pm, prednostno manj kot 250 pm.
- 4. Farmacevtski sestavek po kateremkoli od zahtevkov 1 do 3, kjer zdravilna učinkovina ne veže več kot 15 ut./ut. %, bolj prednostno ne več kot 10 ut./ut. %, še bolj prednostno ne več kot 8 ut./ut. %, in najbolj prednostno ne več kot 5 ut./ut. % vlage pri 25 °C in 90 % relativni vlažnosti.
- 5. Farmacevtski sestavek po kateremkoli izmed zahtevkov od 1 do 4, kjer ima farmacevtsko sprejemljiva pomožna snov z nizko vsebnostjo vlage manj kot 2,5 ut./ut. %, zlasti manj kot 2,0 ut./ut. %, najbolj prednostno manj kot 1,5 ut./ut. % vsebnost vlage.
- 6. Farmacevtski sestavek po kateremkoli od zahtevkov 1 do 5, kjer je farmacevtsko sprejemljiva pomožna snov z nizko vsebnost vlage sposobna vezati vsaj 6 ut./ut. %, prednostno vsaj 9 ut./ut. % vlage pri 25 °C in 90 % relativni vlažnosti.
- 7. Farmacevtski sestavek po kateremkoli od zahtevkov 1 do 6, ki vsebuje vsaj 30 ut./ut. %, bolj prednostno vsaj 40 ut./ut. %, še bolj prednostno vsaj 50 ut./ut. %, in najbolj prednostno vsaj 60 ut./ut. % farmacevtsko sprejemljive pomožne snovi z nizko vsebnostjo vlage.
- 8. Farmacevtski sestavek po kateremkoli od zahtevkov 1 do 7, ki vsebuje manj kot 0,25 ut./ut. % in še bolj prednostno manj kot 0,1 ut./ut. % alkalnih stabilizatorjev in je najbolj prednostno v bistvu brez alkalnih stabilizatoijev.
- 9. Farmacevtski sestavek po kateremkoli od zahtevkov 1 do 8, kjer ima raztopina ali disperzija farmacevtskega sestavka pH manj kot 8, zlasti v območju od 6 do manj kot 8.
- 10. Pakiran farmacevtski sestavek, ki obsega trden farmacevtski sestavek po kateremkoli izmed zahtevkov od 1 do 9, kjer je trden farmacevtski sestavek prisoten v primarni embalaži nizko prepustni za pline.
- 11. Postopek za pripravo farmacevtskega sestavka po kateremkoli od zahtevkov 1 do 9 ali pakiranega farmacevtskega sestavka po zahtevku 10, kjer postopek obsega stiskanje zdravilne učinkovine z vsaj 1 eno pomožno snovjo v odsotnosti topila in po izbiri oblaganje dobljenega sestavka.
- 12. Postopek po zahtevku 11, ki obsega (i) direktno stiskanje homogene zmesi zdravilne učinkovine, pomožne snovi/pomožnih snovi z nizko vsebnostjo vlage in po izbiri dodatnih pomožnih snovi ali (ii) predgranuliranje zmesi zdravilne učinkovine, pomožne snovi/pomožnih snovi z nizko vsebnostjo vlage in po izbiri nadaljnjih pomožnih snovi v odsotnosti topila in stiskanje predgranulirane zmesi. 2
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP08159289A EP2138165A1 (en) | 2008-06-27 | 2008-06-27 | Pharmaceutical composition comprising a statin |
| SI200900097 | 2009-04-08 | ||
| PCT/EP2009/004636 WO2009156173A1 (en) | 2008-06-27 | 2009-06-26 | Pharmaceutical composition comprising a statin |
| EP09769022.6A EP2309992B1 (en) | 2008-06-27 | 2009-06-26 | Pharmaceutical composition comprising a statin |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SI2309992T1 true SI2309992T1 (sl) | 2018-03-30 |
Family
ID=40957425
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI200931792T SI2309992T1 (sl) | 2008-06-27 | 2009-06-26 | Farmacevtski sestavek, ki vsebuje statin |
Country Status (9)
| Country | Link |
|---|---|
| EP (1) | EP2309992B1 (sl) |
| EA (1) | EA024554B1 (sl) |
| ES (1) | ES2657416T3 (sl) |
| HR (1) | HRP20180077T1 (sl) |
| HU (1) | HUE035402T2 (sl) |
| PL (1) | PL2309992T3 (sl) |
| PT (1) | PT2309992T (sl) |
| SI (1) | SI2309992T1 (sl) |
| WO (1) | WO2009156173A1 (sl) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2387566B1 (en) | 2009-01-14 | 2014-05-07 | KRKA, tovarna zdravil, d.d., Novo mesto | Process for the preparation of rosuvastatin |
| TR201009397A2 (tr) | 2010-11-11 | 2012-05-21 | Bi̇lgi̇ç Mahmut | Rosuvastatin içeren farmasötik bileşimler. |
| JP5809467B2 (ja) * | 2011-07-12 | 2015-11-11 | エルメッド エーザイ株式会社 | ピタバスタチン含有組成物及びその製造方法 |
| US10413543B2 (en) | 2015-09-01 | 2019-09-17 | Sun Pharma Advanced Research Company Ltd. | Stable multiparticulate pharmaceutical composition of rosuvastatin |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2648897B2 (ja) | 1991-07-01 | 1997-09-03 | 塩野義製薬株式会社 | ピリミジン誘導体 |
| HU217629B (hu) * | 1991-12-12 | 2000-03-28 | Novartis Ag. | Eljárás fluvasztatint tartalmazó stabilizált gyógyszerkészítmények előállítására |
| GB9903472D0 (en) | 1999-02-17 | 1999-04-07 | Zeneca Ltd | Chemical process |
| GB0001621D0 (en) * | 2000-01-26 | 2000-03-15 | Astrazeneca Ab | Pharmaceutical compositions |
| GB0312896D0 (en) | 2003-06-05 | 2003-07-09 | Astrazeneca Ab | Chemical process |
| US20070191318A1 (en) | 2003-10-22 | 2007-08-16 | Yatendra Kumar | Process for the preparation of amorphous rosuvastatin calcium |
| CZ200486A3 (cs) | 2004-01-16 | 2005-08-17 | Zentiva, A.S. | Způsob výroby hemivápenaté soli (E)-7-[4-(4-fluorfenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxy-6-heptenové kyseliny |
| EP1797046A2 (en) | 2004-09-27 | 2007-06-20 | Ranbaxy Laboratories Limited | Novel processes for preparing amorphous rosuvastatin calcium and a novel polymorphic form of rosuvastatin sodium |
| AU2005305460B2 (en) * | 2004-11-22 | 2011-04-21 | Dexcel Pharma Technologies Ltd. | Stable atorvastatin formulations |
| CA2612587C (en) | 2005-06-24 | 2013-02-19 | Lek Pharmaceuticals D.D. | Process for preparing amorphous rosuvastatin calcium free of impurities |
| AU2006329006B2 (en) * | 2005-12-20 | 2013-02-28 | Lek Pharmaceuticals D.D. | Pharmaceutical composition comprising (E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid |
| WO2007099561A1 (en) | 2006-02-27 | 2007-09-07 | Cadila Healthcare Limited | Process for preparing rosuvastatin calcium |
| HU227610B1 (en) * | 2006-09-18 | 2011-09-28 | Richter Gedeon Nyrt | Pharmaceutical compositions containing rosuvastatin potassium |
| WO2008062476A2 (en) * | 2006-10-31 | 2008-05-29 | Glenmark Pharmaceutical Limited | Pharmaceutical composition comprising rosuvastatin or pharmaceutically accepatble salts thereof |
-
2009
- 2009-06-26 SI SI200931792T patent/SI2309992T1/sl unknown
- 2009-06-26 EP EP09769022.6A patent/EP2309992B1/en active Active
- 2009-06-26 PL PL09769022T patent/PL2309992T3/pl unknown
- 2009-06-26 PT PT97690226T patent/PT2309992T/pt unknown
- 2009-06-26 EA EA201100104A patent/EA024554B1/ru not_active IP Right Cessation
- 2009-06-26 ES ES09769022.6T patent/ES2657416T3/es active Active
- 2009-06-26 HU HUE09769022A patent/HUE035402T2/en unknown
- 2009-06-26 WO PCT/EP2009/004636 patent/WO2009156173A1/en active Application Filing
-
2018
- 2018-01-16 HR HRP20180077TT patent/HRP20180077T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EA024554B1 (ru) | 2016-09-30 |
| EP2309992B1 (en) | 2017-10-25 |
| HRP20180077T1 (hr) | 2018-02-23 |
| ES2657416T3 (es) | 2018-03-05 |
| HUE035402T2 (en) | 2018-05-02 |
| EP2309992A1 (en) | 2011-04-20 |
| PT2309992T (pt) | 2018-01-22 |
| WO2009156173A1 (en) | 2009-12-30 |
| PL2309992T3 (pl) | 2018-05-30 |
| EA201100104A1 (ru) | 2011-08-30 |
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