SI2323634T1 - Ropinirolni sestavek - Google Patents
Ropinirolni sestavek Download PDFInfo
- Publication number
- SI2323634T1 SI2323634T1 SI200931793T SI200931793T SI2323634T1 SI 2323634 T1 SI2323634 T1 SI 2323634T1 SI 200931793 T SI200931793 T SI 200931793T SI 200931793 T SI200931793 T SI 200931793T SI 2323634 T1 SI2323634 T1 SI 2323634T1
- Authority
- SI
- Slovenia
- Prior art keywords
- ropinirole
- composition
- cellulose
- hydrophilic
- hours
- Prior art date
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
- A61K9/2022—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
- 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
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Claims (6)
- ROPINIROLNI SESTAVEK1. Farmacevtski trden ogrodni sestavek, ki je prisoten v obliki tablete, ki ne vsebuje ločenih plasti, pri čemer omenjeni sestavek obsega: a) ropinirol ali njegovo sol; b) enega ali več hidrofilnih tvorcev ogrodja, pri čemer je hidrofilni tvorec ogrodja hidroksipropilmetil celuloza, kjer je koncentracija hidroksipropilmetil celuloznega tvorca ogrodja od 40 do 60% (ut./ut.), glede na celotno težo sestavka brez obloge v primeru obložene tablete; c) enega ali več hidrofilnih nadzorovalcev hitrosti sproščanja, pri čemer je hidrofilni nadzorovalec hitrosti sproščanja karbomer, kjer je koncentracija karbomemega nadzorovalca hitrosti sproščanja od 3 do 40% (ut./ut.), glede na celotno maso sestavka brez obloge v primeru obložene tablete; in d) po izbiri druge pomožne snovi, kjer ima sestavek, kadar ga izmerimo z USP metodo košaric (Basket method) (10 mesh) pri 200 vrt./min v 500 ml fosfatnega pufra pH 6,8, naslednjo in-vitro hitrost raztapljanja; 10 - 30% ropinirola sproščenega v 2 urah; 35-70% ropinirola sproščenega v 8 urah; 55-85% ropinirola sproščenega v 12 urah; in vsaj 70% ropinirola sproščenega v 20 urah.
- 2. Farmacevtski sestavek po zahtevku 1, kjer je ropinirol v obliki ropinirolijevega klorida.
- 3. Farmacevtski sestavek po zahtevku 1 ali zahtevku 2, kjer je hidrofilni nadzorovalec hitrosti sproščanja karbomer homopolimer tipa A.
- 4. Farmacevtski sestavek po katerem koli od zahtevkov 1 do 3, ki obsega: ropinirolijev klorid 0,3 do 3,2 ut. % hidroksipropilmetil celulozo 45-55 ut. % laktozo monohidrat 25 do 35 ut. % magnezijev stearat 2 ut. % karbomer 4 ut. % hidrogenirano ricinusovo olje 10 ut. % koloidni silicijev dioksid 0-1 ut. %.
- 5. Sestavek po kateremkoli od predhodnih zahtevkov, ki obsega vodotopno oblogo.
- 6. Sestavek po zahtevku 5, kjer je obloga izbrana izmed celuloznih etrov, nizko viskoznih razredov hidroksipropilmetil celuloze, hidroksipropil celuloze, hidroksietil celuloze, metil celuloze, polivinil alkohola, natrijeve karboksimetil celuloze.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SI200800192A SI22849A (sl) | 2008-08-01 | 2008-08-01 | Ropinirolni pripravek |
| EP09777576.1A EP2323634B1 (en) | 2008-08-01 | 2009-07-31 | Ropinirole composition |
| PCT/EP2009/005559 WO2010012482A1 (en) | 2008-08-01 | 2009-07-31 | Ropinirole composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SI2323634T1 true SI2323634T1 (sl) | 2018-03-30 |
Family
ID=41228271
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI200800192A SI22849A (sl) | 2008-08-01 | 2008-08-01 | Ropinirolni pripravek |
| SI200931793T SI2323634T1 (sl) | 2008-08-01 | 2009-07-31 | Ropinirolni sestavek |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI200800192A SI22849A (sl) | 2008-08-01 | 2008-08-01 | Ropinirolni pripravek |
Country Status (8)
| Country | Link |
|---|---|
| EP (1) | EP2323634B1 (sl) |
| EA (1) | EA023340B1 (sl) |
| ES (1) | ES2659369T3 (sl) |
| HR (1) | HRP20180222T1 (sl) |
| HU (1) | HUE036279T2 (sl) |
| PL (1) | PL2323634T3 (sl) |
| SI (2) | SI22849A (sl) |
| WO (1) | WO2010012482A1 (sl) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20110262537A1 (en) * | 2008-09-29 | 2011-10-27 | Premchand Nakhat | Extended release dosage form of ropinirole |
| TW201132646A (en) * | 2010-02-22 | 2011-10-01 | Daiichi Sankyo Co Ltd | Oral solid extended release dosage form |
| TW201141544A (en) | 2010-02-22 | 2011-12-01 | Daiichi Sankyo Co Ltd | Oral solid extended release dosage form |
| GR1007629B (el) * | 2011-07-13 | 2012-06-29 | Φαρματεν Αβεε, | Φαρμακευτικο σκευασμα ελεγχομενης αποδεσμευσης ενος μη εργολινικου αγωνιστη της ντοπαμινης |
| RU2665372C2 (ru) | 2012-09-03 | 2018-08-29 | Дайити Санкио Компани, Лимитед | Пероральная фармацевтическая композиция замедленного высвобождения, содержащая гидрохлорид гидроморфона |
| CN104473893A (zh) * | 2014-11-21 | 2015-04-01 | 哈尔滨圣吉药业股份有限公司 | 一种盐酸罗匹尼罗缓释片及其制备方法 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AR030557A1 (es) * | 2000-04-14 | 2003-08-27 | Jagotec Ag | Una tableta en multicapa de liberacion controlada y metodo de tratamiento |
| GB0125088D0 (en) * | 2001-10-18 | 2001-12-12 | Smithkline Beecham Cork Ltd | New use |
| GB0319874D0 (en) * | 2003-08-22 | 2003-09-24 | Glaxo Group Ltd | Novel formulation |
| WO2009023761A2 (en) * | 2007-08-14 | 2009-02-19 | Dr. Reddy's Laboratories Ltd. | Pharmaceutical compositions comprising ropinirole |
-
2008
- 2008-08-01 SI SI200800192A patent/SI22849A/sl not_active IP Right Cessation
-
2009
- 2009-07-31 PL PL09777576T patent/PL2323634T3/pl unknown
- 2009-07-31 SI SI200931793T patent/SI2323634T1/sl unknown
- 2009-07-31 EA EA201100287A patent/EA023340B1/ru not_active IP Right Cessation
- 2009-07-31 WO PCT/EP2009/005559 patent/WO2010012482A1/en active Application Filing
- 2009-07-31 ES ES09777576.1T patent/ES2659369T3/es active Active
- 2009-07-31 EP EP09777576.1A patent/EP2323634B1/en active Active
- 2009-07-31 HU HUE09777576A patent/HUE036279T2/hu unknown
-
2018
- 2018-02-06 HR HRP20180222TT patent/HRP20180222T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP2323634A1 (en) | 2011-05-25 |
| EP2323634B1 (en) | 2017-11-15 |
| ES2659369T3 (es) | 2018-03-15 |
| EA201100287A1 (ru) | 2011-08-30 |
| HRP20180222T1 (hr) | 2018-03-09 |
| HUE036279T2 (hu) | 2018-06-28 |
| SI22849A (sl) | 2010-02-26 |
| PL2323634T3 (pl) | 2018-04-30 |
| EA023340B1 (ru) | 2016-05-31 |
| WO2010012482A1 (en) | 2010-02-04 |
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