HRP20130276T1 - Stabilna äśvrsta disperzija derivata alkaloida dobivenih iz catharanthus roseus i postupak njene priprave - Google Patents
Stabilna äśvrsta disperzija derivata alkaloida dobivenih iz catharanthus roseus i postupak njene priprave Download PDFInfo
- Publication number
- HRP20130276T1 HRP20130276T1 HRP20130276TT HRP20130276T HRP20130276T1 HR P20130276 T1 HRP20130276 T1 HR P20130276T1 HR P20130276T T HRP20130276T T HR P20130276TT HR P20130276 T HRP20130276 T HR P20130276T HR P20130276 T1 HRP20130276 T1 HR P20130276T1
- Authority
- HR
- Croatia
- Prior art keywords
- dispersion
- solid
- polyethylene glycol
- stable dispersion
- derivative
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims 9
- 239000007962 solid dispersion Substances 0.000 title claims 5
- 229940122803 Vinca alkaloid Drugs 0.000 title 1
- 238000004519 manufacturing process Methods 0.000 title 1
- 239000006185 dispersion Substances 0.000 claims 15
- 239000007787 solid Substances 0.000 claims 11
- 239000002202 Polyethylene glycol Substances 0.000 claims 7
- 229920001223 polyethylene glycol Polymers 0.000 claims 7
- 240000001829 Catharanthus roseus Species 0.000 claims 5
- 150000003797 alkaloid derivatives Chemical class 0.000 claims 5
- 239000007903 gelatin capsule Substances 0.000 claims 4
- 239000008188 pellet Substances 0.000 claims 3
- 239000000945 filler Substances 0.000 claims 2
- 239000004014 plasticizer Substances 0.000 claims 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 1
- 238000001816 cooling Methods 0.000 claims 1
- 238000010438 heat treatment Methods 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 238000002844 melting Methods 0.000 claims 1
- 230000008018 melting Effects 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 229920005615 natural polymer Polymers 0.000 claims 1
- 239000008183 oral pharmaceutical preparation Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 239000000741 silica gel Substances 0.000 claims 1
- 229910002027 silica gel Inorganic materials 0.000 claims 1
- 229920001059 synthetic polymer Polymers 0.000 claims 1
- GBABOYUKABKIAF-IELIFDKJSA-N vinorelbine Chemical class C1N(CC=2C3=CC=CC=C3NC=22)CC(CC)=C[C@H]1C[C@]2(C(=O)OC)C1=CC([C@]23[C@H]([C@@]([C@H](OC(C)=O)[C@]4(CC)C=CCN([C@H]34)CC2)(O)C(=O)OC)N2C)=C2C=C1OC GBABOYUKABKIAF-IELIFDKJSA-N 0.000 claims 1
- 229960002066 vinorelbine Drugs 0.000 claims 1
- CILBMBUYJCWATM-HGBQGYOLSA-N vinorelbine D-tartrate Chemical compound OC(=O)[C@@H](O)[C@H](O)C(O)=O.OC(=O)[C@@H](O)[C@H](O)C(O)=O.C1N(CC=2C3=CC=CC=C3NC=22)CC(CC)=C[C@H]1C[C@]2(C(=O)OC)C1=CC([C@]23[C@H]([C@]([C@H](OC(C)=O)[C@]4(CC)C=CCN([C@H]34)CC2)(O)C(=O)OC)N2C)=C2C=C1OC CILBMBUYJCWATM-HGBQGYOLSA-N 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 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
- A61K9/10—Dispersions; Emulsions
-
- 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
- A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4375—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
-
- 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
-
- 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
- A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
-
- 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
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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
- A61K9/28—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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Dispersion Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Cosmetics (AREA)
- Medicines Containing Plant Substances (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Claims (15)
1. Čvrsta stabilna disperzija u vodi topljivih derivata alkaloida dobivenih iz Catharanthus roseus u najmanje jednoj molekuli polietilenglikola molekulske mase između 1000 i 6000, naznačena time da je omjer masa netopljivog derivata alkaloida iz Catharanthus roseus i polietilenglikola između 1.5:1 i 1:10, preferirano između 1:3 i 1:6.
2. Čvrsta stabilna disperzija prema patentnom zahtjevu 1, naznačena time da u vodi topljiv derivat alkaloida iz Catharanthus roseus jest derivat vinorelbina, posebice vinorelbin ditartarata.
3. Čvrsta stabilna disperzija prema patentnom zahtjevu 1 ili 2, naznačena time da rečena disperzija također sadrži omekšivač ili punilo.
4. Čvrsta stabilna disperzija prema patentnom zahtjevu 1 do 3, naznačena time da je u monolitičkom obliku.
5. Čvrsta stabilna disperzija prema patentnom zahtjevu 4, naznačena time da je rečena čvrsta disperzija radijeljena u tvdre želatinske kapsule.
6. Čvrsta stabilna disperzija prema patentnom zahtjevu 4, naznačena time da rečena čvrsta disperzija zajedno s kompresibilnim ekcipijensima jest u obliku tablete.
7. Čvrsta stabilna disperzija prema jednom od patentnih zahtjeva 1 do 3, naznačena time da je u obliku podijeljenih peleta.
8. Čvrsta stabilna disperzija prema patentnom zahtjevu 7, naznačena time da je rečena čvrsta disperzija u obliku podijeljenih peleta razdijeljena u tvrde želatinske kapsule.
9. Postupak priprave stabilnog oralnog farmaceutskog pripravka u vodi topljivih derivata alkaloida alkaloida iz Catharanthus roseus u obliku čvrste diperzije prema patentnim zahtjevima 1 do 8, naznačen time da se izvode sljedeće operacije:
– zagrijavanje polietilenglikola do temperature koje je malo viša od tališta da bi ga se prevelo u tekuće stanje, te
– miješanje u vodi topljivog derivata alkaloida iz Catharanthus roseus u obliku praška s polietilenglikolom dobivenog u prethodnom koraku uz vrtnju, čime nastaje oblik disperzije, te
– hlađenje rečene disperzije čime se prevodi se su čvrsto stanje.
10. Postupak prema patentnom zahtjevu 9, naznačen time da je polietilenglikol, nakon što se čvrsti polietilenglikol potrošio, zagrijavan u prisutnosti omekšivača do maksimalne temperature od 80 °C.
11. Postupak prema patentnom zahtjevu 9, naznačena time da je u disperziju, kada se koristio polučvrsti polietilenglikol, dodano punilo kao što je silikagel, mikrokristalna celuloza i polietilen-oksid.
12. Postupak prema jednom od patentnih zahtjeva 9 do 11, naznačen time da obuhvaća razdiobu rečene disperzije u tvrde želatinske kapsule, a posebice postupkom izlijevanja.
13. Postupak prema jednom od patentnih zahtjeva 9 do 11, naznačena time da je disperzija oblikovana u pelete za pripravu tableta i tvrdih želatinskih kapsula.
14. Postupak prema jednom od patentnih zahtjeva 9 do 11, naznačena time da je disperzija zajedno s prirodnim ili sintetičkim polimerom koji tvori ovojnicu oblikovana da bi se dobile obložene tablete.
15. Postupak prema patentnom zahtjevu 9, naznačena time da su obložene tablete prirpavljene u fluidizatori ili u turbini.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US11/025,348 US20060147518A1 (en) | 2004-12-30 | 2004-12-30 | Stable solid dispersion of a derivative of vinca alkaloid and process for manufacturing it |
| FR0414069A FR2880274B1 (fr) | 2004-12-30 | 2004-12-30 | Dispersion solide stable d'un derive d'alcaloides de vinca et son procede de fabrication |
| PCT/EP2005/056965 WO2006069938A1 (en) | 2004-12-30 | 2005-12-20 | Stable solid dispersion of a derivative of vinca alkaloid and process for manufacturing it |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20130276T1 true HRP20130276T1 (hr) | 2013-04-30 |
Family
ID=36046982
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20130276TT HRP20130276T1 (hr) | 2004-12-30 | 2013-03-27 | Stabilna äśvrsta disperzija derivata alkaloida dobivenih iz catharanthus roseus i postupak njene priprave |
Country Status (22)
| Country | Link |
|---|---|
| US (1) | US9061015B2 (hr) |
| EP (1) | EP1830817B1 (hr) |
| JP (1) | JP5256739B2 (hr) |
| KR (1) | KR101320408B1 (hr) |
| AR (1) | AR052079A1 (hr) |
| AU (1) | AU2005321346B2 (hr) |
| BR (1) | BRPI0519466B8 (hr) |
| CA (1) | CA2591056C (hr) |
| CY (1) | CY1113868T1 (hr) |
| DK (1) | DK1830817T3 (hr) |
| ES (1) | ES2401992T3 (hr) |
| HR (1) | HRP20130276T1 (hr) |
| IL (1) | IL184095A (hr) |
| MX (1) | MX2007008059A (hr) |
| NZ (1) | NZ554793A (hr) |
| PL (1) | PL1830817T3 (hr) |
| PT (1) | PT1830817E (hr) |
| RS (1) | RS52697B (hr) |
| RU (1) | RU2412687C2 (hr) |
| SI (1) | SI1830817T1 (hr) |
| TW (1) | TWI419714B (hr) |
| WO (1) | WO2006069938A1 (hr) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1989212B1 (en) * | 2006-02-17 | 2013-06-19 | Cascade Prodrug Inc. | Treatment of hyperproliferative diseases with vinca alkaloid n-oxide and analogs |
| AU2008214199A1 (en) * | 2007-02-09 | 2008-08-14 | Poniard Pharmaceuticals, Inc. | Encapsulated picoplatin |
| FR2918566B1 (fr) | 2007-07-11 | 2009-10-09 | Pierre Fabre Medicament Sa | Composition pharmaceutique stable d'un sel hydrosoluble de vinflunine. |
| FR2918567B1 (fr) * | 2007-07-11 | 2012-08-03 | Pf Medicament | Composition pharmaceutique stable d'un sel hydrosoluble de vinorelbine. |
| RU2730521C2 (ru) | 2016-03-09 | 2020-08-24 | Синбиас Фарма АГ | Винорелбина монотартрат и его фармацевтическое применение |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6811088B2 (en) * | 1993-05-28 | 2004-11-02 | Symbol Technologies, Inc. | Portable data collection system |
| HN1998000115A (es) * | 1997-08-21 | 1999-06-02 | Warner Lambert Co | Formas de dosificación farmacéuticas sólidas |
| NL1009780C2 (nl) | 1998-07-31 | 2000-02-01 | Peter Hubertus Elisabeth Van D | Plantpot. |
| DE10000792A1 (de) * | 2000-01-11 | 2001-07-19 | Bernhard C Lippold | Formulierungen von Wirkstoffen in Form einer festen Dispersion |
| US20020004070A1 (en) * | 2000-02-24 | 2002-01-10 | Rudnic Edward M. | Antineoplastic product, use and formulation thereof |
| EP1289560A1 (en) * | 2000-06-12 | 2003-03-12 | SmithKline Beecham Corporation | Novel solid dispersion compositions |
| IT1320176B1 (it) * | 2000-12-22 | 2003-11-26 | Nicox Sa | Dispersioni solide di principi attivi nitrati. |
| US20030212102A1 (en) * | 2001-06-12 | 2003-11-13 | Koretke Todd W | Novel solid dispersion compositions |
| EP1530459B1 (en) * | 2002-05-31 | 2010-03-31 | R.P. Scherer Technologies, LLC | Oral pharmaceutical composition for soft capsules containing vinorelbine and method of treatment |
| US20050048119A1 (en) * | 2002-09-20 | 2005-03-03 | Avinash Nangia | Controlled release composition with semi-permeable membrane and poloxamer flux enhancer |
-
2005
- 2005-12-20 AU AU2005321346A patent/AU2005321346B2/en active Active
- 2005-12-20 RU RU2007124572/15A patent/RU2412687C2/ru not_active Application Discontinuation
- 2005-12-20 PT PT58251828T patent/PT1830817E/pt unknown
- 2005-12-20 KR KR1020077009982A patent/KR101320408B1/ko active IP Right Grant
- 2005-12-20 DK DK05825182.8T patent/DK1830817T3/da active
- 2005-12-20 SI SI200531680T patent/SI1830817T1/sl unknown
- 2005-12-20 RS RS20130122A patent/RS52697B/en unknown
- 2005-12-20 WO PCT/EP2005/056965 patent/WO2006069938A1/en active Application Filing
- 2005-12-20 NZ NZ554793A patent/NZ554793A/en unknown
- 2005-12-20 CA CA2591056A patent/CA2591056C/en active Active
- 2005-12-20 BR BRPI0519466A patent/BRPI0519466B8/pt active IP Right Grant
- 2005-12-20 MX MX2007008059A patent/MX2007008059A/es active IP Right Grant
- 2005-12-20 US US11/667,998 patent/US9061015B2/en active Active
- 2005-12-20 PL PL05825182T patent/PL1830817T3/pl unknown
- 2005-12-20 EP EP05825182A patent/EP1830817B1/en active Active
- 2005-12-20 JP JP2007548804A patent/JP5256739B2/ja active Active
- 2005-12-20 ES ES05825182T patent/ES2401992T3/es active Active
- 2005-12-29 TW TW094147096A patent/TWI419714B/zh active
- 2005-12-29 AR ARP050105628A patent/AR052079A1/es unknown
-
2007
- 2007-06-20 IL IL184095A patent/IL184095A/en active IP Right Grant
-
2013
- 2013-03-27 HR HRP20130276TT patent/HRP20130276T1/hr unknown
- 2013-04-02 CY CY20131100270T patent/CY1113868T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| KR101320408B1 (ko) | 2013-10-30 |
| DK1830817T3 (da) | 2013-04-02 |
| IL184095A (en) | 2015-08-31 |
| AU2005321346B2 (en) | 2011-06-23 |
| PT1830817E (pt) | 2013-04-01 |
| BRPI0519466B1 (pt) | 2020-10-20 |
| RU2412687C2 (ru) | 2011-02-27 |
| NZ554793A (en) | 2010-04-30 |
| WO2006069938A1 (en) | 2006-07-06 |
| JP5256739B2 (ja) | 2013-08-07 |
| PL1830817T3 (pl) | 2013-06-28 |
| US20080089935A1 (en) | 2008-04-17 |
| KR20070094598A (ko) | 2007-09-20 |
| CA2591056A1 (en) | 2006-07-06 |
| TW200635619A (en) | 2006-10-16 |
| CY1113868T1 (el) | 2016-07-27 |
| US9061015B2 (en) | 2015-06-23 |
| AR052079A1 (es) | 2007-02-28 |
| BRPI0519466A2 (pt) | 2009-02-03 |
| BRPI0519466B8 (pt) | 2021-05-25 |
| RS52697B (en) | 2013-08-30 |
| JP2008526711A (ja) | 2008-07-24 |
| TWI419714B (zh) | 2013-12-21 |
| ES2401992T3 (es) | 2013-04-26 |
| SI1830817T1 (sl) | 2013-04-30 |
| EP1830817B1 (en) | 2013-01-02 |
| RU2007124572A (ru) | 2009-01-10 |
| AU2005321346A8 (en) | 2011-10-13 |
| AU2005321346A1 (en) | 2006-07-06 |
| CA2591056C (en) | 2013-11-12 |
| MX2007008059A (es) | 2007-07-17 |
| EP1830817A1 (en) | 2007-09-12 |
| IL184095A0 (en) | 2007-10-31 |
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