HRP20220658T1 - Farmaceutski pripravci koji sadrže safinamid - Google Patents
Farmaceutski pripravci koji sadrže safinamid Download PDFInfo
- Publication number
- HRP20220658T1 HRP20220658T1 HRP20220658TT HRP20220658T HRP20220658T1 HR P20220658 T1 HRP20220658 T1 HR P20220658T1 HR P20220658T T HRP20220658T T HR P20220658TT HR P20220658 T HRP20220658 T HR P20220658T HR P20220658 T1 HRP20220658 T1 HR P20220658T1
- Authority
- HR
- Croatia
- Prior art keywords
- particles according
- core
- binding agent
- polymer
- safinamide
- Prior art date
Links
- 229950002652 safinamide Drugs 0.000 title claims 4
- NEMGRZFTLSKBAP-LBPRGKRZSA-N safinamide Chemical compound C1=CC(CN[C@@H](C)C(N)=O)=CC=C1OCC1=CC=CC(F)=C1 NEMGRZFTLSKBAP-LBPRGKRZSA-N 0.000 title claims 4
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 239000002245 particle Substances 0.000 claims 18
- 239000000203 mixture Substances 0.000 claims 10
- 229920000642 polymer Polymers 0.000 claims 9
- 239000011230 binding agent Substances 0.000 claims 5
- 239000002202 Polyethylene glycol Substances 0.000 claims 4
- 239000003795 chemical substances by application Substances 0.000 claims 4
- 229920001223 polyethylene glycol Polymers 0.000 claims 4
- 238000005054 agglomeration Methods 0.000 claims 3
- 230000002776 aggregation Effects 0.000 claims 3
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 3
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 3
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 3
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 3
- 238000000034 method Methods 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 3
- 239000001856 Ethyl cellulose Substances 0.000 claims 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical group C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 2
- 239000012752 auxiliary agent Substances 0.000 claims 2
- 239000001913 cellulose Substances 0.000 claims 2
- 229920002678 cellulose Polymers 0.000 claims 2
- 235000010980 cellulose Nutrition 0.000 claims 2
- 239000011248 coating agent Substances 0.000 claims 2
- 238000000576 coating method Methods 0.000 claims 2
- 229920001249 ethyl cellulose Polymers 0.000 claims 2
- 235000019325 ethyl cellulose Nutrition 0.000 claims 2
- 238000002844 melting Methods 0.000 claims 2
- 230000008018 melting Effects 0.000 claims 2
- 239000006186 oral dosage form Substances 0.000 claims 2
- 229920000193 polymethacrylate Polymers 0.000 claims 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 2
- YKOCHIUQOBQIAC-YDALLXLXSA-N (2s)-2-[[4-[(3-fluorophenyl)methoxy]phenyl]methylamino]propanamide;methanesulfonic acid Chemical compound CS(O)(=O)=O.C1=CC(CN[C@@H](C)C(N)=O)=CC=C1OCC1=CC=CC(F)=C1 YKOCHIUQOBQIAC-YDALLXLXSA-N 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 229920000881 Modified starch Polymers 0.000 claims 1
- 239000008186 active pharmaceutical agent Substances 0.000 claims 1
- 230000002744 anti-aggregatory effect Effects 0.000 claims 1
- 230000001419 dependent effect Effects 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 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
- 239000006191 orally-disintegrating tablet Substances 0.000 claims 1
- 239000004014 plasticizer Substances 0.000 claims 1
- 229940069328 povidone Drugs 0.000 claims 1
- 229950011305 safinamide methanesulfonate Drugs 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
-
- 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
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
-
- 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
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—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
- A61K9/48—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
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Zoology (AREA)
- Pain & Pain Management (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Claims (20)
1. Mnoštvo čestica, naznačeno time, da od kojih svaka sadrži:
a. jezgru koja sadrži safinamid ili njegovu farmaceutski prihvatljivu sol i vezno sredstvo;
b. polimerni sastav koji formira oblogu na navedenoj jezgri.
2. Mnoštvo čestica prema patentnom zahtjevu 1, naznačeno time, da navedena jezgra ima veličinu čestice koja iznosi između 200-450 μm.
3. Mnoštvo čestica prema patentnom zahtjevu 1, naznačeno time, da navedena jezgra sadrži količinu baze safinamida ili njegovog ekvivalenta soli, koja iznosi između 20-60% po masi.
4. Mnoštvo čestica prema jednom od prethodnih patentnih zahtjeva, naznačeno time, da navedena jezgra sadrži safinamid metansulfonat.
5. Mnoštvo čestica prema patentnom zahtjevu 1, naznačeno time, da se navedeno vezno sredstvo bira između povidona (PVP), polietilen glikola (PEG), predželatiniziranog škroba, hidroksipropil metilceluloze (HPMC) i mikrokristalne celuloze ili njihovih mješavina.
6. Mnoštvo čestica prema jednom od prethodnih patentnih zahtjeva, naznačeno time, da navedena jezgra sadrži količinu veznog sredstva kao samoga ili u smjesi, koja iznosi između 2-30% po masi.
7. Mnoštvo čestica prema jednom od prethodnih patentnih zahtjeva, naznačeno time, da navedena jezgra nadalje sadrži farmaceutski prihvatljiva pomoćna sredstva koja se biraju između razrjeđivača, dezintegratora i kliznih sredstava.
8. Mnoštvo čestica prema patentnom zahtjevu 1, gdje je jezgra naznačena time, da njezina rasuta gustoća iznosi između 0,20-0,50 g/ml.
9. Mnoštvo čestica prema patentnom zahtjevu 1, naznačeno time, da se navedena jezgra pripravlja putem aglomeracije topljenjem.
10. Mnoštvo čestica prema patentnom zahtjevu 1, naznačeno time, da navedeni polimerni sastav sadrži polimer koji posjeduje topivost u vodi ovisnu o pH vrijednosti, celulozni polimer koji je topiv u vodi ili celulozni polimer koji nije topiv u vodi, i njihove mješavine.
11. Mnoštvo čestica prema patentnom zahtjevu 10, naznačeno time, da se navedeni polimer bira između bazičnog butiliranog poli-metakrilata, etil celuloze kao same ili u smjesi s hidroksipropilmetil celulozom, i etil celuloze u smjesi s bazičnim butiliranim poli-metakrilatom.
12. Mnoštvo čestica prema patentnom zahtjevu 1, naznačeno time, da se navedeni polimerni sastav nalazi u količini koja iznosi između 20-40% po masi.
13. Mnoštvo čestica prema patentnom zahtjevu 1, naznačeno time, da navedeni polimerni sastav sadrži funkcionalna pomoćna sredstva koja se biraju između plastifikatora, kliznih sredstava, sredstava protiv agregacije i sredstava za formiranje pora.
14. Mnoštvo čestica prema patentnom zahtjevu 1, naznačeno time, da njihova rasuta gustoća iznosi između 0,40-0,60 g/ml.
15. Postupak proizvodnje mnoštva čestica prema patentnom zahtjevu 1, naznačen time, da obuhvaća:
a. aglomeraciju aktivnog farmaceutskog sastojka i veznog sredstva kako bi se dobila jezgra;
b. oblaganje navedene jezgre s polimernim sastavom.
16. Postupak prema patentnom zahtjevu 15, naznačen time, da se navedena jezgra pripravlja putem aglomeracije topljenjem.
17. Postupak prema patentnom zahtjevu 15 ili 16, naznačen time, da navedeno vezno sredstvo jest polietilen glikol (PEG).
18. Tableta koja se oralno dezintegrira, naznačena time, da ona sadrži mnoštvo čestica prema patentnom zahtjevu 1.
19. Uporaba mnoštva čestica prema patentnom zahtjevu 1, naznačena time, da služi u proizvodnji oralnog oblika za doziranje.
20. Uporaba prema patentnom zahtjevu 19, naznačena time, da navedeni oralni oblik za doziranje sadrži količinu baze safinamida ili njegovog ekvivalenta soli, u iznosu od 50 ili 100 mg.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ITUB20163981 | 2016-05-31 | ||
| PCT/EP2017/063063 WO2017207587A1 (en) | 2016-05-31 | 2017-05-30 | Pharmaceutical compositions comprising safinamide |
| EP17728793.5A EP3558261B1 (en) | 2016-05-31 | 2017-05-30 | Pharmaceutical compositions comprising safinamide |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20220658T1 true HRP20220658T1 (hr) | 2022-08-19 |
Family
ID=67997819
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20220658TT HRP20220658T1 (hr) | 2016-05-31 | 2017-05-30 | Farmaceutski pripravci koji sadrže safinamid |
Country Status (10)
| Country | Link |
|---|---|
| EP (1) | EP3558261B1 (hr) |
| DK (1) | DK3558261T3 (hr) |
| ES (1) | ES2915026T3 (hr) |
| HR (1) | HRP20220658T1 (hr) |
| HU (1) | HUE058886T2 (hr) |
| LT (1) | LT3558261T (hr) |
| PL (1) | PL3558261T3 (hr) |
| PT (1) | PT3558261T (hr) |
| RS (1) | RS63344B1 (hr) |
| SI (1) | SI3558261T1 (hr) |
-
2017
- 2017-05-30 SI SI201731166T patent/SI3558261T1/sl unknown
- 2017-05-30 HR HRP20220658TT patent/HRP20220658T1/hr unknown
- 2017-05-30 PL PL17728793.5T patent/PL3558261T3/pl unknown
- 2017-05-30 ES ES17728793T patent/ES2915026T3/es active Active
- 2017-05-30 LT LTEPPCT/EP2017/063063T patent/LT3558261T/lt unknown
- 2017-05-30 RS RS20220512A patent/RS63344B1/sr unknown
- 2017-05-30 DK DK17728793.5T patent/DK3558261T3/da active
- 2017-05-30 HU HUE17728793A patent/HUE058886T2/hu unknown
- 2017-05-30 PT PT177287935T patent/PT3558261T/pt unknown
- 2017-05-30 EP EP17728793.5A patent/EP3558261B1/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| DK3558261T3 (da) | 2022-06-20 |
| HUE058886T2 (hu) | 2022-09-28 |
| RS63344B1 (sr) | 2022-07-29 |
| LT3558261T (lt) | 2022-08-10 |
| PT3558261T (pt) | 2022-05-27 |
| ES2915026T3 (es) | 2022-06-20 |
| EP3558261A1 (en) | 2019-10-30 |
| PL3558261T3 (pl) | 2022-07-25 |
| EP3558261B1 (en) | 2022-03-23 |
| SI3558261T1 (sl) | 2022-07-29 |
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