HRP20221165T1 - Granulat koji sadrži eslikarbazepin acetat, njegova proizvodnja, farmaceutski pripravci koji ga sadrže i njihova upotreba - Google Patents
Granulat koji sadrži eslikarbazepin acetat, njegova proizvodnja, farmaceutski pripravci koji ga sadrže i njihova upotreba Download PDFInfo
- Publication number
- HRP20221165T1 HRP20221165T1 HRP20221165TT HRP20221165T HRP20221165T1 HR P20221165 T1 HRP20221165 T1 HR P20221165T1 HR P20221165T T HRP20221165T T HR P20221165TT HR P20221165 T HRP20221165 T HR P20221165T HR P20221165 T1 HRP20221165 T1 HR P20221165T1
- Authority
- HR
- Croatia
- Prior art keywords
- hpc
- eslicarbazepine acetate
- powder
- granules
- granules according
- Prior art date
Links
- 239000008187 granular material Substances 0.000 title claims 13
- QIALRBLEEWJACW-INIZCTEOSA-N eslicarbazepine acetate Chemical compound CC(=O)O[C@H]1CC2=CC=CC=C2N(C(N)=O)C2=CC=CC=C12 QIALRBLEEWJACW-INIZCTEOSA-N 0.000 title claims 10
- 229960003233 eslicarbazepine acetate Drugs 0.000 title claims 10
- 238000004519 manufacturing process Methods 0.000 title claims 4
- 239000000825 pharmaceutical preparation Substances 0.000 title claims 3
- 239000000843 powder Substances 0.000 claims 9
- 239000002775 capsule Substances 0.000 claims 4
- 239000006185 dispersion Substances 0.000 claims 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 3
- 239000000314 lubricant Substances 0.000 claims 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 239000002245 particle Substances 0.000 claims 2
- 206010010904 Convulsion Diseases 0.000 claims 1
- 238000009826 distribution Methods 0.000 claims 1
- 230000000694 effects Effects 0.000 claims 1
- -1 hydroxypropoxy Chemical group 0.000 claims 1
- 239000004615 ingredient Substances 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
Classifications
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- 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
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
-
- 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
- A61K9/2004—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/08—Antiepileptics; Anticonvulsants
-
- 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
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Pain & Pain Management (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Hydrogenated Pyridines (AREA)
- Medicinal Preparation (AREA)
Claims (14)
1. Granule, naznačene time što sadrže eslikarbazepin acetat i L-HPC, pod uvjetom da drugi sastojci mogu biti samo pomoćne tvari koje nemaju nikakav učinak vezivanja ili razgradnje.
2. Granule, naznačene time što se uglavnom sastoje od eslikarbazepin acetata i L-HPC.
3. Granule prema patentnom zahtjevu 1 ili 2, naznačene time što je količina L-HPC najmanje 4% ukupne mase granule.
4. Granule prema bilo kojem od patentnih zahtjeva 1 do 3, naznačene time što je hidroksipropoksi sadržaj L-HPC-a u granulama 8% ili između 10% i 15%, a poželjno 8%, 11% ili 14%.
5. Granule prema bilo kojem od patentnih zahtjeva 1 do 4, naznačene time što oblik L-HPC čestica nije vlaknast, poželjno je da je njihova D90/D50 vrijednost karakteristična za distribuciju veličine čestica približno 2,2.
6. Metoda za proizvodnju granula prema bilo kojem od patentnih zahtjeva 1 do 5, naznačena time što metoda sadrži sljedeće korake:
a1) prašak eslikarbazepin acetata i L-HPC prah su pomiješani zajedno,
b1) praškasta smjesa dobivena u koraku a1) se granulira s vodom; ili
a2) L-HPC prah se miješa s vodom kako bi se pripremila vodena disperzija,
b2) prašak eslikarbazepin acetata je granuliran s vodenom disperzijom dobivenom u koraku a2);
ili
a3) prašak eslikarbazepin acetata i dio L-HPC praha se miješaju,
b3) drugi dio L-HPC praha se pomiješa s vodom kako bi se pripremila vodena disperzija,
c3) praškasta smjesa dobivena u koraku a3) i vodena disperzija dobivena u koraku b3) su granulirane.
7. Tableta koja sadrži eslikarbazepin acetat, naznačena time što sadrži granule prema bilo kojem od patentnih zahtjeva 1 do 5 i lubrikant.
8. Tableta prema patentnom zahtjevu 7, naznačena time što sadrži 200 mg do 1600 mg, poželjnije 200 mg do 800 mg, najpoželjnije 200 mg, 400 mg, 600 mg ili 800 mg eslikarbazepin acetata.
9. Tableta prema patentnom zahtjevu 7 ili 8, naznačena time što je lubrikant magnezijev stearat.
10. Kapsula koja sadrži eslikarbazepin acetat, naznačena time što sadrži granule prema bilo kojem od patentnih zahtjeva 1 do 5.
11. Kapsula prema patentnom zahtjevu 10, naznačena time što sadrži 200 mg do 400 mg eslikarbazepin acetata.
12. Upotreba granula prema bilo kojem od patentnih zahtjeva 1 do 5 za proizvodnju tableta ili kapsula.
13. Upotreba granula prema bilo kojem od patentnih zahtjeva 1 do 5 za proizvodnju farmaceutskog pripravka za liječenje parcijalnih epileptičkih napada.
14. Upotreba prema patentnom zahtjevu 13, naznačena time što je farmaceutski pripravak poželjno tableta ili kapsula.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| HU1900153A HUP1900153A1 (hu) | 2019-05-14 | 2019-05-14 | Eszlikarbazepin-acetát tartalmú granulátum, ennek elõállítása, ezt tartalmazó egyéb gyógyszerkészítmények, és ezek alkalmazása |
| EP20174336.6A EP3738584B1 (en) | 2019-05-14 | 2020-05-13 | Granulate containing eslicarbazepine acetate, its production, pharmaceutical preparations containing it, and their use |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20221165T1 true HRP20221165T1 (hr) | 2022-11-25 |
Family
ID=89992897
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20221165TT HRP20221165T1 (hr) | 2019-05-14 | 2020-05-13 | Granulat koji sadrži eslikarbazepin acetat, njegova proizvodnja, farmaceutski pripravci koji ga sadrže i njihova upotreba |
Country Status (9)
| Country | Link |
|---|---|
| EP (1) | EP3738584B1 (hr) |
| DK (1) | DK3738584T3 (hr) |
| ES (1) | ES2927618T3 (hr) |
| HR (1) | HRP20221165T1 (hr) |
| HU (2) | HUP1900153A1 (hr) |
| PL (1) | PL3738584T3 (hr) |
| PT (1) | PT3738584T (hr) |
| RS (1) | RS63587B1 (hr) |
| SI (1) | SI3738584T1 (hr) |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8372431B2 (en) * | 2007-10-26 | 2013-02-12 | Bial-Portela & C.A., S.A. | Pharmaceutical composition comprising licarbazepine acetate |
| US10918604B2 (en) | 2015-12-18 | 2021-02-16 | Jubilant Generics Limited | Solid oral dosage forms of eslicarbazepine |
-
2019
- 2019-05-14 HU HU1900153A patent/HUP1900153A1/hu unknown
-
2020
- 2020-05-13 RS RS20220881A patent/RS63587B1/sr unknown
- 2020-05-13 SI SI202030101T patent/SI3738584T1/sl unknown
- 2020-05-13 PL PL20174336.6T patent/PL3738584T3/pl unknown
- 2020-05-13 HU HUE20174336A patent/HUE059904T2/hu unknown
- 2020-05-13 ES ES20174336T patent/ES2927618T3/es active Active
- 2020-05-13 DK DK20174336.6T patent/DK3738584T3/da active
- 2020-05-13 EP EP20174336.6A patent/EP3738584B1/en active Active
- 2020-05-13 PT PT201743366T patent/PT3738584T/pt unknown
- 2020-05-13 HR HRP20221165TT patent/HRP20221165T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| HUE059904T2 (hu) | 2023-01-28 |
| EP3738584B1 (en) | 2022-06-29 |
| RS63587B1 (sr) | 2022-10-31 |
| PT3738584T (pt) | 2022-09-26 |
| DK3738584T3 (da) | 2022-10-03 |
| PL3738584T3 (pl) | 2022-11-14 |
| ES2927618T3 (es) | 2022-11-08 |
| EP3738584A1 (en) | 2020-11-18 |
| HUP1900153A1 (hu) | 2020-11-30 |
| SI3738584T1 (sl) | 2022-11-30 |
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