HRP20160278T1 - Farmaceutski pripravak koji sadrži (s)-2-(2-oksopirolidin-1-il)butanamid - Google Patents
Farmaceutski pripravak koji sadrži (s)-2-(2-oksopirolidin-1-il)butanamid Download PDFInfo
- Publication number
- HRP20160278T1 HRP20160278T1 HRP20160278TT HRP20160278T HRP20160278T1 HR P20160278 T1 HRP20160278 T1 HR P20160278T1 HR P20160278T T HRP20160278T T HR P20160278TT HR P20160278 T HRP20160278 T HR P20160278T HR P20160278 T1 HRP20160278 T1 HR P20160278T1
- Authority
- HR
- Croatia
- Prior art keywords
- solid pharmaceutical
- acid
- pharmaceutical composition
- granules
- composition according
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims 8
- HPHUVLMMVZITSG-LURJTMIESA-N levetiracetam Chemical compound CC[C@@H](C(N)=O)N1CCCC1=O HPHUVLMMVZITSG-LURJTMIESA-N 0.000 title claims 4
- 239000007787 solid Substances 0.000 claims 14
- 239000002253 acid Substances 0.000 claims 8
- 239000008187 granular material Substances 0.000 claims 7
- 239000000825 pharmaceutical preparation Substances 0.000 claims 7
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 6
- 235000003599 food sweetener Nutrition 0.000 claims 3
- 239000000901 saccharin and its Na,K and Ca salt Substances 0.000 claims 3
- 239000003765 sweetening agent Substances 0.000 claims 3
- 150000001732 carboxylic acid derivatives Chemical class 0.000 claims 2
- 239000000945 filler Substances 0.000 claims 2
- 239000004615 ingredient Substances 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 claims 2
- WBZFUFAFFUEMEI-UHFFFAOYSA-M Acesulfame k Chemical compound [K+].CC1=CC(=O)[N-]S(=O)(=O)O1 WBZFUFAFFUEMEI-UHFFFAOYSA-M 0.000 claims 1
- 108010011485 Aspartame Proteins 0.000 claims 1
- UDIPTWFVPPPURJ-UHFFFAOYSA-M Cyclamate Chemical compound [Na+].[O-]S(=O)(=O)NC1CCCCC1 UDIPTWFVPPPURJ-UHFFFAOYSA-M 0.000 claims 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims 1
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims 1
- 235000010358 acesulfame potassium Nutrition 0.000 claims 1
- 229960004998 acesulfame potassium Drugs 0.000 claims 1
- 239000000619 acesulfame-K Substances 0.000 claims 1
- 239000000605 aspartame Substances 0.000 claims 1
- 235000010357 aspartame Nutrition 0.000 claims 1
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims 1
- 229960003438 aspartame Drugs 0.000 claims 1
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 claims 1
- LNMAXKMUGYXKPJ-UHFFFAOYSA-L calcium;1,1-dioxo-1,2-benzothiazol-2-id-3-one Chemical compound [Ca+2].C1=CC=C2C([O-])=NS(=O)(=O)C2=C1.C1=CC=C2C([O-])=NS(=O)(=O)C2=C1 LNMAXKMUGYXKPJ-UHFFFAOYSA-L 0.000 claims 1
- 125000004432 carbon atom Chemical group C* 0.000 claims 1
- 239000000625 cyclamic acid and its Na and Ca salt Substances 0.000 claims 1
- 238000009826 distribution Methods 0.000 claims 1
- 206010015037 epilepsy Diseases 0.000 claims 1
- 239000000314 lubricant Substances 0.000 claims 1
- 239000000845 maltitol Substances 0.000 claims 1
- 235000010449 maltitol Nutrition 0.000 claims 1
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 claims 1
- 229940035436 maltitol Drugs 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 229940100688 oral solution Drugs 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 238000007873 sieving Methods 0.000 claims 1
- 229960001462 sodium cyclamate Drugs 0.000 claims 1
- 239000011975 tartaric acid Substances 0.000 claims 1
- 235000002906 tartaric acid Nutrition 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 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
- 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
- A61K31/4015—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 having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Neurosurgery (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Pain & Pain Management (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Claims (15)
1. Kruti farmaceutski pripravak koji sadrži granule koje nisu šumeće i koje su topljive u vodi i koje sadrže (S)-2-(2-oksopirolidin-1-il)butanamid i farmaceutski prikladnu kiselinu.
2. Kruti farmaceutski pripravak prema zahtjevu 1 gdje farmaceutski prikladna kiselina jest kiselina topljiva u vodi.
3. Kruti farmaceutski pripravak prema zahtjevu 1 ili 2 gdje kiselina(e) jest(su) karboksilna(e) kiselina(e), poželjno (a) karboksilna(e) kiselina(e) s 4 do 12, poželjnije 5 do 12, i još poželjnije 6 do 7 atoma ugljika.
4. Kruti farmaceutski pripravak prema zahtjevu 3 gdje se kiselina(e) izabire(u) između limunske kiseline, sukcinske kiseline, vinske kiseline ili bilo koje njihove kombinacije, a poželjno je to limunska kiselina.
5. Kruti farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva, gdje je(su) kiselina(e) prisutne u bezvodnom obliku.
6. Kruti farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva, gdje granule ne sadrže maltitol.
7. Kruti farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva, dalje sadrži barem jedno sladilo.
8. Kruti farmaceutski pripravak prema zahtjevu 7, gdje se sladilo(a) izabire(u) između natrijevog saharinata, kalcijevog saharinata, acesulfam kalija, natrijevog ciklamata, aspartama ili bilo koje njihove kombinacije, a poželjno je to natrijev saharinat.
9. Kruti farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva, gdje su granule topljive u vodi.
10. Kruti farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva, gdje su granule za oralnu primjenu, poželjno kao oralna otopina.
11. Kruti farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva, gdje granule imaju raspodjelu prosječne veličine čestica od oko 40 µm do 800µm što je procijenjeno analitičkim prosijavanjem.
12. Kruti farmaceutski pripravak prema zahtjevu 1 gdje se granule sastoje od (S)-2-(2-oksopirolidin-1-il)butanamida, farmaceutski prikladne kiseline, punila, sredstva za podmazivanje (lubrikanta), sladila i arome.
13. Kruti farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 10 za uporabu u medicinskom liječenju, posebno za uporabu u postupku liječenja epilepsije.
14. Postupak proizvodnje krutog farmaceutskog pripravka prema bilo kojem od zahtjeva 1 do 13, koji obuhvaća miješanje sastojaka granula i po izboru granuliranje tih sastojaka.
15. Postupak prema zahtjevu 14, gdje se (S)-2-(2-oksopirolidin-1-il)butanamid, barem jedna farmaceutski prikladna kiselina i punilo prosijavaju prije miješanja u prvom koraku miješanja, posebno kroz sito s brojem otvora 20 (engl. mesh).
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP11009922 | 2011-12-16 | ||
| EP12798303.9A EP2790695B1 (en) | 2011-12-16 | 2012-12-10 | Pharmaceutical composition comprising (s)-2-(2-oxopyrrolidin-1-yl)butanamid |
| PCT/EP2012/074931 WO2013087563A1 (en) | 2011-12-16 | 2012-12-10 | Pharmaceutical composition comprising (s)-2-(2-oxopyrrolidin-1-yl)butanamid |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20160278T1 true HRP20160278T1 (hr) | 2016-05-20 |
Family
ID=47324162
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20160278TT HRP20160278T1 (hr) | 2011-12-16 | 2016-03-18 | Farmaceutski pripravak koji sadrži (s)-2-(2-oksopirolidin-1-il)butanamid |
Country Status (11)
| Country | Link |
|---|---|
| EP (1) | EP2790695B1 (hr) |
| CY (1) | CY1117398T1 (hr) |
| DK (1) | DK2790695T3 (hr) |
| ES (1) | ES2568075T3 (hr) |
| HR (1) | HRP20160278T1 (hr) |
| HU (1) | HUE026791T2 (hr) |
| PL (1) | PL2790695T3 (hr) |
| RS (1) | RS54692B1 (hr) |
| SI (1) | SI2790695T1 (hr) |
| SM (1) | SMT201600096B (hr) |
| WO (1) | WO2013087563A1 (hr) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116459225B (zh) * | 2023-04-26 | 2023-11-10 | 东莞市金美济药业有限公司 | 一种艾拉戈克钠片及其制备工艺 |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BRPI0822053A2 (pt) * | 2007-12-21 | 2015-10-20 | Alembic Ltd | novo revestimento de liberação prolongada das composições farmacêuticas do levitiracetam |
| WO2009109547A1 (en) | 2008-03-03 | 2009-09-11 | Ucb Pharma, S.A. | Pharmaceutical solutions, process of preparation and therapeutic uses |
| JP2010024156A (ja) | 2008-07-16 | 2010-02-04 | Ucb Pharma Sa | レベチラセタムを含む医薬組成物 |
| US20100172979A1 (en) | 2008-12-24 | 2010-07-08 | Zhongshui Yu | Controlled-release formulations |
| EP2563340A2 (en) | 2010-04-26 | 2013-03-06 | Mahmut Bilgic | Water soluble pharmaceutical composition |
-
2012
- 2012-12-10 ES ES12798303.9T patent/ES2568075T3/es active Active
- 2012-12-10 SI SI201230509A patent/SI2790695T1/sl unknown
- 2012-12-10 PL PL12798303T patent/PL2790695T3/pl unknown
- 2012-12-10 EP EP12798303.9A patent/EP2790695B1/en active Active
- 2012-12-10 DK DK12798303.9T patent/DK2790695T3/en active
- 2012-12-10 WO PCT/EP2012/074931 patent/WO2013087563A1/en active Application Filing
- 2012-12-10 HU HUE12798303A patent/HUE026791T2/en unknown
- 2012-12-10 RS RS20160212A patent/RS54692B1/en unknown
-
2016
- 2016-03-18 HR HRP20160278TT patent/HRP20160278T1/hr unknown
- 2016-04-05 SM SM201600096T patent/SMT201600096B/it unknown
- 2016-04-06 CY CY20161100278T patent/CY1117398T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP2790695A1 (en) | 2014-10-22 |
| SI2790695T1 (sl) | 2016-09-30 |
| PL2790695T3 (pl) | 2016-07-29 |
| WO2013087563A1 (en) | 2013-06-20 |
| RS54692B1 (en) | 2016-08-31 |
| HUE026791T2 (en) | 2016-07-28 |
| ES2568075T3 (es) | 2016-04-27 |
| SMT201600096B (it) | 2016-07-01 |
| DK2790695T3 (en) | 2016-04-18 |
| CY1117398T1 (el) | 2017-04-26 |
| EP2790695B1 (en) | 2016-03-16 |
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