HRP20201948T1 - Pripravci inhibitora dopa-dekarbokilaze - Google Patents
Pripravci inhibitora dopa-dekarbokilaze Download PDFInfo
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- HRP20201948T1 HRP20201948T1 HRP20201948TT HRP20201948T HRP20201948T1 HR P20201948 T1 HRP20201948 T1 HR P20201948T1 HR P20201948T T HRP20201948T T HR P20201948TT HR P20201948 T HRP20201948 T HR P20201948T HR P20201948 T1 HRP20201948 T1 HR P20201948T1
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- 239000000203 mixture Substances 0.000 title claims 3
- 229940081615 DOPA decarboxylase inhibitor Drugs 0.000 title 1
- 239000000534 dopa decarboxylase inhibitor Substances 0.000 title 1
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims 12
- OAKJQQAXSVQMHS-UHFFFAOYSA-N Hydrazine Chemical compound NN OAKJQQAXSVQMHS-UHFFFAOYSA-N 0.000 claims 6
- PWKSKIMOESPYIA-BYPYZUCNSA-N L-N-acetyl-Cysteine Chemical compound CC(=O)N[C@@H](CS)C(O)=O PWKSKIMOESPYIA-BYPYZUCNSA-N 0.000 claims 6
- 229960004308 acetylcysteine Drugs 0.000 claims 6
- 235000010323 ascorbic acid Nutrition 0.000 claims 6
- 239000011668 ascorbic acid Substances 0.000 claims 6
- 229960005070 ascorbic acid Drugs 0.000 claims 6
- 239000004475 Arginine Substances 0.000 claims 5
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 5
- 229960004205 carbidopa Drugs 0.000 claims 4
- TZFNLOMSOLWIDK-JTQLQIEISA-N carbidopa (anhydrous) Chemical compound NN[C@@](C(O)=O)(C)CC1=CC=C(O)C(O)=C1 TZFNLOMSOLWIDK-JTQLQIEISA-N 0.000 claims 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 4
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 4
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 4
- 229920000053 polysorbate 80 Polymers 0.000 claims 4
- 229940068968 polysorbate 80 Drugs 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- 208000033962 Fontaine progeroid syndrome Diseases 0.000 claims 3
- XUJNEKJLAYXESH-REOHCLBHSA-N L-Cysteine Chemical compound SC[C@H](N)C(O)=O XUJNEKJLAYXESH-REOHCLBHSA-N 0.000 claims 3
- WTDRDQBEARUVNC-LURJTMIESA-N L-DOPA Chemical compound OC(=O)[C@@H](N)CC1=CC=C(O)C(O)=C1 WTDRDQBEARUVNC-LURJTMIESA-N 0.000 claims 3
- WTDRDQBEARUVNC-UHFFFAOYSA-N L-Dopa Natural products OC(=O)C(N)CC1=CC=C(O)C(O)=C1 WTDRDQBEARUVNC-UHFFFAOYSA-N 0.000 claims 3
- 238000002290 gas chromatography-mass spectrometry Methods 0.000 claims 3
- 229960004502 levodopa Drugs 0.000 claims 3
- 239000007788 liquid Substances 0.000 claims 3
- 201000010099 disease Diseases 0.000 claims 2
- 208000035475 disorder Diseases 0.000 claims 2
- VYFYYTLLBUKUHU-UHFFFAOYSA-N dopamine Chemical compound NCCC1=CC=C(O)C(O)=C1 VYFYYTLLBUKUHU-UHFFFAOYSA-N 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 2
- WJYXODNZUPMQOJ-UHFFFAOYSA-N 2-(3,4-dihydroxyphenyl)-2-methylpropanoic acid Chemical compound OC(=O)C(C)(C)C1=CC=C(O)C(O)=C1 WJYXODNZUPMQOJ-UHFFFAOYSA-N 0.000 claims 1
- 208000018737 Parkinson disease Diseases 0.000 claims 1
- 239000004260 Potassium ascorbate Substances 0.000 claims 1
- 235000010376 calcium ascorbate Nutrition 0.000 claims 1
- 229940047036 calcium ascorbate Drugs 0.000 claims 1
- 239000011692 calcium ascorbate Substances 0.000 claims 1
- BLORRZQTHNGFTI-ZZMNMWMASA-L calcium-L-ascorbate Chemical compound [Ca+2].OC[C@H](O)[C@H]1OC(=O)C(O)=C1[O-].OC[C@H](O)[C@H]1OC(=O)C(O)=C1[O-] BLORRZQTHNGFTI-ZZMNMWMASA-L 0.000 claims 1
- 239000008380 degradant Substances 0.000 claims 1
- 229960003638 dopamine Drugs 0.000 claims 1
- 210000005064 dopaminergic neuron Anatomy 0.000 claims 1
- 238000004128 high performance liquid chromatography Methods 0.000 claims 1
- 235000019275 potassium ascorbate Nutrition 0.000 claims 1
- 229940017794 potassium ascorbate Drugs 0.000 claims 1
- CONVKSGEGAVTMB-RXSVEWSESA-M potassium-L-ascorbate Chemical compound [K+].OC[C@H](O)[C@H]1OC(=O)C(O)=C1[O-] CONVKSGEGAVTMB-RXSVEWSESA-M 0.000 claims 1
- 235000010378 sodium ascorbate Nutrition 0.000 claims 1
- PPASLZSBLFJQEF-RKJRWTFHSA-M sodium ascorbate Substances [Na+].OC[C@@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RKJRWTFHSA-M 0.000 claims 1
- 229960005055 sodium ascorbate Drugs 0.000 claims 1
- PPASLZSBLFJQEF-RXSVEWSESA-M sodium-L-ascorbate Chemical compound [Na+].OC[C@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RXSVEWSESA-M 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K31/13—Amines
- A61K31/133—Amines having hydroxy groups, e.g. sphingosine
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
- A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- 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
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
- A61P25/16—Anti-Parkinson drugs
Claims (16)
1. Farmaceutski pripravak tekući pripravak, naznačen time što sadrži:
otprilike 0,75%, težinski, karbidope;
otprilike 6%, težinski, levodope;
otprilike 12% do otprilike 36%, težinski, arginina;
otprilike 0,5%, težinski, askorbinske kiseline ili njezine soli;
otprilike 0,1% do otprilike 0,6%, težinski, l-cisteina, ili njegove soli, ili otprilike 0,01% do otprilike 1%, težinski, N-acetilcisteina (NAC); i
izborno, otprilike 0,1% do otprilike 0,5%, težinski, po mogućnosti otprilike 0,3%, težinski, polisorbata 80;
gdje navedeni pripravak, nakon 1-24 sata na 25 °C, sadrži manje od 0,1 mg/ml hidrazina, što je određeno postupkom GCMS.
2. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što pripravak sadrži manje od 1%, težinski, 3,4-dihidroksifenil-2-metilpropionske kiseline (degradansa), u odnosu na količinu karbidope, što je određeno HPLC-om.
3. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što je navedena sol askorbinske kiseline natrijev askorbat, kalijev askorbat ili kalcijev askorbat.
4. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što sadrži otprilike 15,2%, težinski, arginina, otprilike 0,5%, težinski, askorbinske kiseline, otprilike 0,4%, težinski, l-cisteina i otprilike 0,3%, težinski, polisorbata 80,
5. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što sadrži otprilike 15,2%, težinski, arginina, otprilike 0,5%, težinski, askorbinske kiseline, otprilike 0,5%, težinski, NAC, te otprilike 0,3%, težinski, polisorbata 80,
6. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što sadrži 6%, težinski, levodope, 0,75%, težinski, karbidope, 15,2%, težinski, arginina, 0,5%, težinski, askorbinske kiseline, te 0,5%, težinski, NAC.
7. Farmaceutski pripravak tekući pripravak, naznačen time što sadrži:
otprilike 0,6% do 1,4%, težinski, karbidope;
otprilike 6%, težinski, levodope;
otprilike 15% do otprilike 16%, težinski, arginina;
otprilike 0,5%, težinski, askorbinske kiseline ili njezine soli;
otprilike 0,4%, težinski, l-cisteina ili otprilike 0,5%, težinski, N-acetilcisteina (NAC); i
otprilike 0,3%, težinski, polisorbata 80;
gdje navedeni pripravak, nakon 1-24 sata na 25 °C, sadrži manje od 0,1 mg/ml hidrazina, što je određeno postupkom GCMS.
8. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što sadrži manje od 0,1 mg/ml hidrazina nakon 1-30 dana, na temperaturi od 25 °C, što je određeno GCMS-om.
9. Farmaceutski pripravak tekući pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što je namijenjen upotrebi u liječenju bolesti, poremećaja ili stanja povezanog s gubitkom dopamina ili dopaminergičkih neurona.
10. Pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 9, naznačen time što je navedena bolest, poremećaj ili stanje Parkinsonova bolest.
11. Pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 9 ili 10, naznačen time što se pripravak primjenjuje uglavnom kontinuirano.
12. Pripravak namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 9 do 11, naznačen time što se pripravak primjenjuje supkutano.
13. Pripravak namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 9 do 12, naznačen time što se pripravak primjenjuje na čovjeku.
14. Pripravak namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 9 do 13, naznačen time što se pripravak primjenjuje brzinom od 0,01 ml na sat po mjestu do 0,4 ml na sat po mjestu.
15. Pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 14, naznačen time što se pripravak primjenjuje brzinom od 0,16 ml na sat po mjestu do 0,24 ml na sat po mjestu.
16. Pripravak namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 9 do 11, naznačen time što se pripravak primjenjuje intraduodenalno brzinom od 1,0 ml na sat po danu, a brzinom od 0 ml na sat do 0,5 ml na sat po noći.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201461952477P | 2014-03-13 | 2014-03-13 | |
| US201461990967P | 2014-05-09 | 2014-05-09 | |
| PCT/IL2015/050258 WO2015136538A1 (en) | 2014-03-13 | 2015-03-12 | Dopa decarboxylase inhibitor compositions |
| EP15731727.2A EP3116475B1 (en) | 2014-03-13 | 2015-03-12 | Dopa decarboxylase inhibitor compositions |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20201948T1 true HRP20201948T1 (hr) | 2021-01-22 |
Family
ID=53488380
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20231716TT HRP20231716T1 (hr) | 2014-03-13 | 2015-03-12 | Pripravci inhibitora dopa dekarboksilaze |
| HRP20201948TT HRP20201948T1 (hr) | 2014-03-13 | 2020-12-04 | Pripravci inhibitora dopa-dekarbokilaze |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20231716TT HRP20231716T1 (hr) | 2014-03-13 | 2015-03-12 | Pripravci inhibitora dopa dekarboksilaze |
Country Status (19)
| Country | Link |
|---|---|
| US (4) | US10022320B2 (hr) |
| EP (3) | EP3777833B1 (hr) |
| JP (2) | JP6591995B2 (hr) |
| CN (1) | CN106413754B (hr) |
| AU (1) | AU2015228369B2 (hr) |
| BR (1) | BR112016021034A8 (hr) |
| CA (1) | CA2942244C (hr) |
| DK (2) | DK3116475T3 (hr) |
| ES (2) | ES2967693T3 (hr) |
| FI (1) | FI3777833T3 (hr) |
| HR (2) | HRP20231716T1 (hr) |
| HU (2) | HUE052642T2 (hr) |
| IL (1) | IL247668B (hr) |
| MX (1) | MX2016011837A (hr) |
| PL (2) | PL3777833T3 (hr) |
| PT (2) | PT3116475T (hr) |
| RS (1) | RS65060B1 (hr) |
| RU (1) | RU2684105C2 (hr) |
| WO (1) | WO2015136538A1 (hr) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PT3192500T (pt) | 2009-05-19 | 2021-01-05 | Neuroderm Ltd | Composições para a administração contínua de inibidores da dopa decarboxilase |
| SG10201509316SA (en) | 2010-11-15 | 2015-12-30 | Neuroderm Ltd | Continuous Administration Of L-Dopa, Dopa Decarboxylase Inhibitors, Catechol-O-Methyl Transferase Inhibitors And Compositions For Same |
| US10258585B2 (en) | 2014-03-13 | 2019-04-16 | Neuroderm, Ltd. | DOPA decarboxylase inhibitor compositions |
| ES2967693T3 (es) | 2014-03-13 | 2024-05-03 | Neuroderm Ltd | Composiciones del inhibidor de la dopa descarboxilasa |
| CA2997791A1 (en) | 2015-09-30 | 2017-04-06 | Duke University | Ascorbate formulations and methods of use as contrast agents |
| WO2018154447A1 (en) * | 2017-02-21 | 2018-08-30 | Neuroderm Ltd | Dopa decarboxylase inhibitor compositions |
| SG11202104499RA (en) | 2018-11-15 | 2021-05-28 | Abbvie Inc | Pharmaceutical formulations for subcutaneous administration |
| WO2020178810A1 (en) * | 2019-03-04 | 2020-09-10 | Neuroderm, Ltd. | Pharmaceutical compositions comprising levodopa amide derivatives and uses thereof |
| CN111701024B (zh) * | 2020-05-26 | 2022-05-24 | 上海京新生物医药有限公司 | 一种左旋多巴制剂及其制备方法及其应用 |
| US11331293B1 (en) | 2020-11-17 | 2022-05-17 | Neuroderm, Ltd. | Method for treatment of Parkinson's disease |
| US11844754B2 (en) | 2020-11-17 | 2023-12-19 | Neuroderm, Ltd. | Methods for treatment of Parkinson's disease |
| US11213502B1 (en) | 2020-11-17 | 2022-01-04 | Neuroderm, Ltd. | Method for treatment of parkinson's disease |
| CN113396897B (zh) * | 2021-07-26 | 2022-06-07 | 苏州华测生物技术有限公司 | 一种稳定生物基质中卡比多巴/左旋多巴的方法 |
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