HRP20180514T1 - Kontinuirana primjena l-dopa, inhibitora dopa dekarboksilaze, inhibitora katekol-o-metiltransferaze i sastava za isto - Google Patents
Kontinuirana primjena l-dopa, inhibitora dopa dekarboksilaze, inhibitora katekol-o-metiltransferaze i sastava za isto Download PDFInfo
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- HRP20180514T1 HRP20180514T1 HRP20180514TT HRP20180514T HRP20180514T1 HR P20180514 T1 HRP20180514 T1 HR P20180514T1 HR P20180514T T HRP20180514T T HR P20180514TT HR P20180514 T HRP20180514 T HR P20180514T HR P20180514 T1 HRP20180514 T1 HR P20180514T1
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- Croatia
- Prior art keywords
- weight
- pharmaceutically acceptable
- liquid composition
- acceptable liquid
- carbidopa
- Prior art date
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- 239000000203 mixture Substances 0.000 title claims 12
- WTDRDQBEARUVNC-LURJTMIESA-N L-DOPA Chemical compound OC(=O)[C@@H](N)CC1=CC=C(O)C(O)=C1 WTDRDQBEARUVNC-LURJTMIESA-N 0.000 title claims 8
- WTDRDQBEARUVNC-UHFFFAOYSA-N L-Dopa Natural products OC(=O)C(N)CC1=CC=C(O)C(O)=C1 WTDRDQBEARUVNC-UHFFFAOYSA-N 0.000 title claims 8
- 239000003543 catechol methyltransferase inhibitor Substances 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
- 239000007788 liquid Substances 0.000 claims 9
- 239000004475 Arginine Substances 0.000 claims 7
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 7
- 229960004205 carbidopa Drugs 0.000 claims 7
- 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 7
- 229960004502 levodopa Drugs 0.000 claims 7
- 235000010323 ascorbic acid Nutrition 0.000 claims 6
- 239000011668 ascorbic acid Substances 0.000 claims 6
- 235000010378 sodium ascorbate Nutrition 0.000 claims 6
- 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 6
- 229960005055 sodium ascorbate Drugs 0.000 claims 6
- 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 6
- 229960005070 ascorbic acid Drugs 0.000 claims 5
- RWSXRVCMGQZWBV-WDSKDSINSA-N glutathione Chemical compound OC(=O)[C@@H](N)CCC(=O)N[C@@H](CS)C(=O)NCC(O)=O RWSXRVCMGQZWBV-WDSKDSINSA-N 0.000 claims 4
- PWKSKIMOESPYIA-BYPYZUCNSA-N L-N-acetyl-Cysteine Chemical compound CC(=O)N[C@@H](CS)C(O)=O PWKSKIMOESPYIA-BYPYZUCNSA-N 0.000 claims 2
- 229960004308 acetylcysteine Drugs 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 2
- 229960003180 glutathione Drugs 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- PWKSKIMOESPYIA-UHFFFAOYSA-N 2-acetamido-3-sulfanylpropanoic acid Chemical group CC(=O)NC(CS)C(O)=O PWKSKIMOESPYIA-UHFFFAOYSA-N 0.000 claims 1
- LITUBCVUXPBCGA-WMZHIEFXSA-N Ascorbyl stearate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OC[C@H](O)[C@H]1OC(=O)C(O)=C1O LITUBCVUXPBCGA-WMZHIEFXSA-N 0.000 claims 1
- 239000004261 Ascorbyl stearate Substances 0.000 claims 1
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims 1
- 108010024636 Glutathione Proteins 0.000 claims 1
- 239000011786 L-ascorbyl-6-palmitate Substances 0.000 claims 1
- QAQJMLQRFWZOBN-LAUBAEHRSA-N L-ascorbyl-6-palmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](O)[C@H]1OC(=O)C(O)=C1O QAQJMLQRFWZOBN-LAUBAEHRSA-N 0.000 claims 1
- 208000016285 Movement disease Diseases 0.000 claims 1
- 208000012902 Nervous system disease Diseases 0.000 claims 1
- 208000025966 Neurological disease Diseases 0.000 claims 1
- 208000018737 Parkinson disease Diseases 0.000 claims 1
- 239000004260 Potassium ascorbate Substances 0.000 claims 1
- DWAQJAXMDSEUJJ-UHFFFAOYSA-M Sodium bisulfite Chemical compound [Na+].OS([O-])=O DWAQJAXMDSEUJJ-UHFFFAOYSA-M 0.000 claims 1
- 229940072107 ascorbate Drugs 0.000 claims 1
- 235000010385 ascorbyl palmitate Nutrition 0.000 claims 1
- 235000019276 ascorbyl stearate Nutrition 0.000 claims 1
- 230000015572 biosynthetic process Effects 0.000 claims 1
- 239000011575 calcium 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
- 238000001990 intravenous administration Methods 0.000 claims 1
- 230000000926 neurological effect Effects 0.000 claims 1
- 230000003647 oxidation Effects 0.000 claims 1
- 238000007254 oxidation reaction 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
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
Classifications
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/12—Ketones
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- A61K31/12—Ketones
- A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
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- 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
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- 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 or pantothenic acid
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- 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 or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
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- A61K31/275—Nitriles; Isonitriles
- A61K31/277—Nitriles; Isonitriles having a ring, e.g. verapamil
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
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- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- 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
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- 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
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- 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
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- 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
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- 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
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- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biomedical Technology (AREA)
- Organic Chemistry (AREA)
- Neurosurgery (AREA)
- Dermatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Psychology (AREA)
- Biochemistry (AREA)
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- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Claims (9)
1. Farmaceutski prihvatljiv tekući sastav sadržeći 2,5% do 7% masenog udjela levodopa; do 2% masenog udjela karbidopa; 5% do 18% masenog udjela arginina; i 0,25% do 3% masenog udjela askorbinske kiseline ili farmaceutski prihvatljive soli iste, naznačeno time da spomenuti sastav ima pH vrijednost od 9,1 do 9,8 na 25°C, te je molarni omjer levodopa sa karbidopom u odnosu na arginin 1:1,8 do 1:3,5.
2. Farmaceutski prihvatljiv tekući sastav iz zahtjeva 1, naznačeno time da spomenuti sastav ima pH vrijednost od 9,2 do 9,8 na 25°C.
3. Farmaceutski prihvatljiv tekući sastav iz zahtjeva 1 ili 2, naznačeno time da spomenuta farmaceutski prihvatljiva sol askorbinske kiseline je askorbat, natrijev askorbat, kalcijev askorbat, kalijev askorbat, askorbil palmitat, ili askorbil stearat.
4. Farmaceutski prihvatljiv tekući sastav iz bilo kojeg zahtjeva 1 do 3, nadalje sadržeći agent koji inhibira stvaranje produkata oksidacije.
5. Farmaceutski prihvatljiv tekući sastav iz zahtjeva 4, naznačeno time da je agent L-cistein, N-acetilcistein (NAC), glutation (GSH), Na2-EDTA, Na2-EDTA-Ca, natrijev bisulfit, ili kombinacije istih.
6. Farmaceutski prihvatljiv tekući sastav iz zahtjeva 1 ili 2, sadržeći:
(i) 6% masenog udjela levodopa, 1,5% masenog udjela karbidopa, 1% masenog udjela natrijevog askorbata, i 13,5%, 14,2%, 14,8% ili 16,0% masenog udjela arginina;
(ii) 4,8% masenog udjela levodopa, 1,4% masenog udjela karbidopa, 1% masenog udjela natrijevog askorbata, i 11%, 11,6%, 21,1% ili 12,7% masenog udjela arginina;
(iii) 6% masenog udjela levodopa, 1,5% masenog udjela karbidopa, 1% masenog udjela askorbinske kiseline ili natrijevog askorbata, i 14,8%, 15,8%, 16% ili 16,8% masenog udjela arginina;
(iv) 5.4% masenog udjela levodopa, 1,5% masenog udjela karbidopa, 1% masenog udjela askorbrinske kiseline ili natrijevog askorbata, i 12,3%, 13,5% ili 14,8% masenog udjela arginina; ili
(v) 7% masenog udjela levodopa, 2% masenog udjela karbidopa, 1% masenog udjela askorbinske kiseline ili natrijevog askorbata, i 17,8% masenog udjela arginina.
7. Farmaceutski prihvatljiv tekući sastav iz bilo kojeg zahtjeva 1 do 6, formuliran za kontinuiranu subkutanu, transdermalnu, intraduodenalnu ili intravenoznu primjenu.
8. Farmaceutski prihvatljiv tekući sastav iz bilo kojeg zahtjeva 1 do 7, za upotrebu u liječenju neuroloških poremećaja ili poremećaja pokreta poput Parkinsonove bolesti.
9. Transdermalni flaster sadržeći farmaceutski prihvatljiv tekući sastav prema bilo kojem od zahtjeva 1 do 6.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US41363710P | 2010-11-15 | 2010-11-15 | |
US201161524064P | 2011-08-16 | 2011-08-16 | |
PCT/IL2011/000881 WO2012066538A1 (en) | 2010-11-15 | 2011-11-15 | Continuous administration of l-dopa, dopa decarboxylase inhibitors, catechol-o-methyl transferase inhibitors and compositions for same |
EP11808359.1A EP2640358B1 (en) | 2010-11-15 | 2011-11-15 | Continuous administration of l-dopa, dopa decarboxylase inhibitors, catechol-o-methyl transferase inhibitors and compositions for same |
Publications (1)
Publication Number | Publication Date |
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HRP20180514T1 true HRP20180514T1 (hr) | 2018-05-04 |
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Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20180514TT HRP20180514T1 (hr) | 2010-11-15 | 2018-03-28 | Kontinuirana primjena l-dopa, inhibitora dopa dekarboksilaze, inhibitora katekol-o-metiltransferaze i sastava za isto |
HRP20200366TT HRP20200366T1 (hr) | 2010-11-15 | 2020-03-04 | Kontinuirana primjena l-dopa, inhibitora dopa-dekarboksilaze, inhibitora katekol-o-metil-transferaze i njihovih pripravaka |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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HRP20200366TT HRP20200366T1 (hr) | 2010-11-15 | 2020-03-04 | Kontinuirana primjena l-dopa, inhibitora dopa-dekarboksilaze, inhibitora katekol-o-metil-transferaze i njihovih pripravaka |
Country Status (26)
Country | Link |
---|---|
US (6) | US9421267B2 (hr) |
EP (3) | EP3692982A1 (hr) |
JP (3) | JP5902705B2 (hr) |
KR (1) | KR101859242B1 (hr) |
CN (2) | CN103442693A (hr) |
AU (1) | AU2011330757B2 (hr) |
BR (1) | BR112013011685B1 (hr) |
CA (1) | CA2817888C (hr) |
CL (1) | CL2013001368A1 (hr) |
CY (1) | CY1120005T1 (hr) |
DK (2) | DK3326615T3 (hr) |
ES (2) | ES2660772T3 (hr) |
HR (2) | HRP20180514T1 (hr) |
HU (2) | HUE037005T2 (hr) |
IL (1) | IL263954A (hr) |
LT (1) | LT2640358T (hr) |
MX (1) | MX348225B (hr) |
NZ (1) | NZ610911A (hr) |
PL (2) | PL2640358T3 (hr) |
PT (2) | PT3326615T (hr) |
RS (1) | RS57047B1 (hr) |
RU (2) | RU2740080C2 (hr) |
SG (2) | SG190258A1 (hr) |
SI (1) | SI2640358T1 (hr) |
WO (1) | WO2012066538A1 (hr) |
ZA (1) | ZA201303509B (hr) |
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WO2015115512A1 (ja) * | 2014-01-29 | 2015-08-06 | 独立行政法人産業技術総合研究所 | シクロデキストリンの利用による抗がん活性が増強されたアシュワガンダ葉の水抽出物の調製方法、及びアシュワガンダ葉を含む医薬組成物 |
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