HRP20150349T1 - Stabilni tekuä†i farmaceutski sastav na bazi trazodona - Google Patents
Stabilni tekuä†i farmaceutski sastav na bazi trazodona Download PDFInfo
- Publication number
- HRP20150349T1 HRP20150349T1 HRP20150349TT HRP20150349T HRP20150349T1 HR P20150349 T1 HRP20150349 T1 HR P20150349T1 HR P20150349T T HRP20150349T T HR P20150349TT HR P20150349 T HRP20150349 T HR P20150349T HR P20150349 T1 HRP20150349 T1 HR P20150349T1
- Authority
- HR
- Croatia
- Prior art keywords
- pharmaceutical composition
- composition according
- peg
- mass
- volume
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims 15
- PHLBKPHSAVXXEF-UHFFFAOYSA-N trazodone Chemical compound ClC1=CC=CC(N2CCN(CCCN3C(N4C=CC=CC4=N3)=O)CC2)=C1 PHLBKPHSAVXXEF-UHFFFAOYSA-N 0.000 title claims 6
- 229960003991 trazodone Drugs 0.000 title claims 6
- 239000007788 liquid Substances 0.000 title claims 2
- 239000002904 solvent Substances 0.000 claims 6
- 239000002253 acid Substances 0.000 claims 5
- 150000003839 salts Chemical class 0.000 claims 5
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 3
- 229920002535 Polyethylene Glycol 1500 Polymers 0.000 claims 2
- 229920000604 Polyethylene Glycol 200 Polymers 0.000 claims 2
- 229920002556 Polyethylene Glycol 300 Polymers 0.000 claims 2
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 claims 2
- 229920002582 Polyethylene Glycol 600 Polymers 0.000 claims 2
- 229920002523 polyethylene Glycol 1000 Polymers 0.000 claims 2
- 229920000858 Cyclodextrin Polymers 0.000 claims 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical group Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 1
- 239000008118 PEG 6000 Substances 0.000 claims 1
- 229920002560 Polyethylene Glycol 3000 Polymers 0.000 claims 1
- 229920002562 Polyethylene Glycol 3350 Polymers 0.000 claims 1
- 229920001030 Polyethylene Glycol 4000 Polymers 0.000 claims 1
- 229920002584 Polyethylene Glycol 6000 Polymers 0.000 claims 1
- 239000000654 additive Substances 0.000 claims 1
- 230000000996 additive effect Effects 0.000 claims 1
- 239000003963 antioxidant agent Substances 0.000 claims 1
- 230000003078 antioxidant effect Effects 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 239000000872 buffer Substances 0.000 claims 1
- 239000002738 chelating agent Substances 0.000 claims 1
- 229940097362 cyclodextrins Drugs 0.000 claims 1
- 239000000975 dye Substances 0.000 claims 1
- 235000003599 food sweetener Nutrition 0.000 claims 1
- -1 pH-correctors Substances 0.000 claims 1
- 229940113116 polyethylene glycol 1000 Drugs 0.000 claims 1
- 229940093430 polyethylene glycol 1500 Drugs 0.000 claims 1
- 229940113115 polyethylene glycol 200 Drugs 0.000 claims 1
- 229940068886 polyethylene glycol 300 Drugs 0.000 claims 1
- 229940113125 polyethylene glycol 3000 Drugs 0.000 claims 1
- 229940050929 polyethylene glycol 3350 Drugs 0.000 claims 1
- 229940068918 polyethylene glycol 400 Drugs 0.000 claims 1
- 229940057838 polyethylene glycol 4000 Drugs 0.000 claims 1
- 229940057847 polyethylene glycol 600 Drugs 0.000 claims 1
- 229940093429 polyethylene glycol 6000 Drugs 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 229960004063 propylene glycol Drugs 0.000 claims 1
- 235000013772 propylene glycol Nutrition 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 239000003765 sweetening agent Substances 0.000 claims 1
- VUYXVWGKCKTUMF-UHFFFAOYSA-N tetratriacontaethylene glycol monomethyl ether Chemical compound COCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCO VUYXVWGKCKTUMF-UHFFFAOYSA-N 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
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- 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
- 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
- A61P25/24—Antidepressants
Claims (13)
1. Stabilni tekući farmaceutski sastav koji sadrži vodenu otopinu farmaceutski prihvatljive soli adicijske kiseline od trazodona, naznačen time, da navedeni farmaceutski sastav ima pH-vrijednost između 5,0 i 6,0 te sadrži najmanje dva ko-otapala odabrana iz skupine koju čine propilen-glikol, polietilen-glikol 200 (PEG 200), polietilen-glikol 300 (PEG 300), polietilen-glikol 400 (PEG 400), polietilen-glikol 600 (PEG 600), polietilen-glikol 1000 (PEG 1000), polietilen-glikol 1500 (PEG 1500), polietilen-glikol 3000 (PEG 3000), polietilen-glikol 3350 (PEG 3350), polietilen-glikol 4000 (PEG 4000) i polietilen-glikol 6000 (PEG 6000).
2. Farmaceutski sastav prema zahtjevu 1, naznačen time, da on ima pH-vrijednost između 5,0 i 5,5.
3. Farmaceutski sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da on sadrži ukupnu količinu spomenutih ko-otapala u rasponu od 20% do 90% (masa/volumen).
4. Farmaceutski sastav prema zahtjevu 3, naznačen time, da on sadrži ukupnu količinu spomenutih ko-otapala u rasponu od 30% do 85% (masa/volumen).
5. Farmaceutski sastav prema zahtjevu 4, naznačen time, da on sadrži ukupnu količinu spomenutih ko-otapala u rasponu od 40% do 80% (masa/volumen).
6. Farmaceutski sastav prema zahtjevu 1, naznačen time, da on sadrži dva ko-otapala, svakog neovisno u količini koja je u rasponu od 5% do 50% (masa/volumen), ali u ukupnoj količini koja nije veća od 90% (masa/volumen).
7. Farmaceutski sastav prema zahtjevu 1, naznačen time, da on sadrži tri ko-otapala, svakog neovisno u količini koja je u rasponu od 5% do 40% (masa/volumen), ali u ukupnoj količini koja nije veća od 90% (masa/volumen).
8. Farmaceutski sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da on sadrži spomenutu farmaceutski prihvatljivu sol adicijske kiseline od trazodona u količini između 1% i 15% (masa/volumen).
9. Farmaceutski sastav prema zahtjevu 8, naznačen time, da on sadrži spomenutu farmaceutski prihvatljivu sol adicijske kiseline od trazodona u količini između 3% i 10% (masa/volumen).
10. Farmaceutski sastav prema zahtjevu 8, naznačen time, da on sadrži spomenutu farmaceutski prihvatljivu sol adicijske kiseline od trazodona u količini između 4% i 8% (masa/volumen).
11. Farmaceutski sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da spomenuta farmaceutski prihvatljiva sol adicijske kiseline od trazodona je hidroklorid.
12. Farmaceutski sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da on sadrži najmanje jedan antioksidant.
13. Farmaceutski sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da on sadrži najmanje jedan aditiv odabran iz skupine koju čine kelatni agensi, puferi, pH-ispravljači, tenzidi, ciklodekstrini, bojila, sladila i konzervansi.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT001573A ITMI20071573A1 (it) | 2007-07-31 | 2007-07-31 | Composizione farmaceutica liquida stabile a base di trazodone |
| EP12170235.1A EP2494955B1 (en) | 2007-07-31 | 2008-07-22 | Stable liquid pharmaceutical composition based on trazodone |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20150349T1 true HRP20150349T1 (hr) | 2015-05-22 |
Family
ID=38858941
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20150349TT HRP20150349T1 (hr) | 2007-07-31 | 2015-03-27 | Stabilni tekuä†i farmaceutski sastav na bazi trazodona |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US10292931B2 (hr) |
| EP (2) | EP2182920B1 (hr) |
| JP (1) | JP5426548B2 (hr) |
| KR (1) | KR101493370B1 (hr) |
| CN (1) | CN101784257B (hr) |
| AR (1) | AR068327A1 (hr) |
| AU (1) | AU2008281858B2 (hr) |
| BR (1) | BRPI0814658A2 (hr) |
| CA (1) | CA2692975C (hr) |
| CY (1) | CY1116189T1 (hr) |
| DK (2) | DK2182920T3 (hr) |
| EA (1) | EA016822B1 (hr) |
| ES (2) | ES2531241T3 (hr) |
| GE (1) | GEP20125525B (hr) |
| HK (2) | HK1176280A1 (hr) |
| HR (1) | HRP20150349T1 (hr) |
| IL (1) | IL203167A (hr) |
| IT (1) | ITMI20071573A1 (hr) |
| MX (1) | MX2010001092A (hr) |
| PL (2) | PL2182920T3 (hr) |
| PT (2) | PT2494955E (hr) |
| SG (1) | SG183659A1 (hr) |
| SI (2) | SI2182920T1 (hr) |
| UA (1) | UA102376C2 (hr) |
| WO (1) | WO2009016069A2 (hr) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ITMI20071603A1 (it) | 2007-08-03 | 2009-02-04 | Acraf | Trazodone e trazodone cloridrato in forma purificata |
| WO2012072665A1 (en) | 2010-11-30 | 2012-06-07 | Pharmaneuroboost N.V. | Compositions comprising pipamperone and serotonin antagonist reuptake inhibitors |
| RU2706700C1 (ru) * | 2019-09-24 | 2019-11-20 | Общество с ограниченной ответственностью "Научно-производственная компания "СКиФФ" | Фармацевтическая композиция для коррекции поведения кошек и собак в стрессовых ситуациях |
| BR112022005343A2 (pt) * | 2019-09-26 | 2022-06-14 | Angelini S P A | Trazodona ou um sal da mesma para uso em um método para tratar insônia, composição farmacêutica, xarope, e, método para tratar insônia |
| CN111568861A (zh) * | 2020-05-25 | 2020-08-25 | 河北科星药业有限公司 | 畜禽用盐酸溴己新口服液及其制备方法和应用 |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4154832A (en) * | 1974-08-26 | 1979-05-15 | Bruno Silvestrini | Novel treatment for acute organic cerebral syndromes (strokes) |
| IT1233412B (it) * | 1987-12-02 | 1992-03-30 | Acraf | Uso del trazodone |
| BR9912395A (pt) * | 1998-07-24 | 2001-10-16 | Seo Hong Yoo | Preparação de formas de dosagem de solução clara aquosa com ácidos biliares |
| AU2003903597A0 (en) | 2003-07-11 | 2003-07-24 | Jakov Vaisman | Treatment of premature ejaculation |
| ITMI20071603A1 (it) | 2007-08-03 | 2009-02-04 | Acraf | Trazodone e trazodone cloridrato in forma purificata |
-
2007
- 2007-07-31 IT IT001573A patent/ITMI20071573A1/it unknown
-
2008
- 2008-07-22 CA CA2692975A patent/CA2692975C/en active Active
- 2008-07-22 DK DK08775278.8T patent/DK2182920T3/da active
- 2008-07-22 EP EP08775278A patent/EP2182920B1/en active Active
- 2008-07-22 GE GEAP200811704A patent/GEP20125525B/en unknown
- 2008-07-22 CN CN2008801012992A patent/CN101784257B/zh active Active
- 2008-07-22 PT PT12170235T patent/PT2494955E/pt unknown
- 2008-07-22 PL PL08775278T patent/PL2182920T3/pl unknown
- 2008-07-22 PT PT87752788T patent/PT2182920E/pt unknown
- 2008-07-22 ES ES12170235T patent/ES2531241T3/es active Active
- 2008-07-22 MX MX2010001092A patent/MX2010001092A/es active IP Right Grant
- 2008-07-22 DK DK12170235T patent/DK2494955T3/en active
- 2008-07-22 WO PCT/EP2008/059605 patent/WO2009016069A2/en active Application Filing
- 2008-07-22 SI SI200830897T patent/SI2182920T1/sl unknown
- 2008-07-22 SI SI200831393T patent/SI2494955T1/sl unknown
- 2008-07-22 SG SG2012055679A patent/SG183659A1/en unknown
- 2008-07-22 AU AU2008281858A patent/AU2008281858B2/en active Active
- 2008-07-22 EA EA201070194A patent/EA016822B1/ru not_active IP Right Cessation
- 2008-07-22 ES ES08775278T patent/ES2399569T3/es active Active
- 2008-07-22 UA UAA201000864A patent/UA102376C2/ru unknown
- 2008-07-22 PL PL12170235T patent/PL2494955T3/pl unknown
- 2008-07-22 BR BRPI0814658-6A2A patent/BRPI0814658A2/pt not_active Application Discontinuation
- 2008-07-22 KR KR1020107002151A patent/KR101493370B1/ko active IP Right Grant
- 2008-07-22 JP JP2010518618A patent/JP5426548B2/ja active Active
- 2008-07-22 US US12/667,694 patent/US10292931B2/en active Active
- 2008-07-22 EP EP12170235.1A patent/EP2494955B1/en active Active
- 2008-07-30 AR ARP080103285A patent/AR068327A1/es not_active Application Discontinuation
-
2010
- 2010-01-06 IL IL203167A patent/IL203167A/en active IP Right Grant
- 2010-05-19 HK HK13102337.3A patent/HK1176280A1/xx unknown
- 2010-05-19 HK HK10104941.0A patent/HK1138207A1/xx unknown
-
2015
- 2015-03-27 HR HRP20150349TT patent/HRP20150349T1/hr unknown
- 2015-04-09 CY CY20151100342T patent/CY1116189T1/el unknown
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