DK2494955T3 - Stabil væskeformig farmaceutisk komposition baseret på tradozone. - Google Patents
Stabil væskeformig farmaceutisk komposition baseret på tradozone. Download PDFInfo
- Publication number
- DK2494955T3 DK2494955T3 DK12170235T DK12170235T DK2494955T3 DK 2494955 T3 DK2494955 T3 DK 2494955T3 DK 12170235 T DK12170235 T DK 12170235T DK 12170235 T DK12170235 T DK 12170235T DK 2494955 T3 DK2494955 T3 DK 2494955T3
- Authority
- DK
- Denmark
- Prior art keywords
- pharmaceutical composition
- peg
- composition according
- polyethylene glycol
- trazodone
- Prior art date
Links
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. Stabil væskeformig farmaceutisk komposition, omfattende en vandig opløsning af et farmaceutisk acceptabelt syreadditionssalt af tradozone, kendetegnet ved, at den farmaceutiske komposition har en pH værdi mellem 5,0 og 6,0 og omfatter mindst to co-solventer, som er udvalgt fra en gruppe, som består af propylenglykol, polyethylene glycol 200 (PEG 200), polyethylene glycol 300 (PEG 300), polyethylene glycol 400 (PEG 400), polyethylene glycol 600 (PEG 600), polyethylene glycol 1000 (PEG 1000), polyethylene glycol 1500 (PEG 1500), polyethylene glycol 3000 (PEG 3000), polyethylene glycol 3350 (PEG 3350), polyethylene glycol 4000 (PEG 4000) og polyethylene glycol 6000 (PEG 6000).
2. Farmaceutisk komposition ifølge krav 1, kendetegnet ved, at den har en pH værdi imellem 5,0 og 5,5.
3. Farmaceutisk komposition ifølge et vilkårligt af de foregående krav, kendetegnet ved, at den omfatter en total mængde af de nævnte co-solventer i intervallet fra 20% til 90% (vægt/vol-%).
4. Farmaceutisk komposition ifølge krav 3, kendetegnet ved, at den omfatter en total mængde af de nævnte co-solventer i intervallet fra 30% til 85% (vægt/vol-%).
5. Farmaceutisk komposition ifølge krav 4, kendetegnet ved, at den omfatter en total mængde af de nævnte co-solventer i intervallet fra 40% til 80% (vægt/vol%).
6. Farmaceutisk komposition ifølge krav 1, kendetegnet ved, at den omfatter to co-solventer, som hver er til stede i en mængde i intervallet fra 5% til 50% (vægt/vol%) idet den totale mængde ikke overstiger 90% (vægt/vol-%).
7. Farmaceutisk komposition ifølge krav 1, kendetegnet ved, at den omfatter tre co-solventer som hver er til stede i en mængde i intervallet fra 5% til 40% (vægt/vol%) idet den totale mængde ikke overstiger 90% (vægt/vol%).
8. Farmaceutisk komposition ifølge et vilkårligt af de foregående krav, kendetegnet ved, at den omfatter en mængde af det farmaceutisk acceptable syreadditionssalt af tradozone på mellem 1% og 15% (vægt/vol%).
9. Farmaceutisk komposition ifølge krav 8, kendetegnet ved, at den omfatter en mængde af det farmaceutisk acceptable syreadditionssalt af tradozone på mellem 3 og 10% (vægt/vol-%).
10. Farmaceutisk komposition ifølge krav 8, kendetegnet ved, at den omfatter en mængde af det farmaceutisk acceptable syreadditionssalt af tradozone på mellem 4% og 8% (vægt-%).
11. Farmaceutisk komposition ifølge et vilkårligt af de foregående krav, kendetegnet ved, at det farmaceutisk acceptable syreadditionssalt af tradozone er trazodone hydrochloride.
12. Farmaceutisk komposition ifølge et vilkårligt af de foregående krav, kendetegnet ved at den omfatter mindst én antioxidant.
13. Farmaceutisk komposition ifølge et vilkårligt af de foregående krav, kendetegnet ved, at den omfatter mindst et additiv, som er valgt fra gruppen, som omfatter chelate-ringsmidler, buffere, pH justeringsmidler, overfladeaktive stoffer, cyklodextriner, farvestoffer, sødemidler og konserveringsmidler.
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 |
| EP08775278A EP2182920B1 (en) | 2007-07-31 | 2008-07-22 | Stable liquid pharmaceutical composition based on trazodone |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2494955T3 true DK2494955T3 (da) | 2015-04-13 |
Family
ID=38858941
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK08775278.8T DK2182920T3 (da) | 2007-07-31 | 2008-07-22 | Stabil væskeformig farmaceutisk komposition baseret på trazodon |
| DK12170235T DK2494955T3 (da) | 2007-07-31 | 2008-07-22 | Stabil væskeformig farmaceutisk komposition baseret på tradozone. |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK08775278.8T DK2182920T3 (da) | 2007-07-31 | 2008-07-22 | Stabil væskeformig farmaceutisk komposition baseret på trazodon |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US10292931B2 (da) |
| EP (2) | EP2182920B1 (da) |
| JP (1) | JP5426548B2 (da) |
| KR (1) | KR101493370B1 (da) |
| CN (1) | CN101784257B (da) |
| AR (1) | AR068327A1 (da) |
| AU (1) | AU2008281858B2 (da) |
| BR (1) | BRPI0814658A2 (da) |
| CA (1) | CA2692975C (da) |
| CY (1) | CY1116189T1 (da) |
| DK (2) | DK2182920T3 (da) |
| EA (1) | EA016822B1 (da) |
| ES (2) | ES2531241T3 (da) |
| GE (1) | GEP20125525B (da) |
| HK (2) | HK1176280A1 (da) |
| HR (1) | HRP20150349T1 (da) |
| IL (1) | IL203167A (da) |
| IT (1) | ITMI20071573A1 (da) |
| MX (1) | MX2010001092A (da) |
| PL (2) | PL2182920T3 (da) |
| PT (2) | PT2494955E (da) |
| SG (1) | SG183659A1 (da) |
| SI (2) | SI2182920T1 (da) |
| UA (1) | UA102376C2 (da) |
| WO (1) | WO2009016069A2 (da) |
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/da 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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