CL2017002306A1 - Formulación estable para administración parenteral de tapentadol - Google Patents
Formulación estable para administración parenteral de tapentadolInfo
- Publication number
- CL2017002306A1 CL2017002306A1 CL2017002306A CL2017002306A CL2017002306A1 CL 2017002306 A1 CL2017002306 A1 CL 2017002306A1 CL 2017002306 A CL2017002306 A CL 2017002306A CL 2017002306 A CL2017002306 A CL 2017002306A CL 2017002306 A1 CL2017002306 A1 CL 2017002306A1
- Authority
- CL
- Chile
- Prior art keywords
- tapentadol
- parenteral administration
- relates
- pharmaceutical composition
- stable formulation
- Prior art date
Links
Classifications
-
- 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
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K9/08—Solutions
-
- 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
- A61P25/04—Centrally acting analgesics, e.g. opioids
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Emergency Medicine (AREA)
- Dermatology (AREA)
- Neurosurgery (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pain & Pain Management (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
<p>La invención se relaciona con una composición farmacéutica acuosa para administración parenteral que comprende Tapentadol o un sal fisiológicamente aceptable del mismo, en donde la concentración de Tapentadol queda dentro de la variación de 0.10 hasta 8.00 mg/mL, con base en el peso de la base libre de Tapentadol y con base en el volumen total de la composición; y en donde el valor de pH de la composición se amortigua y queda dentro de la variación de 4.0 hasta 6.0. La invención también se relaciona con un recipiente que comprende la composición farmacéutica y un proceso para la preparación del mismo. La invención también se relaciona con un kit que comprende el contenido de acuerdo con la invención en un empaque. La composición farmacéutica de acuerdo con la invención es particularmente útil para tratar dolor, en especial dolor agudo, de preferencia en pacientes pediátricos</p>
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15161487 | 2015-03-27 | ||
| EP15169730 | 2015-05-28 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CL2017002306A1 true CL2017002306A1 (es) | 2018-03-23 |
Family
ID=55661386
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CL2017002306A CL2017002306A1 (es) | 2015-03-27 | 2017-09-12 | Formulación estable para administración parenteral de tapentadol |
Country Status (28)
| Country | Link |
|---|---|
| US (2) | US20160279078A1 (es) |
| EP (2) | EP3479823B1 (es) |
| JP (1) | JP6923447B2 (es) |
| KR (1) | KR20170132282A (es) |
| CN (1) | CN107847471A (es) |
| AU (1) | AU2016239772B2 (es) |
| BR (1) | BR112017018569A2 (es) |
| CA (1) | CA2979034A1 (es) |
| CL (1) | CL2017002306A1 (es) |
| CO (1) | CO2017009400A2 (es) |
| CY (1) | CY1121371T1 (es) |
| DK (1) | DK3273953T3 (es) |
| EA (1) | EA036258B1 (es) |
| EC (1) | ECSP17064188A (es) |
| ES (2) | ES2822113T3 (es) |
| HK (1) | HK1252705A1 (es) |
| HR (1) | HRP20190231T1 (es) |
| HU (1) | HUE042612T2 (es) |
| IL (1) | IL254136A0 (es) |
| LT (1) | LT3273953T (es) |
| MX (1) | MX2017012312A (es) |
| PE (1) | PE20171651A1 (es) |
| PL (1) | PL3273953T3 (es) |
| PT (2) | PT3479823T (es) |
| RS (1) | RS58301B1 (es) |
| SI (1) | SI3273953T1 (es) |
| TW (1) | TW201642843A (es) |
| WO (1) | WO2016156147A1 (es) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| LT2680832T (lt) | 2011-03-04 | 2019-10-25 | Gruenenthal Gmbh | Tapentadolio vandeninė farmacinė kompozicija, skirta vartoti geriant |
| PT3479823T (pt) | 2015-03-27 | 2020-09-29 | Gruenenthal Gmbh | Formulação estável para administração parentérica de tapentadol |
| KR20190057349A (ko) | 2016-09-23 | 2019-05-28 | 그뤼넨탈 게엠베하 | 타펜타돌의 비경구 투여용 안정한 제제 |
| WO2018153947A1 (en) | 2017-02-23 | 2018-08-30 | Grünenthal GmbH | Tapentadol as local anesthetic |
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| CA2013755C (en) | 1989-04-05 | 1993-11-30 | Simon Benita | Medicinal emulsions |
| DE4426245A1 (de) | 1994-07-23 | 1996-02-22 | Gruenenthal Gmbh | 1-Phenyl-3-dimethylamino-propanverbindungen mit pharmakologischer Wirkung |
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| FR2809619B1 (fr) | 2000-06-06 | 2004-09-24 | Pharmatop | Nouvelles formulations aqueuses de principes actifs sensibles a l'oxydation et leur procede d'obtention |
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| JP4905616B2 (ja) | 2001-04-19 | 2012-03-28 | ライオン株式会社 | ソフトコンタクトレンズ用点眼剤 |
| US6638981B2 (en) | 2001-08-17 | 2003-10-28 | Epicept Corporation | Topical compositions and methods for treating pain |
| PE20030527A1 (es) | 2001-10-24 | 2003-07-26 | Gruenenthal Chemie | Formulacion farmaceutica con liberacion retardada que contiene 3-(3-dimetilamino-1-etil-2-metil-propil) fenol o una sal farmaceuticamente aceptable del mismo y tabletas para administracion oral que la contienen |
| FR2832063B1 (fr) | 2001-11-15 | 2004-08-27 | Aguettant Lab | Procede de production de solutions stables de substances phenoliques et les solutions en resultant |
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| GB201309654D0 (en) | 2013-05-30 | 2013-07-17 | Euro Celtique Sa | Method |
| CN103735500B (zh) | 2014-01-28 | 2016-01-20 | 江苏华泽医药科技有限公司 | 盐酸他喷他多注射液及其制备方法 |
| PT3479823T (pt) | 2015-03-27 | 2020-09-29 | Gruenenthal Gmbh | Formulação estável para administração parentérica de tapentadol |
-
2016
- 2016-03-23 PT PT182065813T patent/PT3479823T/pt unknown
- 2016-03-23 CN CN201680019084.0A patent/CN107847471A/zh active Pending
- 2016-03-23 KR KR1020177031299A patent/KR20170132282A/ko unknown
- 2016-03-23 AU AU2016239772A patent/AU2016239772B2/en active Active
- 2016-03-23 ES ES18206581T patent/ES2822113T3/es active Active
- 2016-03-23 SI SI201630181T patent/SI3273953T1/sl unknown
- 2016-03-23 HU HUE16714327A patent/HUE042612T2/hu unknown
- 2016-03-23 PE PE2017001503A patent/PE20171651A1/es unknown
- 2016-03-23 BR BR112017018569A patent/BR112017018569A2/pt not_active Application Discontinuation
- 2016-03-23 LT LTEP16714327.0T patent/LT3273953T/lt unknown
- 2016-03-23 PT PT16714327T patent/PT3273953T/pt unknown
- 2016-03-23 EP EP18206581.3A patent/EP3479823B1/en active Active
- 2016-03-23 DK DK16714327.0T patent/DK3273953T3/en active
- 2016-03-23 US US15/078,631 patent/US20160279078A1/en not_active Abandoned
- 2016-03-23 TW TW105108920A patent/TW201642843A/zh unknown
- 2016-03-23 JP JP2017550592A patent/JP6923447B2/ja active Active
- 2016-03-23 WO PCT/EP2016/056376 patent/WO2016156147A1/en active Application Filing
- 2016-03-23 EA EA201792144A patent/EA036258B1/ru not_active IP Right Cessation
- 2016-03-23 RS RS20190174A patent/RS58301B1/sr unknown
- 2016-03-23 ES ES16714327T patent/ES2710299T3/es active Active
- 2016-03-23 PL PL16714327T patent/PL3273953T3/pl unknown
- 2016-03-23 MX MX2017012312A patent/MX2017012312A/es active IP Right Grant
- 2016-03-23 EP EP16714327.0A patent/EP3273953B1/en active Active
- 2016-03-23 CA CA2979034A patent/CA2979034A1/en not_active Abandoned
-
2017
- 2017-08-24 IL IL254136A patent/IL254136A0/en unknown
- 2017-09-12 CL CL2017002306A patent/CL2017002306A1/es unknown
- 2017-09-15 CO CONC2017/0009400A patent/CO2017009400A2/es unknown
- 2017-09-26 EC ECIEPI201764188A patent/ECSP17064188A/es unknown
-
2018
- 2018-01-10 US US15/867,254 patent/US11013701B2/en active Active
- 2018-09-19 HK HK18112014.7A patent/HK1252705A1/zh unknown
-
2019
- 2019-02-05 HR HRP20190231TT patent/HRP20190231T1/hr unknown
- 2019-02-06 CY CY20191100162T patent/CY1121371T1/el unknown
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