ECSP17064188A - Formulación estable para administración parenteral de tapentadol - Google Patents
Formulación estable para administración parenteral de tapentadolInfo
- Publication number
- ECSP17064188A ECSP17064188A ECIEPI201764188A ECPI201764188A ECSP17064188A EC SP17064188 A ECSP17064188 A EC SP17064188A EC IEPI201764188 A ECIEPI201764188 A EC IEPI201764188A EC PI201764188 A ECPI201764188 A EC PI201764188A EC SP17064188 A ECSP17064188 A EC SP17064188A
- Authority
- EC
- Ecuador
- Prior art keywords
- tapentadol
- parenteral administration
- relates
- pharmaceutical composition
- stable formulation
- Prior art date
Links
- KWTWDQCKEHXFFR-SMDDNHRTSA-N tapentadol Chemical compound CN(C)C[C@H](C)[C@@H](CC)C1=CC=CC(O)=C1 KWTWDQCKEHXFFR-SMDDNHRTSA-N 0.000 title abstract 4
- 229960005126 tapentadol Drugs 0.000 title abstract 4
- 239000000203 mixture Substances 0.000 title abstract 3
- 238000007911 parenteral administration Methods 0.000 title abstract 2
- 238000009472 formulation Methods 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 3
- 208000002193 Pain Diseases 0.000 abstract 2
- 208000005298 acute pain Diseases 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
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)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Emergency Medicine (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Pain & Pain Management (AREA)
- Organic Chemistry (AREA)
- Biomedical Technology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
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.
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 |
|---|---|
| ECSP17064188A true ECSP17064188A (es) | 2018-03-31 |
Family
ID=55661386
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ECIEPI201764188A ECSP17064188A (es) | 2015-03-27 | 2017-09-26 | Formulación estable para administración parenteral de tapentadol |
Country Status (28)
| Country | Link |
|---|---|
| US (2) | US20160279078A1 (es) |
| EP (2) | EP3273953B1 (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 (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MX369121B (es) | 2011-03-04 | 2019-10-30 | Gruenenthal Gmbh | Formulacion farmaceutica acuosa de tapentadol para administracion oral. |
| EA036258B1 (ru) | 2015-03-27 | 2020-10-20 | Грюненталь Гмбх | Стабильный препарат для парентерального введения тапентадола |
| CN109996533A (zh) | 2016-09-23 | 2019-07-09 | 格吕伦塔尔有限公司 | 用于肠胃外施用他喷他多的稳定制剂 |
| EP3585370A1 (en) | 2017-02-23 | 2020-01-01 | Grünenthal GmbH | Tapentadol as local anesthetic |
| CN114788814B (zh) * | 2021-01-26 | 2023-10-13 | 浙江创新生物有限公司 | 一种高稳定性的注射用达托霉素组合物及其制备方法和其应用 |
| IT202400002503A1 (it) * | 2024-02-07 | 2025-08-07 | S A L F S P A Laboratorio Farm | Formulazione iniettabile sterile a base di rocuronio |
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| 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 |
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| MX374468B (es) | 2011-03-04 | 2025-03-06 | Gruenenthal Gmbh | Composicion farmaceutica acuosa semisolida que contiene tapentadol. |
| MX369121B (es) * | 2011-03-04 | 2019-10-30 | Gruenenthal Gmbh | Formulacion farmaceutica acuosa de tapentadol para administracion oral. |
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| EA036258B1 (ru) | 2015-03-27 | 2020-10-20 | Грюненталь Гмбх | Стабильный препарат для парентерального введения тапентадола |
-
2016
- 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 PT PT182065813T patent/PT3479823T/pt unknown
- 2016-03-23 CA CA2979034A patent/CA2979034A1/en not_active Abandoned
- 2016-03-23 PT PT16714327T patent/PT3273953T/pt unknown
- 2016-03-23 HK HK18112014.7A patent/HK1252705A1/zh unknown
- 2016-03-23 PL PL16714327T patent/PL3273953T3/pl unknown
- 2016-03-23 TW TW105108920A patent/TW201642843A/zh unknown
- 2016-03-23 EP EP16714327.0A patent/EP3273953B1/en active Active
- 2016-03-23 CN CN201680019084.0A patent/CN107847471A/zh active Pending
- 2016-03-23 EP EP18206581.3A patent/EP3479823B1/en active Active
- 2016-03-23 KR KR1020177031299A patent/KR20170132282A/ko not_active Withdrawn
- 2016-03-23 JP JP2017550592A patent/JP6923447B2/ja active Active
- 2016-03-23 DK DK16714327.0T patent/DK3273953T3/en active
- 2016-03-23 ES ES18206581T patent/ES2822113T3/es active Active
- 2016-03-23 MX MX2017012312A patent/MX2017012312A/es active IP Right Grant
- 2016-03-23 US US15/078,631 patent/US20160279078A1/en not_active Abandoned
- 2016-03-23 LT LTEP16714327.0T patent/LT3273953T/lt unknown
- 2016-03-23 BR BR112017018569A patent/BR112017018569A2/pt not_active Application Discontinuation
- 2016-03-23 WO PCT/EP2016/056376 patent/WO2016156147A1/en not_active Ceased
- 2016-03-23 HU HUE16714327A patent/HUE042612T2/hu unknown
- 2016-03-23 HR HRP20190231TT patent/HRP20190231T1/hr unknown
- 2016-03-23 AU AU2016239772A patent/AU2016239772B2/en active Active
- 2016-03-23 PE PE2017001503A patent/PE20171651A1/es unknown
- 2016-03-23 ES ES16714327T patent/ES2710299T3/es active Active
- 2016-03-23 SI SI201630181T patent/SI3273953T1/sl unknown
-
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
-
2019
- 2019-02-06 CY CY20191100162T patent/CY1121371T1/el unknown
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