MX2017012312A - Formulacion estable para administracion parenteral de tapentadol. - Google Patents
Formulacion estable para administracion parenteral de tapentadol.Info
- Publication number
- MX2017012312A MX2017012312A MX2017012312A MX2017012312A MX2017012312A MX 2017012312 A MX2017012312 A MX 2017012312A MX 2017012312 A MX2017012312 A MX 2017012312A MX 2017012312 A MX2017012312 A MX 2017012312A MX 2017012312 A MX2017012312 A MX 2017012312A
- Authority
- MX
- Mexico
- 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
- 239000012458 free base Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 238000004806 packaging method and process 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)
- 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)
- Dermatology (AREA)
- Emergency Medicine (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)
- 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 (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15161487 | 2015-03-27 | ||
| EP15169730 | 2015-05-28 | ||
| PCT/EP2016/056376 WO2016156147A1 (en) | 2015-03-27 | 2016-03-23 | Stable formulation for parenteral administration of tapentadol |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2017012312A true MX2017012312A (es) | 2018-01-18 |
Family
ID=55661386
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2017012312A MX2017012312A (es) | 2015-03-27 | 2016-03-23 | Formulacion estable para administracion 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) | ES2710299T3 (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) | PT3273953T (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 |
|---|---|---|---|---|
| EP3597182A1 (en) | 2011-03-04 | 2020-01-22 | Grünenthal GmbH | Aqueous pharmaceutical formulation of tapentadol for oral administration |
| CN107847471A (zh) | 2015-03-27 | 2018-03-27 | 格吕伦塔尔有限公司 | 他喷他多肠胃外给药的稳定制剂 |
| PE20190908A1 (es) | 2016-09-23 | 2019-06-26 | Gruenenthal Chemie | Formulacion estable para la administracion parenteral de tapentadol |
| 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 |
| WO2025169106A1 (en) * | 2024-02-07 | 2025-08-14 | S.A.L.F. S.P.A. Laboratorio Farmacologico | Sterile injectable formulation based on rocuronium |
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-
2016
- 2016-03-23 CN CN201680019084.0A patent/CN107847471A/zh active Pending
- 2016-03-23 HR HRP20190231TT patent/HRP20190231T1/hr unknown
- 2016-03-23 RS RS20190174A patent/RS58301B1/sr unknown
- 2016-03-23 KR KR1020177031299A patent/KR20170132282A/ko not_active Withdrawn
- 2016-03-23 US US15/078,631 patent/US20160279078A1/en not_active Abandoned
- 2016-03-23 ES ES16714327T patent/ES2710299T3/es active Active
- 2016-03-23 DK DK16714327.0T patent/DK3273953T3/en active
- 2016-03-23 SI SI201630181T patent/SI3273953T1/sl unknown
- 2016-03-23 PT PT16714327T patent/PT3273953T/pt unknown
- 2016-03-23 HK HK18112014.7A patent/HK1252705A1/zh unknown
- 2016-03-23 MX MX2017012312A patent/MX2017012312A/es active IP Right Grant
- 2016-03-23 PE PE2017001503A patent/PE20171651A1/es unknown
- 2016-03-23 EP EP18206581.3A patent/EP3479823B1/en active Active
- 2016-03-23 TW TW105108920A patent/TW201642843A/zh unknown
- 2016-03-23 PL PL16714327T patent/PL3273953T3/pl unknown
- 2016-03-23 ES ES18206581T patent/ES2822113T3/es active Active
- 2016-03-23 EA EA201792144A patent/EA036258B1/ru not_active IP Right Cessation
- 2016-03-23 PT PT182065813T patent/PT3479823T/pt unknown
- 2016-03-23 WO PCT/EP2016/056376 patent/WO2016156147A1/en not_active Ceased
- 2016-03-23 AU AU2016239772A patent/AU2016239772B2/en active Active
- 2016-03-23 JP JP2017550592A patent/JP6923447B2/ja active Active
- 2016-03-23 EP EP16714327.0A patent/EP3273953B1/en active Active
- 2016-03-23 CA CA2979034A patent/CA2979034A1/en not_active Abandoned
- 2016-03-23 LT LTEP16714327.0T patent/LT3273953T/lt unknown
- 2016-03-23 HU HUE16714327A patent/HUE042612T2/hu unknown
- 2016-03-23 BR BR112017018569A patent/BR112017018569A2/pt not_active Application Discontinuation
-
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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