AR114074A1 - PHARMACEUTICAL COMBINATION INCLUDING TRAMADOL HYDROCHLORIDE EXTENDED RELEASE AND IMMEDIATE RELEASE ETORICOXIB, AND ITS USE FOR THE TREATMENT OF PAIN - Google Patents
PHARMACEUTICAL COMBINATION INCLUDING TRAMADOL HYDROCHLORIDE EXTENDED RELEASE AND IMMEDIATE RELEASE ETORICOXIB, AND ITS USE FOR THE TREATMENT OF PAINInfo
- Publication number
- AR114074A1 AR114074A1 ARP180103918A ARP180103918A AR114074A1 AR 114074 A1 AR114074 A1 AR 114074A1 AR P180103918 A ARP180103918 A AR P180103918A AR P180103918 A ARP180103918 A AR P180103918A AR 114074 A1 AR114074 A1 AR 114074A1
- Authority
- AR
- Argentina
- Prior art keywords
- etoricoxib
- solvents
- tramadol hydrochloride
- pharmaceutical combination
- immediate release
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/444—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Combinación farmacéutica que comprende: i) una primera formulación de tramadol clorhidrato de liberación extendida que contiene desde 2,0% a 12,0% p/p de tramadol clorhidrato, y ii) una segunda formulación de etoricoxib de liberación inmediata que contiene desde 6,0% a 18% p/p de etoricoxib, disolventes o vehículos; proceso de fabricación para preparar la combinación farmacéutica y las formulaciones individuales, donde la combinación se presenta en una dosificación única tal como, capsulas, comprimidos, comprimidos en bicapa, granulados y sachets. Además proporciona métodos para prevenir y tratar el dolor, tal como el dolor agudo, y el uso de la combinación farmacéutica para la prevención y el tratamiento del dolor, tal como el dolor agudo. Reivindicación 1: Una combinación farmacéutica caracterizada porque comprende: a) una primera formulación de tramadol clorhidrato de liberación extendida que contiene 2,0% a 12,0% p/p de tramadol clorhidrato como el primer ingrediente farmacéuticamente activo, y 30% a 40% p/p de excipientes farmacéuticamente aceptables; y b) una segunda formulación de etoricoxib de liberación inmediata que contiene 6,0% a 18,0% p/p de etoricoxib como el segundo ingrediente farmacéuticamente activo, y 40% a 52% p/p de excipientes farmacéuticamente aceptables, junto con solventes o vehículos farmacéuticamente aceptables; estando el % p/p referido al peso total de la combinación, y donde los solventes o vehículos no se encuentran incluidos dentro del peso total de la misma. Reivindicación 21: Una formulación farmacéutica de etoricoxib de liberación inmediata caracterizada porque comprende: 10,3% a 31,0% p/p de etoricoxib, 13,8% a 21,2% p/p de meglumina, 5,4% a 8,6% p/p de almidón carboximetil de sodio, 44,8 a 50,0% p/p de celulosa microcristalina, 1,4% a 4,3% p/p de polivinilpirrolidona, 3,4% a 5,2% p/p de estearato de magnesio, 0,2% a 0,4% p/p de un colorante farmacéuticamente aceptable, y etanol y agua como solventes o vehículos; estando el % p/p referido al peso total de la segunda formulación de liberación inmediata, y donde los solventes o vehículos no están incluidos dentro del peso total de la misma.Pharmaceutical combination comprising: i) a first extended release tramadol hydrochloride formulation containing from 2.0% to 12.0% w / w tramadol hydrochloride, and ii) a second immediate release etoricoxib formulation containing from 6 , 0% to 18% w / w etoricoxib, solvents or vehicles; manufacturing process to prepare the pharmaceutical combination and the individual formulations, where the combination is presented in a single dosage such as capsules, tablets, bilayer tablets, granules and sachets. It further provides methods for preventing and treating pain, such as acute pain, and the use of the pharmaceutical combination for the prevention and treatment of pain, such as acute pain. Claim 1: A pharmaceutical combination characterized in that it comprises: a) a first extended release tramadol hydrochloride formulation containing 2.0% to 12.0% w / w of tramadol hydrochloride as the first pharmaceutically active ingredient, and 30% to 40 % w / w of pharmaceutically acceptable excipients; and b) a second immediate release etoricoxib formulation containing 6.0% to 18.0% w / w etoricoxib as the second pharmaceutically active ingredient, and 40% to 52% w / w pharmaceutically acceptable excipients, along with solvents. or pharmaceutically acceptable carriers; being the% w / w referred to the total weight of the combination, and where the solvents or vehicles are not included within the total weight of the same. Claim 21: An immediate release etoricoxib pharmaceutical formulation characterized by comprising: 10.3% to 31.0% w / w of etoricoxib, 13.8% to 21.2% w / w of meglumine, 5.4% a 8.6% w / w sodium carboxymethyl starch, 44.8 to 50.0% w / w microcrystalline cellulose, 1.4% to 4.3% w / w polyvinylpyrrolidone, 3.4% at 5, 2% w / w magnesium stearate, 0.2% to 0.4% w / w of a pharmaceutically acceptable dye, and ethanol and water as solvents or vehicles; the% w / w being referred to the total weight of the second immediate release formulation, and where the solvents or vehicles are not included within the total weight thereof.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/IB2017/058519 WO2019130049A1 (en) | 2017-12-29 | 2017-12-29 | Pharmaceutical combination comprising extended-release tramadol hydrochloride and immediate-release etoricoxib, and its use for the treatment of pain |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR114074A1 true AR114074A1 (en) | 2020-07-15 |
Family
ID=61024811
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP180103918A AR114074A1 (en) | 2017-12-29 | 2018-12-28 | PHARMACEUTICAL COMBINATION INCLUDING TRAMADOL HYDROCHLORIDE EXTENDED RELEASE AND IMMEDIATE RELEASE ETORICOXIB, AND ITS USE FOR THE TREATMENT OF PAIN |
Country Status (4)
| Country | Link |
|---|---|
| AR (1) | AR114074A1 (en) |
| MX (1) | MX2018013070A (en) |
| UY (1) | UY38043A (en) |
| WO (1) | WO2019130049A1 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113521292A (en) * | 2020-04-15 | 2021-10-22 | 江苏恒瑞医药股份有限公司 | Compound preparation of COX-2 inhibitor and tramadol |
Family Cites Families (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT1207994B (en) | 1986-01-03 | 1989-06-01 | Therapicon Srl | WATER SOLUBLE SALTS OF ANTI-INFLAMMATORY AND ANALGESIC ADAPTITY COMPOUNDS, THEIR PREPARATION AND USE IN PHARMACEUTICAL COMPOSITIONS. |
| CN1349423A (en) | 1999-03-01 | 2002-05-15 | 奥索-麦克尼尔药品公司 | Composition comprising tramadol aterial and a selective cox-2 inhibitor drug |
| DK1248618T3 (en) | 1999-11-29 | 2006-07-10 | Merck Frosst Canada Inc | Polymorphic, amorphous and hydrated forms of 5-chloro-3- (4-methanesulfonylphenyl) -6'-methyl- [2,3 '] bipyridinyl |
| PH12001001175B1 (en) | 2000-05-26 | 2006-08-10 | Merck Sharp & Dohme | 5-chloro-3-(4-methanesulfonylphenyl)-6'-methyl- (2,3')bipyridinyl in pure crystalline form and process for synthesis |
| CN100418533C (en) | 2002-02-19 | 2008-09-17 | 阿德科克因格拉姆有限公司 | Pharmaceutical combinations of cox-2 inhibitors and opiates |
| WO2005085199A1 (en) | 2004-01-14 | 2005-09-15 | Cadila Healthcare Limited | Novel polymorphs of etoricoxib |
| AU2006256041B2 (en) | 2005-06-10 | 2012-03-29 | Chugai Seiyaku Kabushiki Kaisha | Stabilizer for protein preparation comprising meglumine and use thereof |
| CN101312714A (en) | 2005-11-22 | 2008-11-26 | 特瓦制药工业有限公司 | Medicament composition of telmisartan |
| BRPI0700133A (en) | 2007-01-29 | 2008-09-16 | Incrementha P D & I Pesquisa D | pharmaceutical composition comprising tramadol and ketoprofen in combination |
| US20080026054A1 (en) | 2007-04-27 | 2008-01-31 | Nectid Inc. | Novel anelgesic combination |
| KR101784777B1 (en) | 2007-11-23 | 2017-11-06 | 그뤼넨탈 게엠베하 | Tapentadol compositions |
| EP2177215A1 (en) | 2008-10-17 | 2010-04-21 | Laboratorios Del. Dr. Esteve, S.A. | Co-crystals of tramadol and NSAIDs |
| CZ2008740A3 (en) | 2008-11-24 | 2010-01-06 | Zentiva, A.S. | Solid pharmaceutical composition with atorvastatin and telmisartan active ingredients |
| EP2281558A1 (en) | 2009-08-06 | 2011-02-09 | Laboratorios Del. Dr. Esteve, S.A. | Pharmaceutical compounds of O-Desmethyl-Tramadol and COX-inhibitors |
| CN104817501B (en) | 2009-10-16 | 2017-09-22 | 埃斯蒂文博士实验室股份有限公司 | The eutectic of C16H25NO2 and former times dry goods |
| WO2012004677A1 (en) | 2010-07-05 | 2012-01-12 | Actavis Group Ptc Ehf | Solid state forms of etoricoxib salts |
| EP2601952A1 (en) | 2011-12-07 | 2013-06-12 | Zentiva, k.s. | Novel pharmaceutically acceptable salts and cocrystals of 5-chloro-3-(4-methanesulfonylphenyl)-6'-methyl-[2,3']bipyridinyl and their therapeutic uses |
| EP2887924B1 (en) | 2012-08-27 | 2017-03-29 | Cadila Healthcare Limited | Pharmaceutical compositions of etoricoxib |
| EP3179987A1 (en) | 2014-07-31 | 2017-06-21 | KRKA, d.d., Novo mesto | Pharmaceutical composition of etoricoxib |
| WO2016036588A1 (en) | 2014-09-03 | 2016-03-10 | Merck Sharp & Dohme Corp. | Pharmaceutical suspensions containing etoricoxib |
| CN104586799A (en) | 2015-01-07 | 2015-05-06 | 万全万特制药江苏有限公司 | Etoricoxib dispersible tablets and preparation method thereof |
| CN105343002B (en) | 2015-11-27 | 2019-07-26 | 济南康和医药科技有限公司 | A kind of Etoricoxib oral microemulsion preparation and preparation method thereof |
| US20170312224A1 (en) * | 2016-04-28 | 2017-11-02 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Extended release formulations of flurbiprofen and tramadol |
| MX2016006464A (en) | 2016-05-18 | 2017-11-17 | Laboratorios Liomont S A De C V | Pharmaceutical composition of a combination of tramadol-etoricoxib hydrochloride for the treatment of pain. |
-
2017
- 2017-12-29 WO PCT/IB2017/058519 patent/WO2019130049A1/en active Application Filing
- 2017-12-29 MX MX2018013070A patent/MX2018013070A/en unknown
-
2018
- 2018-12-28 AR ARP180103918A patent/AR114074A1/en unknown
- 2018-12-28 UY UY0001038043A patent/UY38043A/en not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| MX2018013070A (en) | 2019-10-15 |
| UY38043A (en) | 2019-07-31 |
| WO2019130049A1 (en) | 2019-07-04 |
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Legal Events
| Date | Code | Title | Description |
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| FB | Suspension of granting procedure |