DK2956129T3 - Farmaceutisk sammensætninger indeholdende dexketoprofen og tramadol - Google Patents
Farmaceutisk sammensætninger indeholdende dexketoprofen og tramadol Download PDFInfo
- Publication number
- DK2956129T3 DK2956129T3 DK14705987.7T DK14705987T DK2956129T3 DK 2956129 T3 DK2956129 T3 DK 2956129T3 DK 14705987 T DK14705987 T DK 14705987T DK 2956129 T3 DK2956129 T3 DK 2956129T3
- Authority
- DK
- Denmark
- Prior art keywords
- tramadol
- dexketoprofen
- pharmaceutical composition
- composition according
- acid
- Prior art date
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- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
-
- 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
- A61K31/133—Amines having hydroxy groups, e.g. sphingosine
-
- 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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
-
- 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
-
- 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
- A61P25/06—Antimigraine agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pain & Pain Management (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Inorganic Chemistry (AREA)
- Rheumatology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Claims (20)
1. Farmaceutisk sammensaetning i en fast oral doseringsform, omfattende: i) en kombination af de to aktive aktive farmaceutiske stoffer, dexketoprofen som et salt med organiske eller uorganiske baser og tramadol som et salt med organiske eller uorganiske syrer, hvor: - den organiske eller uorganiske base er udvalgt fra gruppen bestaende af trometamol, trimethylamin, dimethylamin, ethylamin, trimethylamin, diethyla-min, L-lysin, L-arginin, diethanolamin, natriumhydroxid, - den organiske eller uorganiske syre er udvalgt fra gruppen bestaende af salt-syre, hydrogenbromid, phosphorsyre, svovlsyre, methansulfonsyre, benzen-sulfonsyre, toluensulfonsyre, eddikesyre, propionsyre, aeblesyre, maleinsyre, ravsyre, citronsyre, L-vinsyre, maelkesyre, malonsyre, asparaginsyre, gluta-minsyre; ii) et fyldstof, som er mikrokrystallinsk cellulose; iii) et bindemiddel udvalgt fra gruppen bestaende af majsstivelse, pregelatine-ret majsstivelse og hypromellose eller blandinger deraf; iv) en farmaceutisk acceptabel excipiens, hvor alle bestanddelene af sammensaetningen er i fysisk kontakt.
2. Farmaceutisk sammensaetning ifolge krav 1, hvor de to aktive stoffer danner en homogen blanding, hvori de aktive stoffer er grundigt blandet.
3. Farmaceutisk sammensaetning ifolge krav 1, hvor den organiske base er trometamol, og den uorganiske syre er saltsyre.
4. Farmaceutisk sammensaetning ifolge krav 1, hvor den farmaceutisk excipiens er udvalgt blandt oplosningsmiddel, smoremiddel og glidemiddel.
5. Farmaceutisk sammensaetning ifolge krav 1-4, indeholdende en blanding af de to aktive stoffer i et vaegtforhold mellem dexketoprofen og tramadol fra 2:1 til 1:10, svarende til et vaegtforhold mellem dexketoprofentrometamol og tramadol hydrochlorid fra 2,59:1 til 1:7,7.
6. Farmaceutisk sammensaetning ifolge krav 5, indeholdende en blanding af de to aktive stoffer i et vaegtforhold mellem dexketoprofen og tramadol fra 1:1 til 1:6, svarende til et vaegtforhold mellem dexketoprofentrometamol og tramadol hydrochlorid fra 1,3:1 til 1:4,63.
7. Farmaceutisk sammensaetning ifolge krav 1-4 indeholdende de to aktive stoffer, dexketoprofen og tramadol eller salte deraf, i folgende maengder for hver oral doseringsenhed: - dexketoprofen fra 8 til 50 mg, svarende til dexketoprofentrometamol fra 11,8 til 73,8 mg; - tramadol fra 17,6 til 105,4 mg, svarende til tramadolhydrochlorid fra 20 til 120 mg.
8. Farmaceutisk sammensaetning ifolge krav 7, indeholdende de to aktive stoffer, dexketoprofen og tramadol eller salte deraf, i folgende maengder for hver oral doseringsenhed: - dexketoprofen fra 10 til 30 mg, svarende til dexketoprofentrometamol fra 14,8 til 44,29 mg; - tramadol fra 26,3 til 87,8 mg, svarende til tramadolhydrochlorid fra 30 til 100 mg.
9. Farmaceutisk sammensaetning ifolge krav 1-8, indeholdende de to aktive stoffer, dexketoprofen og tramadol eller salte deraf, i folgende specifikke maengder for hver oral doseringsenhed: - dexketoprofen 12,5 mg eller 25 mg, svarende til dexketoprofentrometamol 18,45 mg eller 36,95 mg; - tramadol 32,9 mg eller 65,9 mg, svarende til tramadolhydrochlorid 37,5 mg eller 75 mg.
10. Farmaceutisk sammensaetning ifolge krav 1-9, hvor mikrokrystallinsk cellulose er i et koncentrationsomrade fra 45 til 75 vaegt-% af de samlede maengde.
11. Farmaceutisk sammensaetning ifolge krav 1-10, hvor bindemidlet er ud-valgt fra gruppen bestaende af majsstivelse, pregelatineret majsstivelse og hypromellose eller blandinger deraf, i maengder fra 5 % til 20 %, fortrinsvis fra 7 % til 12 % af den samlede vaegt af sammensaetningen.
12. Farmaceutisk sammensaetning if0lge krav 1-11, hvor oplosningsmidlet er udvalgt blandt croscarmellosenatrium og natriumstivelsesglycolat eller blan-dinger deraf, i maengder fra 4 % til 14 % i forhold til den samlede vaegt af sam-mensaetningen.
13. Farmaceutisk sammensaetning ifolge krav 1-12, hvoroplosningen af de to aktive stoffer, dexketoprofen og tramadol, indtraeder inden for et tidsinterval, der ikke er laengere end 15 minutter, fortrinsvis mellem 3 og 11 minutter.
14. Farmaceutisk sammensaetning ifolge krav 1 til 13, hvor oplosningsha-stigheden og renhedsprofilen af bestanddelene forbliver uaendret i en holdbar-hedsperiode pa 18 maneder ved (25 ± 2)°C og (60 ± 5)% relativ luftfugtighed i aluminium - aluminium og PVC/PVDC emballager.
15. Farmaceutisk sammensaetning ifolge krav 1-14, som er i form af en tablet til ojeblikkelig frigivelse af de aktive bestanddele.
16. Farmaceutisk sammensaetning ifolge krav 15, hvor tabletten omfatter en hypromellose-baseret ydre filmcoating.
17. Farmaceutisk sammensaetning ifolge krav 15, omfattende en polyvinylal-kohol-baseret ydre filmcoating.
18. Farmaceutisk sammensaetning ifolge krav 1-14, som er i form af en kapsel til ojeblikkelig frigivelse af begge de aktive bestanddele.
19. Farmaceutisk sammensaetning ifolge krav 1-18 til anvendelse til behand-ling af akutte smerter i forbindelse med folgende tilstande: hovedpine, tand-pine, inflammationer og migraene.
20. Fremgangsmêde til fremstilling af en farmaceutisk sammensaetning ifolge krav 1 til 18, hvilken fremgangsmade omfatter fluid bed-granulering og fluid bed-torring af en blanding af aktive bestanddele og excipienser.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT000210A ITMI20130210A1 (it) | 2013-02-14 | 2013-02-14 | Composizioni farmaceutiche contenenti dexketoprofene e tramadolo |
| PCT/EP2014/052342 WO2014124862A1 (en) | 2013-02-14 | 2014-02-06 | Pharmaceutical compositions containing dexketoprofen and tramadol |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2956129T3 true DK2956129T3 (da) | 2018-06-18 |
Family
ID=47953547
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK14705987.7T DK2956129T3 (da) | 2013-02-14 | 2014-02-06 | Farmaceutisk sammensætninger indeholdende dexketoprofen og tramadol |
Country Status (46)
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP4188337A1 (en) | 2020-07-31 | 2023-06-07 | KRKA, d.d., Novo mesto | Formulation containing dexketoprofen and tramadol and method for making the same |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU661723B2 (en) | 1991-10-30 | 1995-08-03 | Mcneilab, Inc. | Composition comprising a tramadol material and a non-steroidal anti-inflammatory drug |
| US5516803A (en) * | 1991-10-30 | 1996-05-14 | Mcneilab, Inc. | Composition comprising a tramadol material and a non-steroidal anti-inflammatory drug |
| US5968551A (en) | 1991-12-24 | 1999-10-19 | Purdue Pharma L.P. | Orally administrable opioid formulations having extended duration of effect |
| ES2058024B1 (es) | 1992-11-10 | 1995-05-01 | Menarini Lab | Nuevo derivado arilpropionico, procedimiento de fabricacion del mismo y su utilizacion como analgesico. |
| DE19530575A1 (de) | 1995-08-19 | 1997-02-20 | Gruenenthal Gmbh | Schnell zerfallende Arzneiform von Tramadol oder einem Tramadolsalz |
| ATE219658T1 (de) * | 1998-03-06 | 2002-07-15 | Eurand Int | Schnell zerfallende tablette |
| EP1739072A1 (en) | 2005-06-15 | 2007-01-03 | Laboratorios Menarini S.A. | Polymorphic forms of dexketoprofen trometamol, preparation and pharmaceutical compositions thereof |
| RU2008104638A (ru) | 2005-07-07 | 2009-08-20 | Фарнэм Компаниз, Инк. (Us) | Фармацевтические композиции хорошо растворимых в воде лекарственных средств, обеспечивающих их замедленное высвобождение |
| ITMI20060983A1 (it) * | 2006-05-18 | 2007-11-19 | Formevet S P A | Composizioni farmaceutiche veterinarie per il trattamento del dolore e dell'inifiamazione |
| BRPI0700133A (pt) * | 2007-01-29 | 2008-09-16 | Incrementha P D & I Pesquisa D | composição farmacêutica compreendendo tramadol e cetoprofeno em combinação |
| WO2008150324A1 (en) * | 2007-03-26 | 2008-12-11 | Theraquest Biosciences, Inc. | Subanalgesic doses of drug combinations |
| EP2177215A1 (en) * | 2008-10-17 | 2010-04-21 | Laboratorios Del. Dr. Esteve, S.A. | Co-crystals of tramadol and NSAIDs |
| ES2356762B1 (es) * | 2009-09-04 | 2011-11-24 | Farmalider S.A. | Composicion farmaceutica de ibuprofeno, tramadol y un aminoacido basico, procedimiento para su preparacion y utilizacion de la misma. |
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2013
- 2013-02-14 IT IT000210A patent/ITMI20130210A1/it unknown
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2014
- 2014-02-06 UA UAA201508027A patent/UA115684C2/uk unknown
- 2014-02-06 EP EP14705987.7A patent/EP2956129B1/en active Active
- 2014-02-06 CN CN201480008502.7A patent/CN105007907B/zh active Active
- 2014-02-06 DK DK14705987.7T patent/DK2956129T3/da active
- 2014-02-06 PE PE2015001736A patent/PE20151430A1/es not_active Application Discontinuation
- 2014-02-06 SM SM20180356T patent/SMT201800356T1/it unknown
- 2014-02-06 MX MX2015010431A patent/MX353897B/es active IP Right Grant
- 2014-02-06 GE GEAP201413908A patent/GEP201706649B/en unknown
- 2014-02-06 BR BR112015018952-0A patent/BR112015018952B1/pt active IP Right Grant
- 2014-02-06 CA CA2900979A patent/CA2900979C/en active Active
- 2014-02-06 NZ NZ710967A patent/NZ710967A/en unknown
- 2014-02-06 RS RS20180618A patent/RS57271B1/sr unknown
- 2014-02-06 NO NO14705987A patent/NO2956129T3/no unknown
- 2014-02-06 US US14/767,424 patent/US9949940B2/en active Active
- 2014-02-06 PT PT147059877T patent/PT2956129T/pt unknown
- 2014-02-06 JP JP2015557377A patent/JP6297068B2/ja active Active
- 2014-02-06 WO PCT/EP2014/052342 patent/WO2014124862A1/en active Application Filing
- 2014-02-06 LT LTEP14705987.7T patent/LT2956129T/lt unknown
- 2014-02-06 PL PL14705987T patent/PL2956129T3/pl unknown
- 2014-02-06 MA MA38335A patent/MA38335B1/fr unknown
- 2014-02-06 HU HUE14705987A patent/HUE038417T2/hu unknown
- 2014-02-06 KR KR1020157021833A patent/KR102262408B1/ko active IP Right Grant
- 2014-02-06 AU AU2014218110A patent/AU2014218110B2/en active Active
- 2014-02-06 EA EA201591319A patent/EA029709B1/ru active Protection Beyond IP Right Term
- 2014-02-06 SG SG11201506291UA patent/SG11201506291UA/en unknown
- 2014-02-06 AP AP2015008616A patent/AP2015008616A0/xx unknown
- 2014-02-06 MY MYPI2015002021A patent/MY173102A/en unknown
- 2014-02-06 TR TR2018/10114T patent/TR201810114T4/tr unknown
- 2014-02-06 SI SI201430739T patent/SI2956129T1/en unknown
- 2014-02-06 ES ES14705987.7T patent/ES2672986T3/es active Active
- 2014-02-06 CU CUP2015000081A patent/CU24310B1/xx unknown
- 2014-02-13 UY UY0001035324A patent/UY35324A/es active IP Right Grant
- 2014-02-13 AR ARP140100462A patent/AR094783A1/es not_active Application Discontinuation
- 2014-02-13 TW TW103104694A patent/TWI642430B/zh active
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2015
- 2015-08-11 SA SA515360877A patent/SA515360877B1/ar unknown
- 2015-08-11 EC ECIEPI201534660A patent/ECSP15034660A/es unknown
- 2015-08-12 TN TN2015000345A patent/TN2015000345A1/en unknown
- 2015-08-12 NI NI201500105A patent/NI201500105A/es unknown
- 2015-08-12 PH PH12015501766A patent/PH12015501766B1/en unknown
- 2015-08-12 CR CR20150411A patent/CR20150411A/es unknown
- 2015-08-12 IL IL24051415A patent/IL240514B/en active IP Right Grant
- 2015-08-12 CL CL2015002251A patent/CL2015002251A1/es unknown
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2016
- 2016-04-25 HK HK16104703.2A patent/HK1216840A1/zh unknown
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2018
- 2018-05-30 CY CY20181100578T patent/CY1120301T1/el unknown
- 2018-06-27 HR HRP20180974TT patent/HRP20180974T1/hr unknown
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