HRP20180974T1 - Farmaceutski pripravci koji sadrže deksketoprofen i tramadol - Google Patents
Farmaceutski pripravci koji sadrže deksketoprofen i tramadol Download PDFInfo
- Publication number
- HRP20180974T1 HRP20180974T1 HRP20180974TT HRP20180974T HRP20180974T1 HR P20180974 T1 HRP20180974 T1 HR P20180974T1 HR P20180974T T HRP20180974T T HR P20180974TT HR P20180974 T HRP20180974 T HR P20180974T HR P20180974 T1 HRP20180974 T1 HR P20180974T1
- Authority
- HR
- Croatia
- Prior art keywords
- pharmaceutical preparation
- preparation according
- dexketoprofen
- tramadol
- active ingredients
- Prior art date
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- 229960002783 dexketoprofen Drugs 0.000 title claims 11
- 229960004380 tramadol Drugs 0.000 title claims 11
- TVYLLZQTGLZFBW-GOEBONIOSA-N tramadol Natural products COC1=CC=CC([C@@]2(O)[C@@H](CCCC2)CN(C)C)=C1 TVYLLZQTGLZFBW-GOEBONIOSA-N 0.000 title claims 11
- TVYLLZQTGLZFBW-ZBFHGGJFSA-N (R,R)-tramadol Chemical compound COC1=CC=CC([C@]2(O)[C@H](CCCC2)CN(C)C)=C1 TVYLLZQTGLZFBW-ZBFHGGJFSA-N 0.000 title claims 8
- DKYWVDODHFEZIM-NSHDSACASA-N dexketoprofen Chemical compound OC(=O)[C@@H](C)C1=CC=CC(C(=O)C=2C=CC=CC=2)=C1 DKYWVDODHFEZIM-NSHDSACASA-N 0.000 title claims 8
- 239000008194 pharmaceutical composition Substances 0.000 title claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 19
- 239000004480 active ingredient Substances 0.000 claims 11
- 239000000203 mixture Substances 0.000 claims 6
- QUZMDHVOUNDEKW-MERQFXBCSA-N 2-amino-2-(hydroxymethyl)propane-1,3-diol;(2s)-2-(3-benzoylphenyl)propanoic acid Chemical compound OCC(N)(CO)CO.OC(=O)[C@@H](C)C1=CC=CC(C(=O)C=2C=CC=CC=2)=C1 QUZMDHVOUNDEKW-MERQFXBCSA-N 0.000 claims 5
- 229960005448 dexketoprofen trometamol Drugs 0.000 claims 5
- 150000003839 salts Chemical class 0.000 claims 5
- PPKXEPBICJTCRU-XMZRARIVSA-N (R,R)-tramadol hydrochloride Chemical compound Cl.COC1=CC=CC([C@]2(O)[C@H](CCCC2)CN(C)C)=C1 PPKXEPBICJTCRU-XMZRARIVSA-N 0.000 claims 4
- 229920002261 Corn starch Polymers 0.000 claims 4
- 239000008120 corn starch Substances 0.000 claims 4
- 229960003107 tramadol hydrochloride Drugs 0.000 claims 4
- GETQZCLCWQTVFV-UHFFFAOYSA-N trimethylamine Chemical compound CN(C)C GETQZCLCWQTVFV-UHFFFAOYSA-N 0.000 claims 4
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 3
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 3
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 3
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 3
- 229960003943 hypromellose Drugs 0.000 claims 3
- 150000007522 mineralic acids Chemical class 0.000 claims 3
- 150000007530 organic bases Chemical class 0.000 claims 3
- 239000000546 pharmaceutical excipient Substances 0.000 claims 3
- 238000002360 preparation method Methods 0.000 claims 3
- ROSDSFDQCJNGOL-UHFFFAOYSA-N Dimethylamine Chemical compound CNC ROSDSFDQCJNGOL-UHFFFAOYSA-N 0.000 claims 2
- QUSNBJAOOMFDIB-UHFFFAOYSA-N Ethylamine Chemical compound CCN QUSNBJAOOMFDIB-UHFFFAOYSA-N 0.000 claims 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 2
- 239000011230 binding agent Substances 0.000 claims 2
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 2
- 150000007529 inorganic bases Chemical class 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 2
- 239000008108 microcrystalline cellulose Substances 0.000 claims 2
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 2
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims 2
- 229960000281 trometamol Drugs 0.000 claims 2
- COVZYZSDYWQREU-UHFFFAOYSA-N Busulfan Chemical compound CS(=O)(=O)OCCCCOS(C)(=O)=O COVZYZSDYWQREU-UHFFFAOYSA-N 0.000 claims 1
- 206010019233 Headaches Diseases 0.000 claims 1
- 206010061218 Inflammation Diseases 0.000 claims 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-N L-arginine Chemical compound OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 claims 1
- 229930064664 L-arginine Natural products 0.000 claims 1
- 235000014852 L-arginine Nutrition 0.000 claims 1
- 208000019695 Migraine disease Diseases 0.000 claims 1
- 208000002193 Pain Diseases 0.000 claims 1
- 239000004372 Polyvinyl alcohol Substances 0.000 claims 1
- 229920001328 Polyvinylidene chloride Polymers 0.000 claims 1
- 239000008186 active pharmaceutical agent Substances 0.000 claims 1
- 208000005298 acute pain Diseases 0.000 claims 1
- VRAIHTAYLFXSJJ-UHFFFAOYSA-N alumane Chemical compound [AlH3].[AlH3] VRAIHTAYLFXSJJ-UHFFFAOYSA-N 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000011248 coating agent Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 1
- 238000000354 decomposition reaction Methods 0.000 claims 1
- ZBCBWPMODOFKDW-UHFFFAOYSA-N diethanolamine Chemical compound OCCNCCO ZBCBWPMODOFKDW-UHFFFAOYSA-N 0.000 claims 1
- HPNMFZURTQLUMO-UHFFFAOYSA-N diethylamine Chemical compound CCNCC HPNMFZURTQLUMO-UHFFFAOYSA-N 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 238000005469 granulation Methods 0.000 claims 1
- 230000003179 granulation Effects 0.000 claims 1
- 231100000869 headache Toxicity 0.000 claims 1
- 239000008240 homogeneous mixture Substances 0.000 claims 1
- 230000004054 inflammatory process Effects 0.000 claims 1
- 239000000314 lubricant Substances 0.000 claims 1
- 206010027599 migraine Diseases 0.000 claims 1
- 239000006186 oral dosage form Substances 0.000 claims 1
- 150000007524 organic acids Chemical class 0.000 claims 1
- 229940124531 pharmaceutical excipient Drugs 0.000 claims 1
- 229920002451 polyvinyl alcohol Polymers 0.000 claims 1
- 239000005033 polyvinylidene chloride Substances 0.000 claims 1
- 229940079832 sodium starch glycolate Drugs 0.000 claims 1
- 239000008109 sodium starch glycolate Substances 0.000 claims 1
- 229920003109 sodium starch glycolate Polymers 0.000 claims 1
- 239000007787 solid Substances 0.000 claims 1
- WPLOVIFNBMNBPD-ATHMIXSHSA-N subtilin Chemical compound CC1SCC(NC2=O)C(=O)NC(CC(N)=O)C(=O)NC(C(=O)NC(CCCCN)C(=O)NC(C(C)CC)C(=O)NC(=C)C(=O)NC(CCCCN)C(O)=O)CSC(C)C2NC(=O)C(CC(C)C)NC(=O)C1NC(=O)C(CCC(N)=O)NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C1NC(=O)C(=C/C)/NC(=O)C(CCC(N)=O)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)CNC(=O)C(NC(=O)C(NC(=O)C2NC(=O)CNC(=O)C3CCCN3C(=O)C(NC(=O)C3NC(=O)C(CC(C)C)NC(=O)C(=C)NC(=O)C(CCC(O)=O)NC(=O)C(NC(=O)C(CCCCN)NC(=O)C(N)CC=4C5=CC=CC=C5NC=4)CSC3)C(C)SC2)C(C)C)C(C)SC1)CC1=CC=CC=C1 WPLOVIFNBMNBPD-ATHMIXSHSA-N 0.000 claims 1
- 208000004371 toothache Diseases 0.000 claims 1
- 229940091904 tramadol hydrochloride 37.5 mg Drugs 0.000 claims 1
- 229940081924 tramadol hydrochloride 75 mg Drugs 0.000 claims 1
Classifications
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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)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (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. Farmaceutski pripravak čvrstog oralnog oblika doze, koji sadrži:
i) kombinaciju dvaju aktivnih farmaceutskih sastojaka, deksketoprofena kao sol s organskim ili anorganskim bazama i tramadola kao sol s organskim ili anorganskim kiselinama, gdje je:
- organska ili anorganska baza odabrana iz skupine koju čine trometamol, trimetilamin, dimetilamin, etilamin, trimetilamin, dietilamin, L-lizin, L-arginin, dietanolamin, natrijev hidroksid,
- organska ili anorganska kiselina odabrana iz skupine koju čine klorovodična, bromovodična, fosforna, sumporna, metansulfonska, benzensulfonska, toluensulfonska, octena, propionska, jabučna, maleinska, jantarna, limunska, L-vinska, mliječna, malonska, asparaginska, glutaminska;
ii) punilo koje je mikrokristalna celuloza;
iii) vezivo odabrano iz skupine koju čine kukuruzni škrob, preželatinizirani kukuruzni škrob i hipromeloza, ili njihove smjese;
iv) farmaceutski prihvatljiv ekscipijens,
s tim da su sve komponente pripravka u fizičkom kontaktu.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačeno time da dva aktivna sastojka tvore homogenu smjesu u kojoj su rečeni aktivni sastojci intimno miješani.
3. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačeno time da organska baza jest trometamol a anorganska kiselina jest klorovodična kiselina.
4. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačeno time da je rečeni farmaceutski ekscipijens odabran od sredstva za raspadanje, lubrikanta i glidanta.
5. Farmaceutski pripravak prema patentnim zahtjevima 1-4, koji sadrži smjesu dvaju aktivnih sastojaka masenog omjera deksketoprofena i tramadola od 2:1 do 1:10, ekvivalent masenom omjeru deksketoprofen trometamola i tramadol hidroklorida od 2.59:1 do 1:7.7.
6. Farmaceutski pripravak prema patentnom zahtjevu 5, koji sadrži smjesu dvaju aktivnih sastojaka masenog omjera deksketoprofena i tramadola od 1:1 do 1:6, ekvivalent masenom omjeru deksketoprofen trometamola i tramadol hidroklorida od 1.3:1 do 1:4.63.
7. Farmaceutski pripravak prema patentnim zahtjevima 1-4 koji sadrži dva aktivna sastojka, deksketoprofen i tramadol ili njihove soli, u sljedećim količinama u svakoj jedinici oralne doze:
- deksketoprofen od 8 do 50 mg, ekvivalent deksketoprofen-trometamolu od 11.8 do 73.8 mg;
- tramadol od 17.6 do 105.4 mg, ekvivalent tramadol hidrokloridu od 20 do 120 mg.
8. Farmaceutski pripravak prema patentnom zahtjevu 7, koji sadrži dva aktivna sastojka, deksketoprofen i tramadol ili njihove soli, u sljedećim količinama, u svakoj jedinici oralne doze:
- deksketoprofen od 10 do 30 mg, ekvivalent deksketoprofen-trometamolu od 14.8 do 44.29 mg;
- tramadol od 26.3 do 87.8 mg, ekvivalent tramadol hidrokloridu od 30 do 100 mg.
9. Farmaceutski pripravak prema patentnim zahtjevima 1-8, koji sadrži dva aktivna sastojka, deksketoprofen i tramadol ili njihove soli, u sljedećim specifičnim količinama u svakoj jedinici oralne doze:
- deksketoprofen 12.5 mg ili 25 mg, ekvivalent deksketoprofen-trometamolu 18.45 mg ili 36.95 mg;
- tramadol 32.9 mg ili 65.9 mg, ekvivalent tramadol hidrokloridu 37.5 mg ili 75 mg.
10. Farmaceutski pripravak prema patentnim zahtjevima 1-9, naznačeno time da je mikrokristalna celuloza u rasponu koncentracije od 45 do 75% po ukupnoj masi.
11. Farmaceutski pripravak prema patentnim zahtjevima 1-10, naznačeno time da je vezivo odabrano iz skupine koju čine kukuruzni škrob, preželatinizirani kukuruzni škrob i hipromeloza ili njihove smjese, u količinama od 5% do 20%, preferirano od 7% do 12% po ukupnoj masi pripravka.
12. Farmaceutski pripravak prema patentnim zahtjevima 1-11, naznačeno time da je sredstvo za raspadanje odabrano od natrijeve kroskarmeloze i natrijeva glikolata škroba ili njihovih smjesa, u količinama od 4% do 14% po ukupnoj masi pripravka.
13. Farmaceutski pripravak prema patentnim zahtjevima 1-12, naznačeno time da se oslobađanje dvaju aktivnih sastojaka, deksketoprofena i tramadola, događa u vremenskom rasponu koji nije veći od 15 minuta, preferirano između 3 i 11 minuta.
14. Farmaceutski pripravak prema patentnim zahtjevima 1 do 13, naznačeno time da brzina raspadanja i profil čistoće komponenata ostaju nepromijenjene tijekom roka trajanja od 18 mjeseci pri (25 ± 2)°C te relativnoj vlažnosti od (60 ± 5)% u aluminij-aluminij i PVC/PVDC paketima.
15. Farmaceutski pripravak prema patentnim zahtjevima 1-14, koji je u obliku tablete za trenutno oslobađanje aktivnih sastojaka.
16. Farmaceutski pripravak prema patentnom zahtjevu 15, naznačeno time da rečena tableta sadrži vanjsku ovojnicu zasnovanu na hipromelozi.
17. Farmaceutski pripravak prema patentnom zahtjevu 15, koji sadrži vanjsku ovojnicu zasnovanu na polivinilnom alkoholu.
18. Farmaceutski pripravak prema patentnim zahtjevima 1-14, koji je u obliku kapsule za trenutno oslobađanje obaju aktivnih sastojaka.
19. Farmaceutski pripravak prema patentnim zahtjevima 1-18, za upotrebu za liječenje akutne boli povezane sa sljedećim stanjima: glavobolja, zubobolja, upale i migrena.
20. Metoda priprave farmaceutskog pripravka prema patentnim zahtjevima 1 do 18, rečena metoda obuhvaća granulaciju u vrtložnom sloju i sušenje u vrtložnom sloju smjese aktivnih sastojaka i ekscipijenasa.
Applications Claiming Priority (3)
| 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 |
| EP14705987.7A EP2956129B1 (en) | 2013-02-14 | 2014-02-06 | Pharmaceutical compositions containing dexketoprofen and tramadol |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20180974T1 true HRP20180974T1 (hr) | 2018-08-10 |
Family
ID=47953547
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20180974TT HRP20180974T1 (hr) | 2013-02-14 | 2018-06-27 | Farmaceutski pripravci koji sadrže deksketoprofen i tramadol |
Country Status (45)
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022023211A1 (en) | 2020-07-31 | 2022-02-03 | 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 |
|---|---|---|---|---|
| US5516803A (en) | 1991-10-30 | 1996-05-14 | Mcneilab, Inc. | Composition comprising a tramadol material and a non-steroidal anti-inflammatory drug |
| AU661723B2 (en) | 1991-10-30 | 1995-08-03 | 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 |
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| BRPI0612802A2 (pt) | 2005-07-07 | 2010-11-30 | Farnam Co Inc | composições farmacêuticas de liberação sustentada para medicamentos extremamente hidrossolúveis |
| 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 |
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2013
- 2013-02-14 IT IT000210A patent/ITMI20130210A1/it unknown
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