HRP20240349T1 - Pripravak za produljeno otpuštanje koji sadrži tapentadol i postupak njegove pripreme - Google Patents
Pripravak za produljeno otpuštanje koji sadrži tapentadol i postupak njegove pripreme Download PDFInfo
- Publication number
- HRP20240349T1 HRP20240349T1 HRP20240349TT HRP20240349T HRP20240349T1 HR P20240349 T1 HRP20240349 T1 HR P20240349T1 HR P20240349T T HRP20240349T T HR P20240349TT HR P20240349 T HRP20240349 T HR P20240349T HR P20240349 T1 HRP20240349 T1 HR P20240349T1
- Authority
- HR
- Croatia
- Prior art keywords
- agent
- mixture
- hydrophobic polymer
- further contains
- povidone
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 7
- 238000000034 method Methods 0.000 title claims 5
- 238000013268 sustained release Methods 0.000 title claims 3
- 239000012730 sustained-release form Substances 0.000 title claims 3
- 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 claims 3
- 229960005126 tapentadol Drugs 0.000 title claims 3
- 238000002360 preparation method Methods 0.000 title claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 4
- 229920001600 hydrophobic polymer Polymers 0.000 claims 4
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 3
- 229920001477 hydrophilic polymer Polymers 0.000 claims 3
- 229920002689 polyvinyl acetate Polymers 0.000 claims 3
- 239000011118 polyvinyl acetate Substances 0.000 claims 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 3
- 229940069328 povidone Drugs 0.000 claims 3
- 239000002552 dosage form Substances 0.000 claims 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims 1
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims 1
- 229920001577 copolymer Polymers 0.000 claims 1
- 238000004090 dissolution Methods 0.000 claims 1
- 238000009474 hot melt extrusion Methods 0.000 claims 1
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims 1
- 229920003023 plastic Polymers 0.000 claims 1
- 239000004033 plastic Substances 0.000 claims 1
- 230000001737 promoting effect Effects 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 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
- 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
- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K47/38—Cellulose; Derivatives 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Emergency Medicine (AREA)
- Inorganic Chemistry (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (6)
1. Farmaceutski pripravak s produljenim otpuštanjem otporan na zlouporabu za oralnu primjenu koji sadrži tapentadol ili njegovu farmaceutski prihvatljivu sol, mješavinu polivinil acetata/povidona omjera 8:2 kao hidrofobni polimer koji navedenom pripravku daje čvrstoću pucanja od najmanje 500N i hidroksipropilmetil celulozu kao hidrofilni polimer, pri čemu je hidrofobni polimer u koncentraciji od 15% m/m do 30% m/m i hidrofilni polimer od 10% m/m do 20% m/m.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, koji nadalje sadrži kopolimer vinilpirolidon-vinil acetata kao solubilizatora.
3. Farmaceutski pripravak prema patentnom zahtjevu 1, koji nadalje sadrži sredstvo za povećanje viskoznosti hidroksietil celulozu.
4. Postupak za pripremu farmaceutskog pripravka s produljenim otpuštanjem otpornog na zlouporabu za oralnu primjenu koji sadrži tapentadol ili njegovu farmaceutski prihvatljivu sol, mješavinu polivinil acetata/povidona u omjeru 8:2 kao hidrofobni polimer koji daje čvrstoću pucanja od najmanje 500 N i hidroksipropilmetil celulozu kao hidrofilni polimer, pri čemu je hidrofobni polimer u koncentraciji od 10% m/m do 20% m/m, pri čemu je navedeni postupak ekstruzija vruće taline na temperaturi nižoj od 180°C.
5. Postupak prema patentnom zahtjevu 4, pri čemu se sve komponente miješaju zajedno ili odvojeno u različitim kombinacijama, a dobivena smjesa ili dobivene smjese se zagrijavaju u ekstruderu barem do točke omekšavanja mješavine polivinil acetata/povidona i istiskuju kroz izlazni otvor ekstrudera primjenom sile i još uvijek plastični ekstrudat se gnječi i oblikuje u oblik za doziranje ili se ohlađen i po izboru ponovno zagrijani gnječeni ekstrudat oblikuje u oblik za doziranje.
6. Postupak prema patentnom zahtjevom 4, pri čemu nadalje sadrži sredstvo za povećanje viskoznosti, sredstvo za pospješivanje otapanja i sredstvo za plastifikaciju.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GR20190100148A GR1009791B (el) | 2019-03-26 | 2019-03-26 | Σκευασμα παρατεταμενης αποδεσμευσης που περιλαμβανει ταπενταδολη και μεθοδος παρασκευης αυτου |
| EP20721146.7A EP3946276B1 (en) | 2019-03-26 | 2020-03-23 | Sustained release composition comprising tapentadol and method of preparation thereof |
| PCT/EP2020/025140 WO2020192970A1 (en) | 2019-03-26 | 2020-03-23 | Sustained release composition comprising tapentadol and method of preparation thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20240349T1 true HRP20240349T1 (hr) | 2024-05-24 |
Family
ID=70456723
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20240349TT HRP20240349T1 (hr) | 2019-03-26 | 2020-03-23 | Pripravak za produljeno otpuštanje koji sadrži tapentadol i postupak njegove pripreme |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US20220168241A1 (hr) |
| EP (1) | EP3946276B1 (hr) |
| AU (1) | AU2020246867A1 (hr) |
| BR (1) | BR112021019059A2 (hr) |
| CA (1) | CA3134730A1 (hr) |
| DK (1) | DK3946276T3 (hr) |
| FI (1) | FI3946276T3 (hr) |
| GR (1) | GR1009791B (hr) |
| HR (1) | HRP20240349T1 (hr) |
| LT (1) | LT3946276T (hr) |
| PL (1) | PL3946276T3 (hr) |
| PT (1) | PT3946276T (hr) |
| RS (1) | RS65290B1 (hr) |
| WO (1) | WO2020192970A1 (hr) |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB9401894D0 (en) | 1994-02-01 | 1994-03-30 | Rhone Poulenc Rorer Ltd | New compositions of matter |
| DE4426245A1 (de) | 1994-07-23 | 1996-02-22 | Gruenenthal Gmbh | 1-Phenyl-3-dimethylamino-propanverbindungen mit pharmakologischer Wirkung |
| DE10336400A1 (de) * | 2003-08-06 | 2005-03-24 | Grünenthal GmbH | Gegen Missbrauch gesicherte Darreichungsform |
| FR2897267A1 (fr) | 2006-02-16 | 2007-08-17 | Flamel Technologies Sa | Formes pharmaceutiques multimicroparticulaires pour administration per os |
| US8273798B2 (en) | 2007-06-04 | 2012-09-25 | Shear Kershman Laboratories | Tamper resistant lipid-based oral dosage form for opioid agonists |
| EP2456427B1 (en) * | 2009-07-22 | 2015-03-04 | Grünenthal GmbH | Hot-melt extruded controlled release dosage form |
| US20120015031A1 (en) * | 2010-07-14 | 2012-01-19 | Grunenthal Gmbh | Novel gastro-retentive dosage forms |
| FR2979242A1 (fr) | 2011-08-29 | 2013-03-01 | Sanofi Sa | Comprime contre l'usage abusif, a base de paracetamol et d'oxycodone |
| CN105120846B (zh) | 2013-02-05 | 2019-10-18 | 普渡制药公司 | 抗篡改的药物制剂 |
| MX368846B (es) * | 2013-07-12 | 2019-10-18 | Gruenenthal Gmbh | Forma de dosificación resistente a la alteración que contiene polímero de acetato de etilen-vinilo. |
| WO2017070462A1 (en) * | 2015-10-21 | 2017-04-27 | Nova Southeastern University | Compositions for deterring abuse of pharmaceutical products and alcohol |
| CA3003950C (en) * | 2015-10-23 | 2020-05-12 | Kashiv Pharma Llc | Enhanced abuse-deterrent formulations of oxycodone |
-
2019
- 2019-03-26 GR GR20190100148A patent/GR1009791B/el active IP Right Grant
-
2020
- 2020-03-23 RS RS20240300A patent/RS65290B1/sr unknown
- 2020-03-23 PT PT207211467T patent/PT3946276T/pt unknown
- 2020-03-23 FI FIEP20721146.7T patent/FI3946276T3/fi active
- 2020-03-23 US US17/442,214 patent/US20220168241A1/en active Pending
- 2020-03-23 HR HRP20240349TT patent/HRP20240349T1/hr unknown
- 2020-03-23 DK DK20721146.7T patent/DK3946276T3/da active
- 2020-03-23 EP EP20721146.7A patent/EP3946276B1/en active Active
- 2020-03-23 LT LTEPPCT/EP2020/025140T patent/LT3946276T/lt unknown
- 2020-03-23 AU AU2020246867A patent/AU2020246867A1/en active Pending
- 2020-03-23 CA CA3134730A patent/CA3134730A1/en active Pending
- 2020-03-23 WO PCT/EP2020/025140 patent/WO2020192970A1/en active Application Filing
- 2020-03-23 PL PL20721146.7T patent/PL3946276T3/pl unknown
- 2020-03-23 BR BR112021019059A patent/BR112021019059A2/pt unknown
Also Published As
| Publication number | Publication date |
|---|---|
| LT3946276T (lt) | 2024-04-10 |
| EP3946276A1 (en) | 2022-02-09 |
| WO2020192970A1 (en) | 2020-10-01 |
| PL3946276T3 (pl) | 2024-05-06 |
| EP3946276B1 (en) | 2023-12-13 |
| AU2020246867A1 (en) | 2021-11-18 |
| US20220168241A1 (en) | 2022-06-02 |
| CA3134730A1 (en) | 2020-10-01 |
| PT3946276T (pt) | 2024-03-15 |
| GR1009791B (el) | 2020-08-03 |
| FI3946276T3 (fi) | 2024-03-15 |
| BR112021019059A2 (pt) | 2021-11-30 |
| RS65290B1 (sr) | 2024-04-30 |
| DK3946276T3 (da) | 2024-03-18 |
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