DK2838512T3 - Manipulationssikret og dosisdumpingsikret farmaceutisk doseringsform - Google Patents
Manipulationssikret og dosisdumpingsikret farmaceutisk doseringsform Download PDFInfo
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- DK2838512T3 DK2838512T3 DK13716298.8T DK13716298T DK2838512T3 DK 2838512 T3 DK2838512 T3 DK 2838512T3 DK 13716298 T DK13716298 T DK 13716298T DK 2838512 T3 DK2838512 T3 DK 2838512T3
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- pharmaceutical dosage
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- active ingredient
- pharmacologically active
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- 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
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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
- A61K31/13—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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- 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
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- 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
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/36—Opioid-abuse
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurology (AREA)
- Addiction (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Organic Chemistry (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Psychiatry (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (12)
1. Manipulationssikret farmaceutisk doseringsform, der omfatter en farmakologisk aktiv bestanddel, som er indlejret i en prolongeret release-matrix, der omfatter et prolongeret release-matrix-materiale, der er valgt blandt ikke-ioniske acrylpolymerer, som er afledt af en monomerblanding, der omfatter et første Ci_4-alkyl-(meth)acrylat og et andet Ci4-alkyl-(meth)acrylat, som adskiller sig fra det første C1-4-alkyl-(meth)acrylat, og som tilvejebringer prolongeret release af den farmakologisk aktive bestanddel, modstandsdygtighed overfor opløsningsmiddelekstraktion, modstandsdygtighed overfor knusning og modstandsdygtighed overfor dosisdumping i vandig ethanol; hvor den farmaceutiske doseringsform er monolitisk, har en brudstyrke på mindst 300 N og en udstrækning i en hvilken som helst retning på mindst 2,0 mm; eller er oligopartikelformet eller multipartikelformet, hvor mindst en fraktion af de individuelle partikelformede stoffer har en brudstyrke på mindst 300 N, og hvor de individuelle lægemiddelholdige partikelformede stoffer har en udstrækning i en hvilken som helst retning på mindst 2,0 mm.
2. Farmaceutisk doseringsform ifølge krav 1, hvor det første Ci-4-alkyl-(meth)acrylat er ethylacrylat, og det andet Ci-4-alkyl-(meth)acrylat er methylmethacrylat.
3. Farmaceutisk doseringsform ifølge krav 2, hvor det relative molindhold af ethyl acryl atet inde i den ikke-ioniske acrylpolymer er større end det relative molindhold af methylmethacrylatet inde i den ikke-ioniske acrylpolymer.
4. Farmaceutisk doseringsform ifølge et hvilket som helst af de foregående krav, hvor den ikke-ioniske acrylpolymer har en vægtmæssig gennemsnitsmolekylvægt inden for området fra 100.000 g/mol til 2.000.000 g/mol.
5. Farmaceutisk doseringsform ifølge et hvilket som helst af de foregående krav, hvor prolongeret release-matrixen omfatter et yderligere prolongeret release-matrix-materiale.
6. Farmaceutisk doseringsform ifølge krav 5, hvor det yderligere prolongeret release-matrix-materiale er et hårdt fedt ifølge Ph. Eur. eller en polymer, der er valgt fra gruppen bestående af ionisk acrylpolymerpolymerer, polyalkylenglycoler, polyalkylenoxider, celluloser og cellulosederivater.
7. Farmaceutisk doseringsform ifølge et hvilket som helst af de foregående krav, hvor det samlede indhold af prolongeret release-matrix-materialet og det valgfrit forekommende yderligere prolongeret release-matrix-materiale er inden for området fra 5,0 til 95 vægt-% i forhold til den farmaceutiske doseringsforms samlede vægt.
8. Farmaceutisk doseringsform ifølge et hvilket som helst af de foregående krav, hvor den farmakologisk aktive bestanddel har potentiale for misbrug og potentiale for dosisdumping i ethanol.
9. Farmaceutisk doseringsform ifølge et hvilket som helst af de foregående krav, hvor den farmakologisk aktive bestanddel er et opioid eller et fysiologisk acceptabelt salt deraf.
10. Farmaceutisk doseringsform ifølge et hvilket som helst af de foregående krav, hvor prolongeret release-matrixen ikke omfatter noget polyalkylenoxid med en vægtmæssig gennemsnitsmolekylvægt på mindst 200.000 g/mol.
11. Farmaceutisk doseringsform ifølge et hvilket som helst af de foregående krav, der smelteekstruderes.
12. Fremgangsmåde til fremstilling afen manipulationssikret farmaceutisk doseringsform ifølge et hvilket som helst af kravene 1 til 11, der omfatter en farmakologisk aktiv bestanddel, som er indlejret i en prolongeret release-matrix, der omfatter et prolongeret release-matrix-materiale, der er valgt blandt ikke-ioniske acrylpolymerer, som er afledt af en monomerblanding, der omfatter et første Ci_4-alkyl-(meth)acrylat og et andet Ci4-alkyl-(meth)acrylat, som adskiller sig fra det første C1-4- alkyl-(meth)acrylat, og som tilvejebringer prolongeret release af den farmakologisk aktive bestanddel, hvor prolongeret release-matrix-materialet anvendes i form af en vandig dispersion, og hvor en blanding, der omfatter den farmakologisk aktive bestanddel og prolongeret release-matrix-materialet ekstruderes i nærværelse af vand, og hvor vandet i løbet af ekstruderingsprocessen afdampes fra det ekstruderede materiale.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP12002708 | 2012-04-18 | ||
| PCT/EP2013/057851 WO2013156453A1 (en) | 2012-04-18 | 2013-04-16 | Tamper resistant and dose-dumping resistant pharmaceutical dosage form |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2838512T3 true DK2838512T3 (da) | 2018-11-19 |
Family
ID=48095866
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK13716298.8T DK2838512T3 (da) | 2012-04-18 | 2013-04-16 | Manipulationssikret og dosisdumpingsikret farmaceutisk doseringsform |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US10335373B2 (da) |
| EP (1) | EP2838512B1 (da) |
| JP (1) | JP6282261B2 (da) |
| CN (1) | CN104394851B (da) |
| AR (1) | AR090695A1 (da) |
| AU (1) | AU2013248351B2 (da) |
| CA (1) | CA2868142A1 (da) |
| CY (1) | CY1120783T1 (da) |
| DK (1) | DK2838512T3 (da) |
| EA (1) | EA201401139A1 (da) |
| ES (1) | ES2692944T3 (da) |
| HR (1) | HRP20181716T1 (da) |
| LT (1) | LT2838512T (da) |
| MX (1) | MX362357B (da) |
| PL (1) | PL2838512T3 (da) |
| PT (1) | PT2838512T (da) |
| RS (1) | RS57913B1 (da) |
| SI (1) | SI2838512T1 (da) |
| TR (1) | TR201815502T4 (da) |
| WO (1) | WO2013156453A1 (da) |
Families Citing this family (44)
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|---|---|---|---|---|
| US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
| DE10336400A1 (de) | 2003-08-06 | 2005-03-24 | Grünenthal GmbH | Gegen Missbrauch gesicherte Darreichungsform |
| DE10361596A1 (de) | 2003-12-24 | 2005-09-29 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
| US20070048228A1 (en) | 2003-08-06 | 2007-03-01 | Elisabeth Arkenau-Maric | Abuse-proofed dosage form |
| DE102005005446A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Bruchfeste Darreichungsformen mit retardierter Freisetzung |
| DE102004032049A1 (de) * | 2004-07-01 | 2006-01-19 | Grünenthal GmbH | Gegen Missbrauch gesicherte, orale Darreichungsform |
| DE102005005449A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
| US8445018B2 (en) | 2006-09-15 | 2013-05-21 | Cima Labs Inc. | Abuse resistant drug formulation |
| AU2008258596B2 (en) | 2007-06-04 | 2013-02-14 | Egalet Ltd | Controlled release pharmaceutical compositions for prolonged effect |
| CA2713128C (en) | 2008-01-25 | 2016-04-05 | Gruenenthal Gmbh | Pharmaceutical dosage form |
| NZ594207A (en) | 2009-02-06 | 2013-03-28 | Egalet Ltd | Immediate release composition resistant to abuse by intake of alcohol |
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| DK2838512T3 (da) | 2012-04-18 | 2018-11-19 | Gruenenthal Gmbh | Manipulationssikret og dosisdumpingsikret farmaceutisk doseringsform |
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-
2013
- 2013-04-16 DK DK13716298.8T patent/DK2838512T3/da active
- 2013-04-16 TR TR2018/15502T patent/TR201815502T4/tr unknown
- 2013-04-16 RS RS20181249A patent/RS57913B1/sr unknown
- 2013-04-16 WO PCT/EP2013/057851 patent/WO2013156453A1/en not_active Ceased
- 2013-04-16 EA EA201401139A patent/EA201401139A1/ru unknown
- 2013-04-16 PT PT13716298T patent/PT2838512T/pt unknown
- 2013-04-16 PL PL13716298T patent/PL2838512T3/pl unknown
- 2013-04-16 ES ES13716298.8T patent/ES2692944T3/es active Active
- 2013-04-16 MX MX2014012434A patent/MX362357B/es active IP Right Grant
- 2013-04-16 CA CA2868142A patent/CA2868142A1/en not_active Abandoned
- 2013-04-16 AR ARP130101225A patent/AR090695A1/es unknown
- 2013-04-16 EP EP13716298.8A patent/EP2838512B1/en active Active
- 2013-04-16 JP JP2015506203A patent/JP6282261B2/ja active Active
- 2013-04-16 CN CN201380020860.5A patent/CN104394851B/zh active Active
- 2013-04-16 HR HRP20181716TT patent/HRP20181716T1/hr unknown
- 2013-04-16 AU AU2013248351A patent/AU2013248351B2/en active Active
- 2013-04-16 LT LTEP13716298.8T patent/LT2838512T/lt unknown
- 2013-04-16 SI SI201331224T patent/SI2838512T1/sl unknown
- 2013-04-17 US US13/864,450 patent/US10335373B2/en active Active
-
2018
- 2018-10-23 CY CY181101091T patent/CY1120783T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| MX362357B (es) | 2019-01-14 |
| CN104394851A (zh) | 2015-03-04 |
| MX2014012434A (es) | 2015-01-14 |
| US20130280338A1 (en) | 2013-10-24 |
| JP2015514733A (ja) | 2015-05-21 |
| AR090695A1 (es) | 2014-12-03 |
| LT2838512T (lt) | 2018-11-12 |
| AU2013248351A1 (en) | 2014-10-02 |
| EP2838512B1 (en) | 2018-08-22 |
| EP2838512A1 (en) | 2015-02-25 |
| PT2838512T (pt) | 2018-11-09 |
| CN104394851B (zh) | 2017-12-01 |
| CY1120783T1 (el) | 2019-12-11 |
| SI2838512T1 (sl) | 2018-11-30 |
| ES2692944T3 (es) | 2018-12-05 |
| AU2013248351B2 (en) | 2018-04-26 |
| CA2868142A1 (en) | 2013-10-24 |
| HRP20181716T1 (hr) | 2018-12-28 |
| HK1206647A1 (en) | 2016-01-15 |
| WO2013156453A1 (en) | 2013-10-24 |
| RS57913B1 (sr) | 2019-01-31 |
| JP6282261B2 (ja) | 2018-02-21 |
| EA201401139A1 (ru) | 2015-03-31 |
| TR201815502T4 (tr) | 2018-11-21 |
| PL2838512T3 (pl) | 2018-12-31 |
| US10335373B2 (en) | 2019-07-02 |
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