SI2846835T1 - Heat-formed pharmaceutical dosage form, resistant to abuse and containing zinc - Google Patents
Heat-formed pharmaceutical dosage form, resistant to abuse and containing zinc Download PDFInfo
- Publication number
- SI2846835T1 SI2846835T1 SI201330858T SI201330858T SI2846835T1 SI 2846835 T1 SI2846835 T1 SI 2846835T1 SI 201330858 T SI201330858 T SI 201330858T SI 201330858 T SI201330858 T SI 201330858T SI 2846835 T1 SI2846835 T1 SI 2846835T1
- Authority
- SI
- Slovenia
- Prior art keywords
- pharmaceutical
- zinc component
- formulation according
- zinc
- polyalkylene oxide
- Prior art date
Links
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 title claims abstract 13
- 229910052725 zinc Inorganic materials 0.000 title claims abstract 13
- 239000011701 zinc Substances 0.000 title claims abstract 12
- 239000002552 dosage form Substances 0.000 title abstract 3
- 229920000233 poly(alkylene oxides) Polymers 0.000 claims abstract 6
- 239000002831 pharmacologic agent Substances 0.000 claims abstract 5
- 239000008194 pharmaceutical composition Substances 0.000 claims 6
- 239000000203 mixture Substances 0.000 claims 5
- 125000002947 alkylene group Chemical group 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 238000005299 abrasion Methods 0.000 claims 1
- 238000013270 controlled release Methods 0.000 claims 1
- 239000006185 dispersion Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000011159 matrix material Substances 0.000 claims 1
- 239000000155 melt Substances 0.000 claims 1
- 239000008188 pellet Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 230000000379 polymerizing effect Effects 0.000 claims 1
- 238000003825 pressing Methods 0.000 claims 1
- 238000009834 vaporization Methods 0.000 claims 1
- 230000008016 vaporization Effects 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
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
- A61K9/2004—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
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic 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
- A61K9/20—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
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Neurosurgery (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Pain & Pain Management (AREA)
- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP12003743 | 2012-05-11 | ||
| PCT/EP2013/059728 WO2013167735A1 (en) | 2012-05-11 | 2013-05-10 | Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc |
| EP13721766.7A EP2846835B1 (en) | 2012-05-11 | 2013-05-10 | Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SI2846835T1 true SI2846835T1 (en) | 2018-01-31 |
Family
ID=48407572
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI201330858T SI2846835T1 (en) | 2012-05-11 | 2013-05-10 | Heat-formed pharmaceutical dosage form, resistant to abuse and containing zinc |
Country Status (21)
| Country | Link |
|---|---|
| EP (1) | EP2846835B1 (enExample) |
| JP (2) | JP2015516406A (enExample) |
| CN (1) | CN104428002B (enExample) |
| AU (1) | AU2013257943B2 (enExample) |
| BR (1) | BR112014026768A2 (enExample) |
| CA (1) | CA2870012A1 (enExample) |
| CY (1) | CY1119637T1 (enExample) |
| DK (1) | DK2846835T3 (enExample) |
| EA (1) | EA029171B1 (enExample) |
| ES (1) | ES2650945T3 (enExample) |
| HR (1) | HRP20171718T1 (enExample) |
| HU (1) | HUE035123T2 (enExample) |
| IL (1) | IL234815A0 (enExample) |
| LT (1) | LT2846835T (enExample) |
| MX (1) | MX357783B (enExample) |
| NO (1) | NO2846835T3 (enExample) |
| PL (1) | PL2846835T3 (enExample) |
| PT (1) | PT2846835T (enExample) |
| RS (1) | RS56685B1 (enExample) |
| SI (1) | SI2846835T1 (enExample) |
| WO (1) | WO2013167735A1 (enExample) |
Families Citing this family (30)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
| DE10361596A1 (de) | 2003-12-24 | 2005-09-29 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
| DE102005005446A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Bruchfeste Darreichungsformen mit retardierter Freisetzung |
| US20070048228A1 (en) | 2003-08-06 | 2007-03-01 | Elisabeth Arkenau-Maric | Abuse-proofed dosage form |
| DE10336400A1 (de) | 2003-08-06 | 2005-03-24 | Grünenthal GmbH | Gegen Missbrauch gesicherte Darreichungsform |
| 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 |
| JP5774853B2 (ja) | 2008-01-25 | 2015-09-09 | グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング | 医薬投薬形 |
| PL2997965T3 (pl) | 2009-07-22 | 2019-06-28 | Grünenthal GmbH | Odporna na manipulacje postać dawkowania opioidów wrażliwych na utlenianie |
| WO2011009602A1 (en) | 2009-07-22 | 2011-01-27 | Grünenthal GmbH | Hot-melt extruded controlled release dosage form |
| EP2611426B1 (en) | 2010-09-02 | 2014-06-25 | Grünenthal GmbH | Tamper resistant dosage form comprising inorganic salt |
| ES2487244T3 (es) | 2010-09-02 | 2014-08-20 | Grünenthal GmbH | Forma de dosificación resistente a la manipulación que comprende un polímero aniónico |
| CA2839123A1 (en) | 2011-07-29 | 2013-02-07 | Grunenthal Gmbh | Tamper-resistant tablet providing immediate drug release |
| US20130028972A1 (en) | 2011-07-29 | 2013-01-31 | Grunenthal Gmbh | Tamper-resistant tablet providing immediate drug release |
| JP6117249B2 (ja) | 2012-02-28 | 2017-04-19 | グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング | 薬理学的に活性な化合物および陰イオン性ポリマーを含むタンパーレジスタント剤形 |
| HRP20181716T1 (hr) | 2012-04-18 | 2018-12-28 | Grünenthal GmbH | Farmaceutski oblik doziranja otporan na zlonamjernu uporabu i naglo oslobađanje cjelokupne doze |
| US10064945B2 (en) | 2012-05-11 | 2018-09-04 | Gruenenthal Gmbh | Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc |
| US9737490B2 (en) | 2013-05-29 | 2017-08-22 | Grünenthal GmbH | Tamper resistant dosage form with bimodal release profile |
| WO2014191397A1 (en) | 2013-05-29 | 2014-12-04 | Grünenthal GmbH | Tamper-resistant dosage form containing one or more particles |
| WO2015004245A1 (en) | 2013-07-12 | 2015-01-15 | Grünenthal GmbH | Tamper-resistant dosage form containing ethylene-vinyl acetate polymer |
| HK1224189A1 (zh) | 2013-11-26 | 2017-08-18 | Grünenthal GmbH | 通过低温研磨制备粉状药物组合物 |
| MX2016014738A (es) | 2014-05-12 | 2017-03-06 | Gruenenthal Gmbh | Formulacion en capsula de liberacion inmediata resistente a alteraciones que comprende tapentadol. |
| MX2016015417A (es) | 2014-05-26 | 2017-02-22 | Gruenenthal Gmbh | Multiparticulas protegidas contra vertido de dosis etanolico. |
| JP2018513872A (ja) | 2015-04-24 | 2018-05-31 | グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング | 異なる粒子から２種の薬物の急速放出をもたらすタンパレジスタントな固定用量組合せ |
| WO2016170094A1 (en) | 2015-04-24 | 2016-10-27 | Grünenthal GmbH | Tamper-resistant fixed dose combination providing fast release of two drugs from particles |
| WO2016170093A1 (en) | 2015-04-24 | 2016-10-27 | Grünenthal GmbH | Tamper-resistant fixed dose combination providing fast release of two drugs from particles and a matrix |
| EA035434B1 (ru) | 2015-04-24 | 2020-06-15 | Грюненталь Гмбх | Защищенная от применения не по назначению лекарственная форма с немедленным высвобождением и устойчивостью к экстракции растворителями |
| US11234974B2 (en) | 2015-05-28 | 2022-02-01 | Lumosa Therapeutics Co., Ltd. | Pharmaceutical formulations for sustained release of sebacoyl dinalbuphine ester |
| US10183018B2 (en) | 2015-05-28 | 2019-01-22 | Lumosa Therapeutics Co., Ltd. | Pharmaceutical formulations for sustained release of sebacoyl dinalbuphine ester |
| EP3346991A1 (en) | 2015-09-10 | 2018-07-18 | Grünenthal GmbH | Protecting oral overdose with abuse deterrent immediate release formulations |
Family Cites Families (31)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5082668A (en) | 1983-05-11 | 1992-01-21 | Alza Corporation | Controlled-release system with constant pushing source |
| AU7077287A (en) | 1986-03-31 | 1987-10-08 | Union Carbide Corporation | Alkylene oxide polymerisation catalyst |
| DE3612211A1 (de) | 1986-04-11 | 1987-10-15 | Basf Ag | Kontinuierliches verfahren zum tablettieren |
| US4667013A (en) | 1986-05-02 | 1987-05-19 | Union Carbide Corporation | Process for alkylene oxide polymerization |
| JP3073054B2 (ja) | 1991-07-11 | 2000-08-07 | 住友精化株式会社 | アルキレンオキシド重合体の製造方法 |
| JP2002265592A (ja) | 2001-03-07 | 2002-09-18 | Sumitomo Seika Chem Co Ltd | アルキレンオキシド重合体の製造方法 |
| US7141250B2 (en) | 2001-08-06 | 2006-11-28 | Euro-Celtique S.A. | Pharmaceutical formulation containing bittering agent |
| DE60224293T2 (de) | 2001-09-21 | 2008-12-11 | Egalet A/S | Feste dispersionen mit kontrollierter freisetzung von carvedilol |
| US7300668B2 (en) | 2001-10-29 | 2007-11-27 | Massachusetts Institute Of Technology | System for manufacturing controlled release dosage forms, such as a zero-order release profile dosage form manufactured by three-dimensional printing |
| DE10252667A1 (de) | 2002-11-11 | 2004-05-27 | Grünenthal GmbH | Spirocyclische Cyclohexan-Derivate |
| DE10336400A1 (de) | 2003-08-06 | 2005-03-24 | Grünenthal GmbH | Gegen Missbrauch gesicherte Darreichungsform |
| DE102005005446A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Bruchfeste Darreichungsformen mit retardierter Freisetzung |
| ES2407143T3 (es) | 2003-08-06 | 2013-06-11 | Grünenthal GmbH | Forma de dosificación protegida contra un posible abuso |
| DE10361596A1 (de) | 2003-12-24 | 2005-09-29 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
| US7201920B2 (en) * | 2003-11-26 | 2007-04-10 | Acura Pharmaceuticals, Inc. | Methods and compositions for deterring abuse of opioid containing dosage forms |
| DE10360792A1 (de) | 2003-12-23 | 2005-07-28 | Grünenthal GmbH | Spirocyclische Cyclohexan-Derivate |
| PL1740156T3 (pl) | 2004-04-22 | 2011-12-30 | Gruenenthal Gmbh | Sposób wytwarzania zabezpieczonej przed nadużyciem, stałej postaci aplikacyjnej |
| WO2005105036A1 (en) * | 2004-04-28 | 2005-11-10 | Natco Pharma Limited | Controlled release mucoadhesive matrix formulation containing tolterodine and a process for its preparation |
| PL1765298T3 (pl) | 2004-07-01 | 2013-01-31 | Gruenenthal Gmbh | Sposób wytwarzania stałej postaci dawkowania, która jest zabezpieczona przez nadużywaniem, wykorzystujący wytłaczarkę z przekładnią planetarną |
| WO2006002884A1 (de) | 2004-07-01 | 2006-01-12 | Grünenthal GmbH | Gegen missbrauch gesicherte, orale darreichtungsform |
| DE102004032049A1 (de) * | 2004-07-01 | 2006-01-19 | Grünenthal GmbH | Gegen Missbrauch gesicherte, orale Darreichungsform |
| CA2572352A1 (en) | 2004-07-01 | 2006-01-12 | Gruenenthal Gmbh | Oral dosage form safeguarded against abuse containing (1r,2r)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol |
| US20060177380A1 (en) | 2004-11-24 | 2006-08-10 | Acura Pharmaceuticals, Inc. | Methods and compositions for deterring abuse of orally administered pharmaceutical products |
| DE102005005449A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
| WO2006133733A1 (en) * | 2005-06-13 | 2006-12-21 | Flamel Technologies | Oral dosage form comprising an antimisuse system |
| AU2008207200B2 (en) | 2007-01-16 | 2011-02-17 | Egalet Ltd | Use of i) a polyglycol and ii) an active drug substance for the preparation of a pharmaceutical composition for i) mitigating the risk of alcohol induced dose dumping and/or ii) reducing the risk of drug abuse |
| DE102007011485A1 (de) | 2007-03-07 | 2008-09-11 | Grünenthal GmbH | Darreichungsform mit erschwertem Missbrauch |
| WO2008148798A2 (en) | 2007-06-04 | 2008-12-11 | Egalet A/S | Controlled release pharmaceutical compositions for prolonged effect |
| JP5774853B2 (ja) | 2008-01-25 | 2015-09-09 | グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング | 医薬投薬形 |
| JP2012508773A (ja) | 2008-11-14 | 2012-04-12 | ポートラ ファーマシューティカルズ， インコーポレイテッド | 低いｐＨでの難水溶性のイオン化活性薬剤の制御放出のための固体組成物およびその使用方法 |
| PL2997965T3 (pl) * | 2009-07-22 | 2019-06-28 | Grünenthal GmbH | Odporna na manipulacje postać dawkowania opioidów wrażliwych na utlenianie |
-
2013
- 2013-05-10 NO NO13721766A patent/NO2846835T3/no unknown
- 2013-05-10 EP EP13721766.7A patent/EP2846835B1/en not_active Not-in-force
- 2013-05-10 BR BR112014026768A patent/BR112014026768A2/pt not_active Application Discontinuation
- 2013-05-10 WO PCT/EP2013/059728 patent/WO2013167735A1/en not_active Ceased
- 2013-05-10 RS RS20171251A patent/RS56685B1/sr unknown
- 2013-05-10 SI SI201330858T patent/SI2846835T1/en unknown
- 2013-05-10 MX MX2014013095A patent/MX357783B/es active IP Right Grant
- 2013-05-10 CN CN201380024652.2A patent/CN104428002B/zh not_active Expired - Fee Related
- 2013-05-10 DK DK13721766.7T patent/DK2846835T3/en active
- 2013-05-10 AU AU2013257943A patent/AU2013257943B2/en not_active Ceased
- 2013-05-10 JP JP2015510834A patent/JP2015516406A/ja active Pending
- 2013-05-10 HR HRP20171718TT patent/HRP20171718T1/hr unknown
- 2013-05-10 CA CA2870012A patent/CA2870012A1/en not_active Abandoned
- 2013-05-10 EA EA201401240A patent/EA029171B1/ru not_active IP Right Cessation
- 2013-05-10 LT LTEP13721766.7T patent/LT2846835T/lt unknown
- 2013-05-10 HU HUE13721766A patent/HUE035123T2/en unknown
- 2013-05-10 ES ES13721766.7T patent/ES2650945T3/es active Active
- 2013-05-10 PT PT137217667T patent/PT2846835T/pt unknown
- 2013-05-10 PL PL13721766T patent/PL2846835T3/pl unknown
-
2014
- 2014-09-23 IL IL234815A patent/IL234815A0/en unknown
-
2017
- 2017-11-01 JP JP2017211487A patent/JP6541748B2/ja not_active Expired - Fee Related
- 2017-12-04 CY CY20171101265T patent/CY1119637T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| RS56685B1 (sr) | 2018-03-30 |
| EP2846835B1 (en) | 2017-09-06 |
| ES2650945T3 (es) | 2018-01-23 |
| PT2846835T (pt) | 2017-12-15 |
| EP2846835A1 (en) | 2015-03-18 |
| DK2846835T3 (en) | 2017-12-04 |
| LT2846835T (lt) | 2017-12-27 |
| JP6541748B2 (ja) | 2019-07-10 |
| JP2015516406A (ja) | 2015-06-11 |
| CY1119637T1 (el) | 2018-04-04 |
| CN104428002A (zh) | 2015-03-18 |
| EA201401240A1 (ru) | 2015-04-30 |
| HUE035123T2 (en) | 2018-05-02 |
| JP2018065810A (ja) | 2018-04-26 |
| HRP20171718T1 (hr) | 2017-12-29 |
| AU2013257943B2 (en) | 2017-10-05 |
| CN104428002B (zh) | 2017-08-11 |
| WO2013167735A1 (en) | 2013-11-14 |
| AU2013257943A1 (en) | 2014-10-09 |
| CA2870012A1 (en) | 2013-11-14 |
| BR112014026768A2 (pt) | 2017-06-27 |
| PL2846835T3 (pl) | 2018-02-28 |
| NO2846835T3 (enExample) | 2018-02-03 |
| EA029171B1 (ru) | 2018-02-28 |
| MX357783B (es) | 2018-07-25 |
| IL234815A0 (en) | 2014-12-31 |
| HK1207978A1 (en) | 2016-02-19 |
| MX2014013095A (es) | 2014-12-08 |
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