SI2846835T1 - Toplotno oblikovana farmacevtska odmerna oblika, odporna proti zlorabi in vsebujoča cink - Google Patents
Toplotno oblikovana farmacevtska odmerna oblika, odporna proti zlorabi in vsebujoča cink 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
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)
- Coloring Foods And Improving Nutritive Qualities (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (13)
- EP 2846835 BI Toplotno oblikovana farmacevtska odmema oblika, odporna proti zlorabi in vsebujoča cink Patentni zahtevki1. Toplotno oblikovana farmacevtska odmema oblika, odporna proti zlorabi in obsegajoča: a) farmakološko aktivno sestavino; b) polialkilenoksid, ki ima masnopovprečno molekulsko maso več kot 200 000 g/mol, in c) cinkovo komponento, kjer je vsebnost cinkove komponente vsaj 1 masni del na milijon z ozirom na celotno maso farmacevtske odmeme oblike; ki ima prelomno trdnost vsaj 300 N, izmerjeno skladno z Eur. Ph. 6.0, 2.09.08.
- 2. Farmacevtska odmema oblika po zahtevku 1, ki vsebuje polialkilenoksidni sestavek, ki vključuje polialkilenoksid in cinkovo komponento, in/ali kjer je vsebnost cinkove komponente v območju 0,01-1 mol % z ozirom na vsebnost cinkovih atomov na mol alkilenoksidnih enot, vsebovanih v polialkilenoksidu.
- 3. Farmacevtska odmema oblika po zahtevku 2, kjer je polialkilenoksid mogoče dobiti s polimeriziranjem alkilenoksida v prisotnosti cinkove komponente.
- 4. Farmacevtska odmema oblika po zahtevku 2 ali 3, kjer ima vodna disperzija čistega polialkilenoksidnega sestavka v čisti vodi pri 25 °C in pri koncentraciji 1 mas. % vrednost pH največ 7,7.
- 5. Farmacevtska odmema oblika po katerem koli od zahtevkov 2-4, kjer je vsebnost cinkove komponente vsaj 10 masnih delov na milijon z ozirom na celotno maso polialkilenoksidnega sestavka.
- 6. Farmacevtska odmema oblika po katerem koli od prejšnjih zahtevkov, kjer je vsebnost cinkove komponente največ 10 000 masnih delov na milijon z ozirom na celotno maso farmacevtske odmeme oblike.
- 7. Farmacevtska odmema oblika po katerem koli od prejšnjih zahtevkov, kjer je farmakološko aktivna sestavina opioid.
- 8. Farmacevtska odmema oblika po katerem koli od prejšnjih zahtevkov, kjer je farmakološko aktivna sestavina vdelana v matriks z nadzorovanim sproščanjem, ki obsega polialkilenoksid in cinkovo komponento.
- 9. Farmacevtska odmema oblika po katerem koli od prejšnjih zahtevkov, ki je monolitna ali multipartikulama.
- 10. Farmacevtska odmema oblika po katerem koli od prejšnjih zahtevkov, ki je ekstrudirana iz taline.
- 11. Farmacevtska odmema oblika po katerem koli od prejšnjih zahtevkov, ki je prilagojena za dajanje enkrat na dan, dvakrat na dan ali trikrat na dan.
- 12. Postopek za izdelavo farmacevtske odmeme oblike po katerem koli od prejšnjih zahtevkov, ki obsega stopnji: (a) mešanje farmakološko aktivne sestavine, polialkilenoksidnega sestavka, kot je definiran v katerem koli od zahtevkov 2-5, in po izbiri prisotnih ekscipientov; in (b) oblikovanje zmesi, dobljene v stopnji (a), s stiskanjem s predhodno, sočasno ali kasnejšo izpostavitvijo toploti.
- 13. Postopek po zahtevku 12, kjer izvedemo stopnjo (b) z uporabo ekstruderja.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP12003743 | 2012-05-11 | ||
| EP13721766.7A EP2846835B1 (en) | 2012-05-11 | 2013-05-10 | Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc |
| PCT/EP2013/059728 WO2013167735A1 (en) | 2012-05-11 | 2013-05-10 | Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SI2846835T1 true SI2846835T1 (sl) | 2018-01-31 |
Family
ID=48407572
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI201330858T SI2846835T1 (sl) | 2012-05-11 | 2013-05-10 | Toplotno oblikovana farmacevtska odmerna oblika, odporna proti zlorabi in vsebujoča cink |
Country Status (22)
| Country | Link |
|---|---|
| EP (1) | EP2846835B1 (sl) |
| JP (2) | JP2015516406A (sl) |
| CN (1) | CN104428002B (sl) |
| AU (1) | AU2013257943B2 (sl) |
| BR (1) | BR112014026768A2 (sl) |
| CA (1) | CA2870012A1 (sl) |
| CY (1) | CY1119637T1 (sl) |
| DK (1) | DK2846835T3 (sl) |
| EA (1) | EA029171B1 (sl) |
| ES (1) | ES2650945T3 (sl) |
| HK (1) | HK1207978A1 (sl) |
| HR (1) | HRP20171718T1 (sl) |
| HU (1) | HUE035123T2 (sl) |
| IL (1) | IL234815A0 (sl) |
| LT (1) | LT2846835T (sl) |
| MX (1) | MX357783B (sl) |
| NO (1) | NO2846835T3 (sl) |
| PL (1) | PL2846835T3 (sl) |
| PT (1) | PT2846835T (sl) |
| RS (1) | RS56685B1 (sl) |
| SI (1) | SI2846835T1 (sl) |
| WO (1) | WO2013167735A1 (sl) |
Families Citing this family (30)
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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 |
| US20070048228A1 (en) | 2003-08-06 | 2007-03-01 | Elisabeth Arkenau-Maric | Abuse-proofed dosage form |
| 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 |
| 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 |
| BRPI0906467C1 (pt) | 2008-01-25 | 2021-05-25 | Gruenenthal Gmbh | forma de dosagem farmacêutica com formato exterior modificado resistente à ruptura e com liberação controlada |
| PE20121067A1 (es) | 2009-07-22 | 2012-09-05 | Gruenenthal Chemie | Forma de dosificacion de liberacion controlada extruida por fusion en caliente |
| WO2011009604A1 (en) | 2009-07-22 | 2011-01-27 | Grünenthal GmbH | Oxidation-stabilized tamper-resistant dosage form |
| CA2808541C (en) | 2010-09-02 | 2019-01-08 | Gruenenthal Gmbh | Tamper resistant dosage form comprising an anionic polymer |
| WO2012028319A1 (en) | 2010-09-02 | 2012-03-08 | Grünenthal GmbH | Tamper resistant dosage form comprising inorganic salt |
| AR087360A1 (es) | 2011-07-29 | 2014-03-19 | Gruenenthal Gmbh | Tableta a prueba de manipulacion que proporciona liberacion de farmaco inmediato |
| KR20140053158A (ko) | 2011-07-29 | 2014-05-07 | 그뤼넨탈 게엠베하 | 즉시 약물 방출을 제공하는 탬퍼-저항성 정제 |
| CA2864949A1 (en) | 2012-02-28 | 2013-09-06 | Grunenthal Gmbh | Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer |
| JP6282261B2 (ja) | 2012-04-18 | 2018-02-21 | 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 | 不正使用防止および過量放出防止医薬剤形 |
| US10064945B2 (en) | 2012-05-11 | 2018-09-04 | Gruenenthal Gmbh | Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc |
| CA2913209A1 (en) | 2013-05-29 | 2014-12-04 | Grunenthal Gmbh | Tamper resistant dosage form with bimodal release profile |
| EP3003279A1 (en) | 2013-05-29 | 2016-04-13 | Grünenthal GmbH | Tamper-resistant dosage form containing one or more particles |
| AU2014289187B2 (en) | 2013-07-12 | 2019-07-11 | Grunenthal Gmbh | Tamper-resistant dosage form containing ethylene-vinyl acetate polymer |
| MX371372B (es) | 2013-11-26 | 2020-01-28 | Gruenenthal Gmbh | Preparacion de una composicion farmaceutica en polvo por medio de criomolienda. |
| CA2947786A1 (en) | 2014-05-12 | 2015-11-19 | Grunenthal Gmbh | Tamper resistant immediate release capsule formulation comprising tapentadol |
| WO2015181059A1 (en) | 2014-05-26 | 2015-12-03 | Grünenthal GmbH | Multiparticles safeguarded against ethanolic dose-dumping |
| 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 |
| CA2983634A1 (en) | 2015-04-24 | 2016-10-27 | Grunenthal Gmbh | Tamper-resistant fixed dose combination providing fast release of two drugs from particles |
| JP2018517676A (ja) | 2015-04-24 | 2018-07-05 | 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 | 即時放出および溶媒抽出に対する耐性を有する改変防止製剤 |
| 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 |
| US10183018B2 (en) | 2015-05-28 | 2019-01-22 | Lumosa Therapeutics Co., Ltd. | Pharmaceutical formulations for sustained release of sebacoyl dinalbuphine ester |
| US11234974B2 (en) | 2015-05-28 | 2022-02-01 | Lumosa Therapeutics Co., Ltd. | Pharmaceutical formulations for sustained release of sebacoyl dinalbuphine ester |
| WO2017042325A1 (en) | 2015-09-10 | 2017-03-16 | Grünenthal GmbH | Protecting oral overdose with abuse deterrent immediate release formulations |
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| BRPI0906467C1 (pt) | 2008-01-25 | 2021-05-25 | Gruenenthal Gmbh | forma de dosagem farmacêutica com formato exterior modificado resistente à ruptura e com liberação controlada |
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-
2013
- 2013-05-10 MX MX2014013095A patent/MX357783B/es active IP Right Grant
- 2013-05-10 HU HUE13721766A patent/HUE035123T2/en unknown
- 2013-05-10 JP JP2015510834A patent/JP2015516406A/ja active Pending
- 2013-05-10 EP EP13721766.7A patent/EP2846835B1/en active Active
- 2013-05-10 PL PL13721766T patent/PL2846835T3/pl unknown
- 2013-05-10 ES ES13721766.7T patent/ES2650945T3/es active Active
- 2013-05-10 PT PT137217667T patent/PT2846835T/pt unknown
- 2013-05-10 EA EA201401240A patent/EA029171B1/ru not_active IP Right Cessation
- 2013-05-10 DK DK13721766.7T patent/DK2846835T3/en active
- 2013-05-10 SI SI201330858T patent/SI2846835T1/sl unknown
- 2013-05-10 CA CA2870012A patent/CA2870012A1/en not_active Abandoned
- 2013-05-10 RS RS20171251A patent/RS56685B1/sr unknown
- 2013-05-10 WO PCT/EP2013/059728 patent/WO2013167735A1/en active Application Filing
- 2013-05-10 NO NO13721766A patent/NO2846835T3/no unknown
- 2013-05-10 CN CN201380024652.2A patent/CN104428002B/zh not_active Expired - Fee Related
- 2013-05-10 LT LTEP13721766.7T patent/LT2846835T/lt unknown
- 2013-05-10 BR BR112014026768A patent/BR112014026768A2/pt not_active Application Discontinuation
- 2013-05-10 AU AU2013257943A patent/AU2013257943B2/en not_active Ceased
-
2014
- 2014-09-23 IL IL234815A patent/IL234815A0/en unknown
-
2015
- 2015-09-04 HK HK15108653.4A patent/HK1207978A1/xx not_active IP Right Cessation
-
2017
- 2017-11-01 JP JP2017211487A patent/JP6541748B2/ja not_active Expired - Fee Related
- 2017-11-09 HR HRP20171718TT patent/HRP20171718T1/hr unknown
- 2017-12-04 CY CY20171101265T patent/CY1119637T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| JP2018065810A (ja) | 2018-04-26 |
| CN104428002A (zh) | 2015-03-18 |
| EA029171B1 (ru) | 2018-02-28 |
| JP2015516406A (ja) | 2015-06-11 |
| PL2846835T3 (pl) | 2018-02-28 |
| WO2013167735A1 (en) | 2013-11-14 |
| MX357783B (es) | 2018-07-25 |
| EA201401240A1 (ru) | 2015-04-30 |
| RS56685B1 (sr) | 2018-03-30 |
| LT2846835T (lt) | 2017-12-27 |
| DK2846835T3 (en) | 2017-12-04 |
| ES2650945T3 (es) | 2018-01-23 |
| AU2013257943B2 (en) | 2017-10-05 |
| NO2846835T3 (sl) | 2018-02-03 |
| CA2870012A1 (en) | 2013-11-14 |
| CN104428002B (zh) | 2017-08-11 |
| MX2014013095A (es) | 2014-12-08 |
| HK1207978A1 (en) | 2016-02-19 |
| HRP20171718T1 (hr) | 2017-12-29 |
| EP2846835A1 (en) | 2015-03-18 |
| PT2846835T (pt) | 2017-12-15 |
| IL234815A0 (en) | 2014-12-31 |
| CY1119637T1 (el) | 2018-04-04 |
| EP2846835B1 (en) | 2017-09-06 |
| JP6541748B2 (ja) | 2019-07-10 |
| AU2013257943A1 (en) | 2014-10-09 |
| BR112014026768A2 (pt) | 2017-06-27 |
| HUE035123T2 (en) | 2018-05-02 |
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