HRP20171718T1 - Termooblikovan, farmaceutski oblik doziranja otporan na mijenjanje koji sadrži cink - Google Patents
Termooblikovan, farmaceutski oblik doziranja otporan na mijenjanje koji sadrži cink Download PDFInfo
- Publication number
- HRP20171718T1 HRP20171718T1 HRP20171718TT HRP20171718T HRP20171718T1 HR P20171718 T1 HRP20171718 T1 HR P20171718T1 HR P20171718T T HRP20171718T T HR P20171718TT HR P20171718 T HRP20171718 T HR P20171718T HR P20171718 T1 HRP20171718 T1 HR P20171718T1
- Authority
- HR
- Croatia
- Prior art keywords
- dosage form
- pharmaceutical dosage
- form according
- polyalkylene oxide
- zinc component
- Prior art date
Links
- 239000002552 dosage form Substances 0.000 title claims 15
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 title claims 10
- 239000011701 zinc Substances 0.000 title claims 9
- 229910052725 zinc Inorganic materials 0.000 title claims 9
- 229920000233 poly(alkylene oxides) Polymers 0.000 claims 9
- 239000002831 pharmacologic agent Substances 0.000 claims 4
- 238000002360 preparation method Methods 0.000 claims 3
- 125000002947 alkylene group Chemical group 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 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
- 239000002245 particle Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 238000006116 polymerization reaction Methods 0.000 claims 1
- 238000003825 pressing Methods 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
Claims (13)
1. Termooblikovan, farmaceutski oblik doziranja otporan na mijenjanje naznačen time da sadrži
a) farmakološki aktivni sastojak;
b) polialkilen oksid koji ima ponderiranu prosječnu molekularnu masu od više od 200,000 g/mol; i
c) komponentu cinka, pri čemu je sadržaj navedene komponente cinka barem 1 maseni dio na milijun, u odnosu na ukupnu masu farmaceutskog oblika doziranja;
koji ima čvrstoću na lom od barem 300 N, mjereno u skladu s Eur. Ph. 6.0, 2.09.08.
2. Farmaceutski oblik doziranja prema zahtjevu 1, naznačen time da sadrži pripravak polialkilen oksida koji sadrži polialkilen oksid i komponentu cinka, i/ili pri čemu je sadržaj navedene komponente cinka u rasponu od 0.01 do 1 mol-% bazirano na sadržaju cinkovih atoma po molu jedinica alkilen oksida sadržanih u polialkilen oksidu.
3. Farmaceutski oblik doziranja prema zahtjevu 2, naznačen time da se polialkilen oksid može dobiti polimerizacijom alkilen oksida u prisutnosti komponente cinka.
4. Farmaceutski oblik doziranja prema zahtjevu 2 ili 3, naznačen time da vodena disperzija čistog pripravka polialkilen oksida u čistoj vodi kod 25°C i kod koncentracije od 1 mas.-% ima pH vrijednost od najviše 7.7.
5. Farmaceutski oblik doziranja prema bilo kojem od zahtjeva 2 do 4, naznačen time da je sadržaj navedene komponente cinka najmanje 10 masenih dijelova na milijun, u odnosu na ukupnu masu pripravka polialkilen oksida.
6. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time da je sadržaj navedene komponente cinka najviše 10,000 masenih dijelova na milijun, u odnosu na ukupnu masu farmaceutskog oblika doziranja.
7. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time da farmakološki aktivni sastojak je opioid.
8. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time da je farmakološki aktivni sastojak obuhvaćen u matricu s kontroliranim otpuštanjem koja sadrži polialkilen oksid i komponentu cinka.
9. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time da je monolitni ili višečestični.
10. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time da se ekstrudira iz taline.
11. Farmaceutski oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time da je prilagođen je za primjenu jednom dnevno, dva puta dnevno ili tri puta dnevno.
12. Postupak za proizvodnju farmaceutskog oblika doziranja prema bilo kojem od prethodnih zahtjeva naznačen time da sadrži korake
(a) miješanje farmakološki aktivnog sastojka, pripravka polialkilen oksida kako je definirano u bilo kojem od zahtjeva 2 do 5, te proizvoljno prisutna pomoćna sredstva; te
(b) oblikovanje prešanjem smjese dobivene u koraku (a) uz prethodno, istovremeno, ili naknadno izlaganje toplini.
13. Postupak prema zahtjevu 12, naznačen time da se korak (b) provodi pomoću ekstrudera.
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 |
|---|---|
| HRP20171718T1 true HRP20171718T1 (hr) | 2017-12-29 |
Family
ID=48407572
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20171718TT HRP20171718T1 (hr) | 2012-05-11 | 2017-11-09 | Termooblikovan, farmaceutski oblik doziranja otporan na mijenjanje koji sadrži cink |
Country Status (22)
| Country | Link |
|---|---|
| EP (1) | EP2846835B1 (hr) |
| JP (2) | JP2015516406A (hr) |
| CN (1) | CN104428002B (hr) |
| AU (1) | AU2013257943B2 (hr) |
| BR (1) | BR112014026768A2 (hr) |
| CA (1) | CA2870012A1 (hr) |
| CY (1) | CY1119637T1 (hr) |
| DK (1) | DK2846835T3 (hr) |
| EA (1) | EA029171B1 (hr) |
| ES (1) | ES2650945T3 (hr) |
| HK (1) | HK1207978A1 (hr) |
| HR (1) | HRP20171718T1 (hr) |
| HU (1) | HUE035123T2 (hr) |
| IL (1) | IL234815A0 (hr) |
| LT (1) | LT2846835T (hr) |
| MX (1) | MX357783B (hr) |
| NO (1) | NO2846835T3 (hr) |
| PL (1) | PL2846835T3 (hr) |
| PT (1) | PT2846835T (hr) |
| RS (1) | RS56685B1 (hr) |
| SI (1) | SI2846835T1 (hr) |
| WO (1) | WO2013167735A1 (hr) |
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| US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
| 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 |
| DE10361596A1 (de) | 2003-12-24 | 2005-09-29 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
| 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 |
| CA2713128C (en) | 2008-01-25 | 2016-04-05 | Gruenenthal Gmbh | Pharmaceutical dosage form |
| ES2534908T3 (es) | 2009-07-22 | 2015-04-30 | Grünenthal GmbH | Forma de dosificación de liberación controlada extruida por fusión en caliente |
| CN102639118B (zh) | 2009-07-22 | 2015-07-29 | 格吕伦塔尔有限公司 | 氧化稳定的抗干扰剂型 |
| MX2013002293A (es) | 2010-09-02 | 2013-05-09 | Gruenenthal Gmbh | Forma de dosificacion resistente a alteracion que comprende un polimero anionico. |
| PL2611426T3 (pl) | 2010-09-02 | 2014-09-30 | Gruenenthal Gmbh | Postać dawkowania zawierająca nieorganiczne sole, odporna na zgniatanie |
| RS56527B1 (sr) | 2011-07-29 | 2018-02-28 | Gruenenthal Gmbh | Tableta za trenutno oslobađanje leka rezistentna na zloupotrebu |
| DK2736495T3 (da) | 2011-07-29 | 2017-11-13 | Gruenenthal Gmbh | Misbrugsbestandig tablet som tilvejebringer øjeblikkelig frigivelse af lægemiddel |
| EP2819656A1 (en) | 2012-02-28 | 2015-01-07 | Grünenthal GmbH | Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer |
| MX362357B (es) | 2012-04-18 | 2019-01-14 | Gruenenthal Gmbh | Forma de dosificacion farmaceutica resistente a la adulteracion y resistente a la liberacion inmediata de la dosis. |
| US10064945B2 (en) | 2012-05-11 | 2018-09-04 | Gruenenthal Gmbh | Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc |
| US10154966B2 (en) | 2013-05-29 | 2018-12-18 | Grünenthal GmbH | Tamper-resistant dosage form containing one or more particles |
| AU2014273226B2 (en) | 2013-05-29 | 2019-06-27 | Grunenthal Gmbh | Tamper resistant dosage form with bimodal release profile |
| JP6449871B2 (ja) | 2013-07-12 | 2019-01-09 | 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 | エチレン−酢酸ビニルポリマーを含有する改変防止剤形 |
| BR112016010482B1 (pt) | 2013-11-26 | 2022-11-16 | Grünenthal GmbH | Preparação de uma composição farmacêutica em pó por meio de criomoagem |
| MX2016014738A (es) | 2014-05-12 | 2017-03-06 | Gruenenthal Gmbh | Formulacion en capsula de liberacion inmediata resistente a alteraciones que comprende tapentadol. |
| CN106456550A (zh) | 2014-05-26 | 2017-02-22 | 格吕伦塔尔有限公司 | 避免乙醇剂量倾泻的多颗粒 |
| CA2983640A1 (en) | 2015-04-24 | 2016-10-27 | Grunenthal Gmbh | Tamper-resistant fixed dose combination providing fast release of two drugs from different particles |
| AU2016251302A1 (en) | 2015-04-24 | 2017-11-23 | Grünenthal GmbH | Tamper-resistant fixed dose combination providing fast release of two drugs from particles and a matrix |
| CA2983642A1 (en) | 2015-04-24 | 2016-10-27 | Grunenthal Gmbh | Tamper-resistant dosage form with immediate release and resistance against solvent extraction |
| JP2018515455A (ja) | 2015-04-24 | 2018-06-14 | 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 | 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 |
| 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 |
| CA2998259A1 (en) | 2015-09-10 | 2017-03-16 | Grunenthal Gmbh | Protecting oral overdose with abuse deterrent immediate release formulations |
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| DE102005005449A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
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| TW201022253A (en) | 2008-11-14 | 2010-06-16 | Portola Pharm Inc | Solid composition for controlled release of ionizable active agents with poor aqueous solubility at low pH and methods of use thereof |
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-
2013
- 2013-05-10 JP JP2015510834A patent/JP2015516406A/ja active Pending
- 2013-05-10 AU AU2013257943A patent/AU2013257943B2/en not_active Ceased
- 2013-05-10 CA CA2870012A patent/CA2870012A1/en not_active Abandoned
- 2013-05-10 RS RS20171251A patent/RS56685B1/sr unknown
- 2013-05-10 DK DK13721766.7T patent/DK2846835T3/en active
- 2013-05-10 EP EP13721766.7A patent/EP2846835B1/en active Active
- 2013-05-10 BR BR112014026768A patent/BR112014026768A2/pt not_active Application Discontinuation
- 2013-05-10 CN CN201380024652.2A patent/CN104428002B/zh not_active Expired - Fee Related
- 2013-05-10 HU HUE13721766A patent/HUE035123T2/en unknown
- 2013-05-10 EA EA201401240A patent/EA029171B1/ru not_active IP Right Cessation
- 2013-05-10 PL PL13721766T patent/PL2846835T3/pl unknown
- 2013-05-10 MX MX2014013095A patent/MX357783B/es active IP Right Grant
- 2013-05-10 SI SI201330858T patent/SI2846835T1/en unknown
- 2013-05-10 LT LTEP13721766.7T patent/LT2846835T/lt 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 ES ES13721766.7T patent/ES2650945T3/es active Active
- 2013-05-10 PT PT137217667T patent/PT2846835T/pt unknown
-
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 |
|---|---|
| JP6541748B2 (ja) | 2019-07-10 |
| WO2013167735A1 (en) | 2013-11-14 |
| NO2846835T3 (hr) | 2018-02-03 |
| PT2846835T (pt) | 2017-12-15 |
| AU2013257943B2 (en) | 2017-10-05 |
| CN104428002B (zh) | 2017-08-11 |
| AU2013257943A1 (en) | 2014-10-09 |
| BR112014026768A2 (pt) | 2017-06-27 |
| SI2846835T1 (en) | 2018-01-31 |
| CN104428002A (zh) | 2015-03-18 |
| MX2014013095A (es) | 2014-12-08 |
| LT2846835T (lt) | 2017-12-27 |
| DK2846835T3 (en) | 2017-12-04 |
| EP2846835A1 (en) | 2015-03-18 |
| CA2870012A1 (en) | 2013-11-14 |
| JP2018065810A (ja) | 2018-04-26 |
| EA201401240A1 (ru) | 2015-04-30 |
| ES2650945T3 (es) | 2018-01-23 |
| MX357783B (es) | 2018-07-25 |
| IL234815A0 (en) | 2014-12-31 |
| JP2015516406A (ja) | 2015-06-11 |
| PL2846835T3 (pl) | 2018-02-28 |
| HK1207978A1 (en) | 2016-02-19 |
| HUE035123T2 (en) | 2018-05-02 |
| CY1119637T1 (el) | 2018-04-04 |
| RS56685B1 (sr) | 2018-03-30 |
| EP2846835B1 (en) | 2017-09-06 |
| EA029171B1 (ru) | 2018-02-28 |
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