HRP20171458T1 - Tableta otporna na mijenjanje koja pruža neposredno oslobađanje lijeka - Google Patents
Tableta otporna na mijenjanje koja pruža neposredno oslobađanje lijeka Download PDFInfo
- Publication number
- HRP20171458T1 HRP20171458T1 HRP20171458TT HRP20171458T HRP20171458T1 HR P20171458 T1 HRP20171458 T1 HR P20171458T1 HR P20171458T T HRP20171458T T HR P20171458TT HR P20171458 T HRP20171458 T HR P20171458T HR P20171458 T1 HRP20171458 T1 HR P20171458T1
- Authority
- HR
- Croatia
- Prior art keywords
- tablet according
- particles
- tablet
- active compound
- matrix material
- Prior art date
Links
- 239000003814 drug Substances 0.000 title 1
- 229940079593 drug Drugs 0.000 title 1
- 239000002245 particle Substances 0.000 claims 7
- 150000001875 compounds Chemical class 0.000 claims 5
- 239000011159 matrix material Substances 0.000 claims 5
- 229920000233 poly(alkylene oxides) Polymers 0.000 claims 4
- 239000003795 chemical substances by application Substances 0.000 claims 2
- 238000000338 in vitro Methods 0.000 claims 2
- 239000011230 binding agent Substances 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 239000012943 hotmelt Substances 0.000 claims 1
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 1
- 239000000314 lubricant Substances 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
-
- 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
-
- 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
- A61P25/26—Psychostimulants, e.g. nicotine, cocaine
-
- 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
Landscapes
- Health & Medical 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)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Emergency Medicine (AREA)
- Organic Chemistry (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Addiction (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)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Medicines Containing Plant Substances (AREA)
Claims (12)
1. Tableta otporna na mijenjanje koja sadrži
(i) materijal matrice u količini od barem 40 mas.-%, u odnosu na ukupnu masu tablete; i
(ii) mnoštvo čestica u količini od najviše 60 mas.-% ukupne mase tablete; pri čemu navedene čestice sadrže farmakološki aktivan spoj i polialkilen oksid; i tvore diskontinuiranu fazu unutar materijala matrice;
naznačena time da polialkilen oksid ima molekularnu težinu od više od 20,000 g/mol;
tableta ima pod in vitro uvjetima neposredno oslobađanje farmakološki aktivnog spoja u skladu s Europskom farmakopejom; i
farmakološki aktivan spoj je opioid.
2. Tableta prema zahtjevu 1, naznačena time da ima pod in vitro uvjetima vrijeme raspadanja mjereno u skladu s Europskom farmakopejom od najviše 3 minute.
3. Tableta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time da čestice imaju prosječan promjer od oko 1000±250 µm i/ili prosječnu duljinu od oko 750±250 µm.
4. Tableta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time da je farmakološki aktivan spoj dispergiran u polialkilen oksidu.
5. Tableta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time da je sadržaj polialkilen oksida barem 25 mas.-%, u odnosu na ukupnu masu čestica.
6. Tableta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time da je sadržaj farmakološki aktivnog spoja barem 25 mas.-%, u odnosu na ukupnu masu čestica.
7. Tableta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time da su čestice ekstrudirane iz vruće taljevine.
8. Tableta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time da čestice su prevučene filmom.
9. Tableta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time da je materijal matrice također prisutan u obliku čestica.
10. Tableta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time da je materijal matrice suho granuliran ili kompaktan.
11. Tableta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time da materijal matrice sadrži vezivo, punilo, sredstvo za dezintegraciju i/ili lubrikant.
12. Tableta prema zahtjevu 11, naznačena time da je sredstvo za dezintegraciju umreženo.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP11006253 | 2011-07-29 | ||
PCT/EP2012/003196 WO2013017242A1 (en) | 2011-07-29 | 2012-07-27 | Tamper-resistant tablet providing immediate drug release |
EP12755793.2A EP2736497B1 (en) | 2011-07-29 | 2012-07-27 | Tamper-resistant tablet providing immediate drug release |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20171458T1 true HRP20171458T1 (hr) | 2017-11-17 |
Family
ID=44951601
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20171458TT HRP20171458T1 (hr) | 2011-07-29 | 2017-09-28 | Tableta otporna na mijenjanje koja pruža neposredno oslobađanje lijeka |
Country Status (30)
Country | Link |
---|---|
US (4) | US20130028972A1 (hr) |
EP (1) | EP2736497B1 (hr) |
JP (2) | JP6063462B2 (hr) |
KR (1) | KR20140053158A (hr) |
CN (1) | CN103857386A (hr) |
AR (1) | AR087359A1 (hr) |
AU (1) | AU2012292418B2 (hr) |
BR (1) | BR112014001091A2 (hr) |
CA (1) | CA2839126A1 (hr) |
CL (1) | CL2013003331A1 (hr) |
CO (1) | CO6821948A2 (hr) |
CY (1) | CY1119503T1 (hr) |
DK (1) | DK2736497T3 (hr) |
EA (1) | EA201400173A1 (hr) |
EC (1) | ECSP14013169A (hr) |
ES (1) | ES2648129T3 (hr) |
HK (1) | HK1198131A1 (hr) |
HR (1) | HRP20171458T1 (hr) |
HU (1) | HUE034710T2 (hr) |
IL (1) | IL229516A0 (hr) |
LT (1) | LT2736497T (hr) |
MX (1) | MX348054B (hr) |
NO (1) | NO2736497T3 (hr) |
PE (1) | PE20141650A1 (hr) |
PL (1) | PL2736497T3 (hr) |
PT (1) | PT2736497T (hr) |
RS (1) | RS56527B1 (hr) |
SI (1) | SI2736497T1 (hr) |
WO (1) | WO2013017242A1 (hr) |
ZA (1) | ZA201309299B (hr) |
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US20040253310A1 (en) | 2001-09-21 | 2004-12-16 | Gina Fischer | Morphine polymer release system |
US20040234602A1 (en) | 2001-09-21 | 2004-11-25 | Gina Fischer | Polymer release system |
US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
US8877241B2 (en) | 2003-03-26 | 2014-11-04 | Egalet Ltd. | Morphine controlled release system |
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 |
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 |
US8821928B2 (en) | 2007-06-04 | 2014-09-02 | Egalet Ltd. | Controlled release pharmaceutical compositions for prolonged effect |
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 |
US9005660B2 (en) | 2009-02-06 | 2015-04-14 | Egalet Ltd. | Immediate release composition resistant to abuse by intake of alcohol |
WO2010149169A2 (en) | 2009-06-24 | 2010-12-29 | Egalet A/S | Controlled release formulations |
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NO2736495T3 (hr) | 2011-07-29 | 2018-01-20 | ||
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KR20160031526A (ko) | 2013-07-12 | 2016-03-22 | 그뤼넨탈 게엠베하 | 에틸렌-비닐 아세테이트 중합체를 함유하는 템퍼 내성 투여형 |
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2012
- 2012-07-27 WO PCT/EP2012/003196 patent/WO2013017242A1/en active Application Filing
- 2012-07-27 SI SI201231109T patent/SI2736497T1/sl unknown
- 2012-07-27 AU AU2012292418A patent/AU2012292418B2/en not_active Ceased
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- 2012-07-27 DK DK12755793.2T patent/DK2736497T3/da active
- 2012-07-27 EA EA201400173A patent/EA201400173A1/ru unknown
- 2012-07-27 MX MX2014001167A patent/MX348054B/es active IP Right Grant
- 2012-07-27 CN CN201280038097.4A patent/CN103857386A/zh active Pending
- 2012-07-27 RS RS20171148A patent/RS56527B1/sr unknown
- 2012-07-27 AR ARP120102741A patent/AR087359A1/es unknown
- 2012-07-27 JP JP2014521997A patent/JP6063462B2/ja not_active Expired - Fee Related
- 2012-07-27 US US13/559,635 patent/US20130028972A1/en not_active Abandoned
- 2012-07-27 PE PE2013002884A patent/PE20141650A1/es not_active Application Discontinuation
- 2012-07-27 PT PT127557932T patent/PT2736497T/pt unknown
- 2012-07-27 HU HUE12755793A patent/HUE034710T2/hu unknown
- 2012-07-27 KR KR1020147002755A patent/KR20140053158A/ko not_active Application Discontinuation
- 2012-07-27 CA CA2839126A patent/CA2839126A1/en not_active Abandoned
- 2012-07-27 PL PL12755793T patent/PL2736497T3/pl unknown
- 2012-07-27 EP EP12755793.2A patent/EP2736497B1/en active Active
- 2012-07-27 BR BR112014001091A patent/BR112014001091A2/pt not_active Application Discontinuation
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- 2012-07-27 ES ES12755793.2T patent/ES2648129T3/es active Active
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2013
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- 2013-12-04 CO CO13284672A patent/CO6821948A2/es unknown
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2014
- 2014-01-23 EC ECSP14013169 patent/ECSP14013169A/es unknown
- 2014-11-19 HK HK14111669.1A patent/HK1198131A1/xx not_active IP Right Cessation
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2016
- 2016-03-18 US US15/073,920 patent/US20160199306A1/en not_active Abandoned
- 2016-12-14 JP JP2016241930A patent/JP6316394B2/ja not_active Expired - Fee Related
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2017
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- 2017-10-26 CY CY20171101117T patent/CY1119503T1/el unknown
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2018
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