HRP20100157T1 - Retard tablete hidromorfona - Google Patents
Retard tablete hidromorfona Download PDFInfo
- Publication number
- HRP20100157T1 HRP20100157T1 HR20100157T HRP20100157T HRP20100157T1 HR P20100157 T1 HRP20100157 T1 HR P20100157T1 HR 20100157 T HR20100157 T HR 20100157T HR P20100157 T HRP20100157 T HR P20100157T HR P20100157 T1 HRP20100157 T1 HR P20100157T1
- Authority
- HR
- Croatia
- Prior art keywords
- active substance
- layer
- release
- tablet
- layer containing
- Prior art date
Links
- WVLOADHCBXTIJK-YNHQPCIGSA-N hydromorphone Chemical compound O([C@H]1C(CC[C@H]23)=O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O WVLOADHCBXTIJK-YNHQPCIGSA-N 0.000 title claims abstract 7
- 229960001410 hydromorphone Drugs 0.000 title claims abstract 7
- 239000013543 active substance Substances 0.000 claims abstract 37
- 239000008188 pellet Substances 0.000 claims abstract 12
- 239000011248 coating agent Substances 0.000 claims abstract 4
- 238000000576 coating method Methods 0.000 claims abstract 4
- 150000003839 salts Chemical class 0.000 claims abstract 2
- 239000012453 solvate Substances 0.000 claims abstract 2
- 230000001934 delay Effects 0.000 claims 5
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 239000001856 Ethyl cellulose Substances 0.000 claims 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims 1
- 239000011230 binding agent Substances 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- 229920001249 ethyl cellulose Polymers 0.000 claims 1
- 235000019325 ethyl cellulose Nutrition 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 239000000314 lubricant Substances 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 239000000463 material Substances 0.000 abstract 1
- 230000000979 retarding effect Effects 0.000 abstract 1
Classifications
-
- 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
- A61K9/2072—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
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- 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
Abstract
Tableta, naznačena time što sadrži tabletnu jezgru koja sadrži više peleta s aktivnom tvari i jednom ili više farmaceutski podnošljivih pomoćnih tvari i najmanje jednu oblogu oko tabletne jezgre, gdje peleti koji sadrže aktivnu tvar sadrže kao aktivnu tvar hidromorfon, ili njegovu sol ili solvat, i imaju sljedeću strukturu: a) inertna jezgra, b) sloj koji sadrži aktivnu tvar koji oblaže inertnu jezgru, c) sloj koji oblaže sloj koji sadrži aktivnu tvar i odgađa otpuštanje aktivne tvari, id) dodatni sloj koji sadrži aktivnu tvar koji oblaže sloj koji odgađa otpuštanje aktivne tvari. Patent sadrži još 9 patentnih zahtjeva.
Claims (10)
1. Tableta, naznačena time što sadrži tabletnu jezgru koja sadrži više peleta s aktivnom tvari i jednom ili više farmaceutski podnošljivih pomoćnih tvari i najmanje jednu oblogu oko tabletne jezgre, gdje peleti koji sadrže aktivnu tvar sadrže kao aktivnu tvar hidromorfon, ili njegovu sol ili solvat, i imaju sljedeću strukturu:
a) inertna jezgra,
b) sloj koji sadrži aktivnu tvar koji oblaže inertnu jezgru,
c) sloj koji oblaže sloj koji sadrži aktivnu tvar i odgađa otpuštanje aktivne tvari, i
d) dodatni sloj koji sadrži aktivnu tvar koji oblaže sloj koji odgađa otpuštanje aktivne tvari.
2. Tableta u skladu s patentnim zahtjevom 1, naznačena time što sadrži aktivnu tvar u rasponu koncentracija od 2 do 30 %, prema ukupnoj težini tablete.
3. Tableta u skladu s patentnim zahtjevom 1 ili 2, naznačena time što farmaceutski podnošljive pomoćne tvari koje se komprimira s peletima kako bi se načinilo tabletnu jezgru se bira između veziva, punila, sredstava za raspadanje, maziva, sredstava za kliženje i njihovih smjesa.
4. Tableta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što na tabletnu jezgru se polaže oblogu koja nije obloga koja odgađa otpuštanje aktivne tvari.
5. Pelet koji sadrži aktivnu tvar, naznačen time što kao aktivnu tvar sadrži hidromorfon i ima sljedeću strukturu:
a) inertna jezgra,
b) sloj koji sadrži aktivnu tvar koji oblaže inertnu jezgru,
c) sloj koji oblaže sloj koji sadrži aktivnu tvar i odgađa otpuštanje aktivne tvari i
d) dodatni sloj koji sadrži aktivnu tvar koji oblaže sloj koji odgađa otpuštanje aktivne tvari.
6. Pelet koji sadrži aktivnu tvar u skladu s patentnim zahtjevom 5, naznačen time što sloj koji se oblaže na sloj koji sadrži aktivnu tvar i odgađa otpuštanje aktivne tvari sadrži etilcelulozu kao retardant.
7. Pelet koji sadrži aktivnu tvar u skladu s patentnim zahtjevom 5 ili 6, naznačen time što sadržaj hidromorfona u sloju koji sadrži aktivnu tvar se kreće u rasponu od 2 mg do 80 mg.
8. Pelet koji sadrži aktivnu tvar u skladu s bilo kojim od patentnih zahtjeva 5 do 7, naznačen time što sadržaj hidromorfona u dodatnom sloju koji sadrži aktivnu tvar koji oblaže sloj koji odgađa otpuštanje aktivne tvari se kreće u rasponu od 0,04 mg do 12 mg.
9. Pelet koji sadrži aktivnu tvar u skladu s bilo kojim od patentnih zahtjeva 5 do 8, naznačen time što debljina sloja koji sadrži aktivnu tvar se oblaže na inertnu jezgru se kreće rasponu od 10 µm do 200 µm.
10. Pelet koji sadrži aktivnu tvar u skladu s bilo kojim od patentnih zahtjeva 5 do 9, naznačen time što debljina dodatnog sloja koji sadrži aktivnu tvar se oblaže na sloj koji odgađa otpuštanje aktivne tvari se kreće rasponu od 10 µm do 200 µm.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP07021788A EP2057984B1 (de) | 2007-11-09 | 2007-11-09 | Retardtabletten mit Hydromorphon |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20100157T1 true HRP20100157T1 (hr) | 2010-04-30 |
Family
ID=39272211
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HR20100157T HRP20100157T1 (hr) | 2007-11-09 | 2010-03-18 | Retard tablete hidromorfona |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US20100247647A1 (hr) |
| EP (3) | EP2057984B1 (hr) |
| JP (1) | JP2011503017A (hr) |
| AT (2) | ATE455538T1 (hr) |
| AU (1) | AU2008324466A1 (hr) |
| CA (1) | CA2704646C (hr) |
| DE (1) | DE502007002695D1 (hr) |
| DK (2) | DK2057984T3 (hr) |
| ES (2) | ES2337935T3 (hr) |
| HR (1) | HRP20100157T1 (hr) |
| PL (1) | PL2057984T3 (hr) |
| PT (1) | PT2057984E (hr) |
| RS (1) | RS51313B (hr) |
| SI (1) | SI2057984T1 (hr) |
| WO (1) | WO2009059701A2 (hr) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20130010512A (ko) | 1999-10-29 | 2013-01-28 | 유로-셀티크 소시에떼 아노뉨 | 서방성 하이드로코돈 제형 |
| US10179130B2 (en) | 1999-10-29 | 2019-01-15 | Purdue Pharma L.P. | Controlled release hydrocodone formulations |
| EP1337244A4 (en) | 2000-10-30 | 2006-01-11 | Euro Celtique Sa | HYDROCODON FORMULATIONS WITH CONTROLLED RELEASE |
| US20080069891A1 (en) | 2006-09-15 | 2008-03-20 | Cima Labs, Inc. | Abuse resistant drug formulation |
| US8445018B2 (en) | 2006-09-15 | 2013-05-21 | Cima Labs Inc. | Abuse resistant drug formulation |
| AU2010339882B2 (en) | 2009-12-17 | 2016-10-27 | Cima Labs Inc. | Abuse-resistant formulations |
| EP2568977A1 (en) | 2010-05-11 | 2013-03-20 | Cima Labs Inc. | Alcohol-resistant metoprolol-containing extended- release oral dosage forms |
| EP2446882B8 (de) * | 2010-10-28 | 2014-02-12 | Acino Pharma AG | Arzneimittel mit dem Wirkstoff Hydromorphon mit verbesserter Lagerstabilität |
| EP2606879A1 (en) | 2011-12-21 | 2013-06-26 | Hexal AG | Multiple unit pellet tablet formulation comprising an opioid |
| TWI566786B (zh) * | 2012-09-03 | 2017-01-21 | 第一三共股份有限公司 | 含有氫化嗎啡酮鹽酸鹽之經口用徐放性醫藥組成物 |
| CA2881144A1 (en) * | 2012-11-09 | 2014-05-09 | Purdue Pharma | Pharmaceutical compositions comprising hydromorphone and naloxone |
| US20150118300A1 (en) | 2013-10-31 | 2015-04-30 | Cima Labs Inc. | Immediate Release Abuse-Deterrent Granulated Dosage Forms |
| EP3229788A4 (en) | 2014-12-08 | 2018-06-13 | Cima Labs Inc. | Immediate release abuse-deterrent granulated dosage forms |
| EP3716953A1 (en) | 2017-11-27 | 2020-10-07 | DSM IP Assets B.V. | Freeze-dried multiparticulate solid dosage form |
| TW201943410A (zh) | 2018-04-10 | 2019-11-16 | 荷蘭商帝斯曼知識產權資產管理有限公司 | 具有彈性結構之多顆粒固體劑型 |
| US11324707B2 (en) | 2019-05-07 | 2022-05-10 | Clexio Biosciences Ltd. | Abuse-deterrent dosage forms containing esketamine |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3403329A1 (de) * | 1984-02-01 | 1985-08-01 | Horst Dr. 4019 Monheim Zerbe | Pharmazeutisches produkt in form von pellets mit kontinuierlicher, verzoegerter wirkstoffabgabe |
| GB8626098D0 (en) * | 1986-10-31 | 1986-12-03 | Euro Celtique Sa | Controlled release hydromorphone composition |
| US5266331A (en) | 1991-11-27 | 1993-11-30 | Euroceltique, S.A. | Controlled release oxycodone compositions |
| US5286493A (en) | 1992-01-27 | 1994-02-15 | Euroceltique, S.A. | Stabilized controlled release formulations having acrylic polymer coating |
| US5472712A (en) * | 1991-12-24 | 1995-12-05 | Euroceltique, S.A. | Controlled-release formulations coated with aqueous dispersions of ethylcellulose |
| US5273760A (en) | 1991-12-24 | 1993-12-28 | Euroceltigue, S.A. | Stabilized controlled release substrate having a coating derived from an aqueous dispersion of hydrophobic polymer |
| US5914131A (en) * | 1994-07-07 | 1999-06-22 | Alza Corporation | Hydromorphone therapy |
| US20020006438A1 (en) * | 1998-09-25 | 2002-01-17 | Benjamin Oshlack | Sustained release hydromorphone formulations exhibiting bimodal characteristics |
| DE19539361A1 (de) * | 1995-10-23 | 1997-04-24 | Basf Ag | Verfahren zur Herstellung von mehrschichtigen, festen Arzneiformen zur oralen oder rektalen Verabreichung |
| DE19927688A1 (de) * | 1999-06-17 | 2000-12-21 | Gruenenthal Gmbh | Mehrschichttablette zur Verabreichung einer fixen Kombination von Tramadol und Diclofenac |
| WO2004112746A1 (en) * | 2003-06-26 | 2004-12-29 | Korea Research Institute Of Chemical Technology | Controlled release-drug delivery system for oral administration |
| EP1677768A4 (en) * | 2003-10-03 | 2011-06-29 | Elite Lab Inc | PROLONGED RELEASE OPIOID FORMULATIONS AND METHOD OF USING THE FORMULATIONS |
| US7670624B2 (en) * | 2004-01-29 | 2010-03-02 | Astella Pharma Inc. | Gastrointestinal-specific multiple drug release system |
| US10624858B2 (en) * | 2004-08-23 | 2020-04-21 | Intellipharmaceutics Corp | Controlled release composition using transition coating, and method of preparing same |
| US20070104789A1 (en) * | 2005-11-04 | 2007-05-10 | Donald Spector | Gastro-resistant and ethanol-resistant controlled-release formulations comprising hydromorphone |
| US20070207200A1 (en) * | 2006-03-06 | 2007-09-06 | Pozen Inc. | Dosage forms for administering combinations of drugs |
-
2007
- 2007-11-09 PT PT07021788T patent/PT2057984E/pt unknown
- 2007-11-09 EP EP07021788A patent/EP2057984B1/de active Active
- 2007-11-09 ES ES07021788T patent/ES2337935T3/es active Active
- 2007-11-09 DE DE502007002695T patent/DE502007002695D1/de active Active
- 2007-11-09 SI SI200730176T patent/SI2057984T1/sl unknown
- 2007-11-09 AT AT07021788T patent/ATE455538T1/de active
- 2007-11-09 RS RSP-2010/0084A patent/RS51313B/sr unknown
- 2007-11-09 PL PL07021788T patent/PL2057984T3/pl unknown
- 2007-11-09 DK DK07021788.0T patent/DK2057984T3/da active
-
2008
- 2008-10-24 AU AU2008324466A patent/AU2008324466A1/en not_active Abandoned
- 2008-10-24 ES ES08847385T patent/ES2374690T3/es active Active
- 2008-10-24 JP JP2010532471A patent/JP2011503017A/ja active Pending
- 2008-10-24 DK DK08847385.5T patent/DK2217210T3/da active
- 2008-10-24 WO PCT/EP2008/009033 patent/WO2009059701A2/de active Application Filing
- 2008-10-24 CA CA2704646A patent/CA2704646C/en not_active Expired - Fee Related
- 2008-10-24 EP EP11191245A patent/EP2425822B1/de not_active Revoked
- 2008-10-24 AT AT08847385T patent/ATE536862T1/de active
- 2008-10-24 EP EP08847385A patent/EP2217210B1/de not_active Not-in-force
- 2008-10-24 US US12/741,963 patent/US20100247647A1/en not_active Abandoned
-
2010
- 2010-03-18 HR HR20100157T patent/HRP20100157T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP2425822A1 (de) | 2012-03-07 |
| WO2009059701A3 (de) | 2009-07-16 |
| ATE455538T1 (de) | 2010-02-15 |
| EP2425822B1 (de) | 2012-12-19 |
| PT2057984E (pt) | 2010-03-10 |
| PL2057984T3 (pl) | 2010-05-31 |
| ES2337935T3 (es) | 2010-04-30 |
| EP2217210A2 (de) | 2010-08-18 |
| EP2057984A1 (de) | 2009-05-13 |
| EP2057984B1 (de) | 2010-01-20 |
| WO2009059701A2 (de) | 2009-05-14 |
| DK2057984T3 (da) | 2010-05-03 |
| AU2008324466A1 (en) | 2009-05-14 |
| ATE536862T1 (de) | 2011-12-15 |
| US20100247647A1 (en) | 2010-09-30 |
| DK2217210T3 (da) | 2012-02-13 |
| CA2704646A1 (en) | 2009-05-14 |
| ES2374690T3 (es) | 2012-02-21 |
| JP2011503017A (ja) | 2011-01-27 |
| RS51313B (sr) | 2010-12-31 |
| CA2704646C (en) | 2016-04-05 |
| EP2217210B1 (de) | 2011-12-14 |
| DE502007002695D1 (de) | 2010-03-11 |
| SI2057984T1 (sl) | 2010-04-30 |
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