JP2014530185A5 - - Google Patents
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- Publication number
- JP2014530185A5 JP2014530185A5 JP2014530332A JP2014530332A JP2014530185A5 JP 2014530185 A5 JP2014530185 A5 JP 2014530185A5 JP 2014530332 A JP2014530332 A JP 2014530332A JP 2014530332 A JP2014530332 A JP 2014530332A JP 2014530185 A5 JP2014530185 A5 JP 2014530185A5
- Authority
- JP
- Japan
- Prior art keywords
- dosage form
- drug
- core
- particles
- active layer
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000002552 dosage form Substances 0.000 claims description 87
- 239000003814 drug Substances 0.000 claims description 50
- 229940079593 drug Drugs 0.000 claims description 50
- 239000002245 particle Substances 0.000 claims description 41
- 239000003349 gelling agent Substances 0.000 claims description 25
- 238000000034 method Methods 0.000 claims description 23
- 102000004190 Enzymes Human genes 0.000 claims description 22
- 108090000790 Enzymes Proteins 0.000 claims description 22
- 238000004090 dissolution Methods 0.000 claims description 22
- 239000012530 fluid Substances 0.000 claims description 22
- 230000002496 gastric effect Effects 0.000 claims description 22
- 238000000338 in vitro Methods 0.000 claims description 22
- 239000006186 oral dosage form Substances 0.000 claims description 22
- 230000004888 barrier function Effects 0.000 claims description 21
- 239000007788 liquid Substances 0.000 claims description 14
- 239000000203 mixture Substances 0.000 claims description 14
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 9
- 239000003085 diluting agent Substances 0.000 claims description 9
- 150000001720 carbohydrates Chemical class 0.000 claims description 8
- 239000002775 capsule Substances 0.000 claims description 7
- BRUQQQPBMZOVGD-XFKAJCMBSA-N Oxycodone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(OC)C2=C5[C@@]13CCN4C BRUQQQPBMZOVGD-XFKAJCMBSA-N 0.000 claims description 6
- 239000008101 lactose Substances 0.000 claims description 6
- 229960002085 oxycodone Drugs 0.000 claims description 6
- 150000003839 salts Chemical class 0.000 claims description 6
- OROGSEYTTFOCAN-DNJOTXNNSA-N codeine Chemical compound C([C@H]1[C@H](N(CC[C@@]112)C)C3)=C[C@H](O)[C@@H]1OC1=C2C3=CC=C1OC OROGSEYTTFOCAN-DNJOTXNNSA-N 0.000 claims description 4
- 238000013270 controlled release Methods 0.000 claims description 4
- OROGSEYTTFOCAN-UHFFFAOYSA-N hydrocodone Natural products C1C(N(CCC234)C)C2C=CC(O)C3OC2=C4C1=CC=C2OC OROGSEYTTFOCAN-UHFFFAOYSA-N 0.000 claims description 4
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 4
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 4
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 4
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 4
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims description 4
- BQJCRHHNABKAKU-KBQPJGBKSA-N morphine Chemical compound O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O BQJCRHHNABKAKU-KBQPJGBKSA-N 0.000 claims description 4
- 239000003401 opiate antagonist Substances 0.000 claims description 4
- 235000000346 sugar Nutrition 0.000 claims description 4
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 3
- 239000005715 Fructose Substances 0.000 claims description 3
- 229930091371 Fructose Natural products 0.000 claims description 3
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 claims description 3
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 3
- 229930195725 Mannitol Natural products 0.000 claims description 3
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 3
- 229930006000 Sucrose Natural products 0.000 claims description 3
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 3
- 239000008121 dextrose Substances 0.000 claims description 3
- 239000000594 mannitol Substances 0.000 claims description 3
- 235000010355 mannitol Nutrition 0.000 claims description 3
- 239000005720 sucrose Substances 0.000 claims description 3
- 230000004584 weight gain Effects 0.000 claims description 3
- 235000019786 weight gain Nutrition 0.000 claims description 3
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims description 2
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims description 2
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 2
- UQCNKQCJZOAFTQ-ISWURRPUSA-N Oxymorphone Chemical compound O([C@H]1C(CC[C@]23O)=O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O UQCNKQCJZOAFTQ-ISWURRPUSA-N 0.000 claims description 2
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 2
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 2
- 150000001298 alcohols Chemical class 0.000 claims description 2
- 239000002269 analeptic agent Substances 0.000 claims description 2
- 239000011324 bead Substances 0.000 claims description 2
- 239000001913 cellulose Chemical class 0.000 claims description 2
- 229920002678 cellulose Chemical class 0.000 claims description 2
- 229960004126 codeine Drugs 0.000 claims description 2
- 239000007891 compressed tablet Substances 0.000 claims description 2
- XYYVYLMBEZUESM-UHFFFAOYSA-N dihydrocodeine Natural products C1C(N(CCC234)C)C2C=CC(=O)C3OC2=C4C1=CC=C2OC XYYVYLMBEZUESM-UHFFFAOYSA-N 0.000 claims description 2
- LLPOLZWFYMWNKH-CMKMFDCUSA-N hydrocodone Chemical compound C([C@H]1[C@H](N(CC[C@@]112)C)C3)CC(=O)[C@@H]1OC1=C2C3=CC=C1OC LLPOLZWFYMWNKH-CMKMFDCUSA-N 0.000 claims description 2
- 229960000240 hydrocodone Drugs 0.000 claims description 2
- 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 claims description 2
- 229960001410 hydromorphone Drugs 0.000 claims description 2
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims description 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 2
- 239000003112 inhibitor Substances 0.000 claims description 2
- 239000011159 matrix material Substances 0.000 claims description 2
- 229960005181 morphine Drugs 0.000 claims description 2
- 229960005118 oxymorphone Drugs 0.000 claims description 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 2
- 229920000642 polymer Polymers 0.000 claims description 2
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 2
- 235000019422 polyvinyl alcohol Nutrition 0.000 claims description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 2
- 229940069328 povidone Drugs 0.000 claims description 2
- 150000008163 sugars Chemical class 0.000 claims description 2
- 239000003204 tranquilizing agent Substances 0.000 claims description 2
- 230000002936 tranquilizing effect Effects 0.000 claims description 2
- LLPOLZWFYMWNKH-UHFFFAOYSA-N trans-dihydrocodeinone Natural products C1C(N(CCC234)C)C2CCC(=O)C3OC2=C4C1=CC=C2OC LLPOLZWFYMWNKH-UHFFFAOYSA-N 0.000 claims description 2
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 2
- 229940127450 Opioid Agonists Drugs 0.000 claims 2
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 claims 1
- 230000000147 hypnotic effect Effects 0.000 claims 1
- 239000000932 sedative agent Substances 0.000 claims 1
- 229940125723 sedative agent Drugs 0.000 claims 1
- 239000003402 opiate agonist Substances 0.000 description 4
- 239000002202 Polyethylene glycol Substances 0.000 description 2
- 229920001223 polyethylene glycol Polymers 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000005554 hypnotics and sedatives Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229940125725 tranquilizer Drugs 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161535758P | 2011-09-16 | 2011-09-16 | |
| US61/535,758 | 2011-09-16 | ||
| PCT/IB2012/001916 WO2013038268A1 (en) | 2011-09-16 | 2012-09-14 | Tamper resistant immediate release formulations |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2014530185A JP2014530185A (ja) | 2014-11-17 |
| JP2014530185A5 true JP2014530185A5 (https=) | 2015-10-08 |
| JP6138798B2 JP6138798B2 (ja) | 2017-05-31 |
Family
ID=48577967
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014530332A Active JP6138798B2 (ja) | 2011-09-16 | 2012-09-14 | 不正改変抵抗性即時放出性製剤 |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US20140294947A1 (https=) |
| EP (2) | EP2755638B1 (https=) |
| JP (1) | JP6138798B2 (https=) |
| AU (1) | AU2012310251B2 (https=) |
| ES (2) | ES2703688T3 (https=) |
| IL (1) | IL231482A (https=) |
| MX (1) | MX347961B (https=) |
| WO (1) | WO2013038268A1 (https=) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040234602A1 (en) | 2001-09-21 | 2004-11-25 | Gina Fischer | Polymer release system |
| EP1429744A1 (en) | 2001-09-21 | 2004-06-23 | Egalet A/S | Morphine polymer release system |
| WO2004084868A1 (en) | 2003-03-26 | 2004-10-07 | Egalet A/S | Morphine controlled release system |
| US8821928B2 (en) | 2007-06-04 | 2014-09-02 | Egalet Ltd. | Controlled release pharmaceutical compositions for prolonged effect |
| CA2751667C (en) | 2009-02-06 | 2016-12-13 | Egalet Ltd. | Immediate release composition resistant to abuse by intake of alcohol |
| NZ597283A (en) | 2009-06-24 | 2013-07-26 | Egalet Ltd | Controlled release formulations |
| AU2013285988A1 (en) | 2012-07-06 | 2015-02-12 | Egalet Ltd. | Abuse deterrent pharmaceutical compositions for controlled release |
| CA3042642A1 (en) | 2013-08-12 | 2015-02-19 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
| US10172797B2 (en) | 2013-12-17 | 2019-01-08 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
| US9492444B2 (en) | 2013-12-17 | 2016-11-15 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
| CA2955229C (en) | 2014-07-17 | 2020-03-10 | Pharmaceutical Manufacturing Research Services, Inc. | Immediate release abuse deterrent liquid fill dosage form |
| US9132096B1 (en) | 2014-09-12 | 2015-09-15 | Alkermes Pharma Ireland Limited | Abuse resistant pharmaceutical compositions |
| WO2016064873A1 (en) | 2014-10-20 | 2016-04-28 | Pharmaceutical Manufacturing Research Services, Inc. | Extended release abuse deterrent liquid fill dosage form |
| WO2019070581A1 (en) * | 2017-10-02 | 2019-04-11 | Purdue Pharma L.P | PHARMACEUTICAL COMPOSITIONS COMPRISING GELIFYING AGENT COMPOSITIONS |
| AU2018390826B2 (en) | 2017-12-20 | 2024-09-12 | Purdue Pharma L.P. | Abuse deterrent morphine sulfate dosage forms |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB9401894D0 (en) * | 1994-02-01 | 1994-03-30 | Rhone Poulenc Rorer Ltd | New compositions of matter |
| US5654005A (en) * | 1995-06-07 | 1997-08-05 | Andrx Pharmaceuticals, Inc. | Controlled release formulation having a preformed passageway |
| AU2003271024A1 (en) * | 2002-09-21 | 2004-04-08 | Jin Wang | Sustained release compound of acetamidophenol and tramadol |
| NZ547284A (en) * | 2003-10-31 | 2009-12-24 | Hexal Ag | Pharmaceutical agent-containing formulation comprising a coating of a film forming polymer |
| ES2281851T3 (es) * | 2003-12-09 | 2007-10-01 | Euro-Celtique S.A. | Forma de dosis co-extruida resistente a la manipulacion conteniendo un agente activo y un agente adverso y proceso para preparar el mismo. |
| TWI365880B (en) | 2004-03-30 | 2012-06-11 | Euro Celtique Sa | Process for preparing oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone and oxycodone hydrochloride composition,pharmaceutical dosage form,sustained release oeal dosage form and pharmaceutically acceptable package having less than 25 pp |
| US20080152595A1 (en) * | 2004-11-24 | 2008-06-26 | Acura Pharmaceuticals, Inc. | Methods and compositions for deterring abuse of orally administered pharmaceutical products |
| US8652529B2 (en) * | 2005-11-10 | 2014-02-18 | Flamel Technologies | Anti-misuse microparticulate oral pharmaceutical form |
| US9023400B2 (en) * | 2006-05-24 | 2015-05-05 | Flamel Technologies | Prolonged-release multimicroparticulate oral pharmaceutical form |
| SI2719378T1 (sl) * | 2006-06-19 | 2016-11-30 | Alpharma Pharmaceuticals Llc | Farmacevtski sestavki |
| SA07280459B1 (ar) * | 2006-08-25 | 2011-07-20 | بيورديو فارما إل. بي. | أشكال جرعة صيدلانية للتناول عن طريق الفم مقاومة للعبث تشتمل على مسكن شبه أفيوني |
| AU2008286914B2 (en) * | 2007-08-13 | 2014-10-02 | Ohemo Life Sciences Inc. | Abuse resistant drugs, method of use and method of making |
| EP2079446B1 (en) * | 2007-08-21 | 2011-10-26 | Teva Pharmaceutical Industries Ltd. | Paliperidone sustained release formulation |
| MX2010013169A (es) * | 2008-06-02 | 2010-12-21 | Reddy S Lab Ltd | Formulaciones de niacina de liberacion modificada. |
| PH12013501345A1 (en) * | 2010-12-23 | 2022-10-24 | Purdue Pharma Lp | Tamper resistant solid oral dosage forms |
| AU2012289764B2 (en) * | 2011-07-29 | 2017-03-02 | Grünenthal GmbH | Tamper-resistant tablet providing immediate drug release |
-
2012
- 2012-09-14 EP EP12772421.9A patent/EP2755638B1/en active Active
- 2012-09-14 JP JP2014530332A patent/JP6138798B2/ja active Active
- 2012-09-14 WO PCT/IB2012/001916 patent/WO2013038268A1/en not_active Ceased
- 2012-09-14 ES ES16167881T patent/ES2703688T3/es active Active
- 2012-09-14 AU AU2012310251A patent/AU2012310251B2/en active Active
- 2012-09-14 EP EP16167881.8A patent/EP3078370B1/en active Active
- 2012-09-14 US US14/344,271 patent/US20140294947A1/en not_active Abandoned
- 2012-09-14 MX MX2014003192A patent/MX347961B/es active IP Right Grant
- 2012-09-14 ES ES12772421.9T patent/ES2583132T3/es active Active
-
2014
- 2014-03-12 IL IL231482A patent/IL231482A/en active IP Right Grant
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