JP2015506980A5 - - Google Patents
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- Publication number
- JP2015506980A5 JP2015506980A5 JP2014556658A JP2014556658A JP2015506980A5 JP 2015506980 A5 JP2015506980 A5 JP 2015506980A5 JP 2014556658 A JP2014556658 A JP 2014556658A JP 2014556658 A JP2014556658 A JP 2014556658A JP 2015506980 A5 JP2015506980 A5 JP 2015506980A5
- Authority
- JP
- Japan
- Prior art keywords
- formulation
- formulation according
- viloxazine
- component
- compound
- 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
- 239000000203 mixture Substances 0.000 claims 39
- 238000009472 formulation Methods 0.000 claims 38
- YWPHCCPCQOJSGZ-LLVKDONJSA-N (2r)-2-[(2-ethoxyphenoxy)methyl]morpholine Chemical compound CCOC1=CC=CC=C1OC[C@@H]1OCCNC1 YWPHCCPCQOJSGZ-LLVKDONJSA-N 0.000 claims 13
- 229960001255 viloxazine Drugs 0.000 claims 13
- 150000001875 compounds Chemical class 0.000 claims 11
- 230000000694 effects Effects 0.000 claims 6
- 238000013268 sustained release Methods 0.000 claims 6
- 239000012730 sustained-release form Substances 0.000 claims 6
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 5
- 230000003111 delayed effect Effects 0.000 claims 3
- 230000002496 gastric effect Effects 0.000 claims 3
- 238000002360 preparation method Methods 0.000 claims 3
- 208000006096 Attention Deficit Disorder with Hyperactivity Diseases 0.000 claims 2
- 208000036864 Attention deficit/hyperactivity disease Diseases 0.000 claims 2
- 208000015114 central nervous system disease Diseases 0.000 claims 2
- 239000011248 coating agent Substances 0.000 claims 2
- 238000000576 coating method Methods 0.000 claims 2
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 claims 2
- 150000002433 hydrophilic molecules Chemical class 0.000 claims 2
- 230000002209 hydrophobic effect Effects 0.000 claims 2
- 239000011159 matrix material Substances 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 230000000926 neurological effect Effects 0.000 claims 2
- 230000036470 plasma concentration Effects 0.000 claims 2
- 229920000642 polymer Polymers 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- 208000019116 sleep disease Diseases 0.000 claims 2
- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 claims 1
- HJOCKFVCMLCPTP-UHFFFAOYSA-N 2-[(2-ethoxyphenoxy)methyl]morpholine;hydron;chloride Chemical compound Cl.CCOC1=CC=CC=C1OCC1OCCNC1 HJOCKFVCMLCPTP-UHFFFAOYSA-N 0.000 claims 1
- SSONCJTVDRSLNK-UHFFFAOYSA-N 2-methylprop-2-enoic acid;hydrochloride Chemical compound Cl.CC(=C)C(O)=O SSONCJTVDRSLNK-UHFFFAOYSA-N 0.000 claims 1
- 206010000125 Abnormal dreams Diseases 0.000 claims 1
- 241000220479 Acacia Species 0.000 claims 1
- 241000416162 Astragalus gummifer Species 0.000 claims 1
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims 1
- 229920000623 Cellulose acetate phthalate Polymers 0.000 claims 1
- 229920008347 Cellulose acetate propionate Polymers 0.000 claims 1
- 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
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims 1
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 1
- 235000010643 Leucaena leucocephala Nutrition 0.000 claims 1
- 241000124008 Mammalia Species 0.000 claims 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 1
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims 1
- 239000004372 Polyvinyl alcohol Substances 0.000 claims 1
- 229920001800 Shellac Polymers 0.000 claims 1
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 claims 1
- 229920001615 Tragacanth Polymers 0.000 claims 1
- 206010047700 Vomiting Diseases 0.000 claims 1
- 229920002494 Zein Polymers 0.000 claims 1
- 150000001252 acrylic acid derivatives Chemical class 0.000 claims 1
- 235000010443 alginic acid Nutrition 0.000 claims 1
- 239000000783 alginic acid Substances 0.000 claims 1
- 229920000615 alginic acid Polymers 0.000 claims 1
- 229960001126 alginic acid Drugs 0.000 claims 1
- 150000004781 alginic acids Chemical class 0.000 claims 1
- 239000011324 bead Substances 0.000 claims 1
- 239000007894 caplet Substances 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims 1
- 229940105329 carboxymethylcellulose Drugs 0.000 claims 1
- 235000010418 carrageenan Nutrition 0.000 claims 1
- 239000000679 carrageenan Substances 0.000 claims 1
- 229920001525 carrageenan Polymers 0.000 claims 1
- 229940113118 carrageenan Drugs 0.000 claims 1
- 229920002301 cellulose acetate Polymers 0.000 claims 1
- 229920006217 cellulose acetate butyrate Polymers 0.000 claims 1
- 229940081734 cellulose acetate phthalate Drugs 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 208000035475 disorder Diseases 0.000 claims 1
- 239000002552 dosage form Substances 0.000 claims 1
- 201000006549 dyspepsia Diseases 0.000 claims 1
- 229920001249 ethyl cellulose Polymers 0.000 claims 1
- 235000019325 ethyl cellulose Nutrition 0.000 claims 1
- XPNLOZNCOBKRNJ-UHFFFAOYSA-N ethyl prop-2-enoate;methyl 2-methylprop-2-enoate Chemical compound CCOC(=O)C=C.COC(=O)C(C)=C XPNLOZNCOBKRNJ-UHFFFAOYSA-N 0.000 claims 1
- 229940049654 glyceryl behenate Drugs 0.000 claims 1
- 125000005908 glyceryl ester group Chemical group 0.000 claims 1
- FETSQPAGYOVAQU-UHFFFAOYSA-N glyceryl palmitostearate Chemical compound OCC(O)CO.CCCCCCCCCCCCCCCC(O)=O.CCCCCCCCCCCCCCCCCC(O)=O FETSQPAGYOVAQU-UHFFFAOYSA-N 0.000 claims 1
- 229940046813 glyceryl palmitostearate Drugs 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
- 239000008172 hydrogenated vegetable oil Substances 0.000 claims 1
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims 1
- 229940071826 hydroxyethyl cellulose Drugs 0.000 claims 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 1
- 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 1
- 229920003132 hydroxypropyl methylcellulose phthalate Polymers 0.000 claims 1
- 229940031704 hydroxypropyl methylcellulose phthalate Drugs 0.000 claims 1
- 229920000639 hydroxypropylmethylcellulose acetate succinate Polymers 0.000 claims 1
- 206010022437 insomnia Diseases 0.000 claims 1
- 239000007937 lozenge Substances 0.000 claims 1
- 208000024714 major depressive disease Diseases 0.000 claims 1
- 125000005395 methacrylic acid group Chemical group 0.000 claims 1
- 229920000609 methyl cellulose Polymers 0.000 claims 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 claims 1
- 239000001923 methylcellulose Substances 0.000 claims 1
- 235000010981 methylcellulose Nutrition 0.000 claims 1
- 230000003204 osmotic effect Effects 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 239000011118 polyvinyl acetate Substances 0.000 claims 1
- 229920002689 polyvinyl acetate Polymers 0.000 claims 1
- 229920002451 polyvinyl alcohol Polymers 0.000 claims 1
- 229940068984 polyvinyl alcohol Drugs 0.000 claims 1
- 235000019422 polyvinyl alcohol Nutrition 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 229940069328 povidone Drugs 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 claims 1
- 239000004208 shellac Substances 0.000 claims 1
- 229940113147 shellac Drugs 0.000 claims 1
- 235000013874 shellac Nutrition 0.000 claims 1
- 208000020685 sleep-wake disease Diseases 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 1
- 235000010487 tragacanth Nutrition 0.000 claims 1
- 239000000196 tragacanth Substances 0.000 claims 1
- 229940116362 tragacanth Drugs 0.000 claims 1
- 229960005014 viloxazine hydrochloride Drugs 0.000 claims 1
- 239000000230 xanthan gum Substances 0.000 claims 1
- 235000010493 xanthan gum Nutrition 0.000 claims 1
- 229920001285 xanthan gum Polymers 0.000 claims 1
- 229940082509 xanthan gum Drugs 0.000 claims 1
- 239000005019 zein Substances 0.000 claims 1
- 229940093612 zein Drugs 0.000 claims 1
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261596458P | 2012-02-08 | 2012-02-08 | |
| US61/596,458 | 2012-02-08 | ||
| PCT/US2013/025121 WO2013119794A1 (en) | 2012-02-08 | 2013-02-07 | Modified release formulations of viloxazine |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018018946A Division JP6510093B2 (ja) | 2012-02-08 | 2018-02-06 | ビロキサジンの緩和放出製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2015506980A JP2015506980A (ja) | 2015-03-05 |
| JP2015506980A5 true JP2015506980A5 (https=) | 2016-01-21 |
| JP6290100B2 JP6290100B2 (ja) | 2018-03-07 |
Family
ID=47741312
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014556658A Active JP6290100B2 (ja) | 2012-02-08 | 2013-02-07 | ビロキサジンの緩和放出製剤 |
| JP2018018946A Active JP6510093B2 (ja) | 2012-02-08 | 2018-02-06 | ビロキサジンの緩和放出製剤 |
| JP2019066455A Active JP6832973B2 (ja) | 2012-02-08 | 2019-03-29 | ビロキサジンの緩和放出製剤 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018018946A Active JP6510093B2 (ja) | 2012-02-08 | 2018-02-06 | ビロキサジンの緩和放出製剤 |
| JP2019066455A Active JP6832973B2 (ja) | 2012-02-08 | 2019-03-29 | ビロキサジンの緩和放出製剤 |
Country Status (8)
| Country | Link |
|---|---|
| US (9) | US9358204B2 (https=) |
| EP (2) | EP4233915A3 (https=) |
| JP (3) | JP6290100B2 (https=) |
| AU (4) | AU2013217013B2 (https=) |
| CA (1) | CA2864088C (https=) |
| ES (1) | ES2950875T3 (https=) |
| MX (2) | MX356727B (https=) |
| WO (1) | WO2013119794A1 (https=) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2341912B1 (en) | 2008-09-05 | 2014-01-22 | Supernus Pharmaceuticals, Inc. | Method of treatment of attention deficit/hyperactivity disorder (adhd) |
| AU2013217013B2 (en) * | 2012-02-08 | 2017-04-20 | Supernus Pharmaceuticals, Inc. | Modified release formulations of viloxazine |
| IT201800011125A1 (it) * | 2018-12-14 | 2020-06-14 | Dpl Pharma S P A | Composizioni farmaceutiche orali solide comprendenti matrici monolitiche complesse per la somministrazione cronotropica di medicamenti nel tratto gastroenterico |
| US20240041893A1 (en) * | 2023-10-03 | 2024-02-08 | Innovate Therapeutics Llc | An Extended-Release Pharmaceutical Formulation of Viloxazine And Process For Preparation Thereof |
| KR20250094621A (ko) * | 2023-12-18 | 2025-06-25 | 주식회사 아스트로젠 | (s)-빌록사진 또는 이의 염의 개선된 제조 방법 |
| WO2025210464A1 (en) * | 2024-04-04 | 2025-10-09 | Biophore India Pharmaceuticals Pvt. Ltd | Modified release formulations of viloxazine |
Family Cites Families (30)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1138405A (en) * | 1966-12-28 | 1969-01-01 | Ici Ltd | Morpholine derivatives |
| FR2453639A1 (fr) * | 1979-04-09 | 1980-11-07 | Sanofi Sa | Composition medicamenteuse a liberation programmee immediate-retard a base de naftidrofuryl |
| US4260606A (en) | 1979-07-19 | 1981-04-07 | A. H. Robins Company, Inc. | 3-Methyleneazetidine derivatives |
| US5658590A (en) | 1995-01-11 | 1997-08-19 | Eli Lilly And Company | Treatment of attention-deficit/hyperactivity disorder |
| US5558879A (en) * | 1995-04-28 | 1996-09-24 | Andrx Pharmaceuticals, Inc. | Controlled release formulation for water soluble drugs in which a passageway is formed in situ |
| US6262115B1 (en) * | 1995-05-22 | 2001-07-17 | Alza Coporation | Method for the management of incontinence |
| DE19830201A1 (de) | 1998-07-07 | 2000-01-13 | Boehringer Ingelheim Pharma | Mittel mit antidepressiver Wirkung |
| WO2000006162A1 (de) | 1998-07-27 | 2000-02-10 | Boehringer Ingelheim Pharma Kg | Mittel mit antidepressiver wirkung, mit pramipexol und einem weiteren antidepressivum |
| JP2004517112A (ja) | 2001-01-02 | 2004-06-10 | ファルマシア・アンド・アップジョン・カンパニー | 新規薬物コンビネーション |
| JP4280074B2 (ja) * | 2001-04-25 | 2009-06-17 | 大正製薬株式会社 | マルチプルユニット型徐放性錠剤 |
| SE0102887D0 (sv) * | 2001-08-29 | 2001-08-29 | Astrazeneca Ab | New formulation |
| EA011215B1 (ru) * | 2003-02-21 | 2009-02-27 | Лек Фармасьютиклз Д.Д. | Терапевтическая система, содержащая амоксициллин и клавулановую кислоту, плавающая капсула |
| DE10353196A1 (de) | 2003-11-13 | 2005-06-16 | Röhm GmbH & Co. KG | Mehrschichtige Arzneiform mit einer die Abgabe einer modulatorischen Substanz beeinflussenden Matrix |
| US7119031B2 (en) * | 2004-06-28 | 2006-10-10 | Micron Technology, Inc. | Methods of forming patterned photoresist layers over semiconductor substrates |
| DE102004035938A1 (de) * | 2004-07-23 | 2006-02-16 | Röhm GmbH & Co. KG | Verfahren zur Herstellung von überzogenen Arzneiformen mit stabilem Wirkstofffreigabeprofil |
| US7288347B2 (en) | 2004-08-31 | 2007-10-30 | Xerox Corporation | Method of applying spot varnish to xerographic image and emulsion aggregation toners for use therein |
| JP2008536929A (ja) * | 2005-04-18 | 2008-09-11 | ルビコン・リサーチ・ピーヴィーティー・エルティーディー | 生体強化組成物 |
| US9161918B2 (en) * | 2005-05-02 | 2015-10-20 | Adare Pharmaceuticals, Inc. | Timed, pulsatile release systems |
| WO2007026219A2 (en) | 2005-08-31 | 2007-03-08 | Pfizer Products Inc. | Combinations of a 5-ht1b antagonist with a noradrenalin re-uptake inhibitor or a serotonin noradrenalin reutake inhibitor for treating cns conditions |
| CA2641665A1 (en) * | 2006-02-10 | 2007-08-16 | Boehringer Ingelheim International Gmbh | Modified release formulation |
| PL2457563T3 (pl) * | 2006-05-09 | 2017-09-29 | Mallinckrodt Llc | Stałe postacie dawkowania o zmodyfikowanym uwalnianiu rzędu zerowego |
| ES2555066T3 (es) | 2006-11-17 | 2015-12-28 | Supernus Pharmaceuticals, Inc. | Formulaciones de liberación sostenida de topiramato |
| WO2008122019A1 (en) * | 2007-04-02 | 2008-10-09 | Cypress Biosciences, Inc. | Improving the tolerability of both mirtazapine and reboxetine by using them in combination |
| EP2167096A4 (en) | 2007-06-13 | 2010-07-14 | Cypress Bioscience Inc | IMPROVING TOLERANCE TO MIRTAZAPINE AND A SECOND ACTIVE INGREDIENT BY THE COMBINED USE OF THEM |
| CA2706651A1 (en) * | 2007-12-04 | 2009-06-11 | Merck Sharp & Dohme Corp. | Tryptamine sulfonamides as 5-ht6 antagonists |
| EP2341912B1 (en) | 2008-09-05 | 2014-01-22 | Supernus Pharmaceuticals, Inc. | Method of treatment of attention deficit/hyperactivity disorder (adhd) |
| JP2012525426A (ja) * | 2009-04-30 | 2012-10-22 | スパーナス ファーマシューティカルズ インコーポレイテッド | うつ病を治療する方法 |
| WO2011008298A2 (en) * | 2009-07-16 | 2011-01-20 | Nectid, Inc. | Novel axomadol dosage forms |
| WO2011049309A2 (ko) * | 2009-10-09 | 2011-04-28 | 영진약품공업 주식회사 | 속효성과 지속성을 동시에 갖는 약제학적 조성물 |
| AU2013217013B2 (en) * | 2012-02-08 | 2017-04-20 | Supernus Pharmaceuticals, Inc. | Modified release formulations of viloxazine |
-
2013
- 2013-02-07 AU AU2013217013A patent/AU2013217013B2/en active Active
- 2013-02-07 MX MX2014009528A patent/MX356727B/es active IP Right Grant
- 2013-02-07 CA CA2864088A patent/CA2864088C/en active Active
- 2013-02-07 US US13/761,757 patent/US9358204B2/en active Active
- 2013-02-07 EP EP23172156.4A patent/EP4233915A3/en active Pending
- 2013-02-07 EP EP13705348.4A patent/EP2812074B1/en active Active
- 2013-02-07 JP JP2014556658A patent/JP6290100B2/ja active Active
- 2013-02-07 WO PCT/US2013/025121 patent/WO2013119794A1/en not_active Ceased
- 2013-02-07 ES ES13705348T patent/ES2950875T3/es active Active
-
2014
- 2014-08-07 MX MX2023003000A patent/MX2023003000A/es unknown
-
2016
- 2016-05-18 US US15/157,549 patent/US9603853B2/en active Active
- 2016-06-03 US US15/172,955 patent/US9662338B2/en active Active
-
2017
- 2017-05-25 US US15/605,108 patent/US10265319B2/en active Active
- 2017-07-20 AU AU2017206245A patent/AU2017206245B2/en active Active
-
2018
- 2018-02-06 JP JP2018018946A patent/JP6510093B2/ja active Active
-
2019
- 2019-03-08 US US16/297,194 patent/US20190201407A1/en active Pending
- 2019-03-29 JP JP2019066455A patent/JP6832973B2/ja active Active
- 2019-08-16 AU AU2019216707A patent/AU2019216707B2/en active Active
-
2020
- 2020-09-18 AU AU2020233746A patent/AU2020233746B2/en active Active
-
2023
- 2023-08-10 US US18/232,716 patent/US20230381191A1/en not_active Abandoned
-
2025
- 2025-03-28 US US19/093,755 patent/US20250222004A1/en active Pending
- 2025-04-07 US US19/171,852 patent/US20250228859A1/en active Pending
- 2025-08-21 US US19/306,464 patent/US20250367208A1/en active Pending
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