JP2016523250A5 - - Google Patents
Download PDFInfo
- Publication number
- JP2016523250A5 JP2016523250A5 JP2016521489A JP2016521489A JP2016523250A5 JP 2016523250 A5 JP2016523250 A5 JP 2016523250A5 JP 2016521489 A JP2016521489 A JP 2016521489A JP 2016521489 A JP2016521489 A JP 2016521489A JP 2016523250 A5 JP2016523250 A5 JP 2016523250A5
- Authority
- JP
- Japan
- Prior art keywords
- dosage form
- pharmaceutical dosage
- beads
- cysteamine
- motomeko
- 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
- 239000011324 bead Substances 0.000 claims description 98
- 239000002552 dosage form Substances 0.000 claims description 94
- UFULAYFCSOUIOV-UHFFFAOYSA-N cysteamine Chemical compound NCCS UFULAYFCSOUIOV-UHFFFAOYSA-N 0.000 claims description 52
- 229960003151 mercaptamine Drugs 0.000 claims description 52
- 239000007771 core particle Substances 0.000 claims description 32
- 238000009826 distribution Methods 0.000 claims description 29
- 239000002245 particle Substances 0.000 claims description 22
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 21
- 150000003839 salts Chemical class 0.000 claims description 20
- 238000000034 method Methods 0.000 claims description 19
- 239000012528 membrane Substances 0.000 claims description 13
- 239000002775 capsule Substances 0.000 claims description 12
- 239000000203 mixture Substances 0.000 claims description 8
- 238000004007 reversed phase HPLC Methods 0.000 claims description 8
- 238000003860 storage Methods 0.000 claims description 8
- 238000000825 ultraviolet detection Methods 0.000 claims description 8
- FEWJPZIEWOKRBE-JCYAYHJZSA-M L-tartrate(1-) Chemical compound OC(=O)[C@H](O)[C@@H](O)C([O-])=O FEWJPZIEWOKRBE-JCYAYHJZSA-M 0.000 claims description 6
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 6
- OOTFVKOQINZBBF-UHFFFAOYSA-N cystamine Chemical compound CCSSCCN OOTFVKOQINZBBF-UHFFFAOYSA-N 0.000 claims description 6
- 229940099500 cystamine Drugs 0.000 claims description 6
- 239000007902 hard capsule Substances 0.000 claims description 6
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 6
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 6
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 6
- NSKJTUFFDRENDM-ZVGUSBNCSA-N 2-aminoethanethiol;(2r,3r)-2,3-dihydroxybutanedioic acid Chemical compound NCCS.OC(=O)[C@H](O)[C@@H](O)C(O)=O NSKJTUFFDRENDM-ZVGUSBNCSA-N 0.000 claims description 4
- 239000011230 binding agent Substances 0.000 claims description 4
- 229940008046 cysteamine bitartrate Drugs 0.000 claims description 4
- 238000001125 extrusion Methods 0.000 claims description 4
- 239000000945 filler Substances 0.000 claims description 4
- 238000005469 granulation Methods 0.000 claims description 4
- 230000003179 granulation Effects 0.000 claims description 4
- 229920000642 polymer Polymers 0.000 claims description 4
- 238000005563 spheronization Methods 0.000 claims description 4
- 238000002360 preparation method Methods 0.000 claims description 3
- 229920003138 Eudragit® L 30 D-55 Polymers 0.000 claims description 2
- 239000002253 acid Substances 0.000 claims description 2
- 230000015572 biosynthetic process Effects 0.000 claims description 2
- 239000011248 coating agent Substances 0.000 claims description 2
- 238000000576 coating method Methods 0.000 claims description 2
- 238000001035 drying Methods 0.000 claims description 2
- 239000002702 enteric coating Substances 0.000 claims description 2
- 238000009505 enteric coating Methods 0.000 claims description 2
- GDCRSXZBSIRSFR-UHFFFAOYSA-N ethyl prop-2-enoate;2-methylprop-2-enoic acid Chemical compound CC(=C)C(O)=O.CCOC(=O)C=C GDCRSXZBSIRSFR-UHFFFAOYSA-N 0.000 claims description 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 2
- 229960003943 hypromellose Drugs 0.000 claims description 2
- 239000012535 impurity Substances 0.000 claims description 2
- 239000000126 substance Substances 0.000 claims description 2
- 150000003892 tartrate salts Chemical class 0.000 claims description 2
- 230000001747 exhibiting effect Effects 0.000 claims 2
- 230000009089 cytolysis Effects 0.000 claims 1
- 238000000227 grinding Methods 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 description 3
- 239000012458 free base Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000004584 weight gain Effects 0.000 description 1
- 235000019786 weight gain Nutrition 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361835965P | 2013-06-17 | 2013-06-17 | |
| US61/835,965 | 2013-06-17 | ||
| PCT/US2014/042607 WO2014204881A1 (en) | 2013-06-17 | 2014-06-17 | Delayed release cysteamine bead formulation |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2016523250A JP2016523250A (ja) | 2016-08-08 |
| JP2016523250A5 true JP2016523250A5 (https=) | 2017-08-03 |
| JP6468661B2 JP6468661B2 (ja) | 2019-02-13 |
Family
ID=52019418
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016521489A Active JP6468661B2 (ja) | 2013-06-17 | 2014-06-17 | 遅延放出システアミンビーズ処方、ならびにその作製方法および使用方法 |
Country Status (25)
| Country | Link |
|---|---|
| US (9) | US9233077B2 (https=) |
| EP (2) | EP3939574A1 (https=) |
| JP (1) | JP6468661B2 (https=) |
| KR (2) | KR102281747B1 (https=) |
| CN (2) | CN110664780B (https=) |
| AP (1) | AP2015008925A0 (https=) |
| AR (2) | AR096628A1 (https=) |
| AU (1) | AU2014281702C1 (https=) |
| BR (1) | BR112015031417B1 (https=) |
| CA (2) | CA2914770C (https=) |
| CL (1) | CL2015003662A1 (https=) |
| CU (1) | CU20150178A7 (https=) |
| EA (1) | EA031255B8 (https=) |
| HK (1) | HK1218066A1 (https=) |
| IL (2) | IL302141A (https=) |
| MX (1) | MX375377B (https=) |
| NI (1) | NI201500177A (https=) |
| NZ (1) | NZ714517A (https=) |
| PH (2) | PH12020552266A1 (https=) |
| SG (1) | SG11201510126QA (https=) |
| TN (1) | TN2015000549A1 (https=) |
| TW (1) | TWI649100B (https=) |
| UA (1) | UA117833C2 (https=) |
| WO (1) | WO2014204881A1 (https=) |
| ZA (1) | ZA201508783B (https=) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI649100B (zh) | 2013-06-17 | 2019-02-01 | 地平線罕見醫學製藥有限責任公司 | 延遲釋放型半胱胺珠粒調配物，以及其製備及使用方法 |
| AR096629A1 (es) * | 2013-06-17 | 2016-01-20 | Raptor Pharmaceuticals Inc | Métodos para analizar composiciones de cisteamina |
| WO2017087532A1 (en) * | 2015-11-16 | 2017-05-26 | The Regents Of The University Of California | Methods of treating non-alcoholic steatohepatitis (nash) using cysteamine compounds |
| US10143665B2 (en) | 2015-11-17 | 2018-12-04 | Horizon Orphan Llc | Methods for storing cysteamine formulations and related methods of treatment |
| ITUA20161799A1 (it) * | 2016-03-18 | 2017-09-18 | Recordati Ind Chimica E Farmaceutica S P A | Composizione farmaceutica a rilascio prolungato comprendente cisteamina o un suo sale |
| EP3308773A1 (en) * | 2016-10-11 | 2018-04-18 | Recordati Industria Chimica E Farmaceutica SPA | Formulations of cysteamine and cysteamine derivatives |
| WO2018093364A1 (en) * | 2016-11-16 | 2018-05-24 | The Regents Of The University Of California | Formulations of cysteamine and cystamine |
| US10251850B2 (en) | 2017-01-11 | 2019-04-09 | Lupin Limited | Process for preparation of cysteamine bitartrate |
| IL300825A (en) * | 2017-03-15 | 2023-04-01 | Cerecin Inc | Pharmaceutical preparations with a high drug load of medium-length triglyceride chains and methods related thereto |
| JPWO2023249087A1 (https=) * | 2022-06-24 | 2023-12-28 |
Family Cites Families (45)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2809918A (en) | 1955-10-17 | 1957-10-15 | Victor M Hermelin | Sustained release pharmaceutical preparations |
| DE2010416B2 (de) | 1970-03-05 | 1979-03-29 | Hoechst Ag, 6000 Frankfurt | Oral anwendbare Arzneiform mit Retardwirkung |
| US4110441A (en) | 1974-04-29 | 1978-08-29 | Chinoin Gyogyszer Es Vegyeszeti Termekek Gyara Rt. | Gamma-l-glutamyl cholamine phosphate |
| FR2471186A1 (fr) | 1979-12-10 | 1981-06-19 | Roussel Uclaf | Nouveaux comprimes a delitescence colique, ainsi que leur procede de preparation |
| US4728512A (en) | 1985-05-06 | 1988-03-01 | American Home Products Corporation | Formulations providing three distinct releases |
| US4794001A (en) | 1986-03-04 | 1988-12-27 | American Home Products Corporation | Formulations providing three distinct releases |
| US4959306A (en) | 1986-11-28 | 1990-09-25 | Sclavo, Inc. | Labeling design for a binding assay reagent |
| US5668117A (en) | 1991-02-22 | 1997-09-16 | Shapiro; Howard K. | Methods of treating neurological diseases and etiologically related symptomology using carbonyl trapping agents in combination with previously known medicaments |
| US5225202A (en) | 1991-09-30 | 1993-07-06 | E. R. Squibb & Sons, Inc. | Enteric coated pharmaceutical compositions |
| US5639743A (en) | 1992-11-13 | 1997-06-17 | University Of Georgia Research Foundation | Compositions and methods for treating exocrine gland atrophy |
| CA2236344A1 (en) | 1998-04-30 | 1999-10-30 | Hemosol Inc. | Hemoglobin-haptoglobin complexes |
| UA69413C2 (uk) * | 1998-05-22 | 2004-09-15 | Брістол-Майерс Сквібб Компані | Фармацевтична композиція, яка містить серцевину та ентеросолюбільну оболонку, фармацевтична композиція у вигляді сфероїдальних гранул, спосіб одержання сфероїдальних гранул та спосіб одержання фармацевтичної композиції |
| US6794414B1 (en) | 1998-06-17 | 2004-09-21 | Yeda Research And Development Co. Ltd. | Method and compositions for treating diseases mediated by transglutaminase activity |
| UA73092C2 (uk) | 1998-07-17 | 2005-06-15 | Брістол-Майерс Сквібб Компані | Таблетка з ентеросолюбільним покриттям і спосіб її приготування |
| CN1144585C (zh) * | 2000-12-13 | 2004-04-07 | 华扩达动物科学[I.P.2]有限公司 | 含有半胱胺或其盐类的促进动物快速生长的组合物及用途 |
| US20050004075A1 (en) | 2000-12-13 | 2005-01-06 | Walcom Animal Science (I.P.2) Limited | Composition for regulating animal growth, method of manufacture and use thereof |
| GB2377874B (en) | 2001-07-23 | 2005-06-22 | Walcom Bio Chemicals Ind Ltd | Poultry feed and the use thereof |
| US7449451B2 (en) | 2001-08-29 | 2008-11-11 | Premier Micronutrient Corporation | Use of multiple antioxidant micronutrients as systemic biological radioprotective agents against potential ionizing radiation risks |
| GB2379854B (en) | 2001-09-19 | 2006-04-19 | Walcom Animal Science | Dairy cow feed and the use thereof |
| KR100949318B1 (ko) | 2001-11-29 | 2010-03-23 | 사운드 파마슈티칼스 인코퍼레이티드 | 화학요법의 바람직하지 않은 작용을 개선하기 위한 방법과조성물 |
| ES2497716T3 (es) | 2002-01-04 | 2014-09-23 | Sound Pharmaceuticals Incorporated | Composiciones para utilizar en métodos destinados a tratar la pérdida auditiva |
| GB2386817B (en) | 2002-02-20 | 2006-08-23 | Walcom Animal Science | Feed for fish and use therof |
| US8017651B2 (en) | 2002-11-22 | 2011-09-13 | Bionexus, Ltd. | Compositions and methods for the treatment of HIV-associated fat maldistribution and hyperlipidemia |
| GB2398497A (en) | 2003-02-19 | 2004-08-25 | Walcom Animal Science | Composition for improving immunity of animals |
| US8029822B2 (en) | 2003-05-22 | 2011-10-04 | Osmotica Kereskedelmi és Seolgáltató KFT | Rupturing controlled release device having a preformed passageway |
| TWI372066B (en) | 2003-10-01 | 2012-09-11 | Wyeth Corp | Pantoprazole multiparticulate formulations |
| JP4966665B2 (ja) | 2003-11-19 | 2012-07-04 | オメガ バイオ−ファーマ （アイ．ピー．１） リミテッド | アルコール代謝を改善し、二日酔いの影響を軽減するための材料と方法 |
| US7442720B2 (en) | 2003-12-19 | 2008-10-28 | Omega Bio-Pharma (I.P.3) Limited | Compositions and methods for treating diabetes |
| WO2005092914A1 (en) | 2004-03-22 | 2005-10-06 | Blue Mountain Technology Development Lab | Process for promoting proper folding of human serum albumin using a human serum albumin ligand |
| KR20070005738A (ko) | 2004-05-03 | 2007-01-10 | 오메가 바이오 파마(아이.피.3) 리미티드 | 콜레스테롤 과잉혈증 및 당뇨병의 합병증을 치료하기 위한시스테아민 |
| EP1868580A1 (en) * | 2005-03-29 | 2007-12-26 | Evonik Röhm GmbH | Multiparticulate pharmaceutical form comprising pellets with a matrix which influences the delivery of a modulatory substance |
| PT1879599E (pt) | 2005-04-20 | 2014-01-23 | Hutchinson Fred Cancer Res | Métodos, composições e artigos de fabrico para aumentar a capacidade de sobrevivência de células, tecidos, órgãos, e organismos |
| AR057623A1 (es) | 2005-11-28 | 2007-12-05 | Omega Bio Pharma H K Ltd | Materiales y metodos para el tratamiento de las infecciones virales |
| US20070172514A1 (en) | 2006-01-20 | 2007-07-26 | Francis Chi | Materials and methods for improving livestock productivity |
| EP3659588A1 (en) | 2006-01-27 | 2020-06-03 | The Regents of The University of California | Enterically coated cysteamine and salts thereof |
| EP2636404B1 (en) | 2007-11-30 | 2019-03-20 | The Regents of The University of California | Methods of Treating Non-Alcoholic Steatohepatitis (Nash) Using Cysteamine Products |
| BRPI0907561A2 (pt) | 2008-02-17 | 2015-08-04 | Walcom Animal Science I P 3 Ltd | Materiais e métodos para aperfeiçoamento da saúde de camarões |
| WO2010103365A2 (en) | 2009-03-09 | 2010-09-16 | Council Of Scientific & Industrial Research | Sustained release composition of therapeutic agent |
| SI2408436T1 (sl) * | 2009-03-18 | 2017-06-30 | Evonik Roehm Gmbh | Farmacevtski sestavek z nadzorovanim sproščanjem z odpornostjo na vpliv etanola, ki uporablja oplaščenje, ki vsebuje nevtralne vinil polimere in ekscipiente |
| CN101653426A (zh) | 2009-09-16 | 2010-02-24 | 冯利萍 | 一种高稳型半胱胺盐酸盐的缓释小丸及制备方法 |
| CN101703472B (zh) * | 2009-11-09 | 2011-06-22 | 上海邦成生物科技有限公司 | 一种半胱胺盐酸盐制粒包衣缓释产品及其制备方法 |
| CN102077905B (zh) | 2010-12-10 | 2013-01-02 | 无锡正大畜禽有限公司 | 一种肠溶盐酸半胱胺包膜颗粒的生产方法 |
| JP2014516080A (ja) * | 2011-06-08 | 2014-07-07 | エスティーアイ ファーマ， エルエルシー | 一日一回の投与のための吸収が制御された水溶性の薬学的に活性な有機化合物製剤 |
| MX2014004469A (es) * | 2011-11-22 | 2014-08-01 | Univ California | Metodos y composiciones para tratar inflamacion y lesion isquemica. |
| TWI649100B (zh) | 2013-06-17 | 2019-02-01 | 地平線罕見醫學製藥有限責任公司 | 延遲釋放型半胱胺珠粒調配物，以及其製備及使用方法 |
-
2014
- 2014-06-16 TW TW103120757A patent/TWI649100B/zh active
- 2014-06-16 AR ARP140102285A patent/AR096628A1/es not_active Application Discontinuation
- 2014-06-17 CN CN201910990909.9A patent/CN110664780B/zh active Active
- 2014-06-17 AU AU2014281702A patent/AU2014281702C1/en active Active
- 2014-06-17 BR BR112015031417-1A patent/BR112015031417B1/pt active IP Right Grant
- 2014-06-17 KR KR1020167000255A patent/KR102281747B1/ko active Active
- 2014-06-17 US US14/306,303 patent/US9233077B2/en active Active
- 2014-06-17 CN CN201480034647.4A patent/CN105492000B/zh active Active
- 2014-06-17 CA CA2914770A patent/CA2914770C/en active Active
- 2014-06-17 MX MX2015017366A patent/MX375377B/es active IP Right Grant
- 2014-06-17 IL IL302141A patent/IL302141A/en unknown
- 2014-06-17 EA EA201690036A patent/EA031255B8/ru unknown
- 2014-06-17 KR KR1020217022957A patent/KR102466253B1/ko active Active
- 2014-06-17 TN TN2015000549A patent/TN2015000549A1/en unknown
- 2014-06-17 UA UAA201600331A patent/UA117833C2/uk unknown
- 2014-06-17 NZ NZ714517A patent/NZ714517A/en unknown
- 2014-06-17 EP EP21175359.5A patent/EP3939574A1/en active Pending
- 2014-06-17 JP JP2016521489A patent/JP6468661B2/ja active Active
- 2014-06-17 HK HK16105019.8A patent/HK1218066A1/zh unknown
- 2014-06-17 PH PH1/2020/552266A patent/PH12020552266A1/en unknown
- 2014-06-17 EP EP14813132.9A patent/EP3010491A4/en active Pending
- 2014-06-17 CA CA2938644A patent/CA2938644C/en active Active
- 2014-06-17 WO PCT/US2014/042607 patent/WO2014204881A1/en not_active Ceased
- 2014-06-17 SG SG11201510126QA patent/SG11201510126QA/en unknown
- 2014-06-17 AP AP2015008925A patent/AP2015008925A0/xx unknown
-
2015
- 2015-06-26 US US14/751,639 patent/US9173851B1/en active Active
- 2015-12-01 ZA ZA2015/08783A patent/ZA201508783B/en unknown
- 2015-12-11 US US14/966,490 patent/US20160095827A1/en not_active Abandoned
- 2015-12-14 PH PH12015502783A patent/PH12015502783A1/en unknown
- 2015-12-16 NI NI201500177A patent/NI201500177A/es unknown
- 2015-12-16 CU CUP2015000178A patent/CU20150178A7/es unknown
- 2015-12-17 CL CL2015003662A patent/CL2015003662A1/es unknown
-
2016
- 2016-02-12 US US15/042,823 patent/US20160158170A1/en not_active Abandoned
- 2016-07-26 US US15/220,308 patent/US20160331704A1/en not_active Abandoned
-
2017
- 2017-07-21 US US15/656,579 patent/US20170319514A1/en not_active Abandoned
- 2017-07-21 US US15/656,531 patent/US20170319512A1/en not_active Abandoned
- 2017-07-21 US US15/656,570 patent/US20170319513A1/en not_active Abandoned
-
2018
- 2018-12-12 US US16/218,136 patent/US11090279B2/en active Active
-
2021
- 2021-07-13 IL IL284823A patent/IL284823A/en unknown
-
2023
- 2023-03-16 AR ARP230100660A patent/AR128816A2/es unknown
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP2016523250A5 (https=) | ||
| ES2486245T3 (es) | Sobre de mesalazina con alta carga de fármaco | |
| JP5220746B2 (ja) | 制御放出システム及びその製造方法 | |
| ES2823000T3 (es) | Formulaciones muco-adhesivas de liberación controlada de levodopa y/o ésteres de levodopa y usos de las mismas | |
| CN119868330A (zh) | 在进食状态下具有改善的药代动力学的γ-羟基丁酸酯组合物 | |
| CN101977593B (zh) | 包含弱碱性药物以及有机酸的给药系统 | |
| EA031255B1 (ru) | Состав с отсроченным высвобождением, содержащий гранулы цистеамина, и способы его получения и применения | |
| ES2623176T3 (es) | Composición farmacéutica de memantina | |
| CA2905011C (en) | Extended-release topiramate capsules | |
| US20180161280A1 (en) | Pharmaceutical compositions comprising everolimus | |
| JP2014515356A5 (https=) | ||
| CN1134108A (zh) | 用于控释的新颗粒及含有该颗粒的药物制剂 | |
| WO2015193788A1 (en) | Formulation for oral administration containing mesalazine | |
| MXPA06003602A (es) | Formulaciones de microparticulas de pantoprazol. | |
| JP6510093B2 (ja) | ビロキサジンの緩和放出製剤 | |
| CN103181914A (zh) | 盐酸美金刚缓释胶囊及其制备方法 | |
| WO2012001705A2 (en) | Pharmaceutical compositions of (r)-lansoprazole | |
| CN103068374A (zh) | 代谢型谷氨酸受体5(mglu5)拮抗剂的药物组合物 | |
| US10172878B2 (en) | Extended-release topiramate capsules | |
| JP2016516031A5 (https=) | ||
| WO2011138797A2 (en) | Delayed release oral disintegrating pharmaceutical compositions of lansoprazole | |
| CN103520136A (zh) | 孟鲁斯特钠脉冲胶囊及其制备方法 | |
| WO2008079102A1 (en) | Modified release loxoprofen compositions | |
| Sudke | Design of modified release multiunit drug delivery system for the effective treatment of gastroesophageal diseases using hot-melt coating | |
| HK40013178A (en) | Delayed release cysteamine bead formulation, and methods of making and using same |