JP2009501777A5 - - Google Patents
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- JP2009501777A5 JP2009501777A5 JP2008522096A JP2008522096A JP2009501777A5 JP 2009501777 A5 JP2009501777 A5 JP 2009501777A5 JP 2008522096 A JP2008522096 A JP 2008522096A JP 2008522096 A JP2008522096 A JP 2008522096A JP 2009501777 A5 JP2009501777 A5 JP 2009501777A5
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- Prior art keywords
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- 239000000203 mixture Substances 0.000 claims 14
- 239000003085 diluting agent Substances 0.000 claims 4
- 238000007580 dry-mixing Methods 0.000 claims 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 4
- 239000003349 gelling agent Substances 0.000 claims 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 2
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 2
- 239000000654 additive Substances 0.000 claims 2
- 230000000996 additive Effects 0.000 claims 2
- 239000002216 antistatic agent Substances 0.000 claims 2
- 239000011230 binding agent Substances 0.000 claims 2
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 2
- 239000003086 colorant Substances 0.000 claims 2
- 239000007888 film coating Substances 0.000 claims 2
- 238000009501 film coating Methods 0.000 claims 2
- 239000000796 flavoring agent Substances 0.000 claims 2
- 235000013355 food flavoring agent Nutrition 0.000 claims 2
- 235000003599 food sweetener Nutrition 0.000 claims 2
- 238000009472 formulation Methods 0.000 claims 2
- 239000008187 granular material Substances 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 239000000463 material Substances 0.000 claims 2
- 239000008108 microcrystalline cellulose Substances 0.000 claims 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 2
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 2
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims 2
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims 2
- 239000003765 sweetening agent Substances 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- 239000000080 wetting agent Substances 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 1
Claims (2)
- （１）活性物質を、（Ａ）微結晶性セルロースおよびカルボキシメチルセルロースナトリウムの共処理材料である弱ゲル化剤と（Ｂ）強ゲル化剤との混合物、ならびに場合によって、希釈剤もしくは帯電防止剤またはこれらの混合物を含む群から選択される少なくとも１種の添加剤（Ｄ）と乾式混合するステップと、
（２）得られた乾式混合物を、場合によってアルコールまたはアルコールと水との混合物に溶かした少なくとも１種の結合剤（Ｃ）とともに粒状化するステップと、
（３）ガス発生剤を、ステップ（２）から得られる顆粒と、場合によって、希釈剤、潤滑剤、湿潤剤、甘味剤、着香剤、着色剤およびこれらの混合物を含む群から選択される賦形剤と乾式混合するステップと、
（４）混合物を圧縮して錠剤にするステップと、
（５）場合によって、（４）において得られる錠剤をフィルムコーティングするステップと
を含む、請求項１から１１のいずれか一項に記載の製剤を製造するための方法。 - （１）活性物質を、（Ａ）微結晶性セルロースおよびカルボキシメチルセルロースナトリウムの共処理材料である弱ゲル化剤と（Ｂ）強ゲル化剤との混合物、ならびに場合によって、希釈剤もしくは帯電防止剤またはこれらの混合物を含む群から選択される少なくとも１種の添加剤（Ｄ）、ならびにガス発生剤の少なくとも一部と乾式混合するステップと、
（２）得られた乾式混合物を、場合によってアルコールまたはアルコールと水との混合物に溶かした少なくとも１種の結合剤（Ｃ）とともに粒状化するステップと、
（３）ガス発生剤の残りの部分があれば、ステップ（２）から得られる顆粒と、場合によって、希釈剤、潤滑剤、湿潤剤、甘味剤、着香剤、着色剤およびこれらの混合物を含む群から選択される賦形剤と乾式混合するステップと、
（４）混合物を圧縮して錠剤にするステップと、
（５）場合によって、錠剤をフィルムコーティングするステップと
を含む、請求項１から１１のいずれか一項に記載の製剤を製造するための方法。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP05291542A EP1745775B1 (en) | 2005-07-19 | 2005-07-19 | Gastroretentive formulations and manufacturing process thereof. |
| EP05291542.8 | 2005-07-19 | ||
| PCT/IB2006/002636 WO2007010400A2 (en) | 2005-07-19 | 2006-07-19 | Gastroretentive formulations and manufacturing process thereof |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2009501777A JP2009501777A (ja) | 2009-01-22 |
| JP2009501777A5 true JP2009501777A5 (ja) | 2011-03-31 |
| JP5199084B2 JP5199084B2 (ja) | 2013-05-15 |
Family
ID=35517256
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2008522096A Active JP5199084B2 (ja) | 2005-07-19 | 2006-07-19 | 胃保持型製剤およびそれらの製造方法 |
Country Status (13)
| Country | Link |
|---|---|
| US (1) | US9629800B2 (ja) |
| EP (2) | EP1745775B1 (ja) |
| JP (1) | JP5199084B2 (ja) |
| KR (1) | KR101367814B1 (ja) |
| CN (1) | CN101237858B (ja) |
| AT (1) | ATE396710T1 (ja) |
| AU (1) | AU2006271314B2 (ja) |
| BR (1) | BRPI0612901B8 (ja) |
| CA (1) | CA2616081C (ja) |
| DE (1) | DE602005007205D1 (ja) |
| HK (1) | HK1122729A1 (ja) |
| RU (1) | RU2376983C2 (ja) |
| WO (1) | WO2007010400A2 (ja) |
Families Citing this family (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20080076382A (ko) * | 2007-02-15 | 2008-08-20 | (주)아모레퍼시픽 | 실로스타졸의 제어방출 제제 및 그 제조방법 |
| EP2346351B1 (en) | 2008-09-22 | 2019-07-03 | Rubicon Research Private Limited | Compositions exhibiting delayed transit through the gastrointestinal tract |
| FR2945947B1 (fr) | 2009-05-29 | 2011-07-29 | Flamel Tech Sa | Compositions pharmaceutiques flottantes a liberation controlee |
| US20120100212A1 (en) | 2009-07-06 | 2012-04-26 | Kyorin Pharmaceutical, Co., Ltd. | Tablet having hollow structure |
| EP2361615A1 (en) | 2010-02-19 | 2011-08-31 | Alfred E. Tiefenbacher GmbH & Co. KG | Dipyridamole prolonged-release tablet |
| EP2544666A2 (en) | 2010-03-09 | 2013-01-16 | Council of Scientific and Industrial Research | Gastroretentive, extended release composition of therapeutic agent |
| WO2011125798A1 (ja) * | 2010-03-31 | 2011-10-13 | 持田製薬株式会社 | 易服用性固形製剤 |
| CN101919817B (zh) * | 2010-07-23 | 2012-05-30 | 山东齐都药业有限公司 | 一种拉呋替丁胃内滞留控制释放组合物 |
| JP5976657B2 (ja) | 2011-09-30 | 2016-08-24 | 持田製薬株式会社 | 易服用性固形製剤 |
| DE102012102414A1 (de) | 2012-03-21 | 2013-10-10 | Michael Dittgen | Pharmazeutische Zusammensetzung für die einmal tägliche Anwendung antidiabetischer Arzneimittel wie Metformin mit Zwei-Puls-Freisetzung |
| WO2013168179A2 (en) * | 2012-04-03 | 2013-11-14 | Rubicon Research Private Limited | Controlled release pharmaceutical formulations of antiviral agents |
| CN103110601B (zh) * | 2013-02-04 | 2014-10-29 | 成都恒瑞制药有限公司 | 一种格列齐特胃漂浮片及其制备方法 |
| FR3014692B1 (fr) * | 2013-12-18 | 2016-01-29 | Ethypharm Sa | Compositions pharmaceutiques orales a retention gastrique. |
| TWI705814B (zh) * | 2014-06-20 | 2020-10-01 | 美商梅琳塔有限責任公司 | 醫藥組成物及其用途 |
| CN117599029A (zh) | 2016-03-17 | 2024-02-27 | 硫创治疗公司 | 用于控制释放半胱胺和系统治疗半胱胺敏感性病症的组合物 |
| CN107184560B (zh) * | 2017-06-03 | 2021-02-02 | 寿光富康制药有限公司 | 二甲双胍胃滞留片及制备方法 |
| EP3684418A4 (en) | 2017-09-20 | 2021-06-16 | Thiogenesis Therapeutics, Inc. | TREATMENT METHODS FOR CYSTEAMINE SENSITIVE CONDITIONS |
| EP3737353A1 (en) | 2017-12-18 | 2020-11-18 | Tris Pharma, Inc. | Ghb pharmaceutical compositions comprising a floating interpenetrating polymer network forming system |
| US11337919B2 (en) * | 2017-12-18 | 2022-05-24 | Tris Pharma, Inc. | Modified release drug powder composition comprising gastro-retentive RAFT forming systems having trigger pulse drug release |
| CN109602714B (zh) * | 2018-12-29 | 2020-06-12 | 广东中润药物研发有限公司 | 一种利伐沙班胃滞留片及其制备方法 |
| GB2599950A (en) * | 2020-10-16 | 2022-04-20 | Zentiva Ks | Pharmaceutical compositions with low amounts of nitrosamine impurities and methods for producing the same |
| CN117042629A (zh) * | 2021-01-13 | 2023-11-10 | 杜邦营养美国公司 | 胃滞留药物递送系统 |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS61148115A (ja) * | 1984-12-21 | 1986-07-05 | Tooa Eiyoo Kk | 難溶性薬物の徐放性製剤及びその製造法 |
| GB8618847D0 (en) * | 1986-08-01 | 1986-09-10 | Smith Kline French Lab | Pharmaceutical formulations |
| FR2653337B1 (fr) * | 1989-10-23 | 1992-02-07 | Dow Corning Sa | Element a liberation prolongee et procede pour le fabriquer. |
| US6635280B2 (en) | 1997-06-06 | 2003-10-21 | Depomed, Inc. | Extending the duration of drug release within the stomach during the fed mode |
| ES2234139T3 (es) * | 1997-08-11 | 2005-06-16 | Alza Corporation | Forma de dosificacion de un agente activo de liberacion prolongada adaptada para la retencion gastrica. |
| IN186245B (ja) | 1997-09-19 | 2001-07-14 | Ranbaxy Lab Ltd | |
| CN1203846C (zh) * | 1998-03-19 | 2005-06-01 | 布里斯托尔-迈尔斯斯奎布公司 | 高溶解性药物的双相控释递送系统和方法 |
| EA004443B1 (ru) * | 1998-09-14 | 2004-04-29 | Рэнбакси Лабораториз Лимитед | Лекарственная форма для контролируемого высвобождения ципрофлоксацина для приема один раз в день |
| US6635281B2 (en) * | 1998-12-23 | 2003-10-21 | Alza Corporation | Gastric retaining oral liquid dosage form |
| US6797283B1 (en) | 1998-12-23 | 2004-09-28 | Alza Corporation | Gastric retention dosage form having multiple layers |
| KR100618234B1 (ko) * | 1998-12-23 | 2006-09-01 | 알자 코포레이션 | 다공성 입자를 포함하는 제형 |
| WO2001064183A1 (en) * | 2000-03-03 | 2001-09-07 | Ranbaxy Laboratories Limited | Orally administered controlled delivery system for once daily administration of ciprofloxacin |
| KR20040018394A (ko) * | 2001-07-04 | 2004-03-03 | 썬 파마슈티컬 인더스트리스 리미티드 | 위 정체 제어되는 약물 전달 계 |
| EP1509208A1 (en) * | 2002-02-04 | 2005-03-02 | Ranbaxy Laboratories Limited | Hydrodynamically balancing oral drug delivery system with biphasic release |
| GB0205253D0 (en) * | 2002-03-06 | 2002-04-17 | Univ Gent | Immediate release pharmaceutical granule compositions and a continuous process for making them |
| US7157100B2 (en) | 2002-06-04 | 2007-01-02 | J.B. Chemicals & Pharmaceuticals Ltd. | Pharmaceutical composition for controlled drug delivery system |
| WO2005060942A1 (en) * | 2003-12-19 | 2005-07-07 | Aurobindo Pharma Ltd | Extended release pharmaceutical composition of metformin |
-
2005
- 2005-07-19 EP EP05291542A patent/EP1745775B1/en active Active
- 2005-07-19 DE DE602005007205T patent/DE602005007205D1/de active Active
- 2005-07-19 AT AT05291542T patent/ATE396710T1/de not_active IP Right Cessation
-
2006
- 2006-07-19 KR KR1020087003902A patent/KR101367814B1/ko active IP Right Grant
- 2006-07-19 US US11/996,023 patent/US9629800B2/en active Active
- 2006-07-19 CN CN2006800265896A patent/CN101237858B/zh active Active
- 2006-07-19 RU RU2008106220/15A patent/RU2376983C2/ru active
- 2006-07-19 WO PCT/IB2006/002636 patent/WO2007010400A2/en active Application Filing
- 2006-07-19 BR BRPI0612901A patent/BRPI0612901B8/pt active IP Right Grant
- 2006-07-19 AU AU2006271314A patent/AU2006271314B2/en active Active
- 2006-07-19 JP JP2008522096A patent/JP5199084B2/ja active Active
- 2006-07-19 EP EP06795542A patent/EP1904034A2/en not_active Withdrawn
- 2006-07-19 CA CA2616081A patent/CA2616081C/en active Active
-
2008
- 2008-12-23 HK HK08113911.1A patent/HK1122729A1/xx unknown
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