JP2015502923A - 耐酸性ツーピースハードカプセル用の耐酸性バンディング溶液 - Google Patents
耐酸性ツーピースハードカプセル用の耐酸性バンディング溶液 Download PDFInfo
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- JP2015502923A JP2015502923A JP2014540574A JP2014540574A JP2015502923A JP 2015502923 A JP2015502923 A JP 2015502923A JP 2014540574 A JP2014540574 A JP 2014540574A JP 2014540574 A JP2014540574 A JP 2014540574A JP 2015502923 A JP2015502923 A JP 2015502923A
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- capsule
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Abstract
Description
本明細書に用いるように、以下の用語、成句および記号は、それらを用いる文脈が、特に明記する場合を除き、一般に、以下に記載する意味を有するものとする。
したがって、本開示の一態様は、耐酸性ツーピースハードカプセルをバンディングするための耐酸性バンディング溶液であって、上記カプセルが、伸縮自在に係合したカプセル部分を含み、かつ密閉されているがバンディングされてないこのようなカプセルと比較して改善された耐酸性の性質が与えられている耐酸性バンディング溶液を提供する。
バンディング溶液の3つの試料を、耐酸性ポリマーとして、それぞれHPMCP(HP−55)、CAPまたはHPMCASを用いて調製した。使用したアルカリ化合物は、NH3濃度35%のアンモニア水溶液(Fisher Scientificからのアンモニア溶液0.88S.G.(35%NH3))であった。最初に、ポリマー粉末の質量による適当な量を、室温、撹拌下で水中に分散させて所望の質量比を得た(表1を参照のこと)。次いで、ポリマー粒子がすべて溶解するまで指示量のアンモニア溶液を穏やかな撹拌下で徐々に分散液に加えた。パテントブルーV−C.I.フードブルー5E131の0.1%溶液(ポリマー質量に基づく)を加えてバンディングの目視を補助した。表1は、得られたバンディング溶液の組成物および特徴を示す。
Claims (15)
- ツーピースハードカプセルのカプセル部分の間に耐酸性シールを提供するための耐酸性バンディング組成物であって、該バンディング組成物が、少なくとも1つの耐酸性ポリマー、少なくとも1つのアルカリ化合物および水を含み、ここにおいて、該耐酸性ポリマーが、メタクリル酸コポリマー、酢酸フタル酸セルロース(CAP)、酢酸トリメリト酸セルロース(CAT)、酢酸コハク酸ヒドロキシプロピルメチルセルロース(HPMCAS)、フタル酸ヒドロキシプロピルメチルセルロース(HPMCP)、カルボキシメチルエチルセルロース(CMEC)、ポリビニル誘導体、およびそれらの混合物からなる群から選択され;かつ、該少なくとも1つのアルカリ化合物が、炭酸水素ナトリウム、炭酸ナトリウム、炭酸カリウム、炭酸水素カリウム、水酸化ナトリウム、リン酸三ナトリウム、過ホウ酸ナトリウム、水酸化カリウム、水酸化リチウム、炭酸リチウム、炭酸水素リチウム、炭酸アンモニウム、炭酸水素アンモニウム、水酸化アンモニウム、アンモニア、およびそれらの混合物からなる群から選択されるバンディング組成物。
- 前記組成物が、室温で50cPから10,000まで、好ましくは100cPから5000cPまで、より好ましくは1500cPから3100cPまでの粘度を有する、請求項1に記載の組成物。
- 前記少なくとも1つの耐酸性ポリマーが酢酸ヒドロキシプロピルメチルセルロース(HPMCP)であり、かつ前記少なくとも1つのアルカリ化合物がアンモニアである、請求項1に記載の組成物。
- 前記少なくとも1つの耐酸性ポリマーが酢酸フタル酸セルロース(CAP)であり、かつ前記少なくとも1つのアルカリ化合物がアンモニアである、請求項1に記載の組成物。
- 前記少なくとも1つの耐酸性ポリマーが酢酸コハク酸ヒドロキシプロピルメチルセルロース(HPMCAS)であり、かつ前記少なくとも1つのアルカリ化合物がアンモニアである、請求項1に記載の組成物。
- 少なくとも1つの薬学的に許容されるまたは食品に許容される可塑剤および/または着色剤を更に含む、前記請求項1〜5のいずれか1項に記載の組成物。
- ヒトまたは動物への少なくとも1つの医薬、獣医製品、食品および栄養補助食品の経口投与に使用するための請求項1〜6のいずれか1項に記載の耐酸性バンディング組成物を含む耐酸性ハードカプセル。
- 前記カプセルがディップ成形または射出成形されたヒドロキシプロピルメチルセルロース(HPMC)耐酸性ハードカプセルを含む、請求項7に記載のカプセル。
- 少なくとも1つの耐酸性ポリマー、少なくとも1つのアルカリ化合物および水を含む耐酸性バンディング組成物を用いて耐酸性ハードカプセルをバンディングする方法であって、
望ましいバンディング組成物量を決定すること;
必要なバンディング組成物を測定すること;および
バンディング組成物を耐酸性カプセルに適用すること
を含む方法。 - 前記カプセルがディップ成形または射出成形されたヒドロキシプロピルメチルセルロース(HPMC)耐酸性ハードカプセルを含む、請求項9に記載の方法。
- 前記耐酸性ポリマーがメタクリル酸コポリマー;酢酸フタル酸セルロース(CAP)、酢酸トリメリト酸セルロース(CAT)、酢酸コハク酸ヒドロキシプロピルメチルセルロース(HPMCAS)、フタル酸ヒドロキシプロピルメチルセルロース(HPMCP)、カルボキシメチルエチルセルロース(CMEC)、ポリビニル誘導体およびそれらの混合物からなる群から選択される、請求項9に記載の方法。
- 前記少なくとも1つのアルカリ化合物が、炭酸水素ナトリウム、炭酸ナトリウム、炭酸カリウム、炭酸水素カリウム、水酸化ナトリウム、リン酸三ナトリウム、過ホウ酸ナトリウム、水酸化カリウム、水酸化リチウム、炭酸リチウム、炭酸水素リチウム、炭酸アンモニウム、炭酸水素アンモニウム、水酸化アンモニウム、アンモニアおよびそれらの混合物からなる群から選択される、請求項9に記載の方法。
- 少なくとも1つの薬学的に許容されるまたは食品に許容される可塑剤および/または着色剤を更に含む、請求項9〜12のいずれか1項に記載の方法。
- 前記バンディング組成物を室温でカプセルに適用する、請求項9〜13のいずれか1項に記載の方法。
- カプセル部分の間に耐酸性シールを提供するような、好ましくは改善されたin vitro耐酸性を達成するツーピースカプセルをバンディングする方法であって、該ツーピースカプセルを請求項1〜6のいずれか1項に記載の耐酸性バンディング組成物で処理する方法。
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Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2015522548A (ja) * | 2012-05-21 | 2015-08-06 | キャプシュゲル・ベルジウム・エヌ・ヴィ | ツーピース硬カプセル用の耐酸性バンド溶液 |
JP2018516960A (ja) * | 2015-06-09 | 2018-06-28 | レビオティクス インコーポレイテッドRebiotix,Inc. | マイクロバイオータ回復治療(mrt)組成物及び製造方法 |
JP2018536622A (ja) * | 2015-11-10 | 2018-12-13 | カプスゲル・ベルギウム・ナムローゼ・フェンノートシャップCapsugel Belgium NV | 耐酸性のツーピースハードカプセル用の耐酸性バンディング溶液又はシーリング溶液 |
US10799539B2 (en) | 2015-06-09 | 2020-10-13 | Rebiotix, Inc. | Microbiota restoration therapy (MRT) compositions and methods of manufacture |
US10905726B2 (en) | 2015-06-09 | 2021-02-02 | Rebiotix, Inc. | Microbiota restoration therapy (MRT) compositions and methods of manufacture |
Families Citing this family (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
PL3564357T3 (pl) | 2010-02-01 | 2022-08-08 | Rebiotix, Inc. | Bakterioterapia zapalenia jelita grubego z clostridium difficile |
EP3566698A1 (en) * | 2011-11-09 | 2019-11-13 | Capsugel Belgium NV | Acid resistant banding solution for acid resistant two piece hard capsules |
CA2870134C (en) * | 2012-05-02 | 2020-04-28 | Capsugel France SAS | Aqueous dispersions of hydroxypropyl methylcellulose acetate succinate (hpmcas) |
EP3065720A1 (en) | 2013-11-04 | 2016-09-14 | Capsugel Belgium NV | Methods and systems for improved bioavailability of active pharmaceutical ingredients including esomeprazole |
JP6338447B2 (ja) * | 2014-05-16 | 2018-06-06 | 中日本カプセル 株式会社 | ハードカプセル |
KR102377103B1 (ko) | 2014-05-20 | 2022-03-23 | 뉴트리션 & 바이오사이언시즈 유에스에이 1, 엘엘씨 | 에스테르화된 셀룰로오스 에테르를 포함하는 캡슐 쉘 |
EP3025709B1 (en) * | 2014-11-27 | 2020-09-30 | Capsugel Belgium NV | Dosage form articles for external mucosal applications |
WO2019096833A1 (en) | 2017-11-17 | 2019-05-23 | Evonik Röhm Gmbh | Process for preparing a coated hard shell capsule |
WO2023212749A2 (en) * | 2022-04-29 | 2023-11-02 | Novatek Therapeutics, Llc | Black seed oil formulations |
KR20230167914A (ko) * | 2022-06-03 | 2023-12-12 | 주식회사 서흥 | 장용성 경질캡슐의 제조를 위한 밴딩 용액과 이를 이용하여 제조한 장용성 경질캡슐 |
Citations (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS5732230A (en) * | 1980-07-18 | 1982-02-20 | Parke Davis & Co | Instetine-soluble capsule |
JPS63117761A (ja) * | 1986-11-07 | 1988-05-21 | 辻 新次郎 | ゼラチン硬カプセルのフイルムコ−テイング方法 |
JPH08245423A (ja) * | 1995-03-06 | 1996-09-24 | Shionogi & Co Ltd | 水系腸溶性コーティング液 |
JPH0987169A (ja) * | 1995-07-20 | 1997-03-31 | Tanabe Seiyaku Co Ltd | 消化管下部放出型被覆カプセル製剤 |
JP2005187412A (ja) * | 2003-12-26 | 2005-07-14 | Shionogi Qualicaps Co Ltd | 硬質カプセル剤の製造方法 |
JP2006016372A (ja) * | 2004-07-05 | 2006-01-19 | Shionogi Qualicaps Co Ltd | 腸溶性硬カプセル剤 |
WO2006070578A1 (ja) * | 2004-12-28 | 2006-07-06 | Qualicaps Co., Ltd. | 硬カプセルのバンドシール |
JP2009504630A (ja) * | 2005-08-12 | 2009-02-05 | ワーナー−ランバート カンパニー リミテッド ライアビリティー カンパニー | 基剤としてヒドロキシプロピルメチルセルロース(hpmc)を用いるハードカプセルのバンド処理法。 |
JP2010202550A (ja) * | 2009-03-02 | 2010-09-16 | Qualicaps Co Ltd | 腸溶性カプセル |
US20110033530A1 (en) * | 2009-07-29 | 2011-02-10 | Evonik Roehm Gmbh | Coating composition for the dip coating of capsule halves |
Family Cites Families (32)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB759274A (en) * | 1952-10-21 | 1956-10-17 | Ortho Pharma Corp | Therapeutic preparations containing 2-acylamino-5-nitrothiazole |
US2924920A (en) | 1958-09-02 | 1960-02-16 | Elly T Margolis | Sealing hard-shell gelatin capsules |
US3071513A (en) | 1959-11-23 | 1963-01-01 | Upjohn Co | Process for sealing capsules |
FR2118883A1 (en) | 1970-12-26 | 1972-08-04 | Green Cross Corp | Enteric coating of hard capsules - after pre-sealing with aq org solvent mixtures |
US3927195A (en) * | 1974-01-31 | 1975-12-16 | Lilly Industries Ltd | Production of capsules |
US4138013A (en) * | 1976-08-27 | 1979-02-06 | Parke, Davis & Company | Enteric capsules |
US4656066A (en) | 1982-12-20 | 1987-04-07 | Warner-Lambert Company | Apparatus and method for sealing capsules |
US4756902A (en) | 1986-06-02 | 1988-07-12 | Warner-Lambert Company | Capsule sealing process and product |
US4816259A (en) * | 1987-02-12 | 1989-03-28 | Chase Chemical Company, L.P. | Process for coating gelatin capsules |
US4761932A (en) | 1987-02-13 | 1988-08-09 | Warner-Lambert Company | Capsule sealing machine |
US4734149A (en) | 1987-03-20 | 1988-03-29 | Warner-Lambert Company | Apparatus for heatsealing gelatin capsules containing a medicament |
US4922682A (en) | 1988-01-15 | 1990-05-08 | Warner-Lambert Company | Apparatus and method for sealing and banding capsules |
US4940499A (en) | 1989-05-23 | 1990-07-10 | Warner-Lambert Company | Method and apparatus for sealing capsules containing medicaments |
JPH064531B2 (ja) * | 1990-06-04 | 1994-01-19 | アイセロ化学株式会社 | 大腸崩壊性硬質カプセル |
US5054208A (en) | 1991-02-07 | 1991-10-08 | Novatec, Inc. | Tubular diffuser |
US5851579A (en) * | 1996-10-28 | 1998-12-22 | Eastman Chemical Company | Aqueous enteric coating compositions |
MXPA01003197A (es) | 1998-09-28 | 2004-04-21 | Warner Lambert Co | Suministro enterico y colonico utilizando capsulas de chpm. |
IL130602A0 (en) | 1999-06-22 | 2000-06-01 | Dexcel Ltd | Stable benzimidazole formulation |
US20040170688A1 (en) * | 2001-08-06 | 2004-09-02 | Deshmukh Abhijit Mukund | Enteric formulation of fluoxetin |
EP1344523A1 (en) | 2002-03-11 | 2003-09-17 | Warner-Lambert Company | Ibuprofen solution for hard gelatin capsules |
US20030194430A1 (en) * | 2002-04-10 | 2003-10-16 | Miller Frederick H. | Process for encapsulating multi-phase, multi-compartment capsules for therapeutic compositions |
US20040028737A1 (en) * | 2002-08-12 | 2004-02-12 | Kopran Research Laboratories Limited | Enteric coated stable oral pharmaceutical composition of acid unstable drug and process for preparing the same |
KR100511086B1 (ko) * | 2003-09-17 | 2005-08-30 | 삼성정밀화학 주식회사 | 장용성의 수계 분산 히드록시프로필 메틸셀룰로오스프탈레이트 나노입자의 제조방법 |
EP1886657A1 (en) | 2006-08-11 | 2008-02-13 | Pfizer Products Inc. | Method and apparatus for sealing capsules |
GB0706178D0 (en) | 2007-03-29 | 2007-05-09 | Univ Aston | Enteric pharmaceutical capsules |
EP2175826A1 (de) * | 2007-07-10 | 2010-04-21 | Boehringer Ingelheim International GmbH | Dichtes verschliessen von gefüllten arzneimittelkapseln |
EP2223685A4 (en) | 2007-11-13 | 2013-08-21 | Shanghai Huiyuan Vegetal Capsule Co Ltd | HARD-GEL CELLULAR, GASTRORESISTANT AND GELATIN-FREE ENVELOPE AND PROCESS FOR PREPARING THE SAME |
CA2764181A1 (en) * | 2009-07-02 | 2011-01-06 | Hercules Incorporated | Stable shellac enteric coating formulation for nutraceutical and pharmaceutical dosage forms |
KR101705204B1 (ko) | 2009-09-11 | 2017-02-09 | 롯데정밀화학 주식회사 | 장용성 경질 캡슐용 수성 조성물, 장용성 경질 캡슐의 제조방법 및 장용성 경질 캡슐 |
PL2480218T3 (pl) | 2009-09-24 | 2020-11-16 | Capsugel Belgium Nv | Kapsułki odporne na kwas |
EP3566698A1 (en) * | 2011-11-09 | 2019-11-13 | Capsugel Belgium NV | Acid resistant banding solution for acid resistant two piece hard capsules |
ES2879892T3 (es) | 2012-05-21 | 2021-11-23 | Capsugel Belgium Nv | Uso de una solución banda resistente a los ácidos para sellar cápsulas duras de dos piezas |
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2012
- 2012-11-08 EP EP19157763.4A patent/EP3566698A1/en active Pending
- 2012-11-08 US US14/357,202 patent/US20140360404A1/en not_active Abandoned
- 2012-11-08 ES ES12867724T patent/ES2726534T3/es active Active
- 2012-11-08 WO PCT/IB2012/003133 patent/WO2013150331A1/en active Application Filing
- 2012-11-08 EP EP12867724.2A patent/EP2776016B1/en active Active
- 2012-11-08 JP JP2014540574A patent/JP6219836B2/ja active Active
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2016
- 2016-10-24 US US15/332,915 patent/US9980918B2/en active Active
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2017
- 2017-09-27 JP JP2017185559A patent/JP6836977B2/ja active Active
Patent Citations (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS5732230A (en) * | 1980-07-18 | 1982-02-20 | Parke Davis & Co | Instetine-soluble capsule |
JPS63117761A (ja) * | 1986-11-07 | 1988-05-21 | 辻 新次郎 | ゼラチン硬カプセルのフイルムコ−テイング方法 |
JPH08245423A (ja) * | 1995-03-06 | 1996-09-24 | Shionogi & Co Ltd | 水系腸溶性コーティング液 |
JPH0987169A (ja) * | 1995-07-20 | 1997-03-31 | Tanabe Seiyaku Co Ltd | 消化管下部放出型被覆カプセル製剤 |
JP2005187412A (ja) * | 2003-12-26 | 2005-07-14 | Shionogi Qualicaps Co Ltd | 硬質カプセル剤の製造方法 |
JP2006016372A (ja) * | 2004-07-05 | 2006-01-19 | Shionogi Qualicaps Co Ltd | 腸溶性硬カプセル剤 |
WO2006070578A1 (ja) * | 2004-12-28 | 2006-07-06 | Qualicaps Co., Ltd. | 硬カプセルのバンドシール |
JP2009504630A (ja) * | 2005-08-12 | 2009-02-05 | ワーナー−ランバート カンパニー リミテッド ライアビリティー カンパニー | 基剤としてヒドロキシプロピルメチルセルロース(hpmc)を用いるハードカプセルのバンド処理法。 |
JP2010202550A (ja) * | 2009-03-02 | 2010-09-16 | Qualicaps Co Ltd | 腸溶性カプセル |
US20110033530A1 (en) * | 2009-07-29 | 2011-02-10 | Evonik Roehm Gmbh | Coating composition for the dip coating of capsule halves |
Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2015522548A (ja) * | 2012-05-21 | 2015-08-06 | キャプシュゲル・ベルジウム・エヌ・ヴィ | ツーピース硬カプセル用の耐酸性バンド溶液 |
JP2018083825A (ja) * | 2012-05-21 | 2018-05-31 | キャプシュゲル・ベルジウム・エヌ・ヴィ | ツーピース硬カプセル用の耐酸性バンド溶液 |
JP2018516960A (ja) * | 2015-06-09 | 2018-06-28 | レビオティクス インコーポレイテッドRebiotix,Inc. | マイクロバイオータ回復治療(mrt)組成物及び製造方法 |
US10226431B2 (en) | 2015-06-09 | 2019-03-12 | Rebiotix, Inc. | Microbiota restoration therapy (MRT) compositions and methods of manufacture |
US10391064B2 (en) | 2015-06-09 | 2019-08-27 | Rebiotix, Inc. | Microbiota restoration therapy (MRT) compositions and methods of manufacture |
US10799539B2 (en) | 2015-06-09 | 2020-10-13 | Rebiotix, Inc. | Microbiota restoration therapy (MRT) compositions and methods of manufacture |
US10905726B2 (en) | 2015-06-09 | 2021-02-02 | Rebiotix, Inc. | Microbiota restoration therapy (MRT) compositions and methods of manufacture |
US11654164B2 (en) | 2015-06-09 | 2023-05-23 | Rebiotix, Inc. | Microbiota restoration therapy (MRT) compositions and methods of manufacture |
JP2018536622A (ja) * | 2015-11-10 | 2018-12-13 | カプスゲル・ベルギウム・ナムローゼ・フェンノートシャップCapsugel Belgium NV | 耐酸性のツーピースハードカプセル用の耐酸性バンディング溶液又はシーリング溶液 |
US11246837B2 (en) | 2015-11-10 | 2022-02-15 | Capsugel Belgium, NV | Acid resistant banding or sealing solution for acid resistant two piece hard capsules |
Also Published As
Publication number | Publication date |
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JP6219836B2 (ja) | 2017-10-25 |
JP6836977B2 (ja) | 2021-03-03 |
EP3566698A1 (en) | 2019-11-13 |
US20170035699A1 (en) | 2017-02-09 |
US20140360404A1 (en) | 2014-12-11 |
ES2726534T3 (es) | 2019-10-07 |
US9980918B2 (en) | 2018-05-29 |
EP2776016B1 (en) | 2019-02-20 |
WO2013150331A1 (en) | 2013-10-10 |
JP2018030863A (ja) | 2018-03-01 |
WO2013150331A4 (en) | 2013-12-05 |
EP2776016A1 (en) | 2014-09-17 |
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