JP6306573B2 - ツーピース硬カプセル用の耐酸性バンド溶液 - Google Patents
ツーピース硬カプセル用の耐酸性バンド溶液 Download PDFInfo
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- JP6306573B2 JP6306573B2 JP2015513290A JP2015513290A JP6306573B2 JP 6306573 B2 JP6306573 B2 JP 6306573B2 JP 2015513290 A JP2015513290 A JP 2015513290A JP 2015513290 A JP2015513290 A JP 2015513290A JP 6306573 B2 JP6306573 B2 JP 6306573B2
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- ZCIHMQAPACOQHT-ZGMPDRQDSA-N trans-isorenieratene Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C=C/c1c(C)ccc(C)c1C)C=CC=C(/C)C=Cc2c(C)ccc(C)c2C ZCIHMQAPACOQHT-ZGMPDRQDSA-N 0.000 description 1
- 239000001069 triethyl citrate Substances 0.000 description 1
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 description 1
- 235000013769 triethyl citrate Nutrition 0.000 description 1
- UJMBCXLDXJUMFB-UHFFFAOYSA-K trisodium;5-oxo-1-(4-sulfonatophenyl)-4-[(4-sulfonatophenyl)diazenyl]-4h-pyrazole-3-carboxylate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)C1=NN(C=2C=CC(=CC=2)S([O-])(=O)=O)C(=O)C1N=NC1=CC=C(S([O-])(=O)=O)C=C1 UJMBCXLDXJUMFB-UHFFFAOYSA-K 0.000 description 1
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Images
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A61K9/4833—Encapsulating processes; Filling of capsules
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- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
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- A—HUMAN NECESSITIES
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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Description
インクビヒクル溶液によるDRCAP(商標)のバンド
DRCAPS(商標)耐酸性カプセルに、APAP(N−アセチル−p−アミノフェノール、すなわち、アセトアミノフェンという活性化合物)を充填し、表1に示す赤インクおよびインクビヒクル溶液によりシールした。バンドされたAPAP充填カプセルを、p.H1.2の媒体において、USP溶出法を使用して試験し、pH1.2での2時間の溶出試験後に、溶出したAPAPの割合を測定する計量法により評価した。図1は、APAPを充填され、USP溶出試験法により、240分までの時間にわたって溶出するAPAPの割合を決定するために評価された、バンドされたカプセルの計量方法による結果を示す。
インクビヒクル溶液によるゼラチンカプセル、プルランカプセル、およびHPMCカプセルのバンド
表3に示すシェラック/インクビヒクル溶液を使用して、液体充填カプセルについてのバンドを調査した。これにより、各カプセル材料のバンド品質を容易に観察した。
ロジンを含まない配合物
硬カプセルのバンドを、エタノール59.9wt%、シェラック37wt%、および、水1.6%(エタノール中のものとして)、ソルビタン脂肪酸エステル1%、およびグリセリン脂肪酸エステル0.5%を含むバンド溶液によっても実施した。カプセルは、溶出試験および崩壊試験の両方に関して、ロジン含有またはロジン非含有で同様に機能した。シェラックバンドについてロジンを含まない組成物は、充填される粉末が「生きたプロバイオティクス」であるいくつかの実施形態において、特に有意義である。
バンド後処理
バンドされたカプセルを乾燥する時間の長さは、剤形を取り扱う実際の必要性、およびバンド溶液の特徴に応じて調整することができる。本発明者らは、乾燥プロセスを速くし、バンドが完全に乾燥しないうちに粘着性を低下させるように、滑沢剤であるタルクまたはステアリン酸カルシウムを塗布した。
Claims (16)
- 組成物の総重量に対して、25wt%より多く約45wt%までの範囲の量のシェラックと、少なくとも1種の界面活性剤及び少なくとも1種のアルコールとを含む、ツーピース硬カプセル用の耐酸性バンド組成物。
- 蝋をさらに含む請求項1に記載の組成物。
- 組成物の総重量に対して、約0.1wt%から約5wt%の範囲の量で存在する少なくとも1種の界面活性剤を含む、請求項1または2に記載の組成物。
- 少なくとも1種の界面活性剤は、グリセリン脂肪酸エステル、ソルビタン脂肪酸エステル、およびこれらの混合物から選択される、請求項3に記載の組成物 。
- 少なくとも1種のアルコールは、組成物の総重量に対して、約15wt%から約70wt%の範囲の量で存在する、請求項1〜4のいずれか1項に記載の組成物。
- アルコールは、C2〜C6直鎖状または分枝鎖状アルコールである、請求項1〜5のいずれか1項に記載の組成物。
- 前記アルコールは、95%エタノールとn−ブチルアルコールとの混合物である、請求 項1〜6のいずれか1項に記載の組成物。
- シェラックは、組成物の総重量に対して、約29.5wt%から約45wt%の範囲の量で存在する、請求項1〜7のいずれか1項に記載の組成物。
- 組成物の総重量に対して、約0wt%より多く約8wt%までの量のアンモニア水をさらに含む、請求項1〜8のいずれか1項に記載の組成物。
- 少なくとも1種の可塑剤をさらに含む、請求項1〜9のいずれか1項に記載の組成物。
- ポリアクリレート、ポリメタクリレート、ポリビニルピロリドン、ポリ(酢酸ビニル)、様々なデンプン、アメイゾ、アミロース、およびゼインのようなトウモロコシ製品、ペクチン、アルコキシル化セルロース、ポリエステル、ポリエーテル、タンパク質、核酸、アルブミン、ゼラチン、プルラン、キチン、キトサン、寒天、デンプン、コラーゲン、デキストランおよび改変デキストラン、多糖類、ポリラクチド/ポリグリコリド、ポリアルキルシアノアクリレート、ポリアクリルアミド、ポリソルベート、ポリエチレンエーテル、ポリエチレンエステル、ポリオキシエチレン/ポリオキシプロピレンブロックポリマー、セルロース、アセトフタレート、ヒドロキシプロピルメチルセルロース、セルロースエステル、セルロースジエステル、セルローストリエステル、セルロースエーテル、セルロースエステル−エーテル、セルロースアシレート、セルロースジアシレート、セルローストリアシレート、酢酸セルロース、二酢酸セルロース、三酢酸セルロース、酢酸プロピオン酸セルロース、酢酸ブチル酸セルロース、メチルセルロース、エチルセルロース、ヒドロキシエチルセルロース、プロピルセルロース、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース(ヒプロメロース)、低置換度ヒドロキシプロピルセルロース、およびカルボキシメチルセルロース、ならびにこれらの混合物からなる群から選択される材料から形成される、ツーピース硬カプセルシェル
を含む、シールされたツーピース硬カプセルであって、
ツーピース硬カプセルが、請求項1に記載の組成物から形成された、乾燥シール組成物でシールされ、
カプセルは、耐酸性カプセルである、
前記ツーピース硬カプセル。 - 乾燥シール組成物がさらに蝋を含む、請求項11に記載のカプセル。
- 医薬品、動物用医薬品、食品、および栄養補助食品をヒトまたは動物へ送達する投与形態の製造のための、請求項11または12に記載の、耐酸性バンドを有する耐酸性硬カプセルの使用。
- 組成物の総重量に対して、25wt%より多く約45wt%までの範囲の量のシェラックと、少なくとも1種の界面活性剤及び少なくとも1種のアルコールを含む耐酸性バンド組成物を、ツーピース硬カプセルに塗布することと、バンドされたツーピース硬カプセルを乾燥すること
とを含む、ツーピース硬カプセルをバンドする方法。 - ツーピース硬カプセルを乾燥する前に、バンド組成物に滑沢剤層を塗布することをさらに含む、請求項14に記載の方法。
- 方法は、バンド処理機を使用して実行される、請求項14または15に記載の方法。
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US201261707135P | 2012-09-28 | 2012-09-28 | |
US61/707,135 | 2012-09-28 | ||
PCT/IB2013/001423 WO2013175303A1 (en) | 2012-05-21 | 2013-05-20 | Acid resistant banding solution for two piece hard capsules |
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JP6588193B2 (ja) * | 2014-07-31 | 2019-10-09 | 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 | カプセル製剤 |
EP3167880B1 (en) * | 2015-11-10 | 2019-06-19 | Capsugel Belgium NV | Acid resistant banding or sealing solution for acid resistant two piece hard capsules |
ES2845688T3 (es) | 2016-01-28 | 2021-07-27 | Capsugel Belgium Nv | Composiciones y cápsulas duras resultantes que comprenden concentrados alimentarios colorantes hidrófilos |
JP6578459B1 (ja) * | 2019-02-28 | 2019-09-18 | アピ株式会社 | ハードカプセル及びその製造方法 |
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JPS61280422A (ja) * | 1985-06-05 | 1986-12-11 | Nippon Eranko Kk | 硬質ゼラチンカプセルのバンドシ−ル液 |
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JP4312423B2 (ja) * | 2002-06-14 | 2009-08-12 | ピジョン株式会社 | 腸溶性カプセル剤 |
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EP1752140A1 (en) * | 2005-08-12 | 2007-02-14 | Warner-Lambert Company LLC | Method for banding hard capsules using hydroxypropylmethyl cellulose (HPMC) as a base |
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EP2480218B1 (en) * | 2009-09-24 | 2020-05-27 | Capsugel Belgium NV | Acid resistant capsules |
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WO2011100643A1 (en) * | 2010-02-12 | 2011-08-18 | Sensient Colors Inc. | Enteric coating compositions and methods of making and using the same |
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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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