JP6890182B2 - ハードカプセルシェル用フィルム形成性組成物及びそれから得られたハードカプセルシェル - Google Patents
ハードカプセルシェル用フィルム形成性組成物及びそれから得られたハードカプセルシェル Download PDFInfo
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- JP6890182B2 JP6890182B2 JP2019541122A JP2019541122A JP6890182B2 JP 6890182 B2 JP6890182 B2 JP 6890182B2 JP 2019541122 A JP2019541122 A JP 2019541122A JP 2019541122 A JP2019541122 A JP 2019541122A JP 6890182 B2 JP6890182 B2 JP 6890182B2
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- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4833—Encapsulating processes; Filling of capsules
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- General Preparation And Processing Of Foods (AREA)
- Compositions Of Macromolecular Compounds (AREA)
Description
透明性及び安定性に欠ける。数カ月後、それからの得られたフィルムの強度、可撓性及び可塑性は減少する。これは、平行して、それらの脆砕性及び不透明性の増加をもたらす。また、カプセルシェルの調製に関して、浸漬ステップに必要とされる時間が、それらの配合物に関しては比較的長い(ゼラチン溶液に対する1又は2秒と比較して20秒)。
ドカプセルシェルの調製を可能にする。また、これらのフィルム形成性組成物は、使用が容易であり、カプセル製造業者は、すでに彼らが所有している装置を使用することによって、そしてプロセス設定の有意な変更を必要とせずに、古典的なゼラチン組成物を本発明のフィルム形成性組成物と置き換えることができる。
本発明のフィルム形成性組成物は、それらが加水分解でんぷん、ゲランゴム、イソソルビド、ソルビトール及びグリセロールを含んでなる事実によって特徴づけられる。
− 50〜98%、好ましくは、70〜95%、例えば、80〜90%の加水分解でんぷんと、
− 0.5〜10%、好ましくは、1〜8%、好ましくは、1〜5%、例えば、1〜3%のゲランゴムと、
− 0.5〜10%、好ましくは、1〜8%、好ましくは、1〜5%、例えば、1〜3%のイソソルビドと、
− 0.5〜10%、好ましくは、1〜8%、好ましくは、1〜6%、例えば、2〜5%のソルビトールと、
− 0.5〜10%、好ましくは、1〜8%、好ましくは、1〜6%、例えば、2〜5%のグリセロールと、
− 任意選択的に、0〜0.50%、好ましくは、0.01〜0.50%、好ましくは
、0.05〜0.40%、例えば、0.10〜0.30%の緩衝剤、好ましくは、例えば、KCl、K3PO4、KH2PO4、クエン酸カリウム、好ましくは、KClから選択されるカリウム塩と、
− 任意選択的に、0〜10%、好ましくは、0〜5%、典型的に、0〜3%又はさらには0〜1%の他の成分と
から構成される。
本発明のフィルム形成性組成物は、多かれ少なかれ硬質である食用の水溶性フィルム又はゲルを形成することが可能であり、これはハードカプセルシェルの製造のために有用である。
(a)液体形態の本発明によるフィルム形成性組成物を提供するステップと、
(b)ステップ(a)で得られた組成物によってカプセルシェルを成形するステップと、
(c)ステップ(b)で得られた成形組成物を乾燥させるステップと、
(d)そのようにして得られたカプセルシェルを回収するステップと
を含んでなる方法に従って得ることができる。
次の試験において、フィルム形成性組成物は次の通りに調製された。
ハードカプセルの製造用の工業設備上で組成物IN−1を試験した。
Claims (6)
- 加水分解でんぷん、ゲランゴム、イソソルビド、ソルビトール及びグリセロールを含んでなるフィルム形成性組成物。
- 前記加水分解でんぷんがアルキル化される、請求項1に記載のフィルム形成性組成物。
- 前記加水分解でんぷんがヒドロキシプロピル化される、請求項2に記載のフィルム形成性組成物。
- 加水分解デンプン、ゲランゴム、イソソルビド、ソルビトール及びグリセロールを含んでなるハードカプセルシェル。
- 請求項4に記載のハードカプセルシェルを含んでなるハードカプセル。
- 請求項1〜3のいずれか一項に記載のフィルム形成性組成物を形成するステップを含んでなる、ハードカプセルシェルの製造方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP17305147.5 | 2017-02-08 | ||
EP17305147.5A EP3360544A1 (en) | 2017-02-08 | 2017-02-08 | Film-forming compositions for hard capsule shells and hard capsule shells obtained thereof |
PCT/EP2018/053111 WO2018146165A1 (en) | 2017-02-08 | 2018-02-07 | Film-forming compositions for hard capsule shells and hard capsule shells obtained thereof |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2020507642A JP2020507642A (ja) | 2020-03-12 |
JP6890182B2 true JP6890182B2 (ja) | 2021-06-18 |
Family
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US (1) | US11040105B2 (ja) |
EP (2) | EP3360544A1 (ja) |
JP (1) | JP6890182B2 (ja) |
KR (1) | KR102476977B1 (ja) |
CN (1) | CN110300577B (ja) |
CA (1) | CA3052722A1 (ja) |
CO (1) | CO2019008377A2 (ja) |
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WO (1) | WO2018146165A1 (ja) |
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FR2757173A1 (fr) * | 1996-12-17 | 1998-06-19 | Warner Lambert Co | Compositions polymeres d'origine non-animale pour la formation de films |
US6375981B1 (en) * | 2000-06-01 | 2002-04-23 | A. E. Staley Manufacturing Co. | Modified starch as a replacement for gelatin in soft gel films and capsules |
AU4061702A (en) * | 2001-05-15 | 2003-04-03 | Mcneil-Ppc, Inc. | Dip coating compositions containing starch or dextrin |
JP2005170929A (ja) * | 2003-11-18 | 2005-06-30 | Showa Sangyo Co Ltd | ソフトカプセル基剤 |
US7494667B2 (en) * | 2004-03-02 | 2009-02-24 | Brunob Ii B.V. | Blends of different acyl gellan gums and starch |
US20070128267A1 (en) * | 2005-12-02 | 2007-06-07 | Zhixin Li | Blends of gelling and non-gelling starches with gellan gums and plasticizer |
CN101245157B (zh) * | 2007-02-17 | 2011-06-15 | 长春大成特用玉米变性淀粉开发有限公司 | 成膜剂组合物和含有该组合物的淀粉质植物胶 |
FR2927084B1 (fr) * | 2008-02-01 | 2011-02-25 | Roquette Freres | Procede de preparation de compositions thermoplastiques a base d'amidon plastifie et compositions ainsi obtenues. |
US20120178858A1 (en) * | 2011-01-10 | 2012-07-12 | Andrew Julian Wnuk | Isosorbide-Plasticized Starch And Uses Thereof |
CN102813275B (zh) * | 2011-06-10 | 2015-09-30 | 杭州养生堂保健品有限公司 | 一种咀嚼型软胶囊皮和咀嚼型软胶囊 |
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US20190351062A1 (en) | 2019-11-21 |
CO2019008377A2 (es) | 2019-10-31 |
CN110300577B (zh) | 2022-04-05 |
CN110300577A (zh) | 2019-10-01 |
ES2863317T3 (es) | 2021-10-11 |
KR102476977B1 (ko) | 2022-12-14 |
US11040105B2 (en) | 2021-06-22 |
CA3052722A1 (en) | 2018-08-16 |
EP3360544A1 (en) | 2018-08-15 |
JP2020507642A (ja) | 2020-03-12 |
WO2018146165A1 (en) | 2018-08-16 |
KR20190111928A (ko) | 2019-10-02 |
EP3579822B1 (en) | 2020-12-16 |
EP3579822A1 (en) | 2019-12-18 |
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