JP2020507642A - 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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- GJCOSYZMQJWQCA-UHFFFAOYSA-N 9H-xanthene Chemical compound C1=CC=C2CC3=CC=CC=C3OC2=C1 GJCOSYZMQJWQCA-UHFFFAOYSA-N 0.000 description 1
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- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 description 1
- ZNOZWUKQPJXOIG-XSBHQQIPSA-L [(2r,3s,4r,5r,6s)-6-[[(1r,3s,4r,5r,8s)-3,4-dihydroxy-2,6-dioxabicyclo[3.2.1]octan-8-yl]oxy]-4-[[(1r,3r,4r,5r,8s)-8-[(2s,3r,4r,5r,6r)-3,4-dihydroxy-6-(hydroxymethyl)-5-sulfonatooxyoxan-2-yl]oxy-4-hydroxy-2,6-dioxabicyclo[3.2.1]octan-3-yl]oxy]-5-hydroxy-2-( Chemical compound O[C@@H]1[C@@H](O)[C@@H](OS([O-])(=O)=O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H]2OC[C@H]1O[C@H](O[C@H]1[C@H]([C@@H](CO)O[C@@H](O[C@@H]3[C@@H]4OC[C@H]3O[C@H](O)[C@@H]4O)[C@@H]1O)OS([O-])(=O)=O)[C@@H]2O ZNOZWUKQPJXOIG-XSBHQQIPSA-L 0.000 description 1
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- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 description 1
- 239000004599 antimicrobial Substances 0.000 description 1
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- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
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- 150000004676 glycans Chemical class 0.000 description 1
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 239000000252 konjac Substances 0.000 description 1
- 235000010485 konjac Nutrition 0.000 description 1
- 235000021374 legumes Nutrition 0.000 description 1
- 238000010907 mechanical stirring Methods 0.000 description 1
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- 239000001814 pectin Substances 0.000 description 1
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- 239000000546 pharmaceutical excipient Substances 0.000 description 1
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- 238000011020 pilot scale process Methods 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 229920006254 polymer film Polymers 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 229950008882 polysorbate Drugs 0.000 description 1
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- 229920002451 polyvinyl alcohol Polymers 0.000 description 1
- 235000019422 polyvinyl alcohol Nutrition 0.000 description 1
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 description 1
- 239000001508 potassium citrate Substances 0.000 description 1
- 229960002635 potassium citrate Drugs 0.000 description 1
- QEEAPRPFLLJWCF-UHFFFAOYSA-K potassium citrate (anhydrous) Chemical compound [K+].[K+].[K+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O QEEAPRPFLLJWCF-UHFFFAOYSA-K 0.000 description 1
- 235000011082 potassium citrates Nutrition 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 238000000425 proton nuclear magnetic resonance spectrum Methods 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
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- 238000002791 soaking Methods 0.000 description 1
- 239000007901 soft capsule Substances 0.000 description 1
- 239000007909 solid dosage form Substances 0.000 description 1
- 238000005063 solubilization Methods 0.000 description 1
- 230000007928 solubilization Effects 0.000 description 1
- 230000003381 solubilizing effect Effects 0.000 description 1
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- 239000003765 sweetening agent Substances 0.000 description 1
- 229920001059 synthetic polymer Polymers 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
- 229920001285 xanthan gum Polymers 0.000 description 1
Classifications
-
- 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
- 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
- A61K47/06—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)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- General Preparation And Processing Of Foods (AREA)
- Compositions Of Macromolecular Compounds (AREA)
Abstract
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 (7)
- 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。
- 前記フィルム形成性組成物が本質的に天然由来の成分から構成される、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。
- 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5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1〜4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 |
---|---|---|---|
EP17305147.5A EP3360544A1 (en) | 2017-02-08 | 2017-02-08 | Film-forming compositions for hard capsule shells and hard capsule shells obtained thereof |
EP17305147.5 | 2017-02-08 | ||
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)
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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) |
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JP2003089659A (ja) * | 2001-05-15 | 2003-03-28 | Mcneil Ppc Inc | デンプンまたはデキストリンを含有しているディップ・コーティング組成物 |
JP2005170929A (ja) * | 2003-11-18 | 2005-06-30 | Showa Sangyo Co Ltd | ソフトカプセル基剤 |
JP2007308713A (ja) * | 1996-12-17 | 2007-11-29 | Warner-Lambert Co Llc | カプセル用のポリマーフィルム組成物 |
JP2011511120A (ja) * | 2008-02-01 | 2011-04-07 | ロケット・フルーレ | 可塑化デンプンベース熱可塑性組成物を調製する方法および結果として生じる組成物 |
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JP2014516995A (ja) * | 2011-06-10 | 2014-07-17 | ハンヂョウ・ヤンシェンタン・ヘルスケア・プロダクツ・カンパニー・リミテッド | チュワブル軟カプセルシェルとチュワブル軟カプセル剤 |
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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 |
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2017
- 2017-02-08 EP EP17305147.5A patent/EP3360544A1/en not_active Withdrawn
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2018
- 2018-02-07 ES ES18702733T patent/ES2863317T3/es active Active
- 2018-02-07 JP JP2019541122A patent/JP6890182B2/ja active Active
- 2018-02-07 WO PCT/EP2018/053111 patent/WO2018146165A1/en unknown
- 2018-02-07 CN CN201880010790.8A patent/CN110300577B/zh active Active
- 2018-02-07 EP EP18702733.9A patent/EP3579822B1/en active Active
- 2018-02-07 KR KR1020197020808A patent/KR102476977B1/ko active IP Right Grant
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- 2018-02-07 CA CA3052722A patent/CA3052722A1/en active Pending
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JP2007308713A (ja) * | 1996-12-17 | 2007-11-29 | Warner-Lambert Co Llc | カプセル用のポリマーフィルム組成物 |
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 |
JP2003089659A (ja) * | 2001-05-15 | 2003-03-28 | Mcneil Ppc Inc | デンプンまたはデキストリンを含有しているディップ・コーティング組成物 |
JP2005170929A (ja) * | 2003-11-18 | 2005-06-30 | Showa Sangyo Co Ltd | ソフトカプセル基剤 |
JP2011511120A (ja) * | 2008-02-01 | 2011-04-07 | ロケット・フルーレ | 可塑化デンプンベース熱可塑性組成物を調製する方法および結果として生じる組成物 |
US20120178858A1 (en) * | 2011-01-10 | 2012-07-12 | Andrew Julian Wnuk | Isosorbide-Plasticized Starch And Uses Thereof |
JP2014516995A (ja) * | 2011-06-10 | 2014-07-17 | ハンヂョウ・ヤンシェンタン・ヘルスケア・プロダクツ・カンパニー・リミテッド | チュワブル軟カプセルシェルとチュワブル軟カプセル剤 |
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US11040105B2 (en) | 2021-06-22 |
EP3579822B1 (en) | 2020-12-16 |
CO2019008377A2 (es) | 2019-10-31 |
JP6890182B2 (ja) | 2021-06-18 |
ES2863317T3 (es) | 2021-10-11 |
CN110300577A (zh) | 2019-10-01 |
EP3579822A1 (en) | 2019-12-18 |
CA3052722A1 (en) | 2018-08-16 |
WO2018146165A1 (en) | 2018-08-16 |
US20190351062A1 (en) | 2019-11-21 |
KR20190111928A (ko) | 2019-10-02 |
CN110300577B (zh) | 2022-04-05 |
EP3360544A1 (en) | 2018-08-15 |
KR102476977B1 (ko) | 2022-12-14 |
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