JP5322643B2 - カプセル化された活性成分、カプセル化された活性成分の製造方法および使用 - Google Patents
カプセル化された活性成分、カプセル化された活性成分の製造方法および使用 Download PDFInfo
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- JP5322643B2 JP5322643B2 JP2008528630A JP2008528630A JP5322643B2 JP 5322643 B2 JP5322643 B2 JP 5322643B2 JP 2008528630 A JP2008528630 A JP 2008528630A JP 2008528630 A JP2008528630 A JP 2008528630A JP 5322643 B2 JP5322643 B2 JP 5322643B2
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- 125000002467 phosphate group Chemical group [H]OP(=O)(O[H])O[*] 0.000 description 1
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- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
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- 238000007711 solidification Methods 0.000 description 1
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- 239000000600 sorbitol Substances 0.000 description 1
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- 230000006641 stabilisation Effects 0.000 description 1
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- 150000004043 trisaccharides Chemical class 0.000 description 1
- 235000021122 unsaturated fatty acids Nutrition 0.000 description 1
- 150000004670 unsaturated fatty acids Chemical class 0.000 description 1
- 229920001285 xanthan gum Polymers 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
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- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- DFKDOZMCHOGOBR-UHFFFAOYSA-N zaragozic acid A Natural products O1C(C(O)(C(O2)C(O)=O)C(O)=O)(C(O)=O)C(OC(=O)C=CC(C)CC(C)CC)C(O)C21CCC(=C)C(OC(C)=O)C(C)CC1=CC=CC=C1 DFKDOZMCHOGOBR-UHFFFAOYSA-N 0.000 description 1
Classifications
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- 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
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
-
- A—HUMAN NECESSITIES
- 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
- A23L27/00—Spices; Flavouring agents or condiments; Artificial sweetening agents; Table salts; Dietetic salt substitutes; Preparation or treatment thereof
- A23L27/70—Fixation, conservation, or encapsulation of flavouring agents
- A23L27/72—Encapsulation
-
- A—HUMAN NECESSITIES
- 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
- A23L33/115—Fatty acids or derivatives thereof; Fats or oils
- A23L33/12—Fatty acids or derivatives thereof
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/30—Encapsulation of particles, e.g. foodstuff additives
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
-
- 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
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
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- 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
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5052—Proteins, e.g. albumin
- A61K9/5057—Gelatin
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Polymers & Plastics (AREA)
- Food Science & Technology (AREA)
- Nutrition Science (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Mycology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicinal Preparation (AREA)
- General Preparation And Processing Of Foods (AREA)
- Cosmetics (AREA)
- Manufacturing Of Micro-Capsules (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
活性な薬剤、成分、分子または組成物、たとえば栄養補助食品、医薬品、除草剤、殺虫剤およびその他の多数のもののカプセル化は、濃縮され、容易に輸送可能な、かつ場合により加工可能な形状の活性成分を、該成分が予め決められた場所および時間でカプセル化システムから放出されるまで安定化するという目的を有している。これは活性成分の性質および目的に依存して変動しうる。従来技術は、異なった活性成分および異なった放出場所に適合された種々のカプセル化技術を開示しており、多くのカプセル化システムは、正確に環境および時間に合わせた、極めて特殊な放出特性を提供することが明らかである。
驚いたことに、本発明は、経口投与が意図されている酸素に敏感な活性成分に対する効果的な酸素バリアを提供し、従って貯蔵安定性における安定性の増大を提供する方法を見いだした。さらに、たとえば経口投与され、かつ食品中に配合された場合に、粒子は意外にも胃腸管に到達した時に活性成分を放出する。
(i)疎水性に変性されたデンプン 3〜50質量%および
(ii)デンプン加水分解産物 50〜97質量%
を含有する。
(i)疎水性に変性されたデンプン 3〜50質量%および
(ii)デンプン加水分解産物 50〜97質量%
を含有する。
本発明は、活性成分を含有する粒子に関する。本発明の文脈で粒子とは、平滑な、もしくは不規則な表面を有する任意の形状、たとえば球形、円形、ロッド形、立方形、ディスク形、平坦形、またはフィルム状であってよい。一般に、本発明の粒子の形状は、ガラス状マトリックスの製造方法により決定される。粒子は、その形状に依存して、5μm〜1cm、有利には10μm〜5mmの範囲の平均直径、長さ、厚さまたはその他の寸法を有していてよい。
例1および2
複合コアセルベーションによるコアセルベートマイクロカプセルの製造
暖かい脱イオン水180gおよびゼラチン20gを、攪拌容器中で完全に溶解するまで混合することによって、ゼラチン(ブタゼラチン、Aタイプ、275Broom)のストック溶液(A)を製造した。次いで該溶液を加熱し、かつ50℃に保持した。
マルトデキストリン18DE(Roquette製)90%および変性デンプン(Capsul(登録商標)、National Starch製)の混合物69.5gを、コアセルベート懸濁液に添加し、かつ室温で、完全に溶解するまで十分に混合した。次いでコアセルベート懸濁液を、30000rmpで運転される回転輪を備えたパイロットプラント用噴霧乾燥機(Niro FSD0.8)で噴霧乾燥させた。入口温度は、200℃であり、他方、出口温度はポンプ速度を制御することにより85℃に維持した。その結果、50μmの平均直径を有するコアセルベートマイクロカプセルを含有する粒子の易流動性粉末が得られ、その際、マイクロカプセルは、さらに高分子炭水化物材料を含有するガラス状マトリックス中にカプセル化されている。
凝集防止剤(二酸化珪素)1gを、加工助剤としてコアセルベートのスラリーに添加した。次いでコアセルベート懸濁液を、30000rpmで運転される回転輪を備えたパイロット・プラント用噴霧乾燥機(Niro FSD0.8)上で噴霧乾燥させた。入口温度は150℃であり、他方、出口温度は、ポンプ速度を制御することによって100℃に維持した。易流動性の粉末が製造された。
マルトデキストリン18DE(Roquette製)90%および変性デンプン(Capsul(登録商標)、National Starch製)10%の混合物69.5gを、コアセルベート懸濁液に添加し、完全に溶解するまで室温で十分に混合した。この懸濁液を、ボトムスプレー用に設置された2mmの2流体ノズルを備えたパイロット・プラント用流動床(Glatt AGT150)中へ噴霧し、かつ噴霧気体圧力1バールで運転した。入口温度は120℃であり、他方、出口温度は、ぜん動ポンプの速度を制御することによって60℃に維持した。流動/乾燥ガス流は、140m3/hに設定した。流動床乾燥機は、ジグザグ形空気式分級器を使用して連続モードで運転し(気体流は、0.2バールに設定した)、顆粒を連続的に排出し、かつ所望の平均粒径を制御した。その結果、コアセルベートマイクロカプセルが、ガラス状の炭水化物マトリックス中に埋め込まれた易流動性の球形顆粒が得られた。平均粒径は、400ミクロンである。
スクリュー押出法によるコアセルベートマイクロカプセルをカプセル化するガラス状マトリックス
例3a、3b、3cおよび4aでは、コアセルベートカプセルをスクリュー押出法によりカプセル化した。3aでは、1bの乾燥コアセルベートカプセルを使用し、3bのためには、2bのものを使用し、3cのためには、WO04/041251に開示されている二重コアセルベート粒子を使用した(このタイプの二重コアセルベート粒子は、Ocean Nutririon、カナダ(ONC)からMEG−3(登録商標)として市販されている)。4aのためには、1aのコアセルベートカプセルを使用した。
噴霧乾燥または噴霧造粒によるコアセルベートマイクロカプセルをカプセル化しているガラス状マトリックス
例1a、1bおよび3cの乾燥コアセルベートカプセルは、噴霧乾燥によりガラス状マトリックスにより包囲されて例5a、5b、5cとなるか、または噴霧造粒によって例6a、6b、6cとなる。
噴霧凝集によりコアセルベートマイクロカプセルをカプセル化しているガラス状マトリックス
例1a、1bおよび3cの乾燥コアセルベートカプセルは、噴霧凝集によりガラス状マトリックスにより包囲されて、例7a、7bおよび7cとなった。
Claims (7)
- 1もしくは複数のコアセルベートカプセル中にカプセル化された活性成分を含有する粒子であって、1もしくは複数のコアセルベートカプセルは、さらにガラス状マトリックス中にカプセル化されており、その際、ガラス状マトリックスは、
(i)疎水性に変性されたデンプン 3〜50質量%および
(ii)デンプン加水分解産物 50〜97質量%
を含有するものであり、疎水性に変性されたデンプンは、アルケニルコハク酸エステル化デンプンであり、かつデンプン加水分解産物は、5〜25のデキストロース当量を有するマルトデキストリンであり、活性成分が、多価不飽和脂肪酸(PUFA)リッチなオイルである、1もしくは複数のコアセルベートカプセル中にカプセル化された活性成分を含有する粒子。 - 疎水性に変性されたデンプンが、C3〜C14−アルケニルコハク酸エステル化デンプンである、請求項1記載の粒子。
- アルケニルコハク酸エステル化デンプンが、オクテニルコハク酸エステル化デンプンである、請求項2記載の粒子。
- 活性成分をカプセル化して含有する、請求項1から3までのいずれか1項記載の粒子の製造方法であって、コアセルベーションにより活性成分である多価不飽和脂肪酸リッチなオイルをカプセル化して1もしくは複数のコアセルベートカプセルを得る工程、および1もしくは複数のコアセルベートカプセルの周囲にガラス状のマトリックスを形成する工程を有し、該ガラス状マトリックスは、マトリックス成分として、
(i)疎水性に変性されたデンプン 3〜50質量%および
(ii)デンプン加水分解産物 50〜97質量%
を含有する、活性成分をカプセル化して含有する粒子の製造方法。 - コアセルベートカプセルの周囲にガラス状マトリックスを形成する工程が、コアセルベートカプセルをマトリックス成分と一緒に、噴霧乾燥、噴霧造粒、噴霧凝集および/または押出することにより行われる、請求項4記載の方法。
- コアセルベーションのプロセスが、活性成分の周囲に層を形成する1もしくは複数の親水コロイドを架橋する工程を含む、請求項4または5記載の方法。
- 経口摂取が意図されている活性成分の不所望の、および/または不快な味、異臭または苦味をマスクするための、1もしくは複数のコアセルベートカプセルをカプセル化する、請求項1から3までのいずれか1項記載のガラス状マトリックスの使用。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
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EP05107932.5 | 2005-08-30 | ||
EP05107932 | 2005-08-30 | ||
US71490905P | 2005-09-06 | 2005-09-06 | |
US60/714,909 | 2005-09-06 | ||
PCT/IB2006/052995 WO2007026307A2 (en) | 2005-08-30 | 2006-08-29 | Encapsulated active ingredients, methods of preparation and their use |
Publications (3)
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JP2009506106A JP2009506106A (ja) | 2009-02-12 |
JP2009506106A5 JP2009506106A5 (ja) | 2009-10-15 |
JP5322643B2 true JP5322643B2 (ja) | 2013-10-23 |
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JP2008528630A Expired - Fee Related JP5322643B2 (ja) | 2005-08-30 | 2006-08-29 | カプセル化された活性成分、カプセル化された活性成分の製造方法および使用 |
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US (1) | US20080206325A1 (ja) |
EP (1) | EP1924156B1 (ja) |
JP (1) | JP5322643B2 (ja) |
CN (1) | CN101252845B (ja) |
AT (1) | ATE430488T1 (ja) |
CA (1) | CA2620507C (ja) |
DE (1) | DE602006006695D1 (ja) |
ES (1) | ES2325039T3 (ja) |
RU (1) | RU2008112212A (ja) |
WO (1) | WO2007026307A2 (ja) |
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-
2006
- 2006-08-29 CA CA2620507A patent/CA2620507C/en not_active Expired - Fee Related
- 2006-08-29 CN CN2006800319167A patent/CN101252845B/zh not_active Expired - Fee Related
- 2006-08-29 WO PCT/IB2006/052995 patent/WO2007026307A2/en active Application Filing
- 2006-08-29 JP JP2008528630A patent/JP5322643B2/ja not_active Expired - Fee Related
- 2006-08-29 AT AT06795811T patent/ATE430488T1/de not_active IP Right Cessation
- 2006-08-29 EP EP06795811A patent/EP1924156B1/en not_active Not-in-force
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- 2006-08-29 RU RU2008112212/13A patent/RU2008112212A/ru unknown
- 2006-08-29 ES ES06795811T patent/ES2325039T3/es active Active
- 2006-08-29 US US12/065,032 patent/US20080206325A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
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EP1924156B1 (en) | 2009-05-06 |
RU2008112212A (ru) | 2009-10-10 |
ATE430488T1 (de) | 2009-05-15 |
US20080206325A1 (en) | 2008-08-28 |
CN101252845A (zh) | 2008-08-27 |
ES2325039T3 (es) | 2009-08-24 |
WO2007026307A2 (en) | 2007-03-08 |
CA2620507A1 (en) | 2007-03-08 |
WO2007026307A3 (en) | 2007-07-12 |
JP2009506106A (ja) | 2009-02-12 |
EP1924156A2 (en) | 2008-05-28 |
CA2620507C (en) | 2011-07-19 |
DE602006006695D1 (de) | 2009-06-18 |
CN101252845B (zh) | 2012-03-28 |
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