JP2023002728A - 固体粒子 - Google Patents
固体粒子 Download PDFInfo
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- JP2023002728A JP2023002728A JP2022169709A JP2022169709A JP2023002728A JP 2023002728 A JP2023002728 A JP 2023002728A JP 2022169709 A JP2022169709 A JP 2022169709A JP 2022169709 A JP2022169709 A JP 2022169709A JP 2023002728 A JP2023002728 A JP 2023002728A
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- solid particles
- vitamin
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- emulsifier
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- 235000019149 tocopherols Nutrition 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
- QUEDXNHFTDJVIY-UHFFFAOYSA-N γ-tocopherol Chemical class OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1 QUEDXNHFTDJVIY-UHFFFAOYSA-N 0.000 description 1
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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
- A61K31/23—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of acids having a carboxyl group bound to a chain of seven or more carbon atoms
-
- 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
- A23P10/20—Agglomerating; Granulating; Tabletting
- A23P10/28—Tabletting; Making food bars by compression of a dry powdered mixture
-
- 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
- A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
-
- 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
- A23L33/15—Vitamins
- A23L33/155—Vitamins A or D
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/07—Retinol compounds, e.g. vitamin A
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
- A61K31/222—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having aromatic groups, e.g. dipivefrine, ibopamine
-
- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; 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
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- A23V2250/00—Food ingredients
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- A23V2250/60—Sugars, e.g. mono-, di-, tri-, tetra-saccharides
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Abstract
Description
(i)固体粒子の全重量に対して、ビタミンA及び/又はその誘導体を少なくとも20重量%(wt-%)、
(ii)少なくとも1種類の乳化剤、及び
(iii)少なくとも1種類の非還元糖、
を含む固体粒子(SP)であって、酸化防止剤を全く含まない固体粒子(SP)に関する。
(i)固体粒子の全重量に対して、ビタミンAアセテート及び/又はビタミンAパルミテートを少なくとも20重量%(wt-%)、
(ii)少なくとも1種類の乳化剤、及び
(iii)少なくとも1種類の非還元糖、
を含む固体粒子(SP’)であって、酸化防止剤を全く含まない固体粒子(SP’)に関する。
(i)固体粒子の全重量に対して、ビタミンA及び/又はその誘導体を少なくとも22重量%(wt-%)、
(ii)少なくとも1種類の乳化剤、及び
(iii)少なくとも1種類の非還元糖、
からなる固体粒子(SP1)に関する。
(i)固体粒子の全重量に対して、ビタミンAアセテート及びビタミンAパルミテートを少なくとも22重量%(wt-%)、
(ii)少なくとも1種類の乳化剤、及び
(iii)少なくとも1種類の非還元糖、
からなる固体粒子(SP1’)に関する。
[実施例1]
容器内で脱イオン水370.6gを60~65℃まで加熱した。食品修飾デンプン324.00g及びトレハロース121.2gを添加し、60~65℃で攪拌しながら混合物を溶液状にした。得られた溶液を50~55℃に冷却し、1時間脱気した。続いて、マトリックスシステムにビタミンAアセテート188.78gを添加し、乳化した。プロセスの温度を常に65℃未満に維持した。乳化後、エマルジョンの内相は平均粒径約272nm(Dv(0.1)=100nm、Dv(0.5)=272nm、Dv(0.9)=559nm)を有し、測定はレーザー回折(Malvern 3000)によって実現された。乳化後、ハロゲン水分計(Mettler Toledo,Type HR73-P)によって決定されるエマルジョンの水分を確認し、必要であれば適応させた。その後、トウモロコシデンプン1500gを含有する噴霧皿(spray pan)内に、回転噴霧ノズルを使用してエマルジョン150gを噴霧した。過剰量のトウモロコシデンプンから、得られた粒子を篩い分けし(150~600μm)、水蒸気除去した空気を用いて、室温で乾燥させた。乾燥後の最終生成物粒径は、レーザー回折(Malvern 3000)によって測定された平均246μm(Dv(0.1)=198μm,Dv(0.5)=246μm,Dv(0.9)=303μm)であった。表1に示す組成を有する固体粒子が得られた。
オイル混合物(ビタミンAアセテート188.78g,BHT1.04g)190.82gを使用し、且つ少ない量の修飾食品デンプン(316.75g)を使用して、上述の手順と同じ手順に従った。
この例は実施例1と同様に行われたが、トレハロースの代わりにスクロースを使用した。
この例は実施例2と同様に行われたが、トレハロースの代わりにスクロースを使用した。
ビタミンAアセテート粒子(実施例1及び2で得られた)27g、微結晶性セルロース33.24g、リン酸カルシウム49.86g及びステアリン酸マグネシウム0.2gからなる粉末100gを10分間混合した。圧力35KNでこの最終調製物を圧縮した。錠剤(一般にディスク形状;0.2g)を密閉した茶色のガラス瓶内で室温にて保管し、24か月間保管した後に、ビタミンAアセテート含有量を決定した。
[実施形態1]
(i)固体粒子の全重量に対して22~75重量%の、ビタミンA、ビタミンAアセテート及び/又はビタミンAパルミテート、
(ii)固体粒子の全重量に対して20~70重量%の、少なくとも1種類の乳化剤、及び
(iii)固体粒子の全重量に対して5~55重量%の、少なくとも1種類の非還元糖、
を含む固体粒子であって、
前記少なくとも1種類の乳化剤は、動物原料由来ではない乳化剤であり、
前記固体粒子は、酸化防止剤を全く含まない、固体粒子。
[実施形態2]
前記非還元糖が、トレハロースである、実施形態1に記載の固体粒子。
[実施形態3]
固体粒子の全重量に対して、少なくとも1種類の非還元糖を10~50重量%含む、実施形態1に記載の固体粒子。
[実施形態4]
固体粒子の全重量に対して、ビタミンA、ビタミンAアセテート及び/又はビタミンAパルミテートを25~65重量%含む、実施形態1から3のいずれか1つに記載の固体粒子。
[実施形態5]
前記少なくとも1種類の乳化剤が、修飾(食品)デンプン、ペクチン、アルジネート、カラゲナン、ファーセレラン、リグノスルホネート、多糖ゴム(アカシアゴム(=アラビアゴム)、修飾アカシアゴム、TICゴム、アマニゴム、ガッチゴム、タマリンドゴム及びアラビノガラクタンなど)、植物タンパク質(エンドウ豆、ダイズ、トウゴマ、綿、ジャガイモ、サツマイモ、マニオク、ナタネ、ヒマワリ、ゴマ、アマニ、ベニバナ、レンズマメ、ナッツ、コムギ、米、トウモロコシ、オオムギ、ライ麦、カラスムギ、ルピナス及びモロコシなど)、レシチン、脂肪酸のポリグリセロールエステル、脂肪酸のモノグリセリド、脂肪酸のジグリセリド、ソルビタンエステル、及び糖エステルからなる群から選択される、実施形態1から4のいずれか1つに記載の固体粒子。
[実施形態6]
圧縮錠剤の製造における、実施形態1から5のいずれか1つに記載の固体粒子の使用。
[実施形態7]
実施形態1から5のいずれか1つに記載の固体粒子を含む、圧縮錠剤。
Claims (6)
- (i)固体粒子の全重量に対して22~75重量%の、ビタミンA、ビタミンAアセテート及び/又はビタミンAパルミテート、
(ii)固体粒子の全重量に対して20~70重量%の、少なくとも1種類の乳化剤、及び
(iii)固体粒子の全重量に対して5~55重量%の、少なくとも1種類の非還元糖、
を含む固体粒子であって、
前記少なくとも1種類の乳化剤は、動物原料由来ではない乳化剤であり、
前記少なくとも1種類の乳化剤は、食品修飾デンプン、多糖ゴム及び植物タンパク質からなる群から選択される乳化剤であり、
前記固体粒子は、酸化防止剤を全く含まない、固体粒子。 - 前記非還元糖が、トレハロースである、請求項1に記載の固体粒子。
- 固体粒子の全重量に対して、少なくとも1種類の非還元糖を10~50重量%含む、請求項1に記載の固体粒子。
- 固体粒子の全重量に対して、ビタミンA、ビタミンAアセテート及び/又はビタミンAパルミテートを25~65重量%含む、請求項1から3のいずれか一項に記載の固体粒子。
- 圧縮錠剤の製造における、請求項1から4のいずれか一項に記載の固体粒子の使用。
- 請求項1から4のいずれか一項に記載の固体粒子を含む、圧縮錠剤。
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EP17171890 | 2017-05-19 | ||
EP17171890.1 | 2017-05-19 | ||
JP2019554733A JP2020520894A (ja) | 2017-05-19 | 2018-05-17 | 固体粒子 |
PCT/EP2018/062831 WO2018210981A1 (en) | 2017-05-19 | 2018-05-17 | Solid particles |
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JP2019554733A Division JP2020520894A (ja) | 2017-05-19 | 2018-05-17 | 固体粒子 |
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