Respitose® SV003

微粒子化篩過乳糖

狭い粒度分布

良好な流動性

Inhalation

製品情報

篩過乳糖は、トマホーク型の粒子で、表面が滑らかで流動性の良い結晶性乳糖です。篩過により様々な粒子径を実現し、お客様の製剤設計に最適なグレードを選択することができます。

製造工程における厳格で一貫した粒子径管理、および最新の粒子径測定技術が、弊社の吸入用篩過グレードの成功の基盤となっています。DFEファーマでは、Lactohale®とRespitose®が吸入用乳糖の篩過グレードのブランドとなっています。

粒子径と流動性

Lactohale® および Respitose® の篩過乳糖グレードは、粒子径が制御された医薬用α-乳糖一水和物です。粒度分布は比較的狭く、中央粒径は粉砕乳糖よりも一般的に大きくなっています。Carrの指数(Carr's Index)は、十分良い流動性を示しています。したがって、篩過乳糖は流動性が重要視される製剤設計に有効です。このタイプの乳糖は、リザーバー装置で一般的に使用されています。良好な流動性と粉体層の安定した密度により、投与ユニットは常に一定量の粉体で満たされています。篩過糖は、粉体流動性が要求される他のプラットフォーム、例えばドージングディスクカプセル充填技術においても推奨されます。粉砕された乳糖を使用することで、より高い凝集力を得ることができます。

吸入用乳糖の粒子径は、装置や充填プラットフォームに必要なフローに加えて、一般的に薬物沈着量を最適化するために選択されます。異なる乳糖グレードを組み合わせて使用することで、製剤の流動性と微粉含有量を最適な製品性能に調整することができます。DFEファーマでは、Lactohale®およびRespitose®と呼ばれる、粉砕および篩過された幅広い乳糖グレードをご用意しています。DFEファーマの製品ラインナップをご覧いただき、お客様の製剤ニーズに合ったグレードをご確認ください。また、カスタマイズもご検討ください。

Ph.Eur.、USP-NF、JPに準拠しています。

梱包形態

- 50 kg HDPEドラム（PEライナー付き）

品質保証期間

3年

生産地

オランダVeghel

製品の種類: 篩過乳糖
添加剤の機能性: キャリア
剤形: 吸入

代表的な製品データ

粒度分布(μm)

D10: 31
D50: 61
D90: 95

嵩密度(g/L)

嵩密度(g/L): 630

タップ密度 (g/L)

タップ密度 (g/L): 780

Carrの流動性指数(-)

Carrの流動性指数(-): 19

ドキュメンテーション

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Statement of business continuity planning
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Origin of Milk
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Absence of Melamine Lactose
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Residual solvent lactose
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Shelf life statement lactose
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Particle size measurement of lactose for dry powder inhalers 表示
The influence of lactose particle size on DPI performance 表示
Designing inhalation grade lactose 表示
Exploring the design space for dry powder inhalers 表示
Effect of Lactose Processing on Dry Powder Inhaler Dispersion 表示
Different Types of Lactose Fines have an impact on different dry powder inhalers properties 表示
Effect of Loaded Dose on Delivered Dose in DPI 表示
Measurement of Lactose from DPI in Impactors 表示

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