Respitose® ML003

微粉砕乳糖

一定量の微粒子を含む

凝集性が高い

Inhalation

製品情報

粉砕された吸入乳糖は、不規則な形状の粒子と凝集流動性を持つ、安定性の高い結晶性乳糖です。乳糖は機械的に粉砕され、様々な粒子径になります。これにより、製薬会社は製剤設計のニーズに合った最適なグレードを選択することができます。

製造中の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の組み合わせが、弊社の吸入用粉砕グレードの品質を支えています。DFEファーマでは、Lactohale®とRespitose®が吸入用乳糖のブランドとなっています。

粒子径と流動性

Lactohale® および Respitose® 粉砕乳糖は、粒子径が制御された不規則な形状の粒子で構成されています。粉砕乳糖は通常、幅広い粒度分布を持ち、中央粒径は篩過乳糖よりも小さくなっています。その微細な性質と比較的高い表面積により、粉砕乳糖の流動性は凝集性から非常に凝集性の高いものに分類されます。粉砕乳糖は、例えば、膜充填技術における凝集性や、カプセル充填技術における栓の形成を可能にするために一般的に使用されています。

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、粉砕および篩過した幅広い吸入用乳糖グレードをご用意しています。どのグレードがお客様の製剤設計に適しているか、またカスタマイズの可能性についても、当社の全製品をご覧ください。

Ph.Eur.、USP-NFおよびJPに準拠しています。

梱包形態

- 40 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: 粉砕乳糖
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: 3.7
D50: 38
D90: 112

嵩密度(g/L)

嵩密度(g/L): 560

タップ密度 (g/L)

タップ密度 (g/L): 850

Carrの流動性指数(-)

Carrの流動性指数(-): > 25

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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