Lactohale® 400

無水乳糖

粗粉砕乳糖

不定形粒子

Inhalation

製品情報

Lactohale® 400 は、中央粒径 100μm の粉砕された無水乳糖グレードです。この粗粉砕乳糖グレードは、ある程度の凝集性と比較的良好な流動性が要求される乾燥粉末吸入（DPI）アプリケーションに適しています。無水乳糖であるため、当社の製品群の中でもユニークな製品となっています。Lactohale® 400 は、オランダのBorculoで製造されています。

Lactohale® 400は無水乳糖であるため、DPI製剤で一般的に使用されている乳糖キャリアーとは異なります。無水乳糖は、乳糖一水和物よりも密度が高くなります。さらに、β乳糖の結晶が微結晶であるため、粒子の粗さが大きくなります。無水乳糖は、同じ粒子径の乳糖一水和物とは異なるエアロゾル化性能を発揮することができます。これは、主に乳糖の流動化およびエントレインメントの挙動を支配する界面特性の違いによるものです。

製品の種類: 粉砕乳糖, 製品の種類無水乳糖
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: 6
D50: 102
D90: 272

嵩密度(g/L)

嵩密度(g/L): 650

タップ密度 (g/L)

タップ密度 (g/L): 920

Carrの流動性指数(-)

Carrの流動性指数(-): > 29

Documentation

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Genotoxic impurities statement
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MSDS Anhydrous lactose
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GMP+ DMV - Fonterra Excipients B.V. Borculo
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Halal DFE Pharma B.V. Borculo
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ICHQ3D Elemental Impurities Inhalation Lactose - Lactohale® (EU)
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Product brochure Lactohale® 400 表示
Product specification Lactohale® 400
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Dry Powder Inhalation Brochure 表示

BSE Statement Lactose & Inhalation
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cGMP Statement
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cGMP statement Respitose® & Lactohale®
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ICHQ3D Elemental Impurities Inhalation Lactose - Lactohale® (EU)
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World anti-doping code
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Please follow the instructions to see our documents:
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2. The document will be displayed in your web browser. If a login window to MasterControl appears, please use an incognito/private window, or clear the cache of your browser.
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The PDFs are technically modified by DFE Pharma’s controlled documentation system. Please follow the instructions to download and save our documents:
1. Click on "Download document"
2. The document will open in Master Control, in a window of your browser. Click on Download>PDF
3. This will open a new browser window with an empty document. Click on "Save". The document will be saved to your computer.
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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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