Lactohale® 300

微粉砕

非常に微細な乳糖

製剤の流動性と性能の最適化

Inhalation

製品情報

Lactohale® 300 は、D50 が 5 ミクロンを下回る非常に微細な乳糖です。LH300 は乾燥粉末吸入製剤に使用することで、薬物の沈着量を向上させることができます。微粉末の導入により、いくつかの方法で薬物付着性を向上させることができます。また、Lactohale® 300と粗乳糖をブレンドすることで、お客様の製品プロファイルに合わせた乳糖ブレンドを開発することができます。

Laser Diffraction Particle Size Graph Lactohale 300

薬物付着の改善

DPI製剤に微粉末を添加すると....

乳糖微粉末が高エネルギーの「活性部位」を占めるのに対し、薬物は乳糖キャリア表面の低エネルギー部位を占めるようになり、薬物とキャリアの付着が少なくなり、沈着が改善される。

^{Lucasら(1998) Pharmaceutical Research 15: 562 - 569.}

... 薬物-微粉末の凝集体の形成をサポートする。凝集体は、個々の薬物粒子と比較して高い抗力にさらされるため、キャリアからの剥離が促進される。

^{ルーカスら（1998）Pharmaceutical Research 15: 562 - 569. / Loueyら(2002) Pharmaceutical Research 19: 1524 - 1531.}

... 混合中の高い押圧力から薬剤を保護し、その結果、薬剤とキャリア間の付着が減少し、その結果、沈殿が改善されます。

^{Dickhoffら( 2006) International Journal of Pharmaceutics 327; 17-25.}

...バルク粉末の引張強度を増加させ、その結果、最小流動化エネルギーも増加する。その結果、バルク粉末の初期破砕時に大きな凝集体が形成され、その凝集体はより分散しやすくなり、微粒子率が増加する。

^{Shur et al. (2008) Pharmaceutical Research 25: 1631 - 1640.}

Ph.Eur.、USP-NFおよびJPに準拠。

梱包形態

- 12.5kgカードボードボックス＋アルミライナー

品質保証期間

12ヶ月

生産地

オランダBorculo

製品の種類: 微粉末乳糖
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)

D50: 5
D90: 10

嵩密度(g/L)

嵩密度(g/L): 260

タップ密度 (g/L)

タップ密度 (g/L): 520

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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Residual solvent lactose
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Shelf life statement lactose
IMPORTANT: PLEASE READ BEFORE VIEWING OR DOWLOADING DOCUMENTS
View documents

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:
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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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