BioHale® Sucrose (Inhalation)

Inhalation

製品情報

医薬品有効成分の鼻腔および肺へのドラッグデリバリーには、複数の技術が存在します。キャリアフリーの製剤設計には、噴霧乾燥が好ましい技術として浮上しています。噴霧乾燥は、粒子表面、形状、および密度を修正するために使用することができます。噴霧乾燥の利点は、Biohale® グレードのような添加剤を組み込んで、エアロゾル化および流動特性を修正し、薬物放出を修正することができることです。

Biohale®の添加剤は、高純度の添加剤であり、肺や鼻へのデリバリーに安全に使用することができます。トレハロースとスクロースは共にUSP-NF、PhEurおよびJPにリストされています。これらはGRASに登録されており、非経口および非経口医薬製剤での使用が承認されています。

Biohale® スクロースとBiohale®トレハロース水和物は、どちらも非還元性の結晶性二糖類です。非還元糖は、還元糖に比べてアミノ酸やタンパク質との相溶性が向上し、酸で容易に加水分解されません。

BioHale®添加剤のもう一つの利点は、複雑な分子がその本来のコンフォメーションを維持するのを助けることができる点です。この安定化効果の背後にあるメカニズムについては、いくつかの説があります。乾燥系では、ガラス化理論および水置換理論のいずれにおいても、非晶質ガラスの形成が重要であることが分かっています。

Biohale®添加剤は、得られる粉末の物理的特性を変更するために噴霧乾燥工程で使用することができます。また、治療用タンパク質の凍結保護やクライオプロテクションの用途にもよく使用されます。

包装形態

- 1kgのHDPE容器（PEライナー）

- 20kgのHDPEドラム（PEライナー）

品質保証期間

24ヶ月

製品の種類
添加剤の機能性: キャリア
剤形: 吸入

代表的な製品データ

原料

原料: テンサイから分離

CAS番号

CAS番号: 57-50-1

Tg (°C)

Tg (°C): ~61

ドキュメンテーション

Absence of Melamine Pharmacel, SuperStarch, Disintegrants
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Absence Statement Flavors, Coloring, Sweeteners, Preservatives and Glycols
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BSE statement BioHale (Sucrose, Trehalose)
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Collective statement Sucrose (allergens, latex etc)
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Compliance packaging
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Contaminants Sucrose
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COS Sucrose
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Country of origin Sucrose
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FDA UNI numbers
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Genotoxic impurities statement
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GMO statement Sucrose
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ICHQ3D elemental impurities
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Ingredient declaration Sucrose
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IPEC questionnaire on Nitrosamines
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Nano materials
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No US DMF requirement
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No use of PFC, DEHP, DINP and BPA
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None dangerous substance
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Stability statement BioHale Sucrose
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Residual Solvents Statement BioHale Sucrose
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Safety Information Sucrose
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Brochure Biohale® 表示

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