BioHale® Trehalose Dihydrate

Description

With BioHale® Trehalose Dihydrate we offer the highest purity non-reducing sugars for the use in inhalation applications.

Multiple technologies for nasal and pulmonary drug delivery of active pharmaceutical ingredients exist. For the design of carrier-free formulations, spray drying has emerged as the preferred technology. Spray drying can be used to modify the particle surface, shape and density. An advantage of spray drying is that excipients, like the Biohale® grades, can be incorporated to modify aerosolization and flow properties, as well as to modify the drug release.

Biohale® excipients are high-purity excipients that can be safely used for pulmonary and nasal delivery. Trehalose and sucrose are both listed in the USP-NF, PhEur and JPE. They are GRAS listed and approved for the use in parenteral and non-parenteral pharmaceutical formulations.

Biohale® Sucrose and Biohale® Trehalose dihydrate are both non-reducing crystalline disaccharides. Non-reducing sugars provide improved compatibility over reducing sugars with amino acids and proteins, and are not easily hydrolyzed by acid.

An additional advantage of BioHale® excipients is that they can help complex molecules to maintain their native conformation. There are several theories describing the mechanisms behind this stabilization effect. In dry systems, the formation of an amorphous glass is found to be critical in both the vitrification theory and the water replacement theory.

Biohale® excipients can be used in spray drying processes to modify the physical properties of the resulting powder. They are also commonly used in other applications for the lyoprotection and cryoprotection of therapeutics proteins.

Packaging

• 1 kg HDPE container (PE liner)
• 20 kg HDPE drum (PE liner)