The excipient Trileucine is applied for improving aerosol performance and stability of spray-dried powders for inhalation. At Bachem an LPPS manufacturing process for Trileucine has already been established yielding high quality material.
To allow the application of Trileucine also for aqueous solutions at neutral pH, further development work was performed to enhance the water solubility of the isolated peptide. This was successfully achieved by spray drying, but in a more straightforward way the Trileucine form with higher solubility in water could also be directly obtained by an improved crystallization process based on the results of a polymorph screening study.
To learn more about this development approach as well as about Trileucine properties, manufacturing, and application in general, watch the recording from our webinar on the solubility-directed development of the Trileucine manufacturing process.