Dextran-Based Materials as Excipients in Engineered Particle Formulations: Tailoring Physical Properties to Optimize Performance, Manufacturability, and Safety

May 5, 2011

 

Vodak, David T., Dan E. Dobry, Dwayne T. Friesen, Matthew D. Reed, Andrew P. Gigliotti, Philip J. Kuehl, and David K. Lyon, “Dextran-Based Materials as Excipients in Engineered Particle Formulations: Tailoring Physical Properties to Optimize Performance, Manufacturability, and Safety,” RDD Europe 2011, Vol. 1, R.N. Dalby, P.R. Byron, J. Peart, J.D. Suman, and P.M. Young (eds). Virginia Commonwealth University, Richmond, Virginia (2011) pp. 125-134.

 

Dextrans and derivatized dextrans are considered to have beneficial physical properties as potential carriers in engineered particle formulations. For water-soluble actives, e.g., albuterol sulfate, amorphous dextran-10-based engineered powders were shown to enable dry powder formulations with fine particle fractions greater than 50% and mass median aerodynamic diameters of 2 - 3 μm. In addition, a strategy involving the covalent modification of the dextran backbone extended this formulation approach to the manufacture of water insoluble actives, e.g., fluticasone propionate. Safety data indicated low-level pulmonary and systemic exposures but there appeared to be a relationship between a safe dose of dextran and the amount of dextran required to stabilize the formulation. Future strategies will seek to minimize the excipient load to reduce the associated safety risks.

 

 

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Inhalation