• Vibha Puri Ph.D.
  • Ashish Srivastava M.S.

Proposal Description:

Evolving paradigms in addressing the unique challenges of inhalation drug delivery will be addressed in this educational sunrise session with a particular focus on (a) coherent formulation, process, and device design for consistent and reproducible aerosolized inhalable particle properties throughout the shelf life, and (b) biopharmaceutics of site of lung deposition, dissolution, and biodistribution with focus on appropriate dissolution methods and predictive pharmacokinetics/pharmacodynamics (PK/PD).

This session will cover the fundamentals of pulmonary drug delivery with emphasis on emerging dry powder inhaler research on interparticle adhesion and the place of unconventional formulation ingredients (e.g., hydrophilic polymers and hydrophobic lubricants) and strategies (e.g., blended versus coprocessed particles). Critical performance attributes of the drug-device combination product will be identified and control strategies discussed.

The dissolution and biodistribution talk will focus on unique PK/PD outcomes based on formulation ingredients and particle properties, in addition to the site of lung deposition. The use of mathematical absorption modeling and novel dissolution systems will also be discussed.