Already well-established for locally acting pharmaceuticals, Orally Inhaled and Nasal Drug Products (OINDPs) show great promise for the effective delivery of a variety of systemically-acting therapeutics. Patient acceptability, rapid absorption, gastro-intestinal tract avoidance, and the opportunity for product differentiation are just some of the driving factors.

How characterization can improve the performance of OINDPs

For all OINDPs, the spray droplet or particle size delivered by the device is a critical-to-quality attribute, directly influencing clinical efficacy. The correlation between spray size and in vivo deposition behavior makes spray particle size distribution measurement essential for all inhaled products during development, manufacture and QC. In addition, properties such as the API particle size within the dispersed aerosol, or the rheological properties of liquid and suspension formulations also play an important role in defining efficacy of drug delivery and overall bioavailability. 

Malvern’s solutions for OINDPs include: 

  • Spraytec, enabling an understanding of the dispersion and delivery of OINDP product formulations through spray droplet and particle size analysis
  • Morphologi, providing the ability to predict and control bioavailability by measuring component specific particle size and shape distributions for APIs within nasal spray, nebuliser and inhaler formulations
  • Kinexus, enabling an understanding of the stability and atomization of suspension and liquid formulations by measuring rheological behavior