Advancements in the Development and Manufacturing of Nanosuspension Based Drug Products

Several nanoparticulate drug products joined the market in the last decade with commercial success. More recently, generic copies of originator products joined also the market demonstrating attractive and promising business areas. However, strategic drawbacks and technical limitations are nonetheless obvious to extract the inherent capabilities of nanosuspension based drug products. For instance: When should be a nanosuspension approach selected for a poorly soluble compound? Do we have realized the potential of nanosized drug compounds? Do we have elaborated future drug product manufacturing strategies to enable continuous manufacturing and patient centric approaches? The presentation will provide an overview on the currently commercialized nanosuspension based drug products, and will mainly focus on the following topics to address current strategic drawbacks and technical limitations:

  • In vitro rank ordering of formulation concepts from enabling technologies at the early stage of development.
  • Perspectives and first successes for drug nanoparticles below 100 nm particle size.
  • Continuous manufacturing of solid oral drug products with flexible dose strength using liquid dispensing and forced drying technology.

Michael Juhnke

Senior Fellow Oral Pharmaceutical Development Novartis AG 

Switzerland 

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