digiM AAPS Topical and Transdermal Community 2024

Microstructure CQAs
Tablet

Formulation development and optimization of topical dosage forms often involves some guesswork with selecting formulation and process parameters. Globule characterization can play a pivotal role in offering insights for innovators and generic formulators during the development lifecycle of topical products. Globules within topical products can be achieved through the use of high-resolution 3D X-ray micro-CT, with AI analysis enabling the inspection of products in their native states.

Key Learning Objectives:

  • What globule attributes can we quantify with non-invasive analysis?
  • How can we assess Q3 bioequivalence for topical products?
  • How can these CQAs accelerate process and formulation selection? 

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