Advancing Development through Microstructure Analysis
What are amorphous solid dispersions, and how do we characterize them?
Amorphous solid dispersions play a pivotal role in the development of BCS Class II and IV drug candidates. These poorly soluble compounds require careful consideration in their design, both during the development of intermediates and the final product. In particular, spray dried dispersions (SDDs) require special attention during development and scale up because of the potential interrelationship of factors that affect crystallization tendency, dissolution, formulation and process conditions. While particulate based characterization techniques such as polarized light microscopy, SEM, and laser diffraction are helpful for assessing properties of ensembles of particles, they are limited in the level of detail they can provide in a time and cost effective manner. Furthermore, they don’t yield a quantitative picture of the interior and exterior microstructural characteristics of the ASD particles which can potentially impact performance behavior and may need to be controlled at a later stage to optimize downstream processing characteristics such as compaction.
The DigiM Solution
Reimagining ASD development
via high-resolution analytics
Easy access to best-in-class x-ray micro-CT, x-ray microscopy, SEM, and FIB-SEM systems, supported by DigiM’s decades of expertise in imaging design.
Surpass Traditional Techniques
Quantifiable Critical Quality Attributes
Deep learning analytics is applied to classify particles (yellow), particle voids (red), and intra-particle air (green). Critical quality attributes can then be computed and correlated to process and performance.
Visualization of connected porosity within tablets which had variation in dissolution time, formulated using SDDs from Lab and GMP batches. Transport properties can be predicted directly from quantified 3D imaging data.
Transport Simulation and
Utilizing patented algorithms, the DigiM I2S platform can simulate transport properties directly from 3D imaging data, providing unprecedented correlation and optimization of drug performance through microstructures.
Core Solution Areas for ASD Development
DigiM ASD Customers and Published Work*
*Use of logo does not indicate official company sponsorship or endorsement of DigiM’s services or technologies