digiM Awarded Patent to Characterize Spray-dried Particles with Thin Walls from MicroCT Images

Microstructure CQAs
Full field-of-view pharmaceutical tablet microstructure image showing internal phase distribution and pore network

The US Patent Office issued an allowance notification on a digiM technique to segment and quantify thin wall features from microscopic images commonly seen in drug and material products. The patent (US20210304391A1) is titled “Reconstruction of Thin Wall Features Marginally Resolved by Multi-Dimensional Images”, and priority dated March 25, 2020.

Thin walls in imaging are often marginally resolved due to resolution limit, which traditional image processing techniques incompletely segment and classify as part of a broken wall. Combining geometric continuity principles and curvature sensitive intensity classification, this new technique found applications in mission critical industrial problems such as spray dried dispersions, where the particle wall is a critical material attribute which can impact its processability and compaction properties downstream. The patented technology has been validated and successfully applied in supporting over 150 active ASD drug development pipeline programs, some of which has been published. In a Merck program, wall thickness reconstructed by this method was found to have a direct relationship and impact on the final tablet tensile strength. In another program at Eli Lilly, particle wall thickness quantified by digiM method was found to play a role in the final porosity and dissolution performance of tablets.

Micro-CT image comparison showing DigiM thin wall reconstruction technique applied to spray dried dispersion particles, demonstrating improved segmentation of marginally resolved wall features
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Lonza logo
Lonza logo
AbbVie logo
AbbVie logo
Bausch Health logo
Bausch Health logo
Bristol Myers Squibb logo
Bristol Myers Squibb logo
Merck logo
Merck logo
Moderna logo
Moderna logo
Novartis logo
Novartis logo
Pfizer logo
Pfizer logo
Johnson & Johnson Innovative Medicine logo
Johnson & Johnson Innovative Medicine logo
Roche logo
Roche logo
Mirati Therapeutics logo
Mirati Therapeutics logo
Genentech logo
Genentech logo
Lonza logo
Lonza logo

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Purple tablet dispersing into a fine particle cloud, illustrating drug microstructure disintegration