Pharmaceuticals

Pharmaceuticals

DigiM Featured in FDA workshop

Microstructures are essential in the development of pharmaceuticals. The size, distribution, and interplay of active pharmaceutical ingredients (API), excipients, and porosity are important to the therapeutic performance of a drug or a medical device.     

At DigiM, we have developed an integrated micro-imaging platform to take on challenges in drug formulation, product design, and process development. DigiM pharmaceutical microstructure characterization platform includes high resolution correlative 3D imaging, AI-based image analysis, and image-based release prediction. We analyze a wide range of pharmaceutical samples including solid dosage forms, lyophilized biologics, and combination products, from early formulation development to final products in the market stage. See the sidebar for some of the unique challenges we have solved for our customers.

Discover DigiM's Image-based Solutions

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Formulation Development
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Process and Manufacturing Development
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Drug Performance Assessment
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Q3 Microstructure Bioequivalence

Example key performance attributes for a drug product sample includes but is not limited to:

  • Microporosity
  • API Particle Size Distribution
  • Uniformity and Connectivity of API, Pore, and Excipient
  • Image Based Simulation of Physical Properties (including dissolution/release profile)
  • Geometry and Shape for Quality Control
  • Interface Characterization (including coatings)

Dosage Forms and Application Areas

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Click on the images to learn more about pharmaceutical case studies!
Amorphous Solid Dispersion Tablet
Amorphous Solid Dispersion Tablet
Spray Dried Particles
Spray Dried Particles
IUS System
IUS System
Long-acting Ocular Implant
Long-acting Ocular Implant
ASD Particle
ASD Particle
DigiM microstructure characterization of a lyophilized protein drug product for formulation and process development (freeze drying xrm case study)
Lyophilized Solids
Controlled Release Microencapsulation
Controlled Release Microencapsulation
Enteric Tablet Coating
Enteric Tablet Coating
DigiM FIB-SEM image of a controlled release PLGA microsphere with microporosity
Controlled Release Microspheres
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Presentations and Publications

  1. Zhang, S., Goldman, J., Chen, X., Rowe, J., Lin, S., Zhou, L. (2020). Non-Invasive, Quantitative Characterization of Lyophilized Drug Product Using Three-Dimensional X-Ray Microscopy Analytics. Drug Development & Delivery. 
  2. DigiM Awarded FDA Contract to Study Microstructure Bioquivalence. With UConn. Read the press release. News Medical press release available here.
  3. Zhou, L., Stroud, P., Zhu, A., Hinds, J., Blakely, K., Zhang, S. (2019). Characterization of Spray-Dried Aggregates for Tablet Formulation with Microstructure 3D Imaging Analytics. Poster presented at AAPS PharmSci 360 2019 in San Antonio, Texas. With Eli Lilly. 
  4. Zhou, L., Chen, X., Goldman, J., Rowe, J., Zhang, S., Lin, S. (2019). Non-invasive Three-dimensional X-Ray Microscopy Imaging Technique for Quantitative Characterization of Lyophilized Drug Product. Poster presented at AAPS PharmSci 360 2019 in San Antonio, Texas. With Bristol-Myers Squibb and Moderna.
  5. Zhou, L., Lomeo J., & Zhang, S. (2019). Drug Substance / Drug Product Characterization and Performance Prediction Using High Resolution 3D Micro-Imaging Analysis. Poster presented at Applied Pharmaceutical Analysis 2019 Meeting in Boston, MA and recognized as an Outstanding Poster (September 9-11, 2019). 
  6. Yost, E., Chalus, P., Zhang, S., Peter, S., & Narang, A. S. (2019). Quantitative X-Ray Microcomputed Tomography Assessment of Internal Tablet Defects. Journal of Pharmaceutical Sciences, 108(5), 1818-1830. With Genentech, Lonza, and Roche.