Pharmaceuticals

Pharmaceuticals

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’s 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 include but are 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)

Application Areas by Dosage Form

Industry Proven with Regulatory Attention

*Use of logo does not indicate official company sponsorship or endorsement of DigiM’s services or technologies

Case Studies

Click on the images to learn more about each pharmaceutical case study!