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

Formulation Development
Process and Manufacturing Development
Drug Performance Assessment
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)

Why Microstructure Analysis?

Reduce Costs

Avoid costly pitfalls and unnecessary manufacturing through an intimate correlation of microstructures and product performance.

Advance Decisions

Accelerate mission critical formulation and process decisions through high-resolution insights on microscale phenomena.

Build Insights

Our microstructure analysis is more than a one off result, building long-term insights which can be applied across the entire formulation and process design space.

Knowledge Database

Our team of application scientists are experts in microstructure science, with over a decade of combined experience in pharmaceutical applications.

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!