Accelerate Oral Solid Dosage Development
with Microstructure Analysis
Characterization Challenges
Oral solid dosage form development can be quite complex. In addition to formulation decisions, the manufacturing techniques utilized can have a major impact on the performance of the final drug product. From spray drying to granulation to roller compaction, the impact of different techniques on particulate characteristics will dictate the tableting properties and dissolution performance. The final drug product has its own set of properties to control and monitor, including fracture development, dissolution behavior, coating properties, ASD recrystallization, and more. Microstructures are at the root of all of these properties, and a high-resolution, non-invasive technique is needed to study them.
Helping formulators advance development through enhanced understanding of ingredient selection and manufacturing optimization
The DigiM Solution
At DigiM, we use a combination of non-invasive imaging techniques to quantify the internal structures of oral solid dosage forms and their intermediates. Amongst characterization of final drug product properties, analysis of upstream intermediates has been proven to aid in downstream tableting and dissolution performance.
Custom Solutions
Our analysis has been applied across the entire range of oral solid dosage forms and their stages of development. Discover more below:
SDD and Granule Preparation Methods
Through imaging of intermediates, important quality attributes such as particle size, wall thickness, and internal void space can be studied in thorough detail. These parameters can be critical to controlling downstream tableting and dissolution performance.
High resolution mosaic SEM imaging is utilized to study the internal ingredients of a Claritin-D 12 hour tablet.
Ingredient Distribution
Our AI analysis can quantify the internal distribution of active ingredients, inactive ingredients, and functional excipients, providing unique insights into the structures dictating dissolution and disintegration performance.
Coating Optimization
We apply non-invasive X-ray microscopy and AI image analysis to quantify critical coating parameters such as coating thickness, uniformity, and defects.