Dissolution testing slows every stage of drug development
From early API screening to regulatory filings, dissolution testing is a bottleneck. Lab cycles take weeks, consume scarce materials, and often generate results that don't explain why a formulation succeeds or fails. That leaves formulation scientists guessing and programs falling behind.
dissoLab replaces physical dissolution runs with mechanistic simulations that complete in minutes. Run formulation scenarios in parallel before committing to any physical batch, compressing weeks of lab time into hours.
dissoLab's Idea Mode requires zero physical material. Start predicting dissolution from theoretical parameters alone. As material becomes available, refine predictions with laser diffraction data, 2D images, or 3D scans.
Every dissoLab simulation is grounded in physics-based algorithms tied directly to real microstructure data, not curve fitting. Outputs are audit-ready and traceable to first principles, giving your CMC narrative a defensible scientific foundation.
Stress-test formulation variations virtually before late-stage commitment. dissoLab surfaces poorly understood particle behavior early so teams can course-correct without expensive rework cycles at tech transfer or clinical stages.
dissoLab Software
A cloud-based predictive modeling platform that uses mechanistic, microstructure-informed dissolution simulation. dissoLab tracks full surface area evolution throughout dissolution on a per-pixel basis using actual sample images, not idealized spheres.
Virtual Prototyping
Set up particle geometry and parameters, then predict dissolution profiles before any physical material is made.
Quantify Microstructure Impact
Explore how shape, size distribution, solubility, and media each influence your dissolution profile.
Save Material
Replace costly physical testing cycles with mechanistic simulations from a few images.
De-risk Development
Stress-test formulation variations virtually and build confidence in your dissolution predictions early.
Four Ways to Predict Dissolution
dissoLab supports four versatile simulation inputs, allowing users to tailor their analysis based on available data at any stage of development.
Predict dissolution without any materials made. Set up particle geometry and theoretical parameters to explore formulation concepts before committing to physical batches.
Use laser diffraction particle size measurements to generate dissolution predictions with real distribution data. Ideal when initial materials are available.
Incorporate real particle morphology from SEM, PLM, or Morphologi images. dissoLab uses sGAN structure synthesis to generate representative 3D particles from 2D inputs.
Utilize volumetric imaging data from micro-CT or FIB-SEM for the most detailed analysis, reflecting the full complexity of your drug product microstructure.
From Data to Decision-Ready Predictions
Input Your Data
Upload particle size data, 2D microscopy images, or 3D volumetric scans. Or start with theoretical parameters alone.
Configure Conditions
Set dissolution medium, hydrodynamics, and physio-chemical parameters to match your target in vitro or in vivo conditions.
Run Simulations
Physics-based algorithms compute dissolution profiles incorporating real microstructure geometry. No empirical black-boxes.
Interpret & Act
Review predicted profiles, compare formulation variants, and export auditable results for scientific reports or regulatory dossiers.
What dissoLab Delivers
Across the Product Lifecycle
From early discovery through tech transfer and regulatory filing. dissoLab builds the evidentiary foundation your program needs.
Establish a digital twin strategy to identify and mitigate dissolution risks across the entire product lifecycle before they become batch failures.
Rationalize dissolution method development to minimize analytical method iterations and waste. Arrive at discriminatory methods faster.
Accelerate formulation selection and reduce costly trial-and-error cycles. Make confident go/no-go decisions earlier in development.
Strengthen tech transfer and regulatory submissions with robust, mechanistic data packages that demonstrate deep understanding of your product.
FAQs
Questions And
Answers
Browse through our most commonly asked questions below. If you don't find what you're looking for, reach out to our team directly.
Conventional models simplify particles into idealized spheres and apply Noyes-Whitney globally. dissoLab tracks full surface area evolution on a per-pixel basis using actual sample images, accounting for surface roughness, complex shapes, and real morphological behavior.
No. dissoLab works as a standalone tool. Some simulation modes require segmented image data, which can be produced using digiM's i2s platform or any compatible third-party tool.
Most simulations complete quickly, from seconds to a few minutes. Run time depends on your input data and the complexity of the simulation.
Yes. dissoLab has been validated across a variety of dosage forms, particle sizes, and BCS classes, demonstrating strong correlation with in vitro dissolution data.
