New functionality for transdermal products creates a state-of-the-art IVIVE methodology in combination with the GastroPlus TCAT platform
-Simulations Plus, Inc., a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, announced it has released MembranePlus 3.0 to drive advances to in vitro-in vivo extrapolation (IVIVE) for permeability, hepatocyte, skin penetration, and release assay systems.
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“Our talented team has taken expert input from our collaboration partners to thoughtfully design the intuitive, one-of-a-kind connections between MembranePlus and GastroPlus”
Key enhancements in this new version include:
- New models of in vitro penetration (IVPT) and release (IVRT) tests for transdermal formulations for novel analysis of absorption and dissolution kinetics
- Expanded membrane transport model parameters for improved predictions of permeability coefficients for both small and peptide molecules
- Improved data handling and simulation performance
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Dr. Jessica Spires, Senior Scientist II and lead programmer on MembranePlus, said: “Through collaborations with the FDA and industry partners over the past several years, we have applied original data sets to design and validate models for in vitro dermal product evaluation, including skin penetration and release tests. These extensions now in MembranePlus fit seamlessly with recent improvements to the GastroPlus transdermal compartmental absorption and transit (TCAT) platform, giving researchers a unique and innovative simulation engine to predict exposure following topical administration of numerous formulations dosed in animals and humans. This amplified integration will be appreciated by all markets we support by providing greater insight into formulation strategies, serving as an alternative to animal testing for safety evaluation, and establishing a future foundation for virtual bioequivalence (VBE) assessment.”
“Our talented team has taken expert input from our collaboration partners to thoughtfully design the intuitive, one-of-a-kind connections between MembranePlus and GastroPlus,” added Dr. Haiying Zhou, Director of Simulation Technologies. “Developing computational models for more studies and covering a wider chemical space with our system parameters further reinforces MembranePlus as the preeminent modeling and simulation analysis tool for IVIVE of absorption, clearance, and distribution processes. We look forward to sharing these exciting developments with all users to advance model-informed drug development.”
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