Simulations Plus (“SLP”) Releases DDDPlus 4.0

Keywords: immediate release capsule dosage form, in vitro dissolution, parameter sensitivity analysis, virtual trials
Software: DDDPlus™
Division: PBPK

Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, announced today the release of DDDPlus™ version 4.0 with an impressive set of expanded and powerful capabilities for simulating in vitro dissolution experiments.

DDDPlus 4.0 now includes:

  • Expanded Parameter Sensitivity Analysis
  • New Virtual Trial capability
  • New immediate release capsule dosage form
  • Variety of enhanced input and output functions

Dr. Haiying Zhou, senior scientist and product manager for DDDPlus at Simulations Plus, said: “We believe DDDPlus is the only commercial software available for simulation of in vitro dissolution experiments. It is used in companies around the world as well as by regulatory agencies, including the U.S. Food and Drug Administration (FDA). With this release, we have enhanced the automated Parameter Sensitivity Analysis feature and added a powerful new capability: Virtual Trials. Parameter Sensitivity Analysis enables users to automatically see the effects of varying individual input parameters with all other parameters held constant. Users can now analyze these effects on the full dissolution vs. time profiles. Virtual Trials enable the user to see how much variability should be expected if a particular experiment was run many times. In real life, because there are many variables in both the dosage form and the experiment that cannot be held perfectly constant, running the same experiment many times generates different results each time. Usually, the results are nearly the same, but sometimes they can be different enough to create a problem. The new Virtual Trial capability in DDDPlus enables a formulation scientist to see in minutes what would take hours of work to duplicate in real experiments thereby helping to establish critical dissolution specifications to meet certain regulatory guidelines.”

Walt Woltosz, chairman and chief executive officer of Simulations Plus, added: “When we first developed DDDPlus about eight years ago, no one had done this before, but we believed that such a simulation would prove to be a useful tool for formulation scientists. While it took some time to catch on, DDDPlus has become a successful product that is used by scientists in industry and the FDA to understand the mechanisms that influence in vitro dissolution rates to design in vitro experiments that better mimic how dosage forms dissolve in vivo. The ability to rapidly see the effects of changing formulation variables like the size of the drug particles and different excipients, as well as changing the experimental conditions such as paddle speed, buffer composition, and fluid volume without the need to setup, run, and cleanup can significantly reduce the time and cost needed to identify the appropriate formulation or experiment. A growing number of formulation scientists are realizing the value of having a simulation tool that can guide their next steps.”