DDDPlus™ is an advanced simulation software designed for pharmaceutical formulation and analytical scientists to model and simulate the in vitro dissolution experiment of active pharmaceutical ingredients (API) and formulation excipients. This tool allows users to quickly assess drug product performance under various experimental conditions, facilitating informed decision-making and improving the chances of success in drug development. Traditional dissolution studies, while crucial for developing and characterizing pharmaceutical dosage forms (both immediate and controlled-release), are often time-consuming and material-intensive. Scientists frequently face the challenge of designing products to achieve specific in vitro dissolution rates that correlate with desired in vivo exposure levels, or assessing bioequivalence for different dosing regimens, all while operating under tight deadlines and limited material. DDDPlus™ addresses these challenges by providing a more efficient, predictive strategy, reducing the need for extensive physical testing. The software is built upon carefully implemented theories and novel approaches to dissolution modeling. It enables users to input limited physicochemical and manufacturing data, set up their dissolution methods, and then generates comprehensive simulations. DDDPlus™ also supports the development and implementation of predictive dissolution models for Real-Time Release Testing (RTRT), a critical area for modern drug product manufacturing and regulatory compliance.

Features & Benefits

• Mechanistic Dissolution Modeling
  • Models and simulates in vitro dissolution of APIs and excipients under various experimental conditions, providing rapid insights into drug product performance.
• Predictive Capabilities for Real-Time Release Testing (RTRT)
  • Supports the design, development, validation, and implementation of predictive dissolution models for RTRT, aiding in regulatory submissions and post-approval lifecycle management.
• Intuitive User Interface
  • Offers a simple and intuitive interface for setting up dissolution methods and analyzing results.
• Model Optimization
  • Provides tools for optimizing dissolution models to achieve desired outcomes.
• High-Quality Reporting
  • Generates high-quality plots and figures suitable for reporting and documentation purposes.
• Integration with Other Tools
  • Seamlessly integrates with other Simulations Plus tools, such as ADMET Predictor® (QSAR) and GastroPlus® (PBPK & PBBM), for a comprehensive drug development workflow.