gPROMS FormulatedProducts’s product performance libraries contain models for oral absorption, in vitro dissolution and precipitation, pharmacokinetics, and product stability.
The models can be utilised within the gPROMS FormulatedProducts® framework which brings advanced simulation, model validation, optimization, uncertainty analysis, sensitivity analysis and custom modelling capabilities.
The model libraries were developed in cooperation with leading pharmaceutical companies, and offer many advantages over prior approaches.
In vivo oral absorption
Predict oral absorption performance in the human gastrointestinal tract as a function of product formulation and drug substance properties, patient physiology and ingestion conditions. Utilize mechanistic models to explore the design of clinical formulations of drug products for early stage activities such as candidate selection, risk analysis, formulation prototyping. Accelerate clinical development by progressing compounds faster with lower failure rates, minimizing iterative changes in development by influencing design and process development, and evaluating bioequivalence.
In vitro dissolution
Predict in vitro dissolution and precipitation (e.g. USP II and ASD) as a function of the experimental system, operating procedure, product formulation and drug substance properties. Develop process control strategies, testing protocols, parameterize mechanistic oral absorption models, and develop mechanistic understanding to help explore the design of formulations of drug products for activities such as candidate selection, risk analysis, formulation prototyping, and ensuring bioequivalence.
Pharmacokinetics
Single, two and three compartment models characterizing the distribution, metabolism and elimination in the body of an externally administered drug substance. Use with clinical data to estimate the appropriate disposition model parameters. Then combine with mechanistic oral absorption models to accelerate clinical development by progressing compounds faster with lower failure rates, and minimize iterative changes in development by influencing design and process development.
Stability
Predict how the quality of a drug varies with time under the influence of environmental factors to establish recommended storage conditions, retest periods, and shelf lives. Coupling accelerated stability data with PSE’s stability models enable the user to rapidly predict stability at long-term storage conditions, and provides significant benefits in science-based decision-making throughout development, allowing for an earlier assessment of risk enabling appropriate mitigation strategies to be implemented in a timely manner. PSE’s solid formulation stability models include a range of kinetic options and packaging models that can be applied using a kinetics or an isoconversion approach.
