gPROMS FormulatedProducts® is PSE's modelling platform for the integrated digital design of robust formulated products and their manufacturing processes.
It enables scientists and engineers to screen formulations with complex phase structures for quality attributes, determine whether they can be manufactured robustly, and explore the design space for the whole formulation and manufacturing chain.
Users can screen formulations for end-user attributes, identify risk factors and optimize the formulation and manufacturing processes across application areas: active ingredient manufacture, formulated product manufacture, and product performance.
Active Ingredient manufacture
The active ingredient manufacture models enable you to optimize the design of batch and continuous reaction processes through to downstream steps, such as crystallization and wet milling. Multiple liquid phases and inter-phase mass transfer can be modelled in the active ingredient synthesis steps. Crystallization models can be utilised to describe the evolution of the particle size distribution for single or multiple crystal phases due to primary and secondary nucleation, growth & dissolution, and agglomeration mechanisms.
Formulated product manufacture
Formulated product manufacture models can optimize manufacturing process design and operation of solids processes, to reduce capital and operating costs while ensuring product quality. The model libraries include direct compression and incorporating integrated mixing processes of both active ingredient and excipients which can predict the impact of upstream disturbances on tablet composition. Libraries also include dry granulation, wet granulation, spray drying, and continuous blending and tabletting.
In vivo and in vitro product performance model libraries for absorption, pharmacokinetics, dissolution, and stability that can be applied across the development lifecycle, supporting preclinical activities, through to pivotal trials and post approval changes. Screen candidates for lead optimization, formulation prototyping and developability. Support release testing method development. Accelerate stability assessment studies. De-risk clinical trials, and optimize bioavailability, dissolution, stability, and bioequivalence performance.
Upstream and downstream bioprocessing models for application across the process lifecycle for the design and operation of robust and optimal processing steps. The model libraries include bioreactors, fermentors, chromatography, membranes and lyophilization steps.
Developed with industry partners
Working closely with our partners in the Systems-based Pharmaceutics Alliance and major industrial and academic R&D partners such as ADDoPT, C-SOPS, CMAC, D3P and REMEDIES. The result is a tool based on state-of-the-art science that can address practical challenges. These capabilities enable companies to perform integrated digital design of robust formulated products and their manufacturing processes.
Watch one of our webinars below to find out more information about using advanced mechanistic process modelling tools in a systems-based approach that links product performance to process and formulation parameters. PSE has integrated crystallization, solids processing and oral absorption on a single platform with gPROMS FormulatedProducts.
gPROMS FormulatedProducts is an end-to-end approach using PSE products formerly branded gCRYSTAL, gSOLIDS, and gCOAS.