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The United Kingdom’s Center for Process Innovation (CPI) is investing in a new project, Microstar, which seeks to reduce risk for formulators through the development of accelerated screening methods for predictive design.
The Center for Process Innovation (CPI), the United Kingdom’s technology innovation provider for process manufacturing, announced that it is investing in a new project, Microstar, which seeks to reduce risk for formulators through the development of accelerated screening methods for predictive design. The aim is to develop a methodology and design specification for a novel microfluidic chip to allow rapid formulation stability screening to enable users to quickly understand, forecast, and control the stability of formulated products.
The performance of products, including drugs, consumer goods, and industrial products, relies heavily on the stability of the formulation, especially during transportation and storage. It is anticipated that the Microstar project will enable formulators to quickly test out their formulations using a wide range of variable conditions. Such testing maps out the failure modes for a given formulation over reduced timescales, hence, enabling risk-informed business decisions to be made based on mechanistic understanding with empirical models.
Microfluidics has been selected as the platform of choice for the project because of its ability to impose rapid fluctuations of temperature, pressure, flow, and vibrations, all of which mimic the variable environmental and physical conditions that a drug product may be subjected to. Microfluidics has been used for more than 40 years, particularly in the development of micro- and nano-emulsion formulations; however, it has not yet been developed as a route to accelerate stability screening of formulations, which is the novel approach taken by the Microstar project.
The project consortium includes academic knowledge partners Imperial College and University of Durham, as well as Industrial partners BP and Procter & Gamble, who will provide knowledge of their own formulations, and will provide samples into the project with known stability and breakdown mechanisms.
Microfluidics will be used in parallel with multipass and conventional rheology in order to be able to impose substantial flow fields of the type and magnitude relevant to a range of practical utilization. Specifically within the scope of this project, these will replicate the temperatures and stresses experienced by a lubricant in an engine. The project is expected to complete in late 2020, after which a rig and method of use for accelerated stability testing will be offered by CPI’s National Formulation Center on an open access basis to benefit the UK formulation industry.