Formulation and process development
We aid in solving formulation and process development challenges
to upgrade in efficiency, workflow and effort
to bring products to market faster.
Digital drug product development
In the transition to Pharma 4.0, many aspects on the exact implementation of computational modelling into drug product development remain unclear.
Elegent tries to shed light on several ways in which process models can support the formulator's core work in highlighted cases on this page. Find out more on how a tablet press model can be applied to investigate the effect of main compression force in function of formulation in order to make informed decisions for DPD.
Overall, investing in digital drug product development offers pharmaceutical companies opportunities to accelerate R&D processes, reduce costs, improve patient outcomes,
and adapt to the rising complexity of new drug molecules.
By leveraging the power of digital technologies, the industry can enhance its capabilities and deliver innovative drug products to patients more sustainably, efficiently and effectively.
Specific solutions
Below, you will find a list of formulation- and process development-related inquiries that Elegent can assist you with. Please note that this list is not exhaustive, and we encourage you to reach out to us even if your specific situation is not mentioned. We are dedicated to providing prompt and informative feedback to all inquiries.
Do not hesitate to contact us today.
Depending on the process at hand and dataset availability, we can suggest surrogate powders to conduct OSD process development.
Depending on dataset availability, even in the early stages of pre-clinical development, predictions can be made on tabletting performance in function of formulation properties. Suggestions can be made for initial characterisations, so that these can enhance predictive power and generate even more robust predictions for final tablet quality.
Even minor variations in the characteristics of excipients can have a notable impact on the subsequent stages of drug product development. Factors such as milling grade or other modifications can make a significant difference. At Elegent, we have access to a comprehensive tabletting database that includes information on excipients with diverse properties. This enables us to predict critical quality attributes of tablets for new active pharmaceutical ingredients when combined with different types and versions of excipients. Our database-driven approach allows us to identify the optimal excipient, taking into consideration various optimisation objectives.
When working with a fixed active pharmaceutical ingredient (API) and formulation base, we can conduct simulations to assess the impact of different tablet process settings. By leveraging our deep understanding of the underlying processes, we can determine the optimal process settings or even ranges for a formulation that the client has already deemed optimal. This approach allows us to estimate the most effective process parameters, taking into account the specific formulation requirements identified by the client.
Due to the sheer size of the compression datasets available to Elegent, predictive power is present across a multitude of formulations, multiplied with the various different process settings that the tablets were produced at. A simultaneous estimation of formulation and process settings is thus certainly possible. It can even be worthwhile to assess the product aspects within a range of process settings at certain formulation compositions, as shown in this product development case.