Linking Process Parameters to Dissolution Behaviour in Generic Tablet Development (2026-EU-PO-2784)

In this poster, we present a modelling workflow using JMP Pro 18 to link process parameters with dissolution behaviour for a generic film-coated tablet (FCT) under development.

The dissolution profile is modelled using a three-parameter Weibull growth function (Asymptote, Location, Growth Rate), automatically fitted via a custom JSL script that extracts parameters across batches and integrates them with process data.

The data set includes both discrete and continuous process variables, which are evaluated using the Fit Model platform. Each Weibull parameter is treated as a separate response, and model effects include main factors and their interactions. Effect Screening with a standard least squares personality is used to identify significant contributors.

To ensure model robustness, we reduce input complexity and validate residuals for normality and randomness. Optimisation of input factors is performed using desirability functions, targeting reference product specifications for each response variable. The final model balances multiple responses and prioritises the most influential parameter driving dissolution performance, guiding process decisions towards consistent product behaviour.

This approach demonstrates how JMP can streamline data integration, modelling, and optimisation in pharmaceutical development.