CRS 2018 Poster: Development and Optimization of MR Formulations in the absence of predictive laboratory or preclinical models

The integration of formulation design space, real-time GMP manufacturing, and an iterative sequential pharmacokinetic (PK) study in healthy volunteers was successfully applied to develop an HPMC matrix tablet that achieved the desired PK characteristics for SLx-2101.The key formulation variables influencing performance were the range of dose and release rate, hence a two-dimensional (2D) design space was mapped by manufacturing and characterizing four “regulatory batches” bracketing the corners of the compositional ranges.

Download our poster titled, 'Development and Optimization of MR Formulations in the absence of predictive laboratory or preclinical models' here.