We extends a heartfelt thanks to CoreRx for choosing our instruments for the groundbreaking experiment, "A Data-Based Approach to Selection of Bioavailability Enhancement Strategy Using New Simultaneous Dissolution-Flow Through Permeability Cell for Formulation Development."
To investigate a strategy for screening and estimation of bioavailability enhancement (BAE) for BCS class II, III, and IV drugs. The process uses in-vitro flux of formulated products through biomimetic membranes in conjunction with early phase pharmacokinetic (pk) data from the drug substance to predict relative changes to bioavailability and estimate the area under the curve (AUC) for proposed enhancing formulation(s). Herein we describe the in-vitro permeability testing and results for selection of a BAE formulation for a new BCS class II/IV drug substance. Screening studies were performed using small volume side-by-side flux cells to evaluate candidate excipient/formulation options for improvements to in-vitro solubility and permeability. These data were used to select and prepare 3 test formulations, 1 oral suspension and 2 separate spray dried dispersions. The test formulations were evaluated for biorelevant solubility and permeability using a flow through flux cell apparatus in parallel with a USP dissolution bath and 200 mL vessels. These flux data were compared to the API in capsule permeability in conjunction with invivo pk data for the drug substance to predict relative changes in permeability and estimate the AUC for the new formulations. The test formulations were then submitted for a single dose animal pk study for confirmation and comparison to the in-vitro data. The purpose of this experiment is to evaluate an in-vitro method for better predictions of bioavailability enhancement using existing in-vivo data from early phase animal or human pk studies.
The collaboration with CoreRx exemplifies our shared commitment to advancing pharmaceutical sciences. Looking forward to continued success and impactful discoveries together!
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