Pharmaceutica Analytica Acta

Experimental methods to study interplay of dissolution, solubility and permeability in formulation development

8^th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems

March 07-09, 2016 Madrid, Spain

Balint Sinko

Pion Inc., USA

Posters & Accepted Abstracts: Pharm Anal Acta

Abstract:

Development strategy for insoluble compounds requires not only measurements of the solubility enhancement from formulations but also the assessment for the effect formulations having on permeability. An introduced dissolution-permeability (μFLUX) measurement platform allows simultaneous monitoring for both effects enabling in-vitro setup for early in-vivo predictive formulations testing. Ability to measure concentration of free (solubilized) drug in situ is critical necessity in formulation research because any offline solution handling can disturb quasi-stable (kinetic) phase that low soluble compounds often form in the presence of excipients. Case studies involving 2 different detection techniques based on fiber-optic UV measurements and potentiometric free drug sensors (FDS) will be presented. These case studies will highlight: Combining dissolution and permeability assays for better formulation design, understanding the food effect on bioavailability and more realistic IVIVC; studying if solubility enhancement in the biorelevant media leads to the same gain in the absorption and bioavailability; real time concentration monitoring of free drug in the presence of lipid passed formulations, nanoparticles and binding proteins; monitoring in real time the free API fraction released from nanoparticles and predicting absorption enhancement from nanoparticle formulations and; developing predictive in-vitro method to monitor powder/formulation dissolution and concomitant precipitation processes in dynamically changing biorelevant media.

Biography :

Email: bsinko@pion-inc.com