(637g) Decoupling Solvent Penetration Mechanisms for Dissolution Mechanism Elucidation of Pharmaceutical Tablets

Callegari, G., Rutgers University
Gulak, Y., Rutgers, The State University of New Jersey
Drazer, G., Rutgers University
Cuitino, A., Rutgers University

In recent years there has been a growing effort to understand the underlying dissolution mechanisms. Although most of the studies were on controlled released (CR) tablets, quality by design of immediate release (IR) tablets is gaining interest in the pharmaceutical industry and there is a need for a reliable methodology to characterize drug release.

The performance of IR tablets, is usually controlled by the dynamics of solvent penetration into the tablet through two competing mechanisms: capillarity and diffusion, inducing matrix swelling. We present dissolution experiments in which we monitor solvent infiltration dynamics for tablets produced at different compaction forces simultaneously with tablet deformation by measuring the mass of liquid uptake and through visualization techniques.  We also present finite time dissolution experiments in which tablets are extracted after a certain time in contact with the solvent and thoroughly characterized. We finally present experiments in which, we were able to decouple capillary infiltration and swelling dynamics by using a low-viscosity, non-swelling solvent and also explore different solvent conditions to increase the characteristic swelling time.


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