WHITE PAPER: IDAS – The Future of Dissolution and Permeation Evaluation

Abstract

One of the hurdles for any solid oral drug product (tablet or capsule) is the assessment of dissolution, the
rate, and extent of release of the drug substance (active pharmaceutical ingredient or API) from the
finished, formulated dose form. The protocols and acceptance criteria are specified in regulatory
guidelines published by the various national or regional drug regulatory agencies. The conditions for
these in vitro tests, everyone would agree, are not necessarily relevant to what happens when a
patient swallows a pill, but at least everyone has to get over the same hurdles. Intestinal permeation
of an API is another fundamental parameter that must be evaluated (e.g., across a monolayer of
polarized intestinal epithelial cells in vitro or an intact intestinal mucosa in situ or in vivo) during drug
development, but protocols are less rigidly defined. What is never done is to evaluate both dissolution
and permeation simultaneously, simply because it has not been possible.

Here we discuss a unique, new, proprietary technology platform called the In Vitro Dissolution
Absorption System, or IDAS. While these are early days in terms of exploring the capabilities of IDAS,
we present the results of several applications of the platform and discuss its unique power to
discriminate between formulations and reveal the sometimes surprising interplay between the
processes of dissolution and permeation.

Download this useful white paper.