Applications of USP apparatus 3 in assessing the in vitro release of solid oral dosage forms

Abstract

<p>USP Apparatus 3 (reciprocating cylinder) is a very versatile device for the <italic>in vitro</italic> assessment of release characteristics of solid oral dosage forms, because it enables the product to be subjected to different dissolution media and agitation speeds in a single run. In this paper, a brief history and a description of this system are presented, along with its applications in the development of immediate and modified release products and in the simulation of fasted and fed states using biorelevant media. Furthermore, a comparison is made with the basket and paddle apparatus, especially highlighting the superior hydrodynamics of USP apparatus 3, since the results are not sensitive to factors such as the presence of sample collection probes or air bubbles in the dissolution medium.</p>