چکیده (انگلیسی):

In vitro dissolution testing is important for providing
process control and quality assurance, determination of
stability release characteristics of the product over time, and
facilitating certain regulatory determinations (e.g., absence of
effect of minor formulation changes or of change in manufacturing
site on performance). In the past two decades, the
dissolution test has also been widely discussed to serve as an
indicator of how the formulation will perform in vivo (1–3).
Although basket and paddle methods are currently the
most popular methods for many drug products, both methods
are operated under closed finite sink condition and cannot
mimic the conditions present in the digestive system. A flowthrough
method using the official USP 4 apparatus operated
in open-loop mode is capable of maintaining a continuous
flow of fresh dissolution medium, thus, maintaining infinite
sink conditions (3–6). This operational mode provides an
environment potentially closer to that of the digestive tract.
Thus, this technique may offer advantages for establishing in
vitro and in vivo correlations (IVIVCs).
To compare dissolution testing under finite