Abstract:
The conventional dissolution test, particularly the USP apparatus I and II, remains an important tool in the field of
the pharmaceutical product development. For accurate dissolution characterization, sink conditions, where saturation solubility
of a drug in the dissolution medium is at least three times more than the drug concentration, are significant. These conditions
can be difficult to maintain with formulations containing poorly soluble active pharmaceutical ingredients. This research
summarizes the role of the excipients to enhance dissolution of racecadotril and facilitate the achievement of sink. The
dissolution model utilizes various media (0.1N HCl, Acetate buffer pH 4.5 and Phosphate buffer pH 6.8) with surfactant to
improve the dissolution limitation of racecadotril. Crucially, the acetate buffer pH 4.5 with 0.75% SLS does allow sink conditions
to be maintained and hence the experiment will yield complete dissolution.
Description:
The authors are grateful to the Gujarat Council on Science and
Technology (GUJCOST), Gandhinagar, Gujarat for providing
financial assistance in this work (MRP-2015538).
