Reliable release testing for nanoparticles with the NanoDis System, an innovative sample and separate technique

Abstract

One of the critical quality attributes of nanoparticle formulations is drug release. Their release properties should therefore be well characterized with predictive and discriminative methods. However, there is presently still no standard method for the release testing of extended release nanoformulations. Dialysis techniques are widely used in the literature but suffer from severe drawbacks. Burst release of formulations can be masked by slow permeation kinetics of the free drug through the dialysis membrane, saturation in the membrane, and absence of agitation in the membrane. In this study, the release profile of poly(lactic co-glycolic) (PLGA) nanocapsules loaded with all-trans retinoic acid was characterized using an innovative sample and separate set-up, the NanoDis System, and compared to the release profile measured with a dialysis technique. The NanoDis System showed clear superiority over the dialysis method and was able to accurately characterize the burst release from the capsules and furthermore discriminate between different all-trans retinoic acid nanoparticle formulations.