Abstract: Suspension stability plays a role in the taste and texture of an oral suspension containing one or more active pharmaceutical ingredients (API). The effects of aggregating or flocculating nanoparticles or emulsions can impact this key component where generic oral suspension must demonstrate equivalency to name brand oral suspensions. Zeta potential can be used to quantify and control suspension stability and the formation of aggregates and flocculants, thereby optimizing the taste and texture of a generic oral suspension to match the name brand product. A generic and a name brand oral suspension are visually compared as a qualitative test. The electrophoretic mobility of each suspension is then determined using electrophoretic light scattering (ELS) technology. From the electrophoretic mobility, the electrical potential of a particle or emulsion at the shear or slipping plane or zeta potential, is determined. The larger the absolute millivolt (mV) value of zeta potential, the more stable a suspension will be and the more likely the particles or emulsions will repel each other rather than flocculate. The generic formulation shows zeta potential values that are much smaller than the name brand oral suspension. Visually, the generic oral suspension shows signs of settling and requires shaking before sampling. The generic formulation may require the addition of additives that can increase the zeta potential to the levels of the name brand and aid in stabilizing the suspension.Summary: Zeta potential can be used to quantify and control suspension stability and the formation of aggregates and flocculants, thereby optimizing the taste and texture of a generic oral suspension to match the name brand product.
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