ABSTRACT

Poorly water-soluble drugs pose a significant challenge in their delivery. A large number of drugs are discarded from consideration in their early stages of development owing to poor bioavailability. Such drugs are an excellent candidate for nanoparticle delivery, which can avoid the allergic side effects due to the use of cremaphors (e.g., polyethyoxylated castor oil) in conventional formulations. However, for drugs with crystal forming habits, there is always the hazard of the formation of large microparticles (>10-15mm) from aggregation/bonding of nanoparticles; this can lead to infarction or blockage of the capillaries, resulting in ischemia or oxygen

deprivationandpossible tissuedeath.Hence, thenanoparticles need to be stabilized using biocompatible proteins (e.g., human serum albumin) or polymers (e.g., polylactide, polycaprolactone). An example is the recently approved drug AbraxaneTM

for cancer therapy, which is composed of 130-nm albuminstabilized paclitaxel nanoparticles. This chapter discusses the technology aspect of the protein and polymer-stabilized nanoparticle formation. Though proteins and polymers can be added to the drug nanoparticles in supercritical fluid or milling based technologies, this chapter focuses on the use of emulsions for making stabilized nanoparticles.