Authors: N.R. Bieri, U. Meier, E. Goncalves, D. Zimmermann, M. Juhnke, R. Thakur
Affilation: Novartis Pharma AG, Switzerland
Pages: 194 - 197
Keywords: nanoparticles, spray drying, wet milling, super critical gas processes, precipitation, high pressure homogenization
The pharmaceutical industry is facing the problem of an increasing number of drug substances in development which are either poorly water soluble or show pH dependency of solubility. Drug targeting and tailored delivery poses additional challenges. Nano-sizing of drug solids is expected to solve some of the associated problems as nanoparticles potentially show increased dissolution rates and solubilities, resulting in enhanced bioavailability, reduced dosing volume and improved stability, if properly formulated and potentially reduce food effects. Nanoparticles expand the availability of injectable suspensions with reduced risk of embolism and reduce or even eliminate irritation upon injection in case of drug entrapment. In the current work different approaches for producing drug substance nanoparticles were investigated using both top-down technologies such as super critical gas processes, precipitation and spray drying as well as bottom-up technologies such as high pressure homogenization and wet milling. Advantages of the differently manufactured nanoparticle suspensions on solubility, particle size distribution, morphology etc. are presented, assessed and discussed in this work.