SOLID LIPID NANOPARTICLES (SLN) FOR CONTROLLED DRUG-DELIVERY .1. PRODUCTION, CHARACTERIZATION AND STERILIZATION

Solid lipid nanoparticles (SLN) were produced by high pressure homogen ization of a melted lipid (Dynasan 112) dispersed in water at increase d temperature (70-degrees-C). Soy lecithin and poloxamer 188 were used as surfactants and stabilizers of the particles. The effect of homoge nization parameters (pressure, cycle number) was studied and optimized to yield solid lipid nanoparticles of a quality suitable for intraven ous injection. Particles were characterized by photon correlation spec troscopy (PCS) and zeta potential measurements, the fraction of large particles being the limiting factor for i.v. injection was determined using a Coulter Counter. The optimum formulation was suitable for i.v. injection (monograph 'Particulate Matter', USP XXII). SLN stabilized with soy lecithin could be sterilized by autoclaving.