Sterile, injectable cyclodextrin nanoparticles: effects of gamma irradiation and autoclaving.

Sterility is required as stated by compendial requirements and registration authorities worldwide for an injectable drug carrier system. In this study, injectable nanospheres and nanocapsules prepared from amphiphilic beta-cyclodextrin, beta-CDC6, were assessed for their in vitro properties such as particle size distribution, zeta potential, nanoparticle yield (%), drug entrapment efficiency and in vitro drug release profiles. Different sterilization techniques such as gamma irradiation and autoclaving were evaluated for their feasibility regarding the maintenance of the above mentioned nanoparticle properties after sterilization. It was found that amount these techniques, sterilization with gamma irradiation seemed to be the most appropriate technique with no effect on particle size, drug loading and drug release properties. Gamma irradiation causes some chemical changes on beta-CDC6 observed as changes in zeta potential but this does not lead to any significant changes for nanoparticle properties. Autoclaving caused massive aggregation for the nanoparticles followed by precipitation, which led to the conclusion that excessive heat disrupted nanoparticle integrity. Sterile filtration was not feasible since nanoparticle sizes were larger than the filter pore size and the yield after sterilization was very low. Thus, it can be concluded that blank and drug loaded beta-CDC6 nanospheres and nanocapsules are capable of being sterilized by gamma irradiation.