Effects and efficacy of different sterilization and disinfection methods on electrospun drug delivery systems.

Microbiological quality of a pharmaceutical product is an essential requirement ensuring patient safety, thus effective sterilization/disinfection methods need to be found. The aim of this study was to evaluate the efficacy of different sterilization/disinfection methods on drug-loaded electrospun matrices and the impact of these treatments on the functionality related characteristics of these matrices. The sterilization efficacy of gamma-irradiation, ultraviolet-irradiation, in situ generated chlorine gas and low-pressure argon plasma treatment were evaluated on two different chloramphenicol-loaded electrospun matrices using pristine polycaprolactone (PCL) as a carrier polymer or PCL in combination with polyethylene oxide. Drug stability, solid state properties, morphology, mechanical properties, swelling, biodegradation and drug release kinetics were studied before and after the treatments. It was shown that all tested methods help to reduce bioburden and only plasma treated matrices were not sterile. At the same time drug degradation after the treatment can be considerable and depends not only on the susceptibility of the drug to degradation, but also on matrix properties (e.g. the nature of carrier polymers). Even though no morphological changes were observed, gamma sterilization increased the hardness and elasticity of PCL matrices as a result of increased crystallinity of the polymer. Plasma treatment was able to significantly enhance water absorption to otherwise hydrophobic PCL/CAM matrix and had tremendous impact on its drug release kinetics as the drug was instantly released from otherwise prolonged release formulation.