Radiation sterilization of medicinal formulations of doxorubicin bound to poly(butylcyanoacrylate) nanoparticles

Abstract

Polybutylcyanoacrylate nanoparticles represent a potential system for delivering medicinal agents. The present report describes development of a method for radiation sterilization of medicinal formulations of doxorubicin based on polybutylcyanoacrylate nanoparticles. The physicochemical properties of the medicinal formulation were studied after gamma irradiation and irradiation with accelerated electrons over the dose range 10 -35 kGy. The chemical structure of doxorubicin and the polymer carrier was found to be intact after irradiation at a dose of 25 kGy. Irradiation at these doses also had no effect on the colloidal properties of polymer nanoparticles, which retained their stability to aggregation and sedimentation. The optimum sterilizing dose was 15 kGy.

Effects of gamma irradiation for sterilization on aqueous dispersions of length sorted carbon nanotubes

“…It is likely that the amount of irradiation used in the processing of these samples was greater than the necessary dosage to ensure sterility. It has been reported that sterilization of doxorubicin bound to butylcyanoacrylate nanoparticles could be achieved to European Pharmacopeia regulatory standards with a 15 kGy or lower dose [18], substantially below the 28 kGy dose applied in this study.…”

“…To date there have been relatively few literature reports of the effect of irradiation in general on the properties of nanotube powders [10], films [11][12][13][14][15][16] or devices [15,16], and no reports of the effects on dispersed nanotubes. This information is most lacking in the case of the effects of a common sterilization procedure, gamma irradiation [17,18], as opposed to electron [19,20] or ion irradiation [11,14]. The effects of the sterilization will be of particular importance for separated SWCNT populations, as the length [21,22], chirality [23], and potentially specific enantiomers [24] will likely be selected to maximize efficacy in the regulated applications for which sterilization will be required.…”

Sterilisation of healthcare products by ionising radiation: sterilisation of drug-device products and tissue allografts

“…The drug was also stable. The addition of 100 colony-forming units per gram of bacteria demonstrated that suffi cient levels of sterility could be achieved with 15 kGy (Maksimenko et al ., 2008). The irradiation of PLGA microspheres, containing the SPf66 malarial antigen, at 25 kGy had no apparent effect on SPf66 integrity or on the formulation properties such as morphology, size and peptide loading, although slightly faster vaccine release rates were observed.…”