Drug Synthesis Methods and Manufacturing Technology

Pharmaceutical Chemistry Journal

, Volume 42, Issue 6, pp 363-367

First online:

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

  • O. O. MaksimenkoAffiliated withAll-Russian Scientific Center for Molecular Diagnosis and Treatment
  • , E. P. PavlovAffiliated withState Scientific Center “Institute of Biophysics”, Ministry of Health of the Russian Federation
  • , É. G. TushovAffiliated withOAO G. S. Petrov Science Research Institute of Plastics
  • , A. A. MolinAffiliated withState Scientific Center “Institute of Biophysics”, Ministry of Health of the Russian Federation
  • , Yu. V. StukalovAffiliated withAll-Russian Scientific Center for Molecular Diagnosis and Treatment
  • , T. N. PrudskovaAffiliated withOAO G. S. Petrov Science Research Institute of Plastics
  • , P. G. SveshnikovAffiliated withAll-Russian Scientific Center for Molecular Diagnosis and Treatment
  • , J. KreuterAffiliated withInstitute of Pharmaceutical Technology, J. W. Goethe University
  • , S. É. Gel’perinaAffiliated withAll-Russian Scientific Center for Molecular Diagnosis and Treatment

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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.