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Genotoxicity and Mutagenicity Evaluation of Polyethylene Sebacate Nanoparticles

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Intracellular, targeted biodegradable polymeric nanoparticles (NP) increase the risk of their interactions with cell organelles like DNA and chromosomes leading to genotoxicity and mutagenicity. The present study for the first time reports genotoxicity and mutagenicity evaluation of biodegradable polyethylene sebacate (PES) NP as a strategy to ensure safety as nano drug carrier and development of PES rifampicin (RF) NP for intracellular delivery. PES NP were characterized for particle size by photon correlation spectroscopy and shape using TEM. Genotoxicity was evaluated in vivo using standard battery of tests namely micronucleus test, chromosomal aberration and comet assay. Cyclophosphamide was used as positive control. Mutagenicity was assessed at six different concentrations by in vitro Ames II test. PES NP was found to be nongenotoxic and nonmutagenic and hence used for development of PES RF NP for intracellular delivery of RF. PES RF NP showed very high % entrapment efficiency (84.12%), average size of 384 nm (PDI = 0.214) and sustained release. Based on freeze thaw study trehalose (10%) was used for the freeze drying. Freeze dried PES RF NP showed good stability over a period of three months. The nongenotoxic and nonmutagenic properties suggest PES as safe carrier for intracellular drug delivery.
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Keywords: AMES TEST; BIODEGRADABLE POLYMERS; GENOTOXICITY; NANOTOXICOLOGY; POLYETHYLENE SEBACATE; POLYMERIC DRUG CARRIER

Document Type: Research Article

Publication date: 01 September 2013

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  • Journal of Nanopharmaceutics and Drug Delivery (JND) is an international peer- reviewed journal that covers all aspects of nanotechnology that applies to development, formulation and delivery of pharmaceuticals and diagnostic agents. This includes nanoscale pharmaceutics; tools to understand nanoscale pharmaceutical processes in drug discovery and development; design and development of nanoformulations and nanoscale drug delivery systems; regulatory aspects and policies related to nanopharmaceuticals. The journal has been developed to create a new forum for scientific publications at the interface of nanotechnology and pharmaceutical sciences. JND publishes original rapid communications, full research papers and timely state-of-the-art reviews (with author's photo and biography) encompassing fundamental and applied research in nanomaterials for drug delivery, nanopharmaceutics, nanomedicine, nanodiagnostics, nanobiotechnology and nanotoxicology of drug delivery carriers. Rapid communications on new findings with breakthrough results will be considered for accelerated publication.
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