Safety Issues

Although generalizations can be made for a particular targeted nanoparticle delivery system, specific issues will arise for each type of payload it contains and for each indication. It will be important to balance potential safety concerns for using nanoparticles with their potential benefits for reducing a safety concern that occurs without their use for comparable (or even improved) efficacy. Nanoparticles can tremendously reduce toxicity by sequestering cytotoxic materials from non-specific tissues and organs of the body until reaching the cancer site.59 Polymeric nanoparticles have been loaded with tamoxifen for targeted delivery to breast cancer cells to improve the efficacy to safety quotient relative to direct administration of this cytotoxic agent.60 Coupling of doxoru-bicin-loaded liposomes to antibodies or antibody fragments that can enhance targeting to cancer cells appears quite promising as a means of further improving the efficacy to toxicity profile for this chemotherapeutic.61 PEGylated liposomal doxorubicin has improved tolerability with similar efficacy compared to free drug.62 Liposomal formulations of anthracyclines appear to improve the cardiotoxicity profile of this anti-neoplastic.63 PAMAM dendrimers conjugated to cisplatin not only improved the water solubility characteristics of this chemotherapeutic but also improve its toxicity profile.64 PAMAM dendrimers have also been used to increase the effectiveness of a radioimmu-notherapy approach by increasing the specific accumulation of radioactive atoms at a tumor site as well as improving selectivity of biodistribution.65

As previously mentioned, potential inherent targeting of some nanoparticles may initiate cellular responses, following recognition by immune cell surface receptor systems. Outcomes from such events could produce safety concerns, particularly for repeated exposures. Data suggest additional safety concerns related to the material(s) used in nanoparticle preparation as well as nanoparticle size for some routes of administration. Recent studies have called into question the safety of repeated aerosolized exposure of carbon nanomaterials,66 and nanoparticles have been shown to have a higher inflammatory potential per given mass than do larger particles.57 Such particles may provide an efficient means to actively target lung cancers that is facilitated by the natural properties of these materials. In general, safety issues related to using nanoparticles to target cancers for treatment and diagnosis will be specific for the material used to prepare the particle: its size, the type of targeting mechanism it utilizes, its fate at the targeted site, and its non-targeted distribution and elimination pattern from the body.

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