Abstract
Efficacy and safety of nanomedicines based on polymeric (bio)materials will benefit from a rational implementation of a Safe-by-Design (SbD) approach throughout their development. In order to achieve this goal, however, a standardization of preparation and characterization methods and their accurate reporting is needed. Focusing on the example of chitosan, a biopolymer derived from chitin and frequently used in drug and vaccine delivery vector preparation, this review discusses the challenges still to be met and overcome prior to a successful implementation of the SbD approach to the preparation of chitosan-based protein drug delivery systems.
Highlights
Nanoparticles (NPs) have been extensively investigated as delivery systems for targeted drug delivery, controlled drug release, in vivo imaging, diagnostics, and medical devices
A literature search was performed through PubMed and Science Direct using as Medical Subject Headings (MeSH) keywords chitosan, immune activity, gelation, insulin, encapsulation, and adjuvant
We focused on ionotropic gelation, using tripolyphosphate (TPP) as crosslinker because it is the most used process to prepare Chit NPs
Summary
Nanoparticles (NPs) have been extensively investigated as delivery systems for targeted drug delivery, controlled drug release, in vivo imaging, diagnostics, and medical devices. These systems may offer more convenient routes of administration, decrease drug toxicity, and potentially reduce healthcare costs (Vasile, 2019). Quality control assays for nanomaterial characterization, the need of establishing specialized toxicology studies for nanomedicines, and the lack of suitable standards and dedicated regulatory guidelines are a few examples of the challenges to their development and effective clinical translation (Hua et al, 2018)
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