Abstract
Nanotechnology has enabled the development of novel therapeutic strategies such as targeted nanodrug delivery systems, control and stimulus-responsive release mechanisms, and the production of theranostic agents. As a prerequisite for the use of nanoparticles as drug delivery systems, the amount of loaded drug must be precisely quantified, a task for which two approaches are currently used. However, both approaches suffer from the inefficiencies of drug extraction and of the solid-liquid separation process, as well as from dilution errors. This work describes a new, reliable, and simple method for direct drug quantification in polymeric nanoparticles using attenuated total reflection Fourier transform infrared spectroscopy, which can be adapted for a wide variety of drug delivery systems. Silk fibroin nanoparticles and naringenin were used as model polymeric nanoparticle carrier and drug, respectively. The specificity, linearity, detection limit, precision, and accuracy of the spectroscopic approach were determined in order to validate the method. A good linear relation was observed within 0.00 to 7.89% of naringenin relative mass with an R2 of 0.973. The accuracy was determined by the spike and recovery method. The results showed an average 104% recovery. The limit of detection and limit of quantification of the drug loading content were determined to be 0.3 and 1.0%, respectively. The method’s robustness is demonstrated by the notable similarities between the calibrations carried out using two different equipment setups at two different institutions.
Highlights
The use of nanoparticles as drug delivery systems is already a reality, with more than 50 nanomedicines approved by the Food and Drug Administration (USA) in April 2016, and more to come in the foreseeable future [1]
The specificity of ATR-FTIR spectroscopy was tested by performing a spectral coincidence match where the spectrum of SFNNAR-0.3 was compared with that of pure NAR
The method was shown to be robust, as calibration lines measured in two different institutions showed no statistical differences
Summary
The use of nanoparticles as drug delivery systems is already a reality, with more than 50 nanomedicines approved by the Food and Drug Administration (USA) in April 2016, and more to come in the foreseeable future [1]. Among polymeric nanoparticles used as delivery systems, silk fibroin-based nanoparticles (SFN) from the silkworm Bombyx mori have shown promising results, partly due to their biodegradability, biocompatibility and nontoxicity [10,11,12,13,14,15,16] Their ability to penetrate biological membranes and their high drug loading capacity mean that SFN can greatly improve therapeutic treatments [17,18]. As high drug concentrations are normally used for the loading solution, large dilution factors are needed to keep the analyte signal in the equipment’s operating range, when conventional UV-visible spectrometers or high-pressure liquid chromatographs are used This adds uncertainty, and lowers the accuracy and the precision of the determined drug content. The drug content may change upon storage, in which case an analysis of the loading solution will be meaningless
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