Comparative Colloidal Stability of Commercial Amphotericin B Nanoformulations Using Dynamic and Static Multiple Light Scattering Techniques

Abstract

Background Amphotericin B (AmB) nanoformulations have been widely used for the treatment of invasive fungal infections in clinical practice, all of which are lyophilized solid dosage forms that improve storage stability. The colloidal stability of reconstituted lyophilized nanoparticles in an injection medium is a critical quality attribute that directly affects their safety and efficacy during clinical use. Methods In the present study, the colloidal stability of commercial AmB nanoformulations, including AmB cholesteryl sulfate complex (AmB-CSC) and AmB liposome (AmB-Lipo), was evaluated using the dynamic (DLS) and static multiple light scattering (SMLS) techniques. Results Compared to the DLS technique, the SMLS technique allows for a more objective and accurate evaluation of the colloidal stability of AmB nanoformulations. The results obtained using the SMLS technique demonstrated that AmB-CSC and AmB-Lipo exhibited excellent colloidal stability in both sterile water and 5% dextrose injection. The disk-like structure of the AmB-CSC nanoparticles more readily adsorbed serum proteins to form protein corona compared to the spherical structure of AmB-Lipo after incubation with serum. Additionally, AmB-CSC and AmB-Lipo can significantly reduce the in vitro cytotoxicity and in vivo nephrotoxicity of AmB, which may be attributed to the good colloidal stability and the improved pharmacokinetic profiles of AmB nanoformulations. Conclusion To the best of our knowledge, this study is the first to compare the colloidal stability of commercial AmB nanoformulations. These findings will provide useful information not only to inform the clinical use of available AmB nanoformulations but also for improving the design and conduct of translational research on novel AmB nanomedicines.

AmBisome® Formulations for Pediatrics: Stability, Cytotoxicity, and Cost-Effectiveness Studies

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Antifungal drug resistance in Candida: a special emphasis on amphotericin B

“…A previous study used magnetic nanoparticles as a drug delivery method to increase the fungicidal action of polyene against clinical isolates of Candida species [237]. AmB's in vitro cytotoxicity and in vivo nephrotoxicity may both be considerably reduced by the use of nano‐formulations, such as the AmB cholesteryl sulphate complex (AmB‐CSC) and the AmB liposome (AmB‐Lipo) [238]. Another study has shown that PEG‐cholane nanoformulation of AmB was 15% more active than AmB in buffer [239].…”

A Study on Emulsion Stabilization and Characterization of Rheological Properties of Tragacanth Gum

“…Particle size distribution Determining the emulsion particle size distribution using PSS Nicomp 380 ZLS operating by the dynamic light scattering method is a crucial step in understanding the physical characteristics of the gum. Dynamic light scattering (DLS) has been widely used to measure the particle size and size distribution of various substances, including polysaccharides and nanoparticles, providing accurate and reliable results [18]. Measurements were conducted at ambient temperature on a minimum of two recently fabricated specimens.…”