Orange IV stabilizes silk fibroin microemulsions

Silk fibroin (SF) is a natural biopolymer that has been extensively studied in various applications due to its impressive mechanical properties and biocompatibility. Recently, SF-based particles have been proposed as controlled drug delivery systems. A new and efficient method to prepare SF microemulsions (SF-MEs) was developed by oil-in-water emulsions using high-pressure homogenization to promote emulsification. During SF-ME production, the secondary structure of SF changed to a more stable conformation (from random coil to -sheets), thus allowing the formation of small and stable (140.7 +/- 1.9 nm; polydispersity index, 0.25) SF microparticles (SF-MPs). The efficiency of SF-MP formation was 60%. Orange IV was used as a model compound for incorporation and release studies, although its incorporation into the SF-MEs significantly improved particle size and size distribution over at least 4 wk compared to traditional stabilizers (e.g., poloxamer 407, transcutol, Tween 80, and SDS). This should be a call of attention when using dyes as model compounds since they can influence particle properties and lead to misinterpretation of the results. Orange IV showed an incorporation efficiency of 91% and a controlled release over time. Stable SF-MP formulations, further enhanced by orange IV incorporation, provide an innovative method with potential application in pharmaceutical development due to its associated high biocompatibility and release profile.