Development andin vitroevaluation of a nanoemulsion for transcutaneous delivery

Abstract

Objective The purpose of this study is to develop a nanoemulsion formulation for its use as a transcutaneous vaccine delivery system. Materials and methods With bovine albumin-fluorescein isothiocyanate conjugate (FITC-BSA) as a vaccine model, formulations were selected with the construction of pseudo-ternary phase diagrams and a short-term stability study. The size of the emulsion droplets was furthered optimized with high-pressure homogenization. The optimized formulation was evaluated for its skin permeation efficiency. In vitro skin permeation studies were conducted with shaved BALB/c mice skin samples with a Franz diffusion cell system. Different drug concentrations were compared, and the effect of the nanoemulsion excipients on the permeation of the FITC-BSA was also studied. Results The optimum homogenization regime was determined to be five passes at 20 000 psi, with no evidence of protein degradation during processing. With these conditions, the particle diameter was 85.2 nm ± 15.5 nm with a polydispersity index of 0.186 ± 0.026 and viscosity of 14.6 cP ± 1.2 cP. The optimized formulation proved stable for 1 year at 4 °C. In vitro skin diffusion studies show that the optimized formulation improves the permeation of FITC-BSA through skin with an enhancement ratio of 4.2 compared to a neat control solution. Finally, a comparison of the skin permeation of the nanoemulsion versus only the surfactant excipients resulted in a steady state flux of 23.44 μg/cm2/h for the nanoemulsion as opposed to 6.10 μg/cm2/h for the emulsifiers. Conclusion A novel nanoemulsion with optimized physical characteristics and superior skin permeation compared to control solution was manufactured. The formulation proposed in this study has the flexibility for the incorporation of a variety of active ingredients and warrants further development as a transcutaneous vaccine delivery vehicle.

Topical Nano and Microemulsions for Skin Delivery

“…A number of NSAIDs have been available as gel and cream formulations for many years. There is extensive literature focused on the development and evaluation of ME and NE systems for topical delivery of a number of NSAIDs including diclofenac [ 62 , 63 ], aceclofenac [ 57 , 64 , 65 ], piroxicam [ 66 ], indomethacin [ 67 , 68 , 69 ], ibuprofen, celecoxib [ 70 , 71 ], etoricoxib [ 72 ], naproxen [ 73 ], flufenamic acid [ 50 , 74 , 75 ], ketoprofen [ 39 , 76 , 77 ], flurbiprofen [ 78 ], lornoxicam [ 79 ], and meloxicam [ 80 ]. Consequently, we have focused our discussion on this drug class to illustrate the development and potential of ME/NE formulations for topical and transdermal delivery.…”

Effect of vaccine administration modality on immunogenicity and efficacy

“…A lipid-based vaccine formulation, such as lipid C-based vaccines[149] and emulsion-based vaccines[150] would be ideal due to their compatibility with different forms of vaccines. Several methods have been shown effective, including partial removal of the SC by mild abrasion[151], tape-stripping[152], or device-facilitated creation of aqueous micropores (laser microporation)[153].…”

Emulsions stabilized by soy protein nanoparticles as potential functional non‐dairy yogurts

“…This was attributed to increased surface area, which binds up water molecules and thus increases the effective solids concentration. Ledet et al . also made the same statement while examining the viscosity of nanoemulsion formulation for its use as a transcutaneous vaccine delivery system.…”