Topical arginine solid lipid nanoparticles: Development and characterization by QbD approach

The application of L-arginine, the nonessential amino acid, as in pharmaceutical and cosmetics is raised as it shows the number of advantages for internal and external, applications. But its hydrophilic nature and lower partition co-efficient value limit its penetration through the skin. From the different approaches for topical drug delivery systems, solid lipid nanoparticles are a promising vehicle to carry the drug molecule at the appropriate site of absorption and also ensures the fast therapeutic action. With ability to incorporate lipophilic as well as a hydrophilic molecule. The present investigation aimed to implement the Quality by design concept for the development of SLNs incorporated with arginine molecule for its application on skin in the form of cosmoceutical formulation. The developed formulation will enhance the blood circulation of skin cells and hence beneficial for skin as cosmoceutical dosage form. To enhance the loading of drug molecule in a lipolphilic environment like solid lipid, insitu ion-pairing was carried out using an optimum concentration of oleic acid. The optimization was done by QbD approach considering concentration of poloxamer 188, oleic acid and sonication amplitude as the critical processing parameters. Average particle size and % drug loading were taken as critical product quality attributes using 23 full factorial design. The characterization of freeze dried solid lipid nanoparticles are investigated by transmission electron microscopy, x-ray diffraction study, differential scanning calorimetry and fourier transform infrared spectroscopy. Finally, an in-vitro and ex-vivo drug diffusion stuies were carried out to check the permeation of arginine. The optimized SLN formulation were successfully developed having lower particle size and higher % drug loading with effective skin penetration parameters to achieve the therapeutic benefits of Arginine.