{"sub":3,"#text":"Vitamin D-Loaded Nanoemulsions as a Potential Drug Delivery System for Autistic Children: Formulation Development, Safety, and Pharmacokinetic Studies."}

Scientists created a new liquid form of vitamin D that's easier for the body to absorb. They tested it to make sure it's safe and works better than regular vitamin D supplements. The new formula stayed stable when kept cold and didn't cause harmful effects in animal tests. It was much better absorbed than normal vitamin D, which could help autistic children who often have low vitamin D levels.

This study developed a vitamin D3-loaded nanoemulsion formulation to improve oral bioavailability for managing vitamin D deficiency in autistic children. Researchers prepared eight nanoemulsion formulations using vegetable oils and tested their properties, stability, safety, and effectiveness. The optimal formulation (VD3-NE6) showed high drug content (>98%), appropriate particle size (61-130 nm), and acceptable stability under refrigeration. Safety testing in rats for 3 months showed no toxic effects on blood, kidney, or liver function.

The nanoemulsion demonstrated significantly improved oral bioavailability compared to plain vitamin D3, with increased area under the curve and peak concentration, suggesting potential for better vitamin D deficiency management in autistic children.

This nanoemulsion technology could potentially improve vitamin D supplementation effectiveness in autistic children who commonly experience vitamin D deficiency. However, human clinical trials are needed to confirm safety and efficacy before clinical application can be recommended.

Study conducted only in animal models with no human trials. Sample sizes not reported. Long-term safety and efficacy in autistic children not established. Stability issues observed at room temperature may limit practical use.

The aim of the current study is the development of a vitamin D(VD3)-loaded nanoemulsion (NE) formulation to improve VD3 oral bioavailability for management of vitamin D inadequacy in autistic children. Eight NE formulations were prepared by high-speed homogenization followed by ultrasonication. Four vegetable oils were employed along with two concentrations of Span 20 as the emulsifier. Glycerol, fructose, and mango flavor were included as viscosity modifier, sweetening, and flavoring agents, respectively.

The prepared VD3-loaded NE formulations exhibited high drug content (> 98%), droplet size (DS) ranging from 61.15 to 129.8 nm with narrow size distribution, zeta potential values between - 9.83 and - 19.22 mV, and acceptable pH values (4.59-5.89). Storage stability showed that NE formulations underwent coalescence and phase separation during 6 months at room temperature, whereas at refrigerated conditions, formulations showed slight creaming. The optimum formulation (VD3-NE6) revealed a non-significant DS growth at refrigerated conditions and spherical morphology under transmission electron microscopy. VD3-NE6 did not produce any toxic effects to rats treated orally for 3 months, where normal blood picture and kidney and liver functions were observed compared to control rats.

Also, serum calcium, oxidative stress, and apoptosis biomarkers remained within normal levels, indicating the safety of the optimum formulation. Furthermore, evaluation of VD3-NE6 oral bioavailability depicted a significant increase in AUCand Cwith decreased Tcompared to plain VD3. The optimum formulation demonstrated improved stability, safety, and oral bioavailability indicating the potential for successful management of vitamin D deficiency in autistic children.