Vitamin D3-Loaded Nanoemulsions as a Potential Drug Delivery System for Autistic Children: Formulation Development, Safety, and Pharmacokinetic Studies
AAPS PharmSciTech Volume 24, article number 58, (2023) https://doi.org/10.1208/s12249-023-02501-2
Marwa Hasanein Asfour, Sameh Hosam Abd El-Alim, Ahmed Alaa Kassem, Abeer Salama, Amr Sobhi Gouda, Walaa Samy Nazim, Neveen Hassan Nashaat, Maha Hemimi & Nagwa Abdel Meguid
8 nanoemulsions were tried
Oral nanoemulsion had bigger and faster response (sublinqual would be even faster)
The aim of the current study is the development of a vitamin D3 (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 AUC0–72 and Cmax with decreased Tmax compared 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.
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VitaminDWiki - Nanoemulsion Vitamin D is faster and better - many studies
See also Autism VitaminDWiki
- Overview - Autism and vitamin D
- Most Autism Risk factors are associated with low vitamin D - March 2014
- Autistics have half of the response to Vitamin D – RCT Oct 2018
- Autism decreased in 8 out of 10 children supplemented with vitamin D – April 2015
- Autism rate cut in half when multivitamins (including vitamin D) used during pregnancy – Oct 2017
- Autism and ADHD type disorders were 14X more likely in survey of extreme preterm vaccinated infants - April 2017
- Autism is strongly associated with 31 gut microbiota (bacteria, archaea, fungi, and viruses) – July 2024
- Autism risk is reduced by Vitamin D – early pregnancy or chlldhood – Umbrella review – July 2024