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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 (&gt;\u200998%), droplet size (DS) ranging from 61.15 to 129.8\u00a0nm with narrow size distribution, zeta potential values between\u2009\u2212\u20099.83 and\u2009\u2212\u200919.22\u00a0mV, and acceptable pH values (4.59\u20135.89). Storage stability showed that NE formulations underwent coalescence and phase separation during 6\u00a0months 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\u00a0months, 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 AUC<jats:sub>0\u201372<\/jats:sub> and <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> with decreased <jats:italic>T<\/jats:italic><jats:sub>max<\/jats:sub> 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.<\/jats:p>","DOI":"10.1208\/s12249-023-02501-2","type":"journal-article","created":{"date-parts":[[2023,2,9]],"date-time":"2023-02-09T20:03:02Z","timestamp":1675972982000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":36,"title":["Vitamin D3-Loaded Nanoemulsions as a Potential Drug Delivery System for Autistic Children: Formulation Development, Safety, and Pharmacokinetic Studies"],"prefix":"10.1208","volume":"24","author":[{"given":"Marwa Hasanein","family":"Asfour","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7554-7682","authenticated-orcid":false,"given":"Sameh Hosam","family":"Abd El-Alim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed Alaa","family":"Kassem","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abeer","family":"Salama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amr Sobhi","family":"Gouda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walaa Samy","family":"Nazim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neveen Hassan","family":"Nashaat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maha","family":"Hemimi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nagwa","family":"Abdel Meguid","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,2,9]]},"reference":[{"key":"2501_CR1","doi-asserted-by":"publisher","first-page":"111","DOI":"10.1186\/1471-2431-11-111","volume":"11","author":"JB Adams","year":"2011","unstructured":"Adams JB, Audhya T, McDonough-Means S, Rubin RA, Quig D, Geis E, et al. 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