Nutraceutically-enhanced oral delivery of vitamin D3 via Bio-SNEDDS: Demonstrating in vivo superiority over pediatric formulations.

Autor: Kazi M; Department of Pharmaceutics, College of Pharmacy, POBOX- 2457, King Saud University, Riyadh, 11451, Kingdom of Saudi Arabia. Electronic address: mkazi@ksu.edu.sa., Almarri F; Department of Pharmaceutics, College of Pharmacy, POBOX- 2457, King Saud University, Riyadh, 11451, Kingdom of Saudi Arabia., Shahba AA; Department of Pharmaceutics, College of Pharmacy, POBOX- 2457, King Saud University, Riyadh, 11451, Kingdom of Saudi Arabia., Ahmad A; Department of Clinical Pharmacy, College of Pharmacy, POBOX- 2457, King Saud University, Riyadh, 11451, Kingdom of Saudi Arabia., Albraiki S; Department of Pharmaceutics, College of Pharmacy, POBOX- 2457, King Saud University, Riyadh, 11451, Kingdom of Saudi Arabia., Alanazi FK; Department of Pharmaceutics, College of Pharmacy, POBOX- 2457, King Saud University, Riyadh, 11451, Kingdom of Saudi Arabia.
Jazyk: angličtina
Zdroj: Biochemical and biophysical research communications [Biochem Biophys Res Commun] 2024 May 21; Vol. 709, pp. 149852. Date of Electronic Publication: 2024 Mar 28.
DOI: 10.1016/j.bbrc.2024.149852
Abstrakt: Background: Vitamin D3 (VD3) deficiency among children in Saudi Arabia remains a pressing concern due to its poor bioavailability and the limitations of current pediatric formulations. To address this challenge, we developed a groundbreaking pediatric self-nanoemulsifying drug delivery system (Bio-SNEDDS) for VD3, fortified with black seed oil and moringa seed oil for dual therapeutic benefits. Through meticulous formulation optimization using ternary phase diagrams and comprehensive testing, our Bio-SNEDDS demonstrated exceptional performance.
Methods: Bio-SNEDDS were manufactured by incorporating Black seed oil and moringa seed oil as bioactive nutraceutical excipients along with various cosurfactant and surfactants. Bio-SNEDDS were systematically optimized through ternary phase diagrams, visual tests, droplet size analysis, drug solubilization studies, dispersion assessments, and pharmacokinetic testing in rats compared to Vi-De 3®.
Results: Pseudoternary phase diagrams identified oil blends producing large nanoemulsion regions optimal for SNEDDS formation. The optimized F1 Bio-SNEDDS showed a mean droplet diameter of 33.7 nm, solubilized 154.46 mg/g VD3 with no metabolite formation, and maintained >88% VD3 in solution during 24 h dispersion testing. Notably, in vivo pharmacokinetic evaluation at a high VD3 dose demonstrated an approximately two-fold greater relative bioavailability over Vi-De 3®, validating the superb oral delivery performance of Bio-SNEDDS even under challenging high-dose conditions.
Conclusions: The Bio-SNEDDS provides an effective VD3 delivery strategy with established in vivo superiority over marketed products, along with offering additional health benefits from the natural oils.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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