Feasibility study of an oral biotin suspension suitable for a ketogenic diet for pediatric use

Objectives
Biotin supplementation is part of the management of vitamin deficiencies, particularly in the treatment of vitamin-responsive epilepsies in combination with a ketogenic diet. Currently, capsules are compounded, but their dosage form is poorly adapted to pediatric use and weight-based dosing. The objective of this study was to assess the feasibility and palatability of an oral biotin formulation better suited to the target population.

Methods
A literature review was conducted to identify existing oral biotin formulations. An analysis of biotin consumption and compounded doses during 2025 was performed to determine the most appropriate concentration. The composition of all identified formulations was analyzed. For the palatability study of the selected formulation, three solutions were tested by volunteers: a bitterness control consisting of pyridoxine 50 mg/mL in Inorpha^® (A), a sweet control consisting of Inorpha^® (B), and the biotin preparation (C). Volunteers rated each solution on a scale from 0 to 5 according to five criteria: odor, bitterness, sweetness, taste acceptability, and overall appreciation. Finally, the visual appearance and redispersibility of the preparation of interest were assessed (D).

Results
Three formulations were identified in the literature; only the formulation using Inorpha^® met the predefined criteria. Indeed, the use of Inorpha® complies with the requirements of a ketogenic diet, while a concentration of 10 mg/mL allows treatment of all patients with an acceptable administration volume. Palatability testing was performed in 35 volunteers: three did not detect the bitterness of solution (A), and four did not detect the sweetness of solution (B). For the biotin preparation (C), redispersibility was rated 4.35 ± 0.73 (mean ± standard deviation), visual appearance 3.00 ± 1.40, odor 3.03 ± 1.27, and overall appreciation 3.20 ± 0.97. Bitterness was detected by 19 participants for solution (C), of whom 14 rated it favorably. The taste was considered acceptable by 80% of volunteers (score ≥ 3), and by 78% of those who successfully identified the expected taste characteristics of the control solutions (A) and (B).

Discussion–conclusion
The use of Inorpha^® enabled the development of an easy-to-use biotin suspension, and the majority of volunteers considered its taste acceptable. The 10 mg/mL biotin suspension will be made available to pediatric wards to allow palatability assessment in the target population. Depending on clinical needs, the preparation could be compounded as a hospital preparation, as an HPLC (High-Performance Liquid Chromatography) assay method has been described in the literature and demonstrated stability of the preparation for 84 days at room temperature according to ICH criteria and the GERPAC methodological guidelines. However, this stability study will need to be revalidated within our unit.

Keywords: Biotin, Suspension, Epilepsy

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