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Biotin sodium, also known as D-biotin or simply biotin, is a water-soluble vitamin belonging to the B-complex group.[2] It is a chemically synthesised substance that is already authorised as a medicine in Spain, where it is marketed under the names Medebiotin Fuerte solución inyectable and Medebiotín Fuerte Comprimidos by Laboratorio Reig Jofre, S.A.[1] The substance is classified under the Anatomical Therapeutic Chemical code A11HA05, which places it among other plain vitamin preparations.[1]
Biotin acts as a cofactor for several enzymes involved in the breakdown of certain amino acids and fatty acids. In conditions such as biotinidase deficiency, the body cannot recycle biotin properly, leading to a functional biotin shortage. Providing biotin as a medicine helps restore the activity of these enzymes and supports normal metabolism.[1]
Biotin is available as a tablet and as a solution for injection that is taken by mouth (oral use).[1] The trial also uses a chewable master formula prepared in a hospital pharmacy.[1]
One Phase 3 trial is authorised in Spain, enrolling 14 children with biotinidase deficiency or methylcrotonylglycinuria.[1] The study compares the tolerability of the commercial biotin product with a chewable pharmacy-made formulation, aiming to improve treatment adherence in children with these rare diseases.[1] The primary outcome is a visual scale together with the collection of subjective symptoms reported by the patient.[1]
The sources provided do not include a list of side effects for biotin sodium.
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