European journal of drug metabolism and pharmacokinetics · 2025
Bioavailability and Cellular Compatibility of a Novel Coenzyme Q10 Emulgel as an Alternative Oral Delivery System for Patients with Dysphagia: Preliminary Results from a Randomized Study.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Avila Ailin C, Bernabeu Ezequiel, Chiappetta Diego, Rojas Ana M, Tripodi Valeria P
Аннотация
BACKGROUND: Coenzyme Q10 (CoQ10) plays a vital role in mitochondrial bioenergetics and functions as a potent endogenous antioxidant. Low CoQ10 levels have been associated with various neurodegenerative, metabolic, muscular, and cardiovascular disorders. Early intervention with high-dose oral CoQ10 (5-50 mg/kg/day) can mitigate disease progression and delay the onset of renal disease. We recently developed an emulgel matrix that facilitates the ingestion of high-dose, oil-dissolved CoQ10 for patients with CoQ10 deficiency and secondary dysphagia.
OBJECTIVE: To evaluate the bioavailability and cellular compatibility of this novel CoQ10 emulgel.
METHODS: Two exploratory studies were conducted in healthy adults: a randomized cross-over single-dose trial (n = 6) and a 14-day repeated-dose trial (n = 12) comparing 1 g of CoQ10 administered as emulgel (25 g serving) or solid capsules (2 × size-00). Plasma CoQ10 concentrations were determined by validated HPLC-UV and pharmacokinetic parameters were analyzed using noncompartmental methods. Cellular compatibility was assessed in Vero cells.
RESULTS: The single-dose study in healthy adults demonstrated equivalent bioavailability of 1 g CoQ10 administered via emulgel (25 g serving) and solid capsules (1 g CoQ10 in two size-00 capsules). However, CoQ10 in the emulgel exhibited faster and more efficient absorption. A 14-day repeated-dose study revealed significant higher plasma CoQ10 concentrations with emulgel administration, potentially achieving therapeutic levels. A cellular compatibility assay confirmed the safety of the emulgel.
CONCLUSIONS: These findings indicate that the emulgel matrix does not compromise the bioavailability of oil-dissolved CoQ10 and offers a promising, safe, and comfortable alternative for patients with dysphagia requiring long-term, high-dose CoQ10 supplementation.
OBJECTIVE: To evaluate the bioavailability and cellular compatibility of this novel CoQ10 emulgel.
METHODS: Two exploratory studies were conducted in healthy adults: a randomized cross-over single-dose trial (n = 6) and a 14-day repeated-dose trial (n = 12) comparing 1 g of CoQ10 administered as emulgel (25 g serving) or solid capsules (2 × size-00). Plasma CoQ10 concentrations were determined by validated HPLC-UV and pharmacokinetic parameters were analyzed using noncompartmental methods. Cellular compatibility was assessed in Vero cells.
RESULTS: The single-dose study in healthy adults demonstrated equivalent bioavailability of 1 g CoQ10 administered via emulgel (25 g serving) and solid capsules (1 g CoQ10 in two size-00 capsules). However, CoQ10 in the emulgel exhibited faster and more efficient absorption. A 14-day repeated-dose study revealed significant higher plasma CoQ10 concentrations with emulgel administration, potentially achieving therapeutic levels. A cellular compatibility assay confirmed the safety of the emulgel.
CONCLUSIONS: These findings indicate that the emulgel matrix does not compromise the bioavailability of oil-dissolved CoQ10 and offers a promising, safe, and comfortable alternative for patients with dysphagia requiring long-term, high-dose CoQ10 supplementation.