Bioavailability of vitamin D3 in non-oily capsules: the role of formulated compounds and implications for intermittent replacement

• Autor(a) principal: Coelho,Iara Maria Gomes
• Data de Publicação: 2010
• Outros Autores: Andrade,Luena Dias de, Saldanha,Lunnara, Diniz,Erik Trovão, Griz,Luiz, Bandeira,Francisco
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Arquivos Brasileiros de Endocrinologia & Metabologia (Online)
• Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0004-27302010000200022
• topic: Bioavailability; vitamin D; pharmacokinetics

OBJECTIVE: To evaluate the bioavailability of vitamin D in capsules as compared with oily drops in nuns living in a closed community with very low sun exposure. METHODS: A randomized, 2 x 2 crossover, open clinical trial was conducted, with 18 nuns aged between 20 and 75 years. Samples were collected in the fasting state and at 4, 8, 12 and 24 hours following the administration of capsules and oily drops (both containing vitamin D3 66,000 UI plus vitamin A 13,200 UI) to determine serum 25 hydroxivitamin D concentrations (25OHD), at baseline and 90 days after. The evaluation was based on the maximum concentration (Cmax) and area under the curve (AUC0-24). RESULTS: The capsule formulation presented Cmax and AUC0-24, 5.78% and 0.76%, respectively, greater than the oily drops formulation. CONCLUSION: Both formulations were within the limits for a bioequivalence study, namely C-90% for Cmax and AUC0-24, and the drugs were considered bioequivalent.