Artículos de revistas
Comparative Study Of Relative Bioavailability Between Two Brazilian Different Commercial Formulations Of Sistemic Isotretinoin [estudo Comparativo De Biodisponibilidade Relativa Entre Duas Formulações Comerciais Distintas De Isotretinoína Sistêmica Existentes No Brasil]
Registro en:
Revista Brasileira De Medicina. , v. 60, n. 01/02/15, p. 61 - 64, 2003.
347264
2-s2.0-0037288414
Autor
Stirling S.
Di Spirito M.
DiMarco M.
Morelli G.
Tanguay M.
Wada C.Y.
Institución
Resumen
This study was conducted to evaluate the bioavailability of a new tablet formulation of isotretinoin and its metabolic 4-oxoisotretinoin (80 mg) relative to a reference product. The bioavailability was carried out in 36 healthy subjects in a randomized balanced 2 X 2 crossover design. After dosing, the blood samples were collected at fixed times for a period of 144 hours. The plasma concentrations of the blood samples were analized by a validated chromatography assay. Pharmacokinetic parameters related to the extent of absorption as the area under concentration curve until t (Auc t and the area until infinity (Auc in) and elimination rates as the maximum concentration (Cmax) were analized under the multiplicative model, that is, using log-transformation of these measures. The average bioequivalence between the two formulations was assessed by the parametric 90% confidence interval for the ratio of mean values of T and R of the pharmacokinetic characteristics. The confidence interval was included in the bioequivalence interval of 80%-125%, in all cases. Schuirmann's two one-sided t tests also supported the conclusion of the test formulation bioequivalent to the reference from isotretinoin and 4-oxoisotretinoin. 60 01/02/15 61 64 (2001) Physicians' Desk Reference®, 55 th Ed., , Montvale, New Jersey Lucek, R.W., Colburn, W.A., Clinical pharmacokinetics of the retinoids (1985) Clin Pharacokin, 10, pp. 38-62 Khoo, K.C., Reik, D., Colburn, W.A., Pharmacokinetics of isotretinoin following a single oral dose (1982) J Clin Pharmaco, 22, pp. 395-402 McEvoy, G.K., (2000) AHFS Drug Information® 2000, , Bethesda, Maryland. American Society of Hospital Pharmacists, Inc Allen, J.G., Bloxham, D.P., The pharmacology and pharmacokinetics of the retinoids (1989) Pharmac Ther, 40 (1), pp. 1-27 Schuirmann, D.J., A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability (1987) J Pharmacokinet Biopharm, 15, pp. 657-680 Chow, S.-C., Liu, J.P., (2000) Design and Analysis of Bioavailability and Bioequivalence Studies, 2 nd Edição, , Marcel Dekker, Inc