Bioequivalencia de dos formulaciones de Metformina, tabletas de 850 mg, en voluntarios sanos colombianos / Bioequivalence of two metformin formulations: 850 mg tablets in healthy colombian volunteers

Introducción: la metformina es un antihiperglicemiante útil en el manejo de la diabetes mellitus tipo II, del que se encuentran en el mercado colombiano tanto el producto innovador como diferentes formulaciones genéricas. Para garantizar la seguridad y eficacia de estas últimas, es necesario demostrar su bioequivalencia con respecto al producto innovador.Objetivo: determinar si el producto Dimefor®/Metformina MK es bioequivalente con el producto Glucophage? (referencia) cuando se administran en dosis iguales a un grupo de voluntarios sanos.Método: el estudio se realizó sobre veinticuatro voluntarios que cumplieron con los requisitos de inclusión y decidieron participar espontáneamente después de ser informados sobre su función en el estudio. Se utilizó un diseño aleatorio cruzado, en dos períodos, dos secuencias y doble ciego. Se administró una dosis única de 850 mg de cada producto y se tomaron muestras de sangre por un período de 24 horas. La cuantificación de la metformina se realizó por HPLC (High Performance Liquid Chromatography). Para la determinación estadística de bioequivalencia se utilizó la prueba de Schuirmann.Resultados: los dos productos fueron bioequivalentes con intervalos de confianza contenidos entre 80.0 por ciento y 125.0 por ciento para ln ABC0-8 (84.6 por ciento-100.0 por ciento), ln Cmax (89.1 por ciento-109.0 por ciento) e ln ABC0-Tmax (83.4 por ciento-101.4 por ciento) y entre 80.0 por ciento y 120.0 por ciento para Tmax (85.1 por ciento y 109.8 por ciento).

INTRODUCTION: Metformin is an orally active antidiabetic agent used to treat type II diabetes; it is found in the Colombian market in both the innovator brand and the generic formulations. The latter have to prove some biopharmaceutical quality outcomes to guarantee interchangeable proprieties. OBJECTIVE: To determine whether the drug Dimefor®/Metformina MK is bioequivalent to the reference product Glucophage®, when the products are administrated, at the same dose, to a group of healthy volunteers. METHOD: The study was made with 24 healthy volunteers who met the inclusion criteria and spontaneously decided to participate after being thoroughly informed. We used a two-sequence threeperiod randomized, crossed and double-blind study. The volunteers took an 850 mg dose of each medicine; then, blood samples were taken throughout 24 hours and the metformin quantification in plasma was determined by High Performance Liquid Chromatography with UV detection (HPLC/UV). For statistical analysis, Schuirmann's test was used. RESULTS: The study showed that both preparations are bioequivalent; confidence intervals for ln AUC0-∞, ln Cmax, ln AUC0-Tmax and Tmax were [84.6-100.0%], [89.1-109.0%], [83.4­01.4%] and [85.1-109.8% ], respectively.

Bioavailability of Salbutamol Sulfate Orally Disintegrating Tablets in Healthy Subjects / 中国药房

OBJECTIVE:To study the relative bioavailability and pharmacokinetics of salbutamol sulfate orally disinte?grating tablets.METHODS:A single dose of8mg salbutamol sulfate orally disintegrating tablets or commercial salbutamol tablets was administered in a randomized crossover design in18volunteers and the plasma concentrations of salbutamol were determined by HPLC.The pharmacokinetic parameters were calculated with3p97pharmacokinetic program and the bioequiv?alency was evaluated.RESULTS:The concentration-time curve of two preparations fitted to two-compartment model.The peak plasma levels(C max )of salbutamol sulfate orally disintegrating tablet and commercial salbutamol sulfate tablet were(17.65?6.48)ng/ml and(16.60?6.21)ng/ml,respectively.The peak time(T max )were(1.92?1.18)h and(2.03?1.17)h and AUC 0～24 were(127.23?32.41)ng/(h?ml)and(131.42?37.73)ng/(h?ml),respectively.The relative bioavailability of salbu_ tamol sulfate orally disintegrating tablet was(99.32?15.58)%.CONCLUSION:The results of two one-side tests suggests that salbutamol sulfate orally disintegrating tablet is bioequivalent to the commercial salbutamol tablet.