Metoclopramide is widely used for treatment of nausea. Development of metoclopramide as a medicated chewing gum has the potential advantage related to patient compliance, fast onset of effect and improved bioavailability. In this study, bioavailability of metoclopramide from a new chewing gum device, 3TabGum® was evaluated in healthy volunteers. Medicated chewing gum was well tolerated in all subjects. Compared to immediate release tablet, AUC following administration of chewing gum was higher (224.91 vs. 166.53 ng h/ml), while tmax was smaller (1.38 vs. 1.88 h), suggesting improved bioavailability and rapid onset of drug absorption. However, absorption rate was lower, as evidenced by lower Cmax (17.23 vs. 20.80 ng/ml). Terminal half-life was prolonged (11.58 vs. 5.35 h), implying that initial fast release of metoclopramide is followed by much slower release of the remaining smaller portion of the drug. These results indicate that chewing gum is a promising alternative to current metoclopramide formulations.
Bioavailability of metoclopramide from a new chewing gum device
MAGGI, LAURETTA;CONTE, UBALDO;
2007-01-01
Abstract
Metoclopramide is widely used for treatment of nausea. Development of metoclopramide as a medicated chewing gum has the potential advantage related to patient compliance, fast onset of effect and improved bioavailability. In this study, bioavailability of metoclopramide from a new chewing gum device, 3TabGum® was evaluated in healthy volunteers. Medicated chewing gum was well tolerated in all subjects. Compared to immediate release tablet, AUC following administration of chewing gum was higher (224.91 vs. 166.53 ng h/ml), while tmax was smaller (1.38 vs. 1.88 h), suggesting improved bioavailability and rapid onset of drug absorption. However, absorption rate was lower, as evidenced by lower Cmax (17.23 vs. 20.80 ng/ml). Terminal half-life was prolonged (11.58 vs. 5.35 h), implying that initial fast release of metoclopramide is followed by much slower release of the remaining smaller portion of the drug. These results indicate that chewing gum is a promising alternative to current metoclopramide formulations.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
