Bioavailability of controlled-release metoclopramide. 1st communication: single dose study

Area of Science:

• Pharmacology
• Drug Delivery Systems

Background:

• Metoclopramide monochloride hydrate is commonly administered orally.
• Controlled-release formulations aim to modify drug absorption profiles.

Purpose of the Study:

• To compare the bioavailability of a controlled-release metoclopramide capsule (Gastro-Timelets) with an oral solution.
• To assess the extent of absorption for both metoclopramide formulations.

Main Methods:

• Single oral dose administration of 30 mg metoclopramide in a cross-over study with four healthy volunteers.
• Plasma metoclopramide concentrations were quantified using High-Performance Liquid Chromatography (HPLC).
• Area Under the Curve (AUC) was calculated to determine the extent of absorption.

Main Results:

• Peak plasma metoclopramide concentrations were lower and delayed with the capsule compared to the solution.
• The mean AUC (0-30 h) for the capsule was 943.7 ng/h/ml, and for the solution was 896.2 ng/h/ml.
• Statistical analysis of AUC values indicated equivalent extent of absorption between the two formulations.

Conclusions:

• The controlled-release metoclopramide capsule (Gastro-Timelets) demonstrates comparable bioavailability to the oral solution.
• The findings support the equivalence of absorption for the tested metoclopramide formulations.
• This suggests Gastro-Timelets can be a viable alternative to oral solutions for metoclopramide delivery.