[Bioequivalence and bioavailability after single administration of effervescent ranitidine tablets]

Area of Science:

• Pharmacology
• Clinical Pharmacy
• Drug Formulation

Background:

• Ranitidine is a widely used H2 receptor antagonist for treating acid-related gastrointestinal disorders.
• Standard ranitidine formulations include dispersible tablets.
• Novel drug delivery systems, such as effervescent tablets, aim to improve patient compliance and drug absorption.

Purpose of the Study:

• To assess the relative bioavailability of a 150 mg ranitidine effervescent tablet compared to a 150 mg ranitidine dispersible tablet.
• To determine the bioequivalence between the two ranitidine formulations.
• To evaluate the safety and tolerability of the ranitidine effervescent tablet.

Main Methods:

• An open-label, two-way crossover study involving 12 healthy male volunteers.
• Administration of single oral doses of 150 mg ranitidine effervescent tablet and 150 mg ranitidine dispersible tablet.
• Blood sample collection at predetermined time points to analyze pharmacokinetic parameters (AUC, Cmax).
• A one-week wash-out period between the two treatment phases.

Main Results:

• The ranitidine effervescent tablet demonstrated a relative bioavailability of 99% compared to the dispersible tablet.
• The mean ratio of Cmax (maximum plasma concentration) was 95%.
• Non-parametric 95% confidence intervals for AUC and Cmax were within the accepted bioequivalence range (87-116% and 84-107%, respectively).

Conclusions:

• The ranitidine 150 mg effervescent tablet is bioequivalent to the 150 mg ranitidine dispersible tablet.
• The effervescent formulation is well-tolerated by healthy male volunteers.
• The findings support the use of the ranitidine effervescent tablet as a viable alternative to the dispersible formulation.