A Novel Lorazepam Orodispersible Film: Bioequivalence, Pharmacokinetic, and Tolerability Evaluation Compared with Film-Coated and Orodispersible Tablets in Two Randomized Crossover Studies in Healthy Subjects

Introduction

Lorazepam is a widely prescribed benzodiazepine available in multiple pharmaceutical formulations. A novel lorazepam orodispersible film (ODF) has been developed as an alternative dosage form designed to address administration challenges and enhance treatment adherence. Its pharmacokinetic profile, including the rate and extent of absorption, and its tolerability were evaluated in comparison with commercially available oral formulations in two bioequivalence studies.