Designing an effective dissolution test for bilayer tablets tailored for optimal melatonin release in sleep disorder management.

ABSTRACT: This project aims to investigate the release performance of bilayer tablet (BL-Tablet) designed with both fast and slow-release technology, targeting sleep disorders. The tablet incorporates Melatonin, extracts of Eschscholzia californica and Melissa officinalis. In order to validate the effectiveness of the extended-release profile, an advanced dissolution test was herein proposed. This new method utilizes biorelevant intestinal fluid media and incorporates a stomach-to-intestine fluid changing (SIFC) system. To demonstrate the advantages of employing this method for assessing the controlled release profile of active ingredients, the dissolution results were compared with those obtained using the conventional EU Pharmacopoeia approach. Furthermore, the comparative analysis w

SUBMITTER: Bassetto R 

PROVIDER: S-EPMC11102985 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature