Year: 2026
Type: preprint
Abstract: This study evaluated the Delayed C max Drug Delivery System (DCMax), an erosion-based controlled-release formulation designed to delay peak plasma concentration (Cmax) and sustain drug release. The tablet matrix contained hydroxypropyl methylcellulose, hydroxypropyl methylcellulose acetate succinate, and polyethylene oxide. In-vitr o dissolution and erosion studies confirmed the delayed release profile. In-vivo performance was assessed in six healthy volunteers by measuring salivary caffeine concentrations after administration of immediate-release caffeine tablets and DCMax tablets. DCMax induced a delayed C max of 5 hours compared with 1 hour for the immediate-release formulation, while peak concentrations were lower compared to immediate release. These findings demonstrate that erosion-based drug delivery can achieve delayed release, with potential application in chronotherapy for endocrine disorders. Highlights Erosion-based controlled release tablet may enable chronotherapy dosing Chronotherapeutically-relevant release rate achieved for molecules including thyroid hormone T3 and caffeine in-vitro Drug release rate largely independent of molecule type when the drug load is ≤20% Pharmacokinetic modelling predicts API release profile matching circadian rhythm Clinical study shows delayed Cmax and reduced peak during release
Language: English
Subfield: Pharmaceutical Science
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W7214765925