DCMax - A novel Delayed C max Drug Delivery System for Improved Chronotherapy
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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
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Erosion-based controlled release tablet may enable chronotherapy dosing
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Chronotherapeutically-relevant release rate achieved for molecules including thyroid hormone T3 and caffeine in-vitro
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Drug release rate largely independent of molecule type when the drug load is ≤20%
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Pharmacokinetic modelling predicts API release profile matching circadian rhythm
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Clinical study shows delayed Cmax and reduced peak during release
