DCMax - A novel Delayed Cmax Drug Delivery System for Improved Chronotherapy
Gupta, S.; Punyani, K.; Lohde, J. B.; Knopp, M. M.; Shalom, D. B.
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This study evaluated the Delayed Cmax 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-vitro 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 Cmax 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.
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