DCMax - A novel Delayed Cmax Drug Delivery System for Improved Chronotherapy

This study explored the Delayed Cmax Drug Delivery System (DCMax), a novel erosion-based controlled-release formulation aimed at delaying peak plasma concentration (Cmax) and maintaining drug release. The tablet formulation incorporated hydroxypropyl methylcellulose, hydroxypropyl methylcellulose acetate succinate, and polyethylene oxide.

Through in-vitro dissolution and erosion tests, the delayed release profile of DCMax was validated. To evaluate the in-vivo performance, the study involved six healthy volunteers who underwent salivary caffeine concentration measurements following the ingestion of either immediate-release caffeine tablets or DCMax tablets. The results indicated that DCMax induced a significant delay in Cmax by 5 hours, as opposed to the 1-hour peak observed with the immediate-release formulation.

Furthermore, the peak caffeine concentrations in saliva were lower when using DCMax compared to the immediate-release option. These findings underscore the potential of erosion-based drug delivery systems in achieving delayed release, which could hold promise for chronotherapy applications in treating endocrine disorders.