How Does SyncroDose™ Control Drug Release?

This delivery system works by controlling the rate of water ingress into the coating and subsequent disintegration of the core. Modification of this coating layer can be made to control the rate of release of drug, i.e., extent of lag time and release profile of drug.

The following image demonstrates through animation the gamma image obtained for the referenced scinitigraphy study and illustrates the erosion and subsequent release of the coating (blue) from the core (green) throughout the gastrointestinal tract over time.

Within a few minutes of administration, the SyncroDose tablet enters the stomach. At this point in time, the outer polysaccharide based coating, shown in blue, begins to swell. The tablet core, represented by the green area, remains intact. Over time, the tablet moves along the gastrointestinal tract through the pylorus and into the duodenum. The coating erosion process continues. The tablet core exhibits slower transit and remains subsequently in its entirety. After approximately 3.5 hours, the coat erosion process is completed, exposing the core to the intestinal environmental conditions. Upon exposure, the core bursts open almost immediately and the disintegration process is complete within a few minutes. Following the rapid burst, the drug component of the core becomes available for immediate dissolution and absorption.

Scinitigraphy data for both the coating and core of a SyncroDose Tablet
The following sets of image illustrate independently and with greater detail the in vivo performance of the SyncroDose tablet's core and coat. The tablet core is radiolabelled with ER-171 (0.5MBq) and the compression coating is radiolabelled with Sm-153 (1.5MBq). Click here to view the detailed image with captions.

How Does SyncroDose Work Over Time?

A combination of the time of administration and the body's biologic clock enables the customization of drug delivery to optimize both dose and efficacy.

Results from this pharmacoscintigraphy study demonstrate a customized delivery of drug whereby maximum plasma levels are achieved after five hours, preceded by a predetermined lag time. An excellent in vitro/in vivo correlation was observed. To view the charts in greater detail, select Average Blood Plasma Data or In Vitro Dissolution Data.