The gastrointestinal transit and disintegration characteristics of an
enteric coated timed release formulation were investigated in a group
of six healthy volunteers using the technique of gamma scintigraphy. T
he mean in vivo tablet disintegration time was approx. 10 h post-dose
and 7.5 h after gastric emptying which was in excellent agreement with
that predicted from in vitro methodology. The anatomical site of rele
ase ranged from the caecum to the descending colon and once the onset
of disintegration had been detected by scintigraphy, the time for comp
lete break up was typically in the region of 45-60 min. The enteric co
ated Time Clock(R) system therefore provides for a pharmaceutical prep
aration capable of drug delivery to the colon.