Abstract
A comparative in vitro and in vivo performance study of a novel slow release capsule (prepared using the new laser drilled controlled drug delivery system) and a conventional capsule dosage from has been made using tetracycline hydrochloride as a model drug. The influence of variation in drug delivery system design on the in vivo performance was studied by urinary excretion rate studies in human volunteers. Slow release capsules released its contents relatively slowly, over a period of time, both in vitro and in vivo, as compared to conventional capsules, with significantly similar Ke and t1/2 values. Plasma Cmax and tmax and AUC values were predicted based on the reported correlation between serum and urinary excretion data in single dose trials.