In vitro- In vivo Correlation Studies of Modified Release Tolterodine Tablet Dosage form in Rabbits.

ABSTRACT

Tolterodine is an antimuscarnic drug that is used for sympathetic treatment of urinary incontinence. Tolterodine modified release tablet, was investigated in rabbit for pharmacokinetic and in vitro–in vivo correlation studies. Tablets were prepared and in vitro release was studied in simulated gastric fluid at 150RPMs. New Zealand albino male rabbits have been used as animal model for in vivo study. A sensitive and simple HPLC method was developed for the determination of Tolterodine content in rabbit plasma. In vitro release studies showed that release patterns followed zero order for around 24h. The in vivo–in vitro correlation coefficients obtained from point-to-point analysis were greater than 99% between concentrations at certain time points obtained from release study in simulated gastric fluid and HPLC analysis of rabbit’s plasma. From the in vitro–in vivo correlation prediction it was evident that the Tolterodine matrix assisted tablet is a good for controlled delivery of Tolterodine.