Abstract

In the present study, two sustained release solid and semi-solid matrices were developed using Hydroxypropyl methyl cellulose (HPMC) and Gelucire derivative, Gelucire 50/30. The purpose of the study was in vitro and in vivo correlation of these two sustained release formulations with SR capsules available in market and to know how long the preparation containing HPMC and Gelucire work in the body as compared to the product circulating in the market, so for this two formulations were developed such as solid matrices in tablets form and semi-solid capsules. For the preparation of solid matrices, direct compression method and for semi-solid, filling capsule technology were used. In vitro and in vivo study was perfomed and different parameters were studied such as Cmax, Tmax and AUC for all the three formulations. For determination of Cmax, Tmax ans AUC statistical models were used. In vitrostudy showed that more than 80% drug was released up to 12 h from all the three formulations and no significant difference was observed in release pattern while in vivo study showed prolonged release of the two test formulations after applying statistical models. The drug release from both test formulations was slow thereby providing a prolonged and controlled in vivo delivery of the drug. This proved the superiority of our test capsules and tablets over the reference capsules.

Key words: In vitro and in vivo correlation, deltiazem, kinetic models, statistical analysis.