Published Paper Details:

CR oral drug delivery systems are controlled release Systems that are meant to ensure that the plasma drug concentrations are constant, that dose is reduced and that patients adhere better than other conventional formulations. Nevertheless, predictable drug release and a dependable in vitro-in vivo relationship is one of the major challenges in pharmaceutical development. The goal of the present research was to optimize a new formulation of controlled release and develop a strong in vitroin vivo correlation (IVIVC) to determine in vivo performance based on in vitro data. The systematic design of experiments (DoE) was used to maximize formulation variables such as polymer concentration and matrix composition. The ready-made formulations were tested by in vitro dissolution investigations by using standard USP apparatus and in vivo pharmacokinetic tests to measure such parameters as Cmax, Tmax, and AUC. The optimized formulation showed a regulated and maintained drug release pattern with enhanced pharmacokinetic functioning. It was found that there was a high correlation between the in vitro dissolution and in vivo absorption with an IVIVC of level A which is high predictability of the model. The results affirm that the optimized controlled release system improves therapeutic efficacy, provides long-term effects of drugs, and also lowers the dosing rate, thus making it a promising approach to enhanced delivery of drugs orally.