The goal of the research is to improving the process for making Carvedilol pulsatile drug delivery capsules (CPDDC) by adjusting critical material attributes (CMA) like coating polymer concentration and critical process parameters (CPP) like inlet temperature and atomizing air pressure, as well as their effects on critical quality attributes (CQA) like size of pellet, drug entrapment efficiency, drug release rate for 12 hours from the pulsatile pellets by implementing Boxbehnken design. Almost 15 formulations were made by varying the process parameter and polymer concentration. The CP13 pellet was an optimal formulation out of the 15 formulations, established by the control of CMA, CPP, and CQA. As per the in-vivo pharmacokinetic evidence, the pulsatile coated pellet loaded with carvedilol revealed improved bioavailability than the marketed dosage form, by increasing the plasma drug concentration profile such AUC and Cmax, which shows the enhancement of bioavailability. The chosen CMA (2.5 of polymer concentration) and CPP (40oC Inlet temperature; 1 Kg/cm2 Atomizing air Pressure) are the suitable variables for the preparation of CPDDC, according to the proven response.

Carvedilol; Pulsatile; Particle size; Capsules; Pharmacokinetic.