Formulation and Optimization of Chronotherapeutic Drug Delivery from Carvedilol Sulphate Compression Coated Tablets by using Design of Experiment Approach.

ABSTRACT

The aim of this present work was to develop and optimize compression coated tablet of carvedilol sulphate for chronotherapeutic application by response surface methodology based on 32 factorial designs. Compression coated tablet containing carvedilol phosphate in the core was formulated with an outer coat by eudragit L 100 and ethyl cellulose. The percentage weight ratio of ethyl cellulose to eudragit L 100 and coating level were selected as critical process parameters (CPPs), whereas critical quality attributes (CQAs) were lag time and cumulative percentage drug release at 8 hr in current study. For optimization, the effects of critical process parameters upon the critical quality attributes were modelled using the polynomial equations involving critical process parameters and their interactions for various critical quality attributes. A numerical optimization technique was adopted to achieve optimized formulation which was also used as the check point.The observed responses were closed well with the predicted values. The formulation exhibited pulsed release profile after a programmed lag time and thus suitable for chronotherapeutic delivery. The study demonstrated a successful optimized formulation followed by evaluation of compression coated tablet of carvedilol sulphate for chronotherapeutic drug delivery.