FORMULATION AND EVALUATION OF PULSATILE DRUG DELIVERY SYSTEM CONTAINING DOMPERIDONE AND PARACETAMOL

The objective of the study to formulate and evaluate of pulsatile drug delivery containing combination of domperidone and paracetamol for the treatment of migraine which is used to deliver the drug at specific time as per pathophysiological need of the disease and improvement of therapeutic efficacy and patient compliance. Domperidone and paracetamol in the core tablet was formulated with different concentration of superdisintegrants and microcrystalline cellulose, an outer shell tablet which is formulated with different weight ratios of ethyl cellulose (EC) and hydroxyl propyl methylcellulose (HPMC). The effects of the formulation of core tablet and outer shell of press coated tablets; on drug release and the lag time were investigated. The formulation was optimized based on acceptable tablet properties and in vitro drug release. The release profile of press coated tablet exhibited a lag time dependent upon the amount of HPMC K15 and EC in compression coating, followed by burst release. The optimized batch PRT3 gave a lag time of 6.1 h and drug release of 98.67% and 92.56% of paracetamol and domperidone respectively. This consisted of equal amount of HPMC: EC (75:75 w/w). Based on the results programmable pulsatile release has been achieved by formulation PRT3 which meet the demand of Chrono therapeutic objective of migraine.