Abstract:
OBJECTIVE To prepare propranolol hydrochloride bi-layered pulsatile release tablets, and study the drug release properties of the tablets. METHODS Propranolol hydrochloride core tablets were prepared by direct compression and spray-coated with HPMC E5 swelling layer and eudragit polymeric layer subsequently. The effects of formulation and dissolution methods on the in vitro release profiles of the tablets were studied using in vitro dissolution test. RESULTS Propranolol hydrochloride released from the tablet in pulsatile behavior after a certain lag time. The osmotically active substance sodium chloride, the thickness of the swelling layer and the polymeric layer, and the ratio of Eudragit RS/RL all had effects on the lag time. Dissolution method and the pH of dissolution medium had no influence on the lag time. CONCLUSION The propranolol hydrochloride pulsatile release tablets have pulsatile release characteristics with lag time of about 4 h.