Abstract
Floating Osmotic Drug Delivery System (FODDS) is one of the novel approaches useful for achieving modified drug release pattern in upper gastrointestinal tract. The advantage of FODDS is that the drug release from this system is independent of presence of food, pH, and hydrodynamic conditions of gastrointestinal tract. Diltiazem HCl, a potent calcium channel blocker, used in the management of angina pectoris, arrhythmia and hypertension selected as model drug for the present study. Because of its relatively short half-life and high frequency of dose administration, the development of oral floating osmotic formulation of Diltiazem HCl is highly desirable, so as to improve oral bioavailability along with minimum side effects and improved patient compliance. In the present work we have used 32 factorial design to determine effect of KCl and HPMC K4M on drug release from core tablet. Use of HPMC K4M in the core tablet was made for the purpose of retarding the release of highly water soluble drug Diltiazem HCl from core tablet. Prepared FODDS tablets were evaluated for hardness, friability, drug content and in vitro drug release. All formulations showed zero order drug release kinetics. Optimized F3 formulation has buoyancy lag time of 8 minutes, total floating of 8 hours and in vitro drug release of 98.21%. The F3 formulation was subjected to accelerated stability study and found to be stable after 3 months with no change in release pattern. It is concluded that FODDS offers a new strategy for improving oral bioavailability of Diltiazem HCl.