Design, Development and Evaluation of Pulsatile Drug Delivery System of Ramipril

The aim of the present investigation is to develop a Ramipril pulsatile drug delivery system. Pulsincap is based on an insoluble capsule body filled with Ramipril Egg albumin microspheres and cap filled with uncoated granules, separated by HPMC K4M plug. Ramipril microspheres were prepared by emulsion polymerization method with egg Albumin by varying drug to polymer ratio (1:1, 1:2, 1:3and 1:4). Granules were prepared by wet granulation method by varying concentration of superdisintegrant. Optimized microspheres were evaluated for the interaction study by FT-IR, percentage yield, angle of repose, drug content, SEM and particle size analysis. Optimized granules were evaluated for various parameters like angle of repose, carr's index and drug content. The formaldehyde treated capsule bodies were tested for physical appearance, visual defects, solubility studies and qualitative chemical test for free formaldehyde. The optimized Ramipril loaded pulsincap were evaluated for in vitro drug release and kinetic study. The drug release from optimized Ramipril pulsincap followed Zero order kinetics and mechanism of drug release was governed by peppas - korsmeyer model. Ramipril microspheres with small particle size, good loading capacity are produced by M4 formulation. G4 showed better release profile. Thus optimized formulation were formulated as pulsincap and showed in vitro release up to 24 hours.