Abstract :
Multi-Unit Particulates (MUPs) with matrix pellets are used to develop controlled-release products of various active pharmaceutical ingredients. They may allow improvement in solubility and thereby bioavailability of poorly soluble drugs. Omeprazole magnesium is a derivative of benzimidazole which belongs to the group of proton pump inhibitors that exhibits degradation in gastric acid with short biological life and variability in bioavailability. The drug degradation problem was overcome by the coating of pellets with enteric coating agents which disperse in the gastrointestinal tract more homogenously than single units with a rapid transit time. Pellets were compressed to reduce the tampering risk and transportation difficulty through the esophagus. The coating was done with the bottom spray technique. A batch of 5% concentration of binder optimized for a tablet affects the disintegration of the tablet. A cushioning agent was employed to optimize the acid resistance with a concentration of 12% and the release profile was depicted in pH 6.8 phosphate buffer followed by 0.1N HCl for 2 hours. The optimized batch was evaluated for acid resistance, similarity factor, SEM, dissolution, and stability studies which exhibited maximum resistance in gastric pH with abrupt release in duodenal pH because of the multi-particulate approach.
Keyword :
MultiUnit Particulates, Enteric coating layer, Proton Pump Inhibitor