Review- Long-term Safety Concerns with Proton Pump Inhibitors
- Ali Tauseef, DN Roberts, WM Tierney
- The Am J Med
In the present work emphasize on Esomeprazole magnesium is formulated as delayed release tablets to provide desired effect at certain time in maintained drug concentration without any unwanted effect with patient compliance also to improve it bioavailability by decreasing its expose to gastric acid. A delayed release dosage form is designed to release the drug from the dosage form at a time other than promptly after administration. UV spectrophotometric method has been developed for the estimation of Esomeprazole in pharmaceutical formulations. Then the tablets were prepared by wet granulation method rather than direct compression because of cohesive property of the drug. Optimized core tablet then subjected for enteric coating by selected base coat polymer cellulose derivative for preventing core tablet from moisture. The coated formulations were compared with marketed sample (ESOZ) for optimization. Dissolution results of tablets with enteric coating have shown release of Esomeprazole in simulated gastrointestinal fluid pH 1.2, but most of the drug released in pH 6.8 Phosphate buffer. At the end it was found that prepared formulation gave satisfactory results compared with marketed sample dissolution profile. Hence prepared formulation by-pass the degradation of Esomeprazole by enteric coating approach and can be used as single unit dosage for the treatment of acid-related diseases. Thus a pharmaceutically equivalent, robust formulation of Esomeprazole delayed release tablet was developed.