Design, formulation, and evaluation of delayed release oral dosage form of proton pump inhibitor

Background: A proton pump inhibitor is an acid labile drug which degrades at stomach pH 1.2. Delayed release pellets were prepared to stabilize the formulation applying an enteric coat. Objective: the objective of the study was to design, formulation and evaluation of delayed release oral dosage form of proton pump inhibitor. Materials and Methods: Twelve different formulations of pellets were prepared by fluid bed technology (bottom spray technique) using different polymers for different coating processes namely seal coat (HPMC); drug coat (HPMC); barrier coat (Ethyl cellulose) and enteric coat (HPMC Phthalate). The formulated pellets were evaluated. Results: FTIR studies revealed that there was no physic-chemical interaction between drug and excipients. Micromeritic property study for pellets revealed that the values were within the permissible limits. The pellets were filled into the capsules and evaluated for drug content, %loss on drying, weight variation and in vitro dissolution. Conclusion: The filled weight of the capsule was in the pharmacopeail limits, the 5 drug content of all the formulation was fund to be in the range of 97-99 % and the % LOD was less that 35. F1-F12 formulations exhibited a release in a range of 60-90.37% in 45 min at PH 6.8.Optimized Formulation F10 Exhibited maximum release of 90.37% in 45 min . The barrier coat of the all the formulations effectively prevented the release of the drug in the stomach. The stability study revealed that the formulation F10 was stable when stored at 30°C±2°C/65±5% RH for one month