Enteric coated tablets of novel proton pump inhibitor with super disintegrants design, in-vitro evaluation and stability studies.

ABSTRACT

The current work evaluate directly compressible esomeprazole magnesium trihydrate enteric coated tablets were prepared to deliver drug in upper GIT. Different tablets were prepared with super disintegrants like Ac-Di-Sol, Crospovidone, sodium starch glycolate and diluents like Pharmatose DCL11, Mannogem EZ. Tablets were enteric coated using Acryl-EZE. The tablets were evaluated for hardness, disintegration time and in vitro drug release. The powder bed showed good rheological properties and enteric coated tablets showed acid uptake value <5 indicates significant protection of acid liable drug. The compressional parameters were within the limits, the drug content in all formulations was found to be uniform and consistent. In vitro dissolution studies indicated there is no drug loss during gastric phase. The tablets with Pharmatose DCL11 released higher than Mannogem EZ which colud be due to its hydrophilicity and due to swelling of the super disintegrant. Stability studies indicated that the prepared formulations were stable for a period of four months of all formulations showed comparable dissolution profiles with similarity factor more than fifty at p<0.05. From the above findings it can conclude that an Esomeprazole magnesium trihydrate enteric coated tablet could be developed to deliver the drug in to proximal small intestine.