Development of Tablet Formulations of Enteric Coated Esomeprazole with Acryl EZE

Esomeprazole magnesium trihydrate tablets were formulated by directly compression and enteric coated with Acryl EZE. The rheological characteristics of powder beds were freely flowable and easily compressible. The Compressional parameters after enteric coating were found to be uniform and consistent. The hardness (Kg/cm2) was found in the range of 4.133±0.321 to 4.833±0.153. The enteric coated tablets were not disintegrated in simulated gastric fluid. The drug content in all formulations was found to be uniform and consistent. Accuracy and precision studies indicated drug content uniformity in tablet formulations. The acid uptake studies showed less than 5% acid uptake for all tablets indicated that the drug could be protected from degradation in gastric environment by acryl EZE enteric coating. In the In vitro drug release studies there is no loss during gastric phase. Later the study showed that tablets with lactose DC released higher than mannitol probably owing to its hydrophilicity and due to swelling of the super disintegrant. From the above findings it can conclude that an enteric coated Esomeprazole magnesium trihydrate tablet dosage form could be developed to deliver the drug in to proximal small intestine for more bio availability and to treat peptic ulcer.

Author(s): Putta Rajesh Kumar, Somashekar Shyale, M. Mallikarjuna Gouda and S. M. Shanta Kumar

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