FORMULATION DESIGN AND EVALUATION STUDIES OF ESOMEPRAZOLE
MAGNESIUM TRIHYDRATE ENTERIC COATED DUODENAL
DRUG DELIVERY SYSTEM
Putta Rajesh kumar*1, Somashekar shyale1, Mallikarjuna Gouda.M1, S.M.Shanta Kumar2
1. Department of Pharmaceutics, V.L.College of Pharmacy, Raichur -584103, Karnataka, India.
2. Department of Pharmaceutical Chemistry, V.L.College of Pharmacy, Raichur -584103, India.
Keywords: Esomeprazole magnesium trihydrate, crospovidone, sodium starch
glycolate, croscarmellose sodium and In vitro studies.
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.
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