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Formulation and in Vitro Evaluation of Diclofenac Sodium Delayed Release Tablets

Author(s): Bharghava Bhushan Rao Pathange, K. E. V. Nagoji, Praveen Gaddam, Raju Jukanti and Manoj Kumar Jalagam

Diclofenac sodium, a non-steroidal anti-inflammatory drug inspite of its absorption throughout the G. I tract irritates the G. I wall and is more likely to cause ulcer in stomach. In the present work so as to protect from gastric ulcer, Diclofenac sodium was formulated as delayed release through enteric coating. All the physical parameters like hardness, friability were found to be within the limits through wet granulation process while showing good flow properties. Drug and excepients were confirmed to be standard without any incompatibility by authenticated DSC samples. Disintegrating time (DT) was found to be matched in F4 as that of core innovator. F 11 tablets, which were coated with Eudragit polymers showed better release characteristics compared to that of HPMC and CAP. The optimized formulation F11 were subjected to stability studies as per ICH guidelines, which were found to be intact without any deterioration for 3 months in comparison to innovator sample. All the results were found to be in correlation, by which the stable delayed release Eudragit enteric coated tablets can be subjected for further in vivo studies.

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