ABSTRACT

The goal of the work described in the passage was to develop bi-layer tablets of Aceclofenac, a strong non-steroidal anti-inflammatory medication, with both immediate and sustained release characteristics. The ultimate aim was to achieve quick drug release in the stomach for immediate symptom relief and a steady release in the intestine to maintain the intended therapeutic effect. Dry granulation method is used for first layer for formulations F1 - F4 contains cross carmellose sodium and F5 - F8 contains sodium starch glycolate for immediate release. Second layer was made by wet granulation method for formulations F1 - F4 with ethyl cellulose & for formulations F5 - F8 with HPMCK100M. Various formulations are prepared to obtain desired release profile to show first layer Aceclofenac release in stomach and second layer 98% for 10 h sustained release layer. Pre-compression tests are done to all the formulation and all are passed. Formulations (F1-F8) are tested for hardness, thickness, friability, weight variation and drug content. Goal of this is to optimise the formulation that bi-layer tablet to be released immediately in the stomach and second layer to be released for 10 h in the intestine. Optimized formulation F4 contains cross carmellose sodium as super disintegrants in the first layer and ethyl cellulose in the second layer. Keywords: Aceclofenac bi-layer immediate release (IR) sustained release (SR) in vitro studies release kinetics
Publication date: 01/02/2025

https://ijbpas.com/pdf/2025/February/MS_IJBPAS_2025_8693.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.2.8693