Fabrication and Evaluation of Aceclofenac-loaded Sustained-Release Mucoadhesive Tablet Composed of Cassia fistula Seed Gum-Grafted-Poly (Sodium Acrylate)

Abstract

Aim: This study was aimed to fabricate gastroretentive mucoadhesive sustained-release tablets of aceclofenac with Cassia fistula seed gum-grafted-poly(sodium acrylate) and evaluate them.
 Background: Aceclofenac has several gastric related side effects such as increase in acid secretion, gastritis, burning sensation, nausea, vomiting, etc. Sustained-release tablet may reduce these because of slow drug release. But long term use of conventional sustained-release tablets of NSAIDs showed to develop colorectal ulcer. Gastroretentive sustained-release devices may eliminate this problem.
 Objective: The objective was to synthesis Cassia fistula seed gum-grafted-poly(sodium acrylate) and apply it in the fabrication of novel mucoadhesive sustained-release tablet for aceclofenac delivery in stomach.
 Method: CFSG-grafted-poly(sodium acrylate) (CFSG-g-PSA) was synthesized by microwave-assisted free-radical initiation method using ceric ammonium nitrate (CAN) as free-radical initiator. The tablets were prepared with the graft-copolymer by wet granulation technique. Compatibility between drug and graft-copolymer was checked by FTIR, DSC and PXRD. Surface topography of the uncoated matrix tablets was studied by SEM. The tablets were evaluated for weight variation, content uniformity, dimension, disintegration test, mucoadhesive and drug-release. accelerated stability study was also done.
 Results: FTIR, DSC and PXRD studies substantiated the drug-polymer compatibility. The evaluation parameters were within prescribed limit. The study revealed excellent mucoadhesive property over 10 h and sustained-drug-release pattern following zero order kinetic. Similarity factor was found to be 83.4.
 Conclusion: The study demonstrates a simple approach of functionalization of biopolymer towards development of gastroretentive mucoadhesive sustained-release tablet formulation.