DEVELOPMENT AND IN VITRO ASSESSMENT OF GASTRO-RETENTIVE BILAYER FLOATING TABLET FOR MANAGING HYPERTENSION IN ACUTE CONDITIONS

Document Type : Original Article

Authors

1 124 B. L. Saha Road

2 Cognizant Technology Solutions, Kolkata

3 Department of Pharmaceutical Technology

Abstract

Background: This study disseminates the formulation and in vitro assessment of bilayer floating tablets designed to be retained in the stomach, delivering a combination of amlodipine besylate and atenolol. The tablets aimed to swiftly release amlodipine besylate while ensuring the sustained release of atenolol. The immediate-release layer of the HPMC-based bilayer tablet contained crospovidone and sodium starch glycolate as super disintegrants, along with a combination of guar gum and xanthan gum as binding agents. The sustained release layer included NaHCO3 and citric acid to facilitate floating.

Results: The optimized formulation comprised 60% HPMC K15M, 16.5% Carbopol 934P, and 9% each of crospovidone and NaHCO3 in the immediate release layer, along with 33.33% HPMC K15M, 10% NaHCO3, 1.7% each of natural gums in the sustained release layer, all in w/w. Post-compression, characterisation and in vitro drug release tests were performed. On immersion in simulated gastric fluid (SGF), without enzymes, pH 1.2, at 37 ºC, the tablets floated and remained buoyant without disintegration for more than 20 h. In simulated gastric fluid (SGF), over 99% of amlodipine besylate was released from the immediate release layer within 75 mins, while 99.23% of atenolol was released from the delayed release layer within 12 hours.

Conclusion: A comparison with a similar marketed product indicated the superior performance of the optimal batch in terms of in vitro drug release profile.

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