Formulation and Evaluation of Tramadol HCL Pectin Coated Chitosan LDH Bionanocomposite Beads for Colon Drug Delivery System

Abstract

Background: Tramadol HCl (TH) is a centrally acting analgesic that is used to treat mod-erate to severe pain intestinal disorders. Its use is limited orally due to instability. Objective: The study aims to develop TH Pectin-coated chitosan LDH bionanocomposite beads for colon targeting. Methods: LDH-TH intercalation was done by precipitation reaction and it was used to prepare bi-onanocomposite beads of TH. The developed beads were characterized for bulk density, tap density, angle of repose, HR, CI, particle size, SEM, swelling study, drug loading, and EE. In vitro release study in pH 1.2 HCl buffer, pH 6.8 buffer, and pH 7.4 buffer was performed. The compatibility study was performed using FTIR and DSC studies. Results: The optimised formulation (F8) was found to be spherical and smooth. All other micromerit-ics properties were found within the acceptable range with the particle size of 543μm to 888 μm. The amount of swelling is greatly influenced by the pectin concentration employed in the coating process. Drug loading of batches F1 to F8 ranged from 52.37% to 90.25%. % EE of batches F1 to F8 ranged from 71.92% to 88.78. FTIR and DSC studies showed no physical incompatibility between the drug and used excipients. Batch (F8) showed a more controlled release pattern at the highest coating con-centration of pectin (1.5%). The stability study also revealed that there was no change in the drug release profile. Conclusion: The developed beads can be used to target the colon to prolonged-release characteristics.