Abstract:

To address the medication requirements of different populations, efforts have been made to develop sustained-release formulations of andrographolide. In this study, andrographolide tablets (3D-AGT) and encapsulating agents (3D-AGE) were created using a semi-solid extrusion (SSE) 3D printer with varying release rates. Sodium alginate and chitosan were utilized as excipients to produce a hexagonal 3D-AGT with a diameter of 10.00 mm and a height of 3.00 mm. The 3D-AGE was then assembled by combining the upper layer and the ground floor loaded with andrographolide. Both formulations exhibited smooth surfaces and uniform internal composition. FT-IR analysis confirmed that the chemical structures of andrographolide and the excipients remained intact throughout the printing process. The drug loading capacity of 3D-AGT preparations, formulated with four different excipient ratios, exceeded 85%. Additionally, two 3D-AGE preparations (10 and 20 mg) were successfully loaded with the drug. In vitro drug release tests demonstrated that both 3D-AGT and 3D-AGE preparations exhibited satisfactory drug release performance. However, the proportions of excipients and drug loading had minimal impact on the cumulative drug dissolution effect. In terms of antibacterial activity against Escherichia coli, both preparations displayed antibacterial rates of nearly 85% or higher in vitro. Furthermore, the average results from nine volunteers indicated that 3D-AGE effectively masked the bitter taste of andrographolide. This study suggested that the release rate of andrographolide could be regulated using SSE 3D printing through careful structural design and adjustment of printing parameters, thus providing a novel approach for personalized traditional Chinese medicine preparations.

Key words: Semi-solid extrusion, 3D printing, Andrographolide, Release rate, Taste masking