Fusion of Traditional Herbal Drug with Advanced 3-D Printed Dosage Form: Design, Development and Characterization

Abstract

Background

The current scenario demands the design of personalized medicine with fewer side effects. The study aims to design a Liquisolid compact containing a 3D printed tablet (LSC-3DPT) of C.pulcherrima (CP) flower extract to treat urolithiasis utilizing the upgraded statistical regulatory framework.

Results and Discussion

The extraction of terpenes from CP was carried out, and its potency was evaluated in terms of CaCl₂ aggregation, growth, nucleation, and turbidity assays, as well as its ability to inhibit in vitro CaOx crystals. The extract showed reasonable anti-urolithiatic properties, having a p-value < 0.05 with the existing treatment. The observed sticky nature and poor aqueous solubility of the extract were resolved by the liquisolid compact (LSC) technique. The extract was adsorbed into Neusilin (NS). The developed LSC displayed excellent micrometric properties and better solubility. Furthermore, it was loaded into a 3D-printed tablet using FDM technology to make it patient-centric. FMEA scrutinized the percentage infill and layer thickness as critical process parameters, whereas drug release and hardness were identified as critical quality attributes. A central composite design showed the significant effect of process parameters on the quality of LSC-3DPT. The optimized batch exhibited the desired hardness (3.93 ± 0.07), controlled release up to 12 h, and excellent stability.

Conclusion

LSC-3DPT was used to customize doses, design flexible shapes and sizes, and modulate terpene release thereby enhancing patient compliance. The CP extract was used to treat the patient suffering from urolithiasis. The novel amalgamated, systematically developed LSC-3DPT will be assessed in a pre-clinical study for better assurance.

Graphical Abstract