(230e) Swellable Cross-Linked Biopolymer to Enhance Ink Rheology and Mechanical Properties of 3D Printed Thin Film Incorporated with Pharmaceutical Active

Oral drug delivery constitutes 52% of the marketed drug product (i.e. tablet, capsule, etc.) [1]. However, swallowing a pill is a bottleneck for about 28% of patients predominantly children and geriatrics [1]. Hence, a polymer-based oral thin film is a promising alternative oral delivery route for pharmaceutical actives or drugs [2]. 3D Printing is an advanced manufacturing technology fast adopted in the pharmaceutical industry to make personalized medicine by tuning the dosage [3]. This research assesses the suitability of sodium starch glycolate (SSG), a swellable cross-linked biopolymer primarily used as a dispersant, to enhance the rheology of printing ink and the mechanical properties of the 3D printed thin film incorporated with Fenofibrate (BCS Class II) a cholesterol-reducing drug. 30 g batch of water-based printing ink (in the form of a paste) was prepared. The materials compositions of the ink include sodium alginate (base biopolymer), Fenofibrate (20%, w/w), SSG (property enhancer), glycerine (plasticizer), and polyvinylpyrrolidone (solubilizer or wetting agent). To obtain a uniform paste, Thinky mixture ARE-310 was used for 10 minutes at 2000 rpm. Ink rheology was evaluated using flow/viscosity, amplitude sweeps (1Hz frequency with a shear strain range from 0.001 to 1000%), and thixotropy tests. The thixotropy test comprised three intervals- the first and third intervals contained oscillation and the second interval was a rotation to deform the ink. Pressure-assisted microsyringe (PAM) type 3D printer (Cellink BioX) with printing conditions (410 mm diameter nozzle, an infill density of 50%, pressure of 60 kPa, and speed of 10 mm/s) were utilized to print these thin films (10 mm x 15 mm x 0.35 mm). The 3D-printed film was dried in an oven at 40°C for 24-48 hours. The viscosity curves show good shear thinning properties - the viscosity gradually decreases with the increase of shear rate which is an important property for film 3D printing. The thixotropy test shows a fast recovery which requires further investigation to correlate with film 3D printing. The films show good mechanical properties and testing results (Young’s modulus, tensile strength, and elongation at break) are within the range found in the literature. Overall, it was a successful 3D-printed film. Other physical characteristics of the film such as dissolution test, scanning electron microscopy (SEM), etc. are in progress. Differential scanning calorimetry (DSC) and X-ray diffraction (XRD) will be done to ensure no drug degradation is observed. The findings will be discussed.

References:

[1] Borges, A. F., Silva, C., Coelho, J. F., & Simões, S. (2015). Oral films: Current status and future perspectives II—Intellectual property, technologies and market needs. Journal of Controlled Release, 206, 108-121.

[2] Elbadawi, M., Nikjoo, D., Gustafsson, T., Gaisford, S., & Basit, A. W. (2021). Pressure-assisted microsyringe 3D printing of oral films based on pullulan and hydroxypropyl methylcellulose. International Journal of Pharmaceutics, 595, 120197.

[3] Azad, M. A., Olawuni, D., Kimbell, G., Badruddoza, A. Z. M., Hossain, M. S., & Sultana, T. (2020). Polymers for extrusion-based 3D printing of pharmaceuticals: A holistic materials–process perspective. Pharmaceutics, 12(2), 124.