Polymer-based thin film is a promising oral delivery route of pharmaceutical actives or drugs for the pediatric and geriatric population who suffers from swallowing difficulty. 3D Printing is a rapidly growing technology in the pharmaceutical industry to tune dosage and make it personalized. This research assesses the suitability of sodium alginate, a biopolymer, based printing ink formulation developed initially for a pill to print thin film comprised of Fenofibrate (BCS Class II) as a cholesterol-reducing drug. Water-based printing ink (in the form of a paste) of 30 g batch size was prepared, including sodium alginate, Fenofibrate (20%, w/w), mannitol (filler), polyethylene glycol (plasticizer), and polyvinylpyrrolidone (solubilizer or dispersing agent). Thinky mixture (ARE-310) was used for 10 minutes at 2000 rpm and obtained a uniform paste. Flow/viscosity, amplitude sweeps, and thixotropy tests were done to evaluate the rheological properties of the ink. Amplitude sweeps were performed at 1Hz frequency with a shear strain range from 0.001 to 1000%. 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 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 printing. The thixotropy test shows a slow recovery which is favorable for good film printing. Overall, it was a successful 3D-printed film. However, printed films do not show good mechanical properties. Printed films are brittle, whereas they should be flexible. The mechanical properties of the films are dependent on the ink formulation. Hence, functional excipients optimization (composition, substitution, etc) is required that is in progress and findings will be discussed.

Biopolymer sodium alginate-based 3D printed thin film development for pharmaceutical active delivery

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