Development of 3D DLP Printed Sustained Release Ibuprofen Tablets and Their Pharmacokinetic Evaluation in Rats.

Abstract

The objective of the present study was to develop digital light processing (DLP) 3D printed sustained release ibuprofen (IBU) tablets using 3D DLP printers for evaluation in in vitro release and in vivo pharmacokinetic studies with their in vitro-in vivo correlation. The resin formulation and printing parameters were optimized using quality by design (QbD) approach, and IBU tablets were printed using DLP printers which works at 385 and 405nm wavelengths. Our results demonstrated that formulation consisting of polyethylene glycol diacrylate (PEGDA) 700, water, IBU, and riboflavin printed at 40-s bottom layer exposure time and 30-s exposure time produced tablets using both 385 and 405nm wavelengths. In vitro dissolution studies showed > 70% drug release at the end of 24h when printed at 405nm wavelength with no significant difference between tablets printed at 385nm. In vivo pharmacokinetic evaluation of the optimized 3D printed tablets printed at 405nm at oral dose of 30mg/kg in rats showed sustained release of IBU with significantly (p < 0.05) higher Cmax of 30.12 ± 2.45µg/mL and AUC(0-24h) of 318.97 ± 16.98 (µg/mL × h) compared to marketed IBU tablet (control). In vivo-in vitro correlation studies showed 80% of drug was absorbed in vivo within 3h from the pulverized 3D printed tablet, whereas intact 3D tablet showed sustained release of IBU with > 75% IBU release in 24h in vitro. Overall, IBU tablets fabricated using DLP printing demonstrated sustained release and enhanced systemic absorption with no significant difference in their release profile at different wavelengths.