(56a) 3D Printed Complex Dosage Forms Embedded with Engineered BCS Class II Drug Particles

Recent work suggests complex structured dosage forms can be manufactured where drug particles can be integrated via 3D printing technology. However, incorporating engineered drug particles into 3D printed structures so that various intermediate and final product properties can be enhanced, for example, good mechanical properties and drug content uniformity of feed materials, has yet to be explored. It is hypothesized that engineered particles enable uniform distribution of drug into molten polymeric matrix via twin screw extruder (TSE). This distinct feature of engineered particles leads to obtaining enhanced dissolution profile from 3D structured dosage forms. The printable filaments containing varying drug loading (DL) %, and different extent of particle engineering as well as filament their mechanical properties were considered in this investigation. Griseofulvin (GF) and Hydroxypropyl cellulose (HPC) SL grade was used as the model BCS Class II drug and the polymeric matrix, respectively. The feed materials having four different DL% (5, 10, 15, and 25 wt.% GF) incorporating engineered and non-engineered particles were extruded by HME and 3D structured tablets from the feed materials were successfully created via FDM 3D printer. No drug degradation was observed in TGA results for any cases. All the drug particles kept their crystalline structure from HME extrusion (140 ºC) as well as FDM printing (170 ºC). The feed materials containing engineered particles exhibited higher tensile strength and better modulus of elasticity, regardless of the drug loading. Moreover, 3D printed tablets containing engineered particles showed enhanced drug release for all DL%. Overall, the 3D printed tablets embedded with engineered drug particles resulted in tablets without any degradation/recrystallization issues and demonstrated enhanced dissolution profiles for four different dosage amounts.