3D Printing Novel Enteric Capsule Shells for Personalized Drug Delivery

Individualized drug delivery presents a viable strategy for enhancing medication efficacy and patient safety. It involves producing small batches of custom dosages tailored to each patient's individual needs. However, current pharmaceutical manufacturing processes are not designed for personalized dosage forms. Additive manufacturing processes have great potential in the pharmaceutical industry due to the customizable nature of 3D printing technologies and the increasing demand for customized pharmaceutics and drug delivery systems. Conventional enteric capsules are prepared by dip coating to achieve gastro-resistant release, but the manufacturing process is erratic and unreliable. This study aimed to investigate the feasibility of manufacturing enteric capsules from enteric polymers using the hot melt extrusion ( HME) and fused filament fabrication (FFF) process. HME was utilized to prepare filaments using enteric polymers, Hypromellose acetate succinate (HPMC-AS), and Eudragit-L 100- 55, with plasticizers, sorbitol, and polyethylene glycol 4000 (PEG- 4000), and a thermoplastic polymer, polyvinyl alcohol (PVA). A computer-aided design program was utilized to design size 0 capsules. The prepared capsule design and filaments were used to fabricate capsules using the FFF process. Powdered red dye was used to simulate the drug and its release from FFF fabricated capsules was evaluated in simulated gastric and intestinal fluids, pH 1.2 and 6.8, respectively. Various combinations of enteric polymer, plasticizer, and thermoplastic polymer were examined. Thermogravimetric analysis (TGA) showed that the temperatures used for processing polymer blends were well below their thermal degradation temperatures, and dye release profiles were generated using image analysis software. This study demonstrates that capsules made with HPMCAS, PEG-4000, and PVA via the FFF process are suitable for controlling drug release and that the release profile can be modified by making small changes to the formulation.