(M1530-06-33) Development of 3D-Printed Expandable Gastroretentive Drug Delivery System by Applying the Design of Experiment Approach

Purpose: Gastroretentive (GR) systems are designed to prolong a drug's residence time in the stomach to improve its bioavailability, leading to better therapeutic efficacy for drugs with a narrow absorption window in the upper gastrointestinal tract. This study aimed to develop an expandable gastroretentive drug delivery system by applying 3D printing technology and the design of experiment (DoE) approach to achieve stable gastroretention and improve the bioavailability of a drug.

Methods: The expandable drug delivery system consists of a 3D-printed capsular device that can be expanded in the stomach, an immediate-release (IR) tablet, and a sustained-release (SR) tablet of a model drug, rebamipide. The capsular device is originally swallowable in size, but once in the stomach, it is expanded as the inner IR tablet dissolves and releases the drug from the SR tablet, while maintaining in the stomach by its expanded size. Only after the drug release is completed does the capsular device lose the expanding arms and move to the small intestine. Mixture design was applied to determine the formulation compositions of the IR and SR tablets to control the time of expansion and gastric residence, respectively. The in vitro performance of the GR system was assessed by in vitro dissolution tests.

Results: Finally, the in vivo pharmacokinetic study showed that the average relative bioavailability of rebamipide from the GR system was 209.68% compared to the IR reference in Beagle dogs (n=3).

Conclusion: The present GR drug delivery system may be useful in developing novel dosage forms to improve oral bioavailability for various drugs.

Acknowledgements: This work was supported by the National Research Foundation of Korea(NRF) grant funded by the Korean government (NRF-2023R1A2C1007013 and RS-2024-00348330).