Development of Personalized Colonic Drug Delivery Systems Prepared by 3D-Printing Technology

Abstract
Colonic drug delivery systems (CDDS) show several advantages for treatment of inflammatory bowel disease such as improving the clinical outcomes and minimizing side effects of corticosteroids. However, variation of the patient's gastrointestinal tract (GIT) in terms of transit time and pH causes the fluctuation of the drug releasing site in the GIT resulting in low therapeutic efficiency. Consequently, 3D-printing techniques have been applied for preparation of personalized colonic drug delivery systems in this study. Prednisolone was selected as a model drug and prepared in the form of a core tablet. Polylactic acid (PLA) and polyvinyl alcohol (PVA) were printed as a tablet housing and a drug control release plug, respectively. A two-factor full factorial model was utilized to design the experiment and partial least square regression (PLS) models were generated to reveal and predict drug release time of the system. From the results, only thickness of the PVA plug significantly affected the drug release at sampling times of 5, 6, 10, and 24 h. The relations between thickness of the plug and drug releases at 5, 6, and 10 h are quadratic but that of 24 h is linear. The relation between thickness of the plug and drug releases is quadratic. The drug could not be completely released in 24 h because the drug was entrapped by PVA gel. The search results show the possibility to utilize the PLS models to modify drug release time for individual patients. However, alteration of plug polymer is a suggestion to obtain complete drug release.