Preparation and evaluation of 3D-printed tacrolimus tablets based on mesoporous silica solubilization

Tacrolimus (FK506) has limited clinical applications due to its poor solubility and narrow therapeutic window. Therefore, strategies to enhance its solubility and enable personalized dosing are highly valuable. Recently, loading drug molecules into mesoporous silica has emerged as a novel strategy to improve the solubility of poorly soluble drugs. Concurrently, 3D printing technology offers a new approach for fabricating personalized dosage forms for drugs with a narrow therapeutic index. In this study, poly(ethylene glycol) 32-stearate was selected as the matrix material and combined with the drug-loaded solid dispersion to successfully prepare semi-solid materials with good printability under anhydrous conditions. This approach effectively addresses the challenge of maintaining the drug in an amorphous state. Using semi-solid extrusion (SSE) 3D printing technology, the material was fabricated into tablets of four different sizes. The successful loading of the drug in its amorphous form was confirmed by characterization techniques including differential scanning calorimetry (DSC), X-ray diffraction (XRD), and nitrogen adsorption analysis (BET/BJH). Physico-mechanical characterization, content uniformity testing, in vitro dissolution studies, and stability tests demonstrated that the printed tablets possess satisfactory mechanical properties, meet the requirements for in vitro dissolution, and exhibit excellent stability. This study presents a promising strategy for personalized therapy with FK506.