3DPBDCT: 3D Printed Bosentan-Dexolve® Complex Loaded Tablet—Fabrication, Statistical Optimization and Characterization
摘要
A substantial challenge in dosage form development is to design a formulation which was tailored to meet the specific needs of individual patients. The primary focus of the current study was to design, optimize, and characterize a 3D-printed Bosentan-Dexolve complex-loaded tablet (3DPBDCT) using the fused deposition modeling (FDM) technique, incorporating progressive statistical and analytical tools that control the release of Bosentan (BST). BST was selected as a prototypical medicine. The solubility of BST was improved by complexation with Dexolve. BST:Dexolve® (1:1) improved maximum solubility. Complex was loaded to form 3DPBDCT by FDM using the cavity method. A donut shape was chosen for the design of optimized 3DPBDCT due to its controlled release and better post-fabrication results. CCD had found a significant relationship between chosen CMAs and CQAs. 3DPBDCT gave the desired pre- and post-fabrication results. Optimal 3DPBDCT can release 98.22% BST in 12 h with better stability. Predicted in vivo pharmacokinetic data were comparable to reported data. The newly designed formulation yielded better-controlled BST release, achieving the desired post-fabrication results. Newly designed 3DPBDCT opens a new direction in the Pharmaceutical field.
Graphical abstract