Three-dimensional (3D) printing is a powerful technology that has wide-ranging applications, including many in the pharmaceutical industry. Among the approaches that are being explored in the production of pharmaceutical dosage forms powder-based systems which utilize either drop-on-powder or selective laser sintering and liquid-based systems which use drop-on-drop deposition or stereolithography are frequently applied. With liquid-based technology, either UV, laser energy or high temperature is used to induce polymerization and build the 3D structure. The process of 3D printing offers the potential to produce medications tailored to the needs of patients and dosage forms in various shapes, sizes and textures with different release profiles that can be difficult to produce using conventional techniques.
In this white paper, the use of 3D printing to overcome challenges during formulation development is explored, with a focus on enhancement of bioavailability of active pharmaceutical ingredients (APIs) in solid dispersions. It is estimated that 60–70% of drug substances currently in clinical pipelines are categorized as Class II in the Biopharmaceuticals Classification System (BCS) which indicates low solubility. For an oral formulation, the proper API solubility is critical for absorption in the gastrointestinal tract. If solubility issues cannot be overcome during formulation development, an otherwise promising therapeutic candidate may have to be abandoned.