Preformulation of 3D Printable Pharmaceutical Dosage Forms

Preformulation studies are designed to ensure a pharmaceutical dosage form will be produced within the best scenario of materials and processing conditions to guarantee the required performance and stability. In the context of medicines production by 3D printing, a preformulation protocol for 3D printable dosage forms needs to consider the particularities of additive manufacturing. This chapter proposes to draw guidelines for developing a protocol to perform preformulation studies of such 3D printable medicines. For this, an overview involving both physical and chemical characterization of materials combining several techniques, their fundamentals, and applications is provided. Criteria for designing a preformulation protocol adapted to the printing technology, the processing stages, and the drug product to be manufactured are discussed in light of possible characterization techniques. This step in developing 3D medicines should provide information on the chemical stability and physical properties of materials as well as on drug-excipient interactions. The 3D printing by fused deposition modeling will be the central point of this chapter since this technique is the most widely explored in the pharmaceutical field.