A case study on decentralized manufacturing of 3D printed medicines

3D Printing Direct Powder Extrusion in the Production of Drug Delivery Systems: State of the Art and Future Perspectives

“…Therefore, processed material in the form of pellets obtained from HME extrudates and powders obtained from the milled pellets was used as feeding materials. Seoane-Viaño et al [ 29 ] also had to perform a prior step, in particular a dry granulation step, to obtain a material with sufficient flowability for the successful direct extrusion and printing of tablets using this 3D printer. This was also the case of Pflieger et al [ 30 ], who used granules previously prepared by HME as feeding material in the single-screw extrusion-based printer Flexdose TM (Digital Health Systems GmbH (Schwäbisch Gmünd, Germany)) to produce immediate-release tablets.…”

“…Moreover, flowability was also influenced by the drug load (mixtures containing 35% w / w praziquantel have a more reproducible flow than those with 50% w / w drug). A previous dry granulation step was also necessary to obtain a formulation based on Kollidon ® VA64 and mannitol with sufficient flowability to be printed by DPE [ 29 ].…”

“…The most commonly used geometrical shape for the manufacturing of oral dosage forms by DPE is a simple cylinder. Nevertheless, this 3D printing technology can lead to complex internal designs, resulting in structures such as core–shell and multi-compartment [ 8 , 14 , 15 , 16 , 20 , 22 , 23 , 24 , 26 , 28 , 29 , 30 , 34 , 35 ]. These modifications allow the combination of different drugs in the same dosage form and/or modulation of drug release profiles, as described in the following section.…”

“…Its low T g (100 °C) makes it suitable for DPE, although it often requires the addition of a plasticizer. Recently, this polymer has been used to prepare immediate-release cylindrical tablets containing efavirenz (5–35% w / w ) for the treatment of HIV [ 29 ]. The efavirenz granulates were formulated with Kollidon ® VA64 (40% w / w ) and mannitol (20–55% w / w ) and magnesium stearate (5% w / w ) as plasticizers and were used as the feeding material for DPE.…”

3D Printing Pharmaceuticals: Current Status and Future Opportunities

“…Currently, personalized dosing using 3D printing technologies is undergoing early-stage evaluation through demonstration projects in Europe, 12 China, 13 and Singapore. 14 Although the personalized dosing practice can be implemented via the extemporaneous compounding pathway or hospital-based preparation, the regulatory requirements for widely deploying 3D-printed personalized dosing are not clearly defined at this time in Europe, China, or the United States.…”