3D powder bed tablet printing: From a R&D printer to a scalable GMP printer
Powder bed-based 3D printing has been used to produce pharmaceutical tablets mainly under laboratory conditions. To advance the technology for commercial use, laboratory’s proof of principles should be translated to and validated under good manufacturing practice (GMP) conditions. In this study, lactose/starch-based formulations with 10 and 30% w/w API (acetaminophen) drug loading were transferred from the Netherlands Organization for Applied Scientific Research (TNO) R&D printer to a scalable Aprecia GMP printer. First, the critical material attributes (flowability and wettability) of the blends were studied to determine their suitability for small-scale printing.
Second, formulations were printed on both the R&D and GMP equipment to study the effect of the printer change on the tablet critical quality attributes, such as dimensions, mass, tensile strength, and API release. We found that tablets with targeted mechanical and dissolution characteristics could be printed with both R&D and GMP equipment while maintaining identical compositions for the powder blends.
Nevertheless, the transfer from the R&D printer to the GMP printer required modification of the print settings. The composition of the printing ink was adjusted to accommodate the nozzle requirements of the GMP printer. This adjustment in ink composition resulted in a different balance between the tensile strength and dissolution of certain formulations. Our results demonstrate that the production of lactose/starch-based tablet formulations can be successfully transferred from R&D to GMP printing equipment. Tablets produced on both printers had generally acceptable tensile strengths (above 0.2 MPa) and dissolution characteristics, although the changes in print settings resulted in slightly different product properties.
2.1. Materials
The materials used were milled lactose monohydrate, sodium starch glycolate (Primojel®), fully pregelatinized potato starch (DFE Pharma, Germany), and fne acetaminophen powder with a particle size of x50 = 20–25 μm (Tiefenbacher, Germany). This type and grade of API was selected as model of Biopharmaceutics Classifcation System (BCS) class 1 API of small particle size.
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Korinde A. Van den Heuvel, Alberto Berardi, Lisa B. Buijvoets, Bastiaan H.J. Dickhoff, 3D powder bed tablet printing: From a R&D printer to a scalable GMP printer, Journal of Drug Delivery Science and Technology, Volume 87, 2023, 104865, ISSN 1773-2247,
https://doi.org/10.1016/j.jddst.2023.104865.