3D printing in pharmaceuticals: An emerging technology full of challenges

Wadher, Kamlesh; Trivedi, Rashmi V.; Wankhede, N.; Kale, Manoj B.; Umekar, Milind J.

doi:10.1016/j.pharma.2020.08.007

Cited by 12 publications

(8 citation statements)

References 92 publications

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“…Therefore, destructive quality control approaches are not profitable and in-line testing is unavoidable. Furthermore, there is hardly any system on the market that meets the cleaning requirements of pharmaceutical equipment [ 75 ].…”

Section: Fdm Printing At Site Of Care—stricter Requirements For Dosin...mentioning

confidence: 99%

Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design

Quodbach

Bogdahn

Breitkreutz

et al. 2021

Ther Innov Regul Sci

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Abstract3d printing is capable of providing dose individualization for pediatric medicines and translating the precision medicine approach into practical application. In pediatrics, dose individualization and preparation of small dosage forms is a requirement for successful therapy, which is frequently not possible due to the lack of suitable dosage forms. For precision medicine, individual characteristics of patients are considered for the selection of the best possible API in the most suitable dose with the most effective release profile to improve therapeutic outcome. 3d printing is inherently suitable for manufacturing of individualized medicines with varying dosages, sizes, release profiles and drug combinations in small batch sizes, which cannot be manufactured with traditional technologies. However, understanding of critical quality attributes and process parameters still needs to be significantly improved for this new technology. To ensure health and safety of patients, cleaning and process validation needs to be established. Additionally, adequate analytical methods for the in-process control of intermediates, regarding their printability as well as control of the final 3d printed tablets considering any risk of this new technology will be required. The PolyPrint consortium is actively working on developing novel polymers for fused deposition modeling (FDM) 3d printing, filament formulation and manufacturing development as well as optimization of the printing process, and the design of a GMP-capable FDM 3d printer. In this manuscript, the consortium shares its views on quality aspects and measures for 3d printing from drug-loaded filaments, including formulation development, the printing process, and the printed dosage forms. Additionally, engineering approaches for quality assurance during the printing process and for the final dosage form will be presented together with considerations for a GMP-capable printer design.

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Section: Fdm Printing At Site Of Care—stricter Requirements For Dosin...mentioning

confidence: 99%

Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design

Quodbach

Bogdahn

Breitkreutz

et al. 2021

Ther Innov Regul Sci

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“…In navigation [43], contour maps are used to represent risk regions and safe navigation routes. In additive manufacturing [44][45][46][47], contour maps are used to describe the details of the model to be 3D printed.…”

Section: Introductionmentioning

confidence: 99%

Bearing Severity Fault Evaluation Using Contour Maps—Case Study

et al. 2021

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Increasing industrial competitiveness has led to an increased global interest in condition monitoring. In this sector, rotating machinery plays an important role, where the bearing is one of the most critical components. Many vibration-based signal treatments are already being used to identify features associated with bearing faults. The information embedded in such features are employed in the construction of health indicators, which allow for evaluation of the current operating status of the machine. In this work, the use of contour maps to represent the diagnosis map of a bearing, used as a health map, is presented for the first time. The results show that the proposed method is promising, allowing for the satisfactory detection and evaluation of the severity of bearing damage. In this initial stage of the research, our results suggest that this method can improve the classification of bearing faults and, therefore, optimise maintenance processes.

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“…In many cases, the optimal solubility–permeability balance is based on the extent to which membrane–aqueous partitioning is maximized; that is, the intersection where both are at their highest relative values [ 76 ]. Formulation methods to increase either solubility or dissolution rates for BCS class II and IV APIs identified in the literature include: 3D printing [ 63 , 77 , 78 , 79 ]; Amorphous solid dispersion [ 59 , 80 , 81 ]; Complexation [ 82 , 83 ]; Fusion [ 84 , 85 ]; Hot-melt extrusion [ 84 , 86 ]; Lipid microemlusion [ 54 ]; Lyophilization [ 84 , 87 , 88 ]; Micelles [ 87 ]; Nanosizing [ 60 , 89 ]; and Spray drying [ 59 , 60 ]. …”

Section: The Next Wave Of Oral Liquid Formulation Development—formula...mentioning

confidence: 99%

Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update

Parrish

Ashworth²,

Löbenberg

et al. 2022

Pharmaceutics

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The purpose of this work was to evaluate the suitability of recent US Food and Drug Administration (US-FDA)-approved and marketed oral liquid, powder, or granule products for children in North America, to identify the next group of Active Pharmaceutical Ingredients (APIs) that have high potential for development as commercially available FDA-approved finished liquid dosage forms, and to propose lists of compounded nonsterile preparations (CNSPs) that should be developed as commercially available FDA-approved finished liquid dosage forms, as well as those that pharmacists should continue to compound extemporaneously. Through this identification and categorization process, the pharmaceutical industry, government, and professionals are encouraged to continue to work together to improve the likelihood that patients will receive high-quality standardized extemporaneously compounded CNSPs and US-FDA-approved products.

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3D printing in pharmaceuticals: An emerging technology full of challenges

Cited by 12 publications

References 92 publications

Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design

Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design

Bearing Severity Fault Evaluation Using Contour Maps—Case Study

Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update

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