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.
Due to demographic development and rising problems in cost and resource management in health care and social systems, higher demands with respect to assistance for the elderly in everyday life are to be expected. Especially the need for mobile walker to assist people with developmental differences has risen throughout the years. Against this background, ergonomic product design is used in most parts of the construction of such walkers and their properties. On this basis, much care is taken in designing the man/technology interfaces (MTI) to increase the usability of medical products. Surveys of users have shown that an improvement of MTI of mobile walkers is necessary. This medical equipment allows deriving forces which need to be transmitted by the human hand. The ergonomic design of the walker handles needs to be adapted to the user requirements. In this paper, several problems with conventional handles and the problems such handles cause are discussed. To prove the benefits of adapting the handles to ensure better support, conclusions based on the results from experiments that were carried out are drawn. Increasing the usability by reconstructing the product with a user-oriented geometry and taking ergonomic aspects into consideration is achieved comparatively easily.
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