How can oral paediatric formulations be improved? A challenge for the XXI century

Moreira, Miguel; Sarraguça, Mafalda C.

doi:10.1016/j.ijpharm.2020.119905

Cited by 19 publications

(11 citation statements)

References 92 publications

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“…The general principle of pharmaceutical 3d printing, or additive manufacturing, renders this approach a promising candidate for the automated manufacturing of solid pediatric medicines [ 1 ]. Solid medicines have significant benefits over the use of liquids for the treatment of children.…”

Section: Introductionmentioning

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: Introductionmentioning

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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show abstract

“…It comprises various organoleptic properties as appearance, smell, taste, after-taste and mouth-feel [80]. Improving organoleptic properties will inherently lead to an increased willingness of pediatric patients in taking their medicine, but also in being able to mistake these drug products as candy [68,81,82]. In this light, any formulation that can be perceived by children as candy should be carefully considered before prescribing such a drug product.…”

Section: Discussionmentioning

confidence: 99%

3D Printing of Pediatric Medication: The End of Bad Tasting Oral Liquids?—A Scoping Review

et al. 2022

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3D printing of pediatric-centered drug formulations can provide suitable alternatives to current treatment options, though further research is still warranted for successful clinical implementation of these innovative drug products. Extensive research has been conducted on the compliance of 3D-printed drug products to a pediatric quality target product profile. The 3D-printed tablets were of particular interest in providing superior dosing and release profile similarity compared to conventional drug manipulation and compounding methods, such as oral liquids. In the future, acceptance of 3D-printed tablets in the pediatric patient population might be better than current treatments due to improved palatability. Further research should focus on expanding clinical knowledge, providing regulatory guidance and expansion of the product range, including dosage form possibilities. Moreover, it should enable the use of diverse good manufacturing practice (GMP)-ready 3D printing techniques for the production of various drug products for the pediatric patient population.

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“…Factors affecting the acceptability, safety and access to paediatric medication and the critical acceptability attributes have been described in detail by many review papers to facilitate decision making regarding the selection and development of the most suitable paediatric medicines [24,34,35].…”

Section: Dosage Form and Patient Acceptabilitymentioning

confidence: 99%

Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a conect4children expert group white paper

Walsh¹,

Schaufelberger

Iurian

et al. 2021

Brit J Clinical Pharma

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Improved global access to novel age-appropriate formulations for paediatric subsets, either of new chemical entities or existing drugs, is a priority to ensure that medicines meet the needs of these patients. However, despite regulatory incentives, the introduction to the market of paediatric formulations still lags behind adult products. This is mainly caused by additional complexities associated with the development of acceptable age-appropriate paediatric medicines. This position paper recommends the use of a paediatric Quality Target Product Profile (pQTPP) as an efficient tool to facilitate early planning and decision making across all teams involved in paediatric formulation development during the children-centric formulation design for new chemical entities, or to repurpose/reformulate off-patent drugs. Essential key attributes of a paediatric formulation are suggested and described. Moreover, greater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age-appropriate medicinal products. Acceptability testing should be a secondary endpoint in paediatric clinical trials to ensure postmarketing adherence is not compromised by a lack of acceptability. Not knowing the indications and the related age groups and potential dosing regimens early enough is still a major hurdle for efficient paediatric formulation development; however the proposed pQTPP could be a valuable collaborative tool for planning and decision making to expedite paediatric product development, particularly for those with limited experience in developing a paediatric product.

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How can oral paediatric formulations be improved? A challenge for the XXI century

Cited by 19 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

3D Printing of Pediatric Medication: The End of Bad Tasting Oral Liquids?—A Scoping Review

Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a conect4children expert group white paper

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