Publications by authors named "Daniel Schaufelberger"

The colour of a product plays an important role in consumer experiences, and in the context of pharmaceutical products, this could potentially affect a patient's expectations, behaviours, and adherence. Several studies have been conducted on adults, but little is known about children's opinions on colours of medicines and to what extent medicines' colour affects their acceptability. To address this gap, a systematic search in PubMed, Scopus, MEDLINE, and Web of Science was conducted.

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The aim of this study was to develop an age-appropriate tablet of mebendazole 500 mg to be used in large donation programs by the World Health Organization (WHO) for preventive chemotherapy of soil-transmitted helminth (STH) infections in pre-school and school-age children living in tropical and subtropical endemic areas. To that end, a new oral tablet formulation was developed that can be either chewed or given to young (≥1 year old) children by spoon after rapid disintegration to a soft mass with the addition of a small amount of water directly on the spoon. Although the tablet was manufactured using conventional fluid bed granulation, screening, blending, and compression processes, one of the main challenges was to combine properties of a chewable, dispersible, and regular (solid) immediate release tablet to meet the predefined requirements.

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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.

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Article Synopsis
  • A two-day workshop on pediatric formulation development was held in June 2019, organized by M-CERSI, the FDA, and the IQ Drug Product Pediatric PWG, bringing together diverse participants from industry, regulatory bodies, and academia.
  • The workshop included sessions that covered formulation challenges, analytical strategies, clinical considerations, and regulatory insights, with a focus on improving drug product acceptability for pediatric use.
  • Key topics discussed involved dosing vehicle selection, the impact of pediatric pharmacokinetics on drug design, regional regulatory differences, and collaboration opportunities for advancing pediatric formulations.
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Purpose: The compatibility of doripenem diluted for infusion with 82 other drugs during simulated Y-site administration was studied.

Methods: Five-milliliter samples of doripenem 5 mg/mL in 5% dextrose injection and separately in 0.9% sodium chloride injection were combined with 5 mL of 82 other drugs, undiluted or diluted in 5% dextrose injection or 0.

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