The STEP (Safety and Toxicity of Excipients for Paediatrics) database. Part 1—A need assessment study

Salunke, Smita; Giacoia, George P.; Tuleu, Catherine

doi:10.1016/j.ijpharm.2012.05.004

Cited by 64 publications

(34 citation statements)

References 10 publications

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“…The excipients used in paediatric formulations need to be appropriate for the age group [116][117][118] to avoid the consequences of excipient toxicity. Acceptability of medicines to paediatric patients is also of great importance in the child receiving adequate therapy.…”

Section: Discussionmentioning

confidence: 99%

Formulations for children: problems and solutions

Batchelor

Marriott

2015

Brit J Clinical Pharma

168

107

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Paediatric formulation design is complex as there is a need to understand the developmental physiological changes that occur during childhood and their impact on the absorption of drugs. Paediatric dose adjustments are usually based on achieving pharmacokinetic or pharmacodynamic profiles equivalent to those achieved in adult populations. However, differences in the way in which children handle adult products or the use of bespoke paediatric formulations can result in unexpected pharmacokinetic drug profiles with altered clinical efficacy. Differences in drug formulations need to be understood by healthcare professionals involved in the prescribing, administration or dispensing of drugs to children such that appropriate advice is given to ensure that therapeutic outcomes are achieved. This issue is not confined to oral medicines but is applicable for all routes of administration encountered in paediatric therapy.

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Section: Discussionmentioning

confidence: 99%

Formulations for children: problems and solutions

Batchelor

Marriott

2015

Brit J Clinical Pharma

168

107

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“…Its aim is to improve systematic data collection on excipient toxicity and tolerance in children. [64][65][66] A similar initiative, ESNEE (European Study of Neonatal Exposure to Excipients), has developed a platform for the systematic assessment of excipients in neonates. 67 …”

Section: Potential Limitations Of Pediatric Drug Formulationsmentioning

confidence: 99%

Pediatric Drug Formulations: A Review of Challenges and Progress

et al. 2014

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Children differ from adults in many aspects of pharmacotherapy, including capabilities for drug administration, medicine-related toxicity, and taste preferences. It is essential that pediatric medicines are formulated to best suit a child' s age, size, physiologic condition, and treatment requirements. To ensure adequate treatment of all children, different routes of administration, dosage forms, and strengths may be required. Many existing formulations are not suitable for children, which often leads to off-label and unlicensed use of adult medicines. New regulations, additional funding opportunities, and innovative collaborative research initiatives have resulted in some recent progress in the development of pediatric formulations. These advances include a paradigm shift toward oral solid formulations and a focus on novel preparations, including flexible, dispersible, and multiparticulate oral solid dosage forms. Such developments have enabled greater dose flexibility, easier administration, and better acceptance of drug formulations in children. However, new pediatric formulations address only a small part of all therapeutic needs in children; moreover, they are not always available. Five key issues need to be addressed to stimulate the further development of better medicines for children: (1) the continued prioritization of unmet formulation needs, particularly drug delivery in neonates and treatment gaps in pediatric cancers and childhood diseases in developing countries; (2) a better use of existing data to facilitate pediatric formulation development; (3) innovative technologies in adults that can be used to develop new pediatric formulations; (4) clinical feedback and practice-based evidence on the impact of novel formulations; and (5) improved access to new pediatric formulations. Pediatrics

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“…Les agents sucrants, destinés à masquer le goût du principe actif, pourraient être à l'origine de carries dentaires ou provoquer des déséquilibres de diabète [10]. Afin d'améliorer la sécurité des FOL, l'évalua-tion de la toxicité des excipients chez l'enfant est désormais un axe important en recherche pédiatrique, avec création de plateformes européennes et américaines de recueil des évé-nements indésirables (EI) liés aux excipients [16][17][18]. La reconstitution des supensions, le calcul et la mesure du volume de FOL à administrer sont des étapes longues, déli-cates et sources d'erreurs pour les soignants.…”

Section: Forme Orale Liquideunclassified