Development and evaluation of medicines for paediatric use
type: Dataset
contact point: Organization
  fn: CCSD
keyword: taste-masking
keyword: theses
keyword: sdvmheplife-sciences-q-biohuman-health-and-pathology
keyword: masquage-de-gout
keyword: infoeu-reposemanticsdoctoralthesis
keyword: spray-drying
keyword: formes-seches-orodispersibles
landing page: https://theses.hal.science/tel-00786310
description: The development of paediatric formulations involves an urgent need but also presents many difficulties, e.g. the safety data of existing and new excipients in children stay restrictive; the development of palatable formulations for better compliance is requisite and challenging; the appropriateness of dosage form faces to dysphagia issue and flexibility of dosing for a large range of age. The aim of this work was (i) to develop a taste-masking formulation of a model drug (acetaminophen) on the one hand, and (ii) to elaborate a process for manufacture of fast disintegrating minigranules on the other hand. Sodium caseinate and lecithin, potentially tolerable and safe excipients for paediatric use, were utilized in order to encapsulate the drug through spray-drying. Taste-masking effect was demonstrated by in vitro drug release study and electronic tongue analysis. The characterization of spray-dried particles showed a difference in the surface composition according to the sodium caseinate/lecithin ratio, which related to the taste-masking efficiency. A study was subsequently undertaken to evaluate the effect of process and formulation parameters on the taste-masking efficiency. A full factorial design allowed screening for the most important variables that affect the released amount of drug during the early minutes, i.e. quantity of sodium caseinate and lecithin. An optimized formulation was successfully achieved by simplex design that released the drug 7-fold less than the unmasked drug during the first two minutes. Another approach to improve the taste-masking effect included the use of calcium caseinate rather than sodium caseinate. Calcium caseinate was showed to be more effective in delaying the drug release to a higher extent in association with lecithin. Indeed, the lower the released amount, the better the taste-masking. A multiparticulate dosage form of fast disintegration was developed through extrusion-spheronization followed by freeze-drying. The pellets e…
identifier: NNT: 2012LIL2S012
issued: 2026-05-14T14:48:53.261528
language: fr
modified: 2026-05-14T14:48:53.261534

test_moissonnage_selune
type: Agent

Development and evaluation of medicines for paediatric use
type: Distribution
access URL: https://theses.hal.science/tel-00786310
format: HTML
issued: 2026-05-14T14:48:53.282273
modified: 2026-05-14T14:48:53.246497