title: The Milky Way: paediatric milk-based dispersible tablets prepared by direct compression - a proof-of-concept study.
abstract: OBJECTIVE
  Dispersible tablets are proposed by the World Health Organization as the preferred paediatric formulation. It was hypothesised that tablets made from a powdered milk-base that disperse in water to form suspensions resembling milk might be a useful platform to improve acceptability in children.
  
  
  METHODS
  Milk-based dispersible tablets containing various types of powdered milk and infant formulae were formulated. The influence of milk type and content on placebo tablet properties was investigated using a design-of-experiments approach. Responses measured included friability, crushing strength and disintegration time. Additionally, the influence of compression force on the tablet properties of a model formulation was studied by compaction simulation.
  
  
  RESULTS
  Disintegration times increased as milk content increased. Compaction simulation studies showed that compression force influenced disintegration time. These results suggest that the milk content, rather than type, and compression force were the most important determinants of disintegration.
  
  
  CONCLUSIONS
  Up to 30% milk could be incorporated to produce 200 mg 10-mm flat-faced placebo tablets by direct compression disintegrating within 3 min in 5-10 ml of water, which is a realistic administration volume in children. The platform could accommodate 30% of a model active pharmaceutical ingredient (caffeine citrate).
authors.affiliation: University College London School of Pharmacy, 29 - 39 Brunswick Square, London, WC1N 1AX, UK.
authors.forename: Samuel E F
authors.initials: SE
authors.lastname: Orubu
authors.affiliation: University College London School of Pharmacy, 29 - 39 Brunswick Square, London, WC1N 1AX, UK.
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Hobson
authors.affiliation: University College London School of Pharmacy, 29 - 39 Brunswick Square, London, WC1N 1AX, UK.
authors.forename: Abdul W
authors.initials: AW
authors.lastname: Basit
authors.affiliation: University College London School of Pharmacy, 29 - 39 Brunswick Square, London, WC1N 1AX, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Tuleu
mesh_terms: D000818:Animals; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D019245:Compressive Strength; D004339:Drug Compounding; D006801:Humans; D008892:Milk / Q000737:chemistry* / Q000378:metabolism; D012995:Solubility; D013607:Tablets / Q000008:administration & dosage / Q000737:chemistry* / Q000378:metabolism; D013718:Tensile Strength
chemical_list: D013607:Tablets
keywords: design of experiments ; direct compression; milk-based tablets