The Pharmaceutical Journal
Vol 275 No 7371 p472
15 October 2005

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Formulations in paediatric trials should be reported

Reporting of formulation information needs to be improved in drug trials that include children, say researchers.

Three UK pharmacists, from the School of Pharmacy, University of London, Great Ormond Street Hospital, London, and the Institute of Child Health, London, reviewed 76 papers from paediatric drug trials that had been published in highly cited, peer-reviewed journals.

They say that drug formulation reporting was largely inadequate with 20 publications (26 per cent) not stating the formulation used.

When the formulation was reported, less than half (49 per cent) used a paediatric formulation. And none of the papers that described tablet crushing gave any supporting pharmacokinetic data (Pediatrics 2005;116:e559).