Acceptability of different oral formulations in infants and preschool children

Objective Liquid medicines are easy to swallow. However, they may have disadvantages, such as a bad taste or refrigerated storage conditions. These disadvantages may be avoided by the use of oral solid medicines, such as powders or tablets. The aim of this study was to investigate the acceptability of and preference among four oral formulations in domiciliary infants and preschool children in The Netherlands. Methods Parents administered four oral placebo dosage forms that were aimed at a neutral taste, at home, to their child (1–4 years of age) twice on one day following a randomised cross-over design: small (4 mm) tablet, powder, suspension and syrup. They were asked to report the child's acceptability by a score on a 10 cm visual analogue scale (VAS score) and by the result of the intake. At the end of the study, they were asked to report the preference of the child and themselves. Results 183 children were included and 148 children were evaluated. The data revealed a period/cross-over effect. The estimate of the mean VAS score was significantly higher for the tablet than for the suspension (tablet 9.39/9.01; powder 8.84/8.20, suspension 8.26/7.90, syrup 8.35/8.19; data day 1/all days). The estimate of the mean number of intakes fully swallowed was significantly higher for the tablet than for the other formulations (all p values <0.05). Children and parents preferred the tablet and syrup over the suspension and the suspension over the powder (all p values <0.05). Conclusions All formulations were well accepted. The tablets were the best accepted formulation; the tablets and syrup the most preferred. Trial Registration number ISRCTN63138435.

[1]  R. Cohen,et al.  Study of the acceptability of antibiotic syrups, suspensions, and oral solutions prescribed to pediatric outpatients , 2009, European Journal of Pediatrics.

[2]  G. Giguere,et al.  Ranitidine (Zantac®) Syrup versus Ranitidine Effervescent Tablets (Zantac® EFFERdose®) in Children , 2006, Paediatric drugs.

[3]  M. Nahata Lack of pediatric drug formulations. , 1999, Pediatrics.

[4]  E. van de Vijver,et al.  Treatment of Infants and Toddlers With Cystic Fibrosis–related Pancreatic Insufficiency and Fat Malabsorption With Pancrelipase MT , 2011, Journal of pediatric gastroenterology and nutrition.

[5]  R. Remmel,et al.  Comparison of sprinkle versus syrup formulations of valproate for bioavailability, tolerance, and preference. , 1992, The Journal of pediatrics.

[6]  D. Evans,et al.  Improving adherence to malaria treatment for children: the use of pre‐packed chloroquine tablets vs. chloroquine syrup , 2001, Tropical medicine & international health : TM & IH.

[7]  P. van Assema,et al.  Vitamin D supplementation in young children: associations with Theory of Planned Behaviour variables, descriptive norms, moral norms and habits , 2010, Public Health Nutrition.

[8]  C. Tuleu,et al.  Minitablets: New Modality to Deliver Medicines to Preschool-Aged Children , 2009, Pediatrics.

[9]  L. Christrup,et al.  Patients' evaluation of shape, size and colour of solid dosage forms , 2001, Pharmacy World and Science.

[10]  D. V. van Riet-Nales,et al.  Effects of the pharmaceutical technologic aspects of oral pediatric drugs on patient-related outcomes: a systematic literature review. , 2010, Clinical therapeutics.

[11]  Tony Nunn,et al.  Formulation of medicines for children. , 2005, British journal of clinical pharmacology.

[12]  R. Qu,et al.  Sample size calculation for bioequivalence studies with high-order crossover designs. , 2003, Controlled clinical trials.

[13]  J. Breitkreutz,et al.  Acceptance of uncoated mini-tablets in young children: results from a prospective exploratory cross-over study , 2012, Archives of Disease in Childhood.

[14]  J. Walsh,et al.  Delivery devices for the administration of paediatric formulations: overview of current practice, challenges and recent developments. , 2011, International journal of pharmaceutics.

[15]  M. Fowler,et al.  Adherence to tablet and liquid formulations of antiretroviral medication for paediatric HIV treatment at an urban clinic in Uganda , 2011, Annals of tropical paediatrics.

[16]  I. Espelid,et al.  Caries preventive effect of fluoride in milk, salt and tablets: A literature review , 2009, European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry.

[17]  D. V. van Riet-Nales,et al.  The availability and age-appropriateness of medicines authorized for children in The Netherlands. , 2011, British journal of clinical pharmacology.

[18]  S. Twetman,et al.  Outcome of an oral health outreach programme for preschool children in a low socioeconomic multicultural area. , 2008, International Journal of Paediatric Dentistry.