71 participants aged 4-12 years were recruited to the study (mean age = 7 years). Thesample was refused on 7 out of 213 occasions; furthermore there were 9 instanceswhere following administration of the sample, it was spat out by the participant.Therefore a simple measure of acceptability as used in other studies, whereswallowing of the dosage form, even with chewing, was measured as an acceptableformulation [3-5] suggested that in this study the overall acceptance rate was 92.5%.

Researcher observations demonstrated that many children exhibited facialexpressions during administration of the multiparticulate products but, no trends inthe frequency of these behaviours based on the size of the multiparticulates beingsampled were found (C). There were 20 instances (out of 197) where the participantsvoiced disgust following the sample which was lower than anticipated.

Typically acceptance on a hedonic scale is a neutral to positive face. The results shownin (D) highlight that the hedonic participant-reported outcomes for the multiparticulates ranged from 30-64% for the range of samples assessed. There were notrend to suggest that there was an optimum particle size (p = 0.306). In addition, nosignificant differences in palatability preferences of coated and uncoated particleswere found.

(D) Hedonic score answers shown as percentage scores of participant responses

when asked about the sample grittiness

Overall, only 30% of children stated that they would be willing to take this every day if it were a medicine.

Evaluating the acceptability and mouthfeel of multiparticulates within a paediatric population1P.Mistry, 2J.Hodson, 3J.Bennett, 1H.Batchelor1 School of Pharmacy, Institute of Clinical Sciences, University of Birmingham, Edgbaston, B15 2TT, UK2University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston, Birmingham, UK3Pfizer Global R & D, Ramsgate Rd, Sandwich, Kent CT13 9NJ.

INTRODUCTION

This work was conducted as part of the SPaeDD-UK project (Smart Paediatric DrugDevelopment – UK, accelerating paediatric formulation developmenthttp://www.paediatricscienceuk.com).The authors would like to thank all participants for their participation in this study aswell as Thinktank science museum in Birmingham for hosting the study.

ACKNOWLEDGMENTS

CONCLUSIONS

RESULTS

MATERIALS AND METHODS

REFERENCES[1] Chen, A. W. et al 1996. Age appropriate hedonic scales to measure food preferences of young children. J Sens Stud, 11, 141-163[2] Zeinstra, G. G. et al.. 2009. Facial expressions in school-aged children are a good indicator of ‘dislikes’, but not of ‘likes’. Food Qual Pref, 20, 620-624[3] Klingmann, V. et al. 2013. Favorable acceptance of mini-tablets compared with syrup: a randomized controlled trial in infants and preschool children. J Pediatr, 163, 1728-1732 e1.[4] Kluk, A. et al. 2015. Can preschool-aged children swallow several minitablets at a time? Results from a clinical pilot study. Int J Pharm, 485, 1-6.[5] Spomer, N. et al. 2012. Acceptance of uncoated mini-tablets in young children: results from a prospective exploratory cross-over study. Arch Dis Child, 97, 283-6.

The administration of medicines to children poses a challenge to many parents andhealth care professionals; this is linked to the lack of age-appropriate oralformulations. Strategies such as crushing tablets or mixing medicine with food anddrinks are used to aid this problem, yet these strategies can affect medicine efficacy,dosing accuracy and bioavailability.

Multiparticulate formulations can be used as medicines; they offer the potential ofcoating to taste-mask coupled with flexible dosing. However, there is limitedknowledge on how mouthfeel can affect the palatability and overall acceptability ofmultiparticulate products.

We conducted an ethically approved study that was designed to compare participant-reported outcomes to researcher observations in the assessment of acceptability ofplacebo multiparticulate formulations.

Children (aged 4-12 years) sampled three unique 500mg samples of neutral tastingplacebo multi particulate products. The sample was administered on a medicinespoon with approximately 3mL spring water. Samples available ranged in size from200 to 700 µm and were available as coated (c) or uncoated (u) versions of each size.

After each sample intake participants had free access to water to clean their palate;the volume of water consumed was recorded.

A questionnaire was completed immediately after sample intake which included a 5-point hedonic facial scale (Chen et al., 1996) to assess grittiness, sample volume,mouthfeel and taste (A). Voluntary feedback from the participant was also optional.

Participants’ facial expressions and behaviours were recorded prior to, during andpost intake using a 12-point tick chart based on the behavioural observations, ofchildren tasting food (Zeinstra et al., 2009) (B). The following observations were usedas indicators of unacceptable mouthfeel:

• Sample 1 5 minute break• Sample 2

• 5 minute break• Sample 3

Consent from parent/carer and child

Researcher observes child

Child completes questionnaire after each test sample

Facial Expressions Behaviours (prior to / after)

Eyes squeezed/ shut Voices disgust

Brow bulge Resistance

Nose wrinkled Spits out/ vomits

Pursed lips Refusal

0

10

20

30

40

50

60

70

80

90

% o

f p

art

icip

an

ts d

isp

layin

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his

beh

avio

ur

200c

200u

350c

350u

500c

500u

700c

700u

This is the first study to evaluate the mouthfeel of multi particulates in children. Theability to swallow the complete dose of multiparticulates (500 mg) was 92.5% inchildren and there were no differences in acceptance of the particles based on thesize range investigated.

The scale used was well understood by children, however it is apparent that theyseemed to measure liking the product and not acceptability. Novel materials arecomplex and perhaps multiple administrations are required to accurately measureacceptance. Further investigation, using a different vehicle or a dosing device toadminister the multi particulates may improve the palatability of this formulation andparticipant reported outcomes.

(A)

(B)

(C)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

200c 200u 350c 350u 500c 500u 700c 700u

n=35 n=18 n=36 n=19 n=33 n=14 n=37 n=14

5

4

3

2

1

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