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. 2023 Jun 14;15(6):1729. doi: 10.3390/pharmaceutics15061729

Table 2.

Evaluation criteria.

A. Scoring Criteria for Swallowability
Score Observation
1 Swallowed No chewing took place during deglutition and no residuals of the solid were found during oral inspection.
2 Chewed/left over Chewing was observed before deglutition and/or that the whole or parts of the solid were found in the mouth during oral inspection and/or some mini-tablets left over on the spoon (≥80% should have been swallowed).
3 Spat out No deglutition took place and the solid was no longer in the child’s mouth.
4 Choked on The solid was swallowed the wrong way or a cough was caused.
5 Refused to take The child did not allow the investigator to place the solid in the mouth and/or <80% of mini-tablets swallowed.
B. Definition of acceptability derived from swallowability alone
Criteria
Acceptable Yes Swallowability score was 1 or 2
No Swallowability score was >2 (3–5)
C. Scoring criteria for palatability
Score Assessment Interpretation
1 Pleasant Positive hedonic pattern: Tongue protrusion, smack of mouth and lips, finger sucking, corner elevation
2 Neutral Neutral mouth and body movements, and face expressions (irregular and involving lips)
3 Unpleasant Negative aversive pattern: Gape, nose wrinkle, eye squinch, frown, grimace, head shake, arm flail
D. Scoring criteria for composite acceptability endpoint derived from palatability and swallowability
Palatability Swallowability score
1 2 ≥3
Pleasant High Good No
Neutral Good Low No
Unpleasant Low No No
E. Acceptability as composite acceptability endpoint
Yes: High/good
No: low/no