Erosive Potential of Sugar Free and Sugar Containing Pediatric Medicines Given Regularly and Long Term to Children

Abstract

To assess the erosive potential of 94 pediatric medicines of various therapeutic groups in vitro. In vitro measurement of endogenous pH and titratable acidity (mmol) of 94 formulations was done. Endogenous pH was measured using a pH meter, followed by titration with 0.1-M NaOH using phenolphthalein as indicator. Overall, 55 (59%) formulations had an endogenous pH of <5.5. The mean (±SD) endogenous pH and titratable acidity for 45 SC formulations were 5.52 ± 1.18 and 0.165 ± 0.131 mmol, respectively; for 49 sugars-free (SF) formulations, these figures were 5.81 ± 1.43 and 0.393 ± 1.225 mmol (P > 0.05).Compared with their SC bioequivalents, eight SF medicines showed no significant differences for pH or titratable acidity, while 10 higher-strength medicines showed lower pH (P 0.035) and greater titratable acidity (P 0.026) than their lower-strength equivalents. Chewable and dispersible tablets, gastrointestinal medicines and antibiotics were significant predictors of higher pH. In contrast, effervescent tablets, and nutrition and blood preparations were significant predictors of higher titratable acidity. Pediatric SF medicines were not more erosive than SC medicines in vitro; a more significant predictor of their erosive potential was dose form. Higher the dose form more was the erosive potential of the medicine.