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Published on: September 20, 2019
Comparative Sensory Evaluation of Pediatric Liquid Omeprazole Formulations Available in the UK
Sejal R Ranmal1, Elisa Alessandrini2, Catherine Tuleu2
1UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London, WC1N 1AX, UK. sejal.ranmal@ucl.ac.uk.
Insights
Compounded omeprazole preparations are less palatable than licensed versions, with significant taste and aftertaste aversions. Developing better-tasting pediatric formulations is crucial for patient acceptance.
Area of Science:
- Pharmacology
- Sensory Science
- Pediatric Medicine
Background:
- Omeprazole is a key treatment for pediatric acid-related disorders.
- Licensed liquid omeprazole formulations have variable global availability.
- Compounded preparations are often used, with inconsistent sensory profiles.
Purpose of the Study:
- To evaluate the palatability of different omeprazole liquid formulations.
- To compare sensory characteristics of compounded versus licensed preparations.
- To inform the development of acceptable pediatric formulations.
Main Methods:
- Randomized, single-blind sensory evaluation study.
- 30 adult volunteers assessed six UK omeprazole liquid formulations.
- Visual analog and hedonic scales measured taste, aftertaste, smell, mouthfeel, and overall acceptability.
Main Results:
- Compounded sodium bicarbonate suspension showed significantly higher taste and aftertaste aversiveness.
- A licensed menthol-flavored oral solution had the lowest taste aversiveness and highest acceptability.
- Other licensed formulations were generally mildly to moderately aversive.
Conclusions:
- Significant sensory differences exist between compounded and licensed omeprazole liquids.
- Palatability is a critical factor for pediatric formulation acceptance.
- Development of palatable, age-appropriate formulations is essential.
Background:
Omeprazole is a widely prescribed proton pump inhibitor used to treat gastroesophageal reflux disease and other acid-related disorders in children. Despite its clinical importance, the availability of licensed liquid formulations varies worldwide, often resulting in the use of extemporaneously compounded preparations. These liquid products have varying sensory characteristics that can influence patient acceptability.
Methods:
A randomized, single-blind sensory evaluation study was conducted with a panel of 30 adult volunteers (aged 24 ± 2.6 years; 77% female) to assess the palatability of six omeprazole liquid formulations available in the UK. Participants rated taste, aftertaste, smell, and mouthfeel aversiveness using a visual analog scale, overall acceptability using a 5-point facial hedonic scale, and provided qualitative feedback.
Results:
The compounded 8.4% sodium bicarbonate suspension had a significantly more aversive taste (mean ± standard deviation: 74 ± 31; median [interquartile range]: 83 [63-100]) and aftertaste (55 ± 33; 61 [23-80]) compared with all licensed formulations (p < 0.001), with bitterness being a prominent attribute. The licensed menthol-flavored 10-mg/15-mL oral solution received the lowest taste aversiveness rating (17 ± 23; 6 [1-19]), and the highest overall acceptability. Other licensed formulations were generally rated as mild to moderately aversive, with some irritating or burning sensations also reported.
Conclusions:
A sensory analysis revealed clear differences between compounded and licensed omeprazole formulations, highlighting the importance of developing and prescribing palatable age-appropriate formulations for pediatric populations.
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