Sejal R Ranmal, Elisa Alessandrini, Catherine Tuleu
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引用次数: 0
Abstract
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.
期刊介绍：
Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes:
-Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs.
-Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice.
-Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed.
-Studies focusing on the application of drug delivery technology in healthcare.
-Short communications and case study reports that meet the above criteria will also be considered.
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