Background Some drug forms are not adapted to young children or the elderly. Lists of crushable tablets are already published but do not t consider palatability, which is an additional challenge for drug compliance.
Purpose To determine the palatability of diluted oral solid medications and oral liquid forms.
Material and methods The powder extracted from crushed tablets or opened capsules was diluted in water and flavoured suspending excipient. The minimum solvent needed for dissolution was determined by increments of 1 mL. The solution was then smelled and tasted by three pharmacists to determine the taste and the palatability score (PS) using the 5-point numeric rating scale (1=really bad; 5=really good) of the European Medicines Agency. PS were reported on a visual analogue scale for each drug. The quantity tested by each pharmacist was two drops. The time between two medications was at least 5 min. The possibility of administration of a fraction of the dose was also determined. Modified release formulations and cytotoxic drugs were excluded. Liquid forms were tested with the same method.
Results One-hundred and fifty drugs were tested including 43 liquid forms and 107 solid forms. The average PS was smaller for diluted solid forms than for liquid forms (2.3 vs 2.9, p<0.001). This can be explained by the more frequent bitterness of diluted solid forms (87% vs 14%, p<0.001). PS was less than 3/5 for each tester in 72% of solid forms vs 60% of liquid forms (p<0.001). A dose fraction can be used for 76 diluted solid forms. Flavoured suspending excipient can mask the taste of 80/107 solid medication but only when the bitterness was low. Some medications cause other sensations: tricyclic antidepressants are anaesthetics for mucosa, naftidrofuryl and febuxostat are irritants for esophagus and glycerin in the formulation causes a warm sensation in the mouth.
Conclusion This database provides part of the answer regarding the acceptability of a treatment. PS is an important factor in compliance, particularly in the paediatric population. This method requires to be validated because taste varies with age, ethnic … This study must be completed by other elements such as pH of the solution, stability of the active substance or solubility parameters.
References and/or acknowledgements https://www.ema.europa.eu/documents/presentation/presentation-acceptability-palatability-methods-available-assessment_en.pdf
No conflict of interest.