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Journal de Pharmacie Clinique

Flavouring and taste evaluation of an oral paediatric solution of phenobarbital Volume 26, issue 2, Avril-Mai-Juin 2007

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Introduction: the pharmaceutical industry supplies normally oral drugs in solid forms that are generally poorly adapted to paediatric needs. This obliges hospital pharmacies to prepare capsules with dosages suited to the age and weight of the children. Working with phenobarbital capsules as an example, it was decided to replace the standard form by an oral liquid to facilitate use and to reduce the risk of errors. The main difficulty resides in the choice of a flavouring agent, necessary to mask the extremely bitter taste of phenobarbital. Materials and methods: several flavoured formulations of a paediatric oral liquid solution were developed and evaluation of their acceptability was carried out with adult volunteers using a standard questionnaire. Two solutions were retained and their chemical and physical stabilities were determined. Results: the solution finally chosen had a concentration of sodium phenobarbital of 5 mg/mL. It contained 40% v/v of glycerol (98%), 0.1% v/v of methyl and propyhydroxybenzoate as preservatives, sodium saccharin as sweetening agent, and was flavoured with a raspberry / lemon combination. The stability of the solution, validated by an adapted HPLC method, indicated that the solution was stable for at least 5 months at room temperature. Conclusion: an oral liquid form of phenobarbital without alcohol has been developed with emphasis on finding the best flavour and with the preoccupation of ensuring an excellent acceptability by the children. This preparation has been used for over a year in the paediatric unit to the entire satisfaction of the children and the healthcare workers.