LAUSR

Purpose The pediatric population is represented by a diverse group of patients and, as a consequence, additional factors and parameters determining their dosage and taste must be taken into account. The aim of this work is to prepare and analyze an innovative chewable solid drug formulation that would appeal to pediatric patients. In particular, the present study presents a new taste masking processing wherein the drug’s disagreeable taste and the associated unpleasant throat burning sensation are covered with honey and chocolate. Methods Ibuprofen was used as the active pharmaceutical ingredient dispersed in formula after being suitably pretreated. Honey and agar are the two main excipients of the formulation while the new pharmaceutical preparation is further coated with milk chocolate to mask its bitter taste. Vitamins A and E were also added in a separate formula as an alternative choice which, apart from the curative action of ibuprofen, display additional benefits. During the development of the analytical methods, liquid/solid and solid phase extraction was performed. Moreover, for the chromatographic determination, a RP-C18 column and two different mobile phases containing acetonitrile and phosphate buffer were used. Results The methods were validated on the basis of international guidelines. The recoveries of the active ingredients were 97–102% while the RSD values were 0.06–0.53%. The new preparation was found to be stable for at least 1 year. Conclusions Considering children’s difficulty in swallowing medicines with a bitter taste, palatable ibuprofen formulations were made. Their preparative and analytic methods were validated according to ICH guidelines.