Ruben Lozanoa, Pankaj A. Shaha, Manoj Nerurkarb, and Sandrine Iszc. aAnalytical R&D;, bPharmaceutics R&D;, Bristol-Myers Squibb, New Brunswick, NJ, and cAlpha MOS, Toulouse, France.

Abstract
Many active pharmaceutical ingredients can impart an unpleasant taste or odor, usually associated with bitterness. To produce a desirable oral drug product, especially if destined for pediatric use, development efforts focus on masking the unpleasant taste/odor, often by adding flavoring or sweetening agents to the formulation. Organoleptic analysis of such prototype products is commonly performed by human taste panels. However, in an effort to eliminate human testing due to the safety risks, alternative analytical means are being sought. The novel lectronic tongue?technology is being utilized by the food/beverage and pharmaceutical industries to evaluate product taste characteristics. It provides relative measurements of nonvolatile or low-volatile molecules and dissolved organic compounds that are responsible for taste and flavor sensations. Results of such taste evaluations are presented here from analyses using the Alpha MOS Astree E-tongue. For example, prototype developmental formulations of a liquid drug product containing different levels and combinations of sucrose, aspartame, and a flavor component (bubble gum or cherry) were analyzed. Fingerprint patterns of the samples and eference?chemicals were obtained by the E-tongue. Using Principal Component Analysis, a relative weetness index?was established, allowing comparisons among the prototype formulations and conclusions about effects of the added flavor excipients on taste characteristics. The E-tongue technology offers the potential to provide taste evaluation during formulation development or to be used as a quality-control tool, and thus significantly reduce the amount of human testing.

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