The development of effectively formulated oral drug products is key to ensuring patient compliance and desired clinical outcomes. Given the increasing regulatory expectations for the development of bespoke age-appropriate products, critical performance features now include palatability and overall acceptability in addition to standard drug-delivery requirements for oral medications. Understanding and modifying the taste attributes of aversive drug substances is, therefore, important. There are several taste-masking techniques available, which involve either modification of the API itself or the formulation; however, there are as yet no standardized industry approaches for assessing whether the poor taste of a drug has been effectively masked.

Although in-vitro and preclinical methods can be applied, the resulting data are, at best, incomplete and, at worst, misleading. Approaches that have greater correlation with human response and, ideally, incorporate clinical assessment of the formulation are, therefore, required. This article reviews the breadth of taste-masking techniques available, the methods used to evaluate taste, and how an integrated approach to formulation development and clinical assessment can deliver significant benefits for product development and validation. 

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