Proposed Tool to Compare and Assess the Applicability of Taste Assessment Techniques for Pharmaceuticals

Palatability is amongst the most important determinants of whether or not a child will take a medicine. In order to increase concordance with treatment regimens it is often necessary to utilise a range of formulation techniques to improve the palatability of medicines. These can include selecting a different molecule or ver-sion of a molecule (such as a different polymorph or salt form), various taste masking techniques and/or the inclusion of flavours and sweeteners. In order to be able to understand the taste of the Active Pharmaceutical Ingredient (API) and to validate the formulation approach used, it is necessary to be able to use the most reliable taste evaluation method possi-ble. Multiple in vivo and in vitro methods exist nowadays or are proposed in the literature but are often little understood by the pharmaceutical product development community. In particular, different methods may be more relevant at different stages of product development. The aim of this article is to propose a tool to guide the selection of the most appropriate method for the desired evaluation. A spreadsheet-based tool is proposed that is designed to allow the systematic assessment of the applicability of any taste assessment technique existing or new to the users proposed application. A series of criteria are defined that will allow the user to assess the analytical, usability and availability factors for the technique that is being considered. Such a systematic review will help the user to understand the benefits and risks of using each methodology for that application. The use of the tool is illustrated based on currently available data and literature. As new/ existing methods are developed/improved, the outcomes of the tool may change. (c) 2021 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.

Automated summary

Palatability is crucial for children's acceptance of medicines. Various formulation techniques, including taste masking and flavoring, can be used to improve palatability. However, the pharmaceutical product development community may have limited understanding of the different taste evaluation methods available. This article proposes a spreadsheet-based tool to help guide the selection of the most appropriate method for taste evaluation, taking into account analytical, usability, and availability factors. The tool allows systematic assessment of different techniques and helps users understand the benefits and risks of each methodology.