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Evaluating the taste masking effectiveness of various flavors in a stable formulated pediatric suspension and solution using the Astree™ electronic tongue

1.Introduction

Pediatric formulation development requires an understanding of the physicochemical stability and the taste of the pharmaceutical drug product. The masking of unpleasant organolepticpropertie soft heactive pharmaceutical ingredient(APIcreates an other level of complexity during formulation development. The majority of APIs have a bitter taste and as most pediatric formulations are delivered or ally as a suspension, film coated tablet, capsule, syrup, solution, effervescent tablet, bulk or algranules, bulk or alpowder, and solidinacapsule tomix with food or drink the reist heneed for taste modulations.

2.Experimental

2.1.Materials

2.2.Equipment

2.2.1.X-rayDiffractometer(XRD)

2.2.2.Rheometer

2.2.3.Chromatographic(HPLC)system

2.2.4.Astree™ electronictongue

2.3.Methods

2.3.1.Formulations

2.3.1.1.Powder for reconstitution to a suspension formulation for active pharmaceutical ingredient compound X.

2.3.1.2.Powder for reconstitution to a solution formulation for active pharmaceutical ingredient compound Y.

2.3.2.XRPD sample preparation and analysis of compound X

2.3.3.Rheometry sample preparation and viscosity measurements

2.3.4.HPLC sample preparation and analysis of compound Y

2.3.5.Astree™ e-Tongue sample preparation and analysis

3.Results and discussion

3.1.Characterization of the physical stability of compound X suspension formulation

3.1.1.Monitoring the stability of compound X in suspension with XRPD

3.1.2.Selection of compound X suspension formulation

3.1.3.The effect of povidone(PVP) on the rheology of suspension “formulationT”

3.2.Characterization of the chemical stability of compound Y solution formulations

3.2.1.Monitoring the in-usestability of compound Y in solution with HPLC

3.2.2.Formulations election for compound Y powder for reconstitution to a solution

3.3.Astree™ electronic tongue measurements

3.3.1.Sensor potentiometric response and data analysis

4.Conclusion
We have demonstrated that the physicalstability of apediatric powder for reconstitution to asuspension formulation can be effectively evaluated using Xray powder diffractionand that the chemical stability of asolution can be monitored by high pressure liquid chromatography.The setechnique shave already be enproven to bevery useful in the early phase of pharma ceutical drug product develop-ment to select themoststable formulation for latest age development.The A stree™ e Tongue has demonstrated to be a good predictor of the change in taste perception of suspension and solution formulation swith different flavoring systems.The use of principal component analysis to compute the distanceand discrimination in dexvaluesto differentiate the tastep erception of apair of formulation has shown that the addition of Grapeor Vanillat othe suspension of compound Xworsensthetaste.However,the taste of compound X suspension was improved by the addition of Lemon and Cherry flavors.Likewise,the taste of compound Ysolution was effectively improved by Vanilla,Cherry,and Strawberry flavors.The seresultsin dicated that inthe early stages of formulation development the e-Tongue can be used toeliminate flavors that doittle to improve the palatability of aformulation.