A novel data-driven approach to assess the chewability and grittiness of the chewable tablets using a texture analysis.

Abstract

Context: Chewable tablet palatability significantly impacts patient compliance, but current pharmacopeias have no standardized evaluation methods. This requires developing an objective system for assessing the palatability of chewable dosage forms, which will aid in setting quality control standards.

Objective: Using a texture analyzer, this study aimed to develop an objective, data-driven approach to evaluate chewability and grittiness in chewable tablets.

Methods: 10 commercially available chewable tablet formulations were assessed, with subjective sensory evaluations supplemented by texture analysis-based measurements to quantify attributes of chewability and grittiness. To evaluate chewability, measurements of axial compression force, work, and adhesion were conducted, establishing optimal conditions of 400 N, 3 mm, and 50% strain to simulate oral chewing. For grittiness, a correlation between particle size and linear distance value was demonstrated, with Calcium carbonate used as a reference material to establish a standardized evaluation scale.

Results: Results indicated a strong correlation between tablet formulations and their sensory and texture analysis scores, with stickiness largely influenced by formulation ingredients such as milk powder and cacao powder. And the particle size of the insoluble material in the tablets largely influences the grit sensation.

Conclusion: We developed a novel data-driven approach that offers a standardized assessment system to evaluate palatability characteristics in chewable tablets, facilitating more consistent formulation comparisons and potential optimization for consumer acceptability. This approach highlights the utility of texture analysis in transitioning empirical palatability assessments to objective, quantifiable methods, which may extend to other oral dosage forms.