An index for evaluating difficulty of Chewing Index for chewable tablets

Area of Science:

• Pharmaceutical Technology
• Materials Science
• Biomedical Engineering

Background:

• Chewable tablets require specific mechanical properties for patient compliance.
• Quantifying the ease of chewing is crucial for developing effective oral dosage forms.
• Existing methods may not fully capture the complex forces involved in mastication.

Purpose of the Study:

• To introduce and validate a novel Chewing Difficulty Index (CDI) for chewable tablets.
• To assess the relationship between tablet dimensions, mechanical strength, and chewing effort.
• To investigate the impact of salivary fluid exposure on chewable tablet mechanical properties.

Main Methods:

• The Chewing Difficulty Index was defined as the product of tablet thickness and hardness (measured via diametral loading).
• Mechanical properties (dimensions, hardness, tensile strength) of commercial and in-house chewable tablets were measured.
• Tablets were exposed to simulated salivary fluid for 30 seconds to evaluate changes in mechanical strength.

Main Results:

• The proposed Chewing Difficulty Index correlated well with the perceived force required for chewing.
• Tablets with varying thickness but similar hardness demonstrated the index's effectiveness.
• A 30-second exposure to simulated saliva significantly reduced tablet hardness and the Chewing Difficulty Index (p < 0.05).

Conclusions:

• The Chewing Difficulty Index is a valuable tool for assessing the chewability of oral solid dosage forms.
• Tablet mechanical properties, particularly hardness and thickness, are key determinants of chewing difficulty.
• Saliva-mediated softening is an important factor influencing the mechanical behavior and perceived ease of chewing of these tablets.