title: An index for evaluating difficulty of Chewing Index for chewable tablets.
abstract: Chewing difficulty index, a potential measure of difficulty in chewing the chewable tablets, has been described herein as the product of tablet thickness and tablet hardness measured under the diametral loading. The proposed index was evaluated by measuring the dimensions and mechanical strength of commercial and in-house prepared chewable tablets. Data collected on tablets with different thickness but same hardness or tensile strength suggests that the proposed index provides a good assessment of the force needed to chew the chewable tablets. Influence of brief exposure to salivary fluid during chewing on the mechanical strength of the chewable tablets was also evaluated. Thirty seconds exposure to the simulated salivary fluid was also found to significantly reduce (p < 0.05) the hardness and the chewing difficulty index of a number of evaluated chewable tablet drug products.
authors.affiliation: Food and Drug Administration, Center for Drug Evaluation and Research, Division of Product Quality Research , Silver Spring, MD , USA and.
authors.forename: Abhay
authors.initials: A
authors.lastname: Gupta
authors.forename: Nallaperumal
authors.initials: N
authors.lastname: Chidambaram
authors.forename: Mansoor A
authors.initials: MA
authors.lastname: Khan
mesh_terms: D002626:Chemistry, Pharmaceutical; D006244:Hardness; D006801:Humans; D066298:In Vitro Techniques; D008409:Mastication; D012463:Saliva / Q000737:chemistry; D013607:Tablets; D013718:Tensile Strength
chemical_list: D013607:Tablets
keywords: Adverse events; chewable tablets; simulated salivary fluid; tablet breaking force; tablet hardness; tablet quality