More Info Sought on Chewable Tablet Guidance

AstraZeneca says that a draft FDA guidance on quality attribute considerations for chewable tablets does not have any text related to tablet hardness or chewing difficulty on stability. “Tablets may harden over time or can turn into a moist gritty mass as superdisintegrants can pick up moisture and soften the tablets,” the company says in a comment letter. “Both situations are undesirable.” The company also recommends that chewable tablets with functionally coated particles should be tested to ensure that the functional coating continues to function after the tablet is chewed in practice.

Pfizer’s comment says the document is unclear as to which, if any, of the recommendations need to be applied to currently marketed products under either an NDA, ANDA, or OTC. It also asks for clarification on the scope of the guidance, and suggests limiting it to tablet dosage forms only and not to things such as gummy dosage forms.

Line-by-line specific comments were provided by Shire and Genentech.