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First Extended-Release Chewable Tablet Wins FDA Nod
The FDA has approved the first extended-release (ER) chewable tablet, developed by Tris Pharma. Prior ER tablets and capsules typically carried the warning “should not be chewed or crushed.”
With other ER dosage forms, chewing or crushing can cause “dose dumping,” which can increase the concentration of a drug in the body, thereby producing adverse effects or even drug-induced toxicity. In clinical studies, the new ER chewable tablet technology released drug consistently, regardless of whether the tablet was chewed or swallowed whole.
The ER chewable tablets are an extension of Tris Pharma’s LiquiXR platform, a particulate-based technology in which hundreds of millions of tiny (about 100 microns) particles deliver drug over time. Controlled release is facilitated by a flexible particle coating, which is why chewing does not compromise the release profile, according to Tris. The same particles can be used to formulate various oral ER dosage forms, such as liquid suspensions, dispersible tablets, film strips, and ODT’s. Moreover, the chewable tablets can be scored like any immediate-release tablets.
Source: Tris Pharma; December 16, 2015.