Tris Pharma, Inc. (“Tris”) announced that the U.S. Food and Drug Administration (FDA) approved the first-ever extended-release (ER) chewable tablet, capping off a highly productive year with three Tris-developed NDAs approved in a calendar year.
Prior to Tris’ breakthrough ER chewable technology, extended-release tablets and capsules typically carried a warning, “should not be chewed or crushed.” With other controlled-release dosage forms, chewing or crushing can cause dose dumping which can greatly increase the concentration of a drug in the body and thereby produce adverse effects or even drug-induced toxicity. In clinical studies, Tris has demonstrated its extended-release chewable tablet technology releases drug consistently whether it is chewed or swallowed whole. This patent-protected technology offers patients convenience, flexibility and confidence.
ER chewable tablets are an extension of Tris’ LiquiXR® platform, a particulate based technology where hundreds of millions of tiny (about 100 microns) particles deliver drug over time. The extended release is facilitated by an extremely robust and flexible particle coating, which is why chewing does not compromise the release profile. The same particles can be used to formulate various oral extended-release dosage forms such as liquid suspensions, dispersible tablets, film strips, and ODT’s. Further, Tris’ ER chewable technology can be scored just like any immediate-release tablet.
Tris Pharma is a specialty pharmaceutical company focused on the research and development of technologies-driven products. Tris has pioneered the delivery of sustained release in the liquid, chewable/ODT and strip dosage forms so patients do not have to swallow a pill. Tris’ Nobuse technology provides abuse deterrence for opioids and other abuse-prone drugs.
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