DURECT Corporation
ORAL DOSAGE FORM WITH DRUG COMPOSITION, BARRIER LAYER AND DRUG LAYER

Abstract:

The present disclosure provides dosage forms designed to deliver active pharmaceutical ingredients (APIs) in a controlled release manner. For instance, the present disclosure includes dosage forms with adequate time of onset of action and reduced lag times in the fed state. Such dosage forms find use in a variety of conditions where a rapid onset of action is desired followed by an extended release phase for the active agent, for example in the treatment of ADHD, pain or anxiety. In some cases, the dosage form includes a drug composition including a pharmacologically active agent, a barrier layer covering at least a portion of the drug composition, and a drug layer covering at least a portion of the barrier layer, wherein the drug layer includes the pharmacologically active agent. Related methods of making and administering the disclosed dosage forms are also provided.