Abstract
An experimental easily swallowable oral sustained-release dosage form of acetaminophen (APAP) that can be administered to patients every 12 hours was formulated and evaluated in 8 healthy, adult volunteers. The test product was compared to a well-characterized, commercially available immediate-release acetaminophen caplet. Multiple doses of these two products were administered to 8 healthy human subjects in a two-way cross-over design. Saliva samples were collected over a period of 24–48 h depending upon the administered treatment. The time course of acetaminophen concentrations in saliva was analyzed using non-compartmental methods. Results indicate that it is possible to maintain the desired therapeutic concentration over a 12-h dosing interval using the molded tablet dosage form.
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