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An aqueous based polymeric coating system, polydimethyl-siloxane elastomer latex, was employed to coat acetaminophen tablets. Drug release characteristics due to this polymer coating were monitored by in-vitrQ dissolution tests. It was found that heat treatment of the coating and the desiccation pretreatment significantly changed the drug release profiles compared to untreated, coated tablets. The slowest drug release rate was obtained by desiccating the coated tablets for 24 hours or more followed by heat treatment a t 40OC for at least 4.5 hours. Rupturing of the coating layer during dissolution testing was observed only if the curing process was not utilized. As expected, drug released a t a given time was inversely proportional to the coating thickness.

The degradation profile indicates that development of solution or solid dosage from of GS-4104 with adequate shelf-life stability at room temperature is feasible.