Promethazine hydrochloride (PMZ), an anti histaminic drug, was shown to be cytotoxic in vitro and in vivo at concentrations of 10-4 molar or greater regardless of pH. A controlled-release microencapsulated formulation was developed that eliminated leukocyte infiltration (irritation) in the nasal epithelium at PMZ concentrations greater than the in vitro cytotoxic limit. Alleviation of cytotoxicity could result from controlled release and accelerated absorption of PMZ.
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