Taste Abatement of Hydroxyzine Hydrochloride by Cation Exchange Resins

Hydroxyzine hydrochloride is histamine H1 antagonist, antipruritic and anxiolytic, sedative and hypnotic agent. It helps in suppression of histaminic edema, flare and pruritus, but it has poor patient compliance due to its bitterness. So its taste should be masked to formulate it in a palatable dosage form. Hence an attempt was made to mask the taste of Hydroxyzine hydrochloride with strong and weak cation exchange resins. The complex formation of drug with different cation exchange resins was carried out to block the functional group responsible for causing bitter taste. DSC analysis, X-ray diffractometry, FTIR spectra and decomplexation studies give evidences of complex formation.Hydroxyzine hydrochloride shows good complexation and effective taste masking with strong cation exchanger like Tulsion-343, Tulsion-344 and weak cation exchanger like Indion-234. But Tulsion-343 and Tulsion-344 resins affect the drug release from complex at gastric pH due to their sustained release action. The complex for formulation was selected considering the results obtained from release of drug from complex at salivary pH as well as at gastric pH, sensory evaluation of complex. Accelerated stability studies (at 40°C ± 2°C /75% RH±5% RH) on the selected resinate indicate that there are no significant change in drug content and in vitro dissolution profile (p < 0.05).