Effect of hydrophilic polymers on the release of diltiazem hydrochloride from elementary osmotic pumps.

Diltiazem hydrochloride (DLTZ) is a freely water-soluble drug, because of its higher aqueous solubility, the suitability of the drug with elementary osmotic pumps is restricted. Plain DLTZ elementary osmotic pump had shown higher release rate. Drug entrapment in polymer matrix or addition of release retardant materials (various polymers) can reduce the release rate of drug. In present study, effect of appropriate hydrophilic polymers (HP) on the release pattern was investigated. Ingredients of the system were optimized for parameters like drug:polymer ratio and amount of osmogent, for the desired release pattern. Two optimized formulations were selected for further characterization. Theoretical release rate of the formulations were also determined and compared. Different dissolution models were applied to drug release data in order to establish release mechanism and kinetics. Criteria for selecting the most appropriate model were based on best goodness of fit and smallest sum of squared residuals.