ABSTRACT:
Oral controlled release of rosiglitazone maleate was studied by using modified pulsincap technique. Modified pulsincaps were prepared with different proportions of the hydrophilic polymer, HPMC ( Hydroxy Propyl Methyl Cellulose). Drug-polymer mixtures were prepared in the ratios 5:2, 5:3, 5:4, and 5:5 respectively. The prepared drug-polymer mixtures were evaluated for micromeritic properties and to conform the reproducibility of the method of mixing. Drug-polymer mixture equivalent to 8 mg of rosiglitazone maleate was filled into the hardened body of the capsule for the preparation of modified pulsincaps. The prepared pulsincaps were evaluated for weight variation, drug content and drug release kinetics. Rosiglitazone maleate release from the prepared pulsincaps was uniformly slow and extended for a period of time more than 12 hrs in case of RH5 pulsincaps. The drug release from the prepared pulsincaps followed Zero order kinetics. The Zero order release rate constant K0 was decreased as the polymer concentration increased. The plots of log fraction drug released versus time of all the pulsincaps were found to be linear and found that the mechanisam of drug release followed peppas model. It was found that diffusional exponent (n) values of all the pulsincaps were ranging from 0.5737- 0.6948 indicating that the drug release mechanism followed non-Fickian diffusion. Drug –polymer interaction studies by using FTIR, DSC were performed on the pure drug and drug-polymer mixtures which indicated no drug- polymer interaction.