Document Type : Original Article
Authors
1
Department of Pharmaceutics, Faculty of Pharmacy, Hamdard University, Karachi, Pakistan
2
Department of Pharmaceutics, Hamdard Institute of Pharmaceutical Sciences, Hamdard University, Islamabad, Pakistan
3
Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Dow University of Health Science, Karachi, Pakistan
4
Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Pakistan
5
Department of Pharmaceutics, Institute of Pharmaceutical Sciences, Jinnah Sindh Medical University, Karachi, Pakistan
Abstract
Formulation of controlled release matrix tablets of Itopride hydrochloride (ITP) was done using direct compression method. Different polymers were used to evaluate the influence of different types (HPM, EC, Kollidon® SR), concentration (20-40%) and viscosity grade (HPMC-4000 cps, HPMC-100000 cps, EC-10 cps and Kollidon SR) on drug release. Twelve different tablet formulations were designed with constant amount of ITP in each tablet formulation (150 mg). The dissolution studies of CR matrix formulations were carried out in acidic buffer (pH 1.2) and phosphate buffer (pH 6.8). Drug release kinetics was studied for first order, Zero-order, Higuchi, Korsmeyer-Peppas and Weibull models using DD Solver (an add-in software for MS Excel). Formulation ECF7, ECF8 and ECF9 containing EC (20-40%) greatly controlled the release rate of drug over an extended period of 12 hr. However, drug release from tablets formulations K4F3, K100F5 and ECF8, followed zero-order kinetics with regression coefficient of 0.966-0.999. The release mechanism of tablets formulations K4F2, KK4F3, K4F4, ECF7, KSRF10, KSRF11 and KSRF12 were non-fickian diffusion, whereas the release mechanism from formulations K4F1, K100F5, K100F6, ECF8 and ECF9 were super case-II transport mechanism. It was concluded that HPMC and ethylcellulose (EC-10cps) in the percentage range of 20-30% were excellent release controlling polymers for itopride HCl.
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