Formulation and Development of Ranolazine Sustained Release Dosage Forms
Author (s): Sanyasi Swain1*, Santanu Mohapatro2
The physical-chemical properties indicated that the Ranolazine was slightly soluble in water. The sustained release tablets of the ranolazine was prepared using hydrophilic semi synthetic polymer (HPMC), a hydrophobic pH dependent polymer (Eudragit L100), and MCC PH101 as diluent. Wet granulation method was adopted using Hydro-alcoholic solution containing Water & Isopropyl alcohol as a granulating agent. In vitro drug release profile (theoretical) can be calculated based on available pharmacokinetic data. HPMC K4M, HPMC K100M, &Eudragit were used in the current study to retard the drug release. The drug release study was carried by USP dissolution apparatus II. Desired release profile was achieved using a combination polymer HPMC K100M &Eudragit L100. Results of in vitro percentage drug release studies indicated that among different trials, Batch T10 showed acceptable percentage drug release profile comparable to theoretical drug release profile and also all the physical parameters, evaluation tests in desirable limits. From the kinetic models study, Higuchi model was fitted for Batch T10 and shows diffusion release mechanism. The process was found simple and assumed to be successful at the commercial stage.
Keywords: Ranolazine, HPMC K4M, HPMC K100M, Eudragit L100