Development and Evaluation of Elementary Osmotic Pump Tablet of Tizanidine Hydrochloride

Abstract

Aim The objective of present research work was to develop a sustained release osmotic tablet of Tizanidine HCl using suitable osmogens.Methodology Tizanidine HCl containing elementary osmotic tablets were prepared using a wet granulation process. Initially dried granules were screened for various pre compression evaluation parameters. Further dried granules were punched using 8 mm die cavity in a tablet punching machine. Thus developed tablets were evaluated for post compression parameters like tablet hardness thickness weight variation friability dissolution studies stability studies and scanning electron microscopy. Prior to dissolution studies an orifice was drilled on surface of tablet and the size of orifice was determined using SEM analysis.Results The pre compression evaluation for all the formulations had shown good results which in turn confirm excellent flow properties of granules. All formulations exhibited a weight gain of roughly 5-7. Dissolution studies confirm that the drug release pattern was controlled up to 24 hours formulation F9 had the maximum drug release around 97.27 at the end of 24 hours. The drug release was impacted by the amount of added osmogen microcrystalline cellulose and lactose concentrations. SEM studies were carried out to find the membrane surface diameter of the orifice and it was found to be 0.3 mm and revealed that the coat was intact devoid of pores after the dissolution. Kinetic study confirmed that all the formulations followed Zero order kinetics. Optimized formulation F9 was stable at room temperature and elevated temperature upto 30 days.Conclusion Developed Tizanidine HCl elementary osmotic pump tablets showed prolonged release of drug and found reproducible results for all the in vitro evaluation parameters.