Formulation development and evaluation of immediate release tablet of terbinafine hydrochloride

Abstract

The immediate release tablet of antifungal drug Terbinafine hydrochloride were prepared developed and evaluated to increase solubility and bioavailability of low soluble drug by using wet granulation method. The tablets were prepared by varying concentrations and compositions of microcrystalline cellulose, sodium starch glycolate, hydroxyl propyl methyl cellulose, magnesium stearate, and colloidal silicon dioxide for seven trial batches. The drug excipient compatability study was studied by photostability study. No significant changes were observed in photostability study. The tablets were evaluated for disintegration test, content uniformity, and friability. Invitro drug release profile Terbinafine hydrochloride was examined in four different media PH0.1N HCL, PH4.5 acidic buffers, PH6.8 phosphate buffer and PH3.0 citrate buffer for 45 minutes. The drug release for trial batch no.7 shows 100.4% of drug release and innovator shows 102% of drug release. The formulation trial no 6 and 7 showed no significant changes during the study period of accelerated stability study for 3 months. The result of all formulation 7 showed that good developed formulation of immediate release tablet containing Terbinafine hydrochloride drug was similar to the marketed product with all respect and stable to effect of temperature and humidity.