Trazodone-Immediate Release Tablets by using Natural & Synthetic Super Disintegrants

Abstract

The present study was an attempt to formulate and evaluate immediate release tablets of an ant-depressant drugs Trazodone hydrochloride. Preformulation studies were carried out during the early stages of this work. It has found that Trazodone hydrochloride is having maximum absorption at wavelength 248 nm. The organoleptic characteristics, solubility, particle analysis, BD, TD, CI and HR of the drug were done. The photostability study and forced degradation study of the drug shows above 99% purity. The drug-polymer compatibility study was carried out to determine the interactions between the drug and the polymers used in the study. The IR spectra revealed that polymers and excipients used were compatible with drugs. The Immediate release/Fast dissolving tablets were formulated using Sodium starch glycolate as super disintegrant by wet granulation technique. Prepared tablets were evaluated for Pre-compression Parameters and Post  compression parameters. Flow properties–Angle of repose, loose bulk density, tapped density, %Carr’s compressibility and also Hausner’s ratio was determined to all the formulations which showed good flow property. The shape and colour of all formulations were found to be round in shape and white in colour. The thickness found uniform in all formulations except the formulation F1 and F2. Amongst all the developed formulations,  Trazodone hydrochloride immediate release tablets formulated by using sodium starch glycolate as super disintegrant, MCC pH 102 as diluent and pregelatinized starch as binder  shows hardness (85 ± 10 N), Friability (NMT 1%), thickness (4.5 ± 0.1 mm), Diameter (9.52  ±0.02) and it is fulfilling all the parameters. All formulations shown good in vitro disintegration time (4510 sec). This indicates rapid disintegration. Also in all formulations, the %Cumulative drug release is not less than 85% in 15 minutes. Stability studies were conducted for formulation F3 at 400 C/75% RH and 60⁰C for 3 months.