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Abstract

FORMULATION AND DEVELOPMENT OF IMMEDIATE RELEASE TABLET OF ANTIDEPRESSANT (TRAZODONE) DRUG

Ram Ujagar Singh* and Ram Kumar Roy

Abstract

The present study was an attempt to formulate and evaluate immediate release tablets of an anti-depressant drug 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 photo stability 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’s revealed that, polymers and excipients used were compatible with drug. The Immediate release/Fast dissolving tablets were formulated using Sodium starch glycolate as superdisintegrant 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 superdisintegrant, MCC pH 102 as diluent and pregelatinised 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 (4510 sec). This indicates rapid disintegration. Also in all formulations, the %Cumulative drug released is not less than 85% in 15 minutes. Stability studies were conducted for formulation F3 at 400C/75% RH and 60oC for 3 months. The tablets were visually tested for colour variation with initial and there was no significant changes observed. There was also no changes occur in their weight, thickness, hardness and diameter. Not much variation or change was observed in any parameters throughout the study period. Thus, the formulation F3 found to be stable. The formulation F3 was compared with the marketed formulation. It shown that there was no significant change in in-vitro dissolution profile in between the formulation F3 and the marketed formulation. The prepared immediate release tablets disintegrate in seconds without need of water and enhance the absorption; this leads to increase in the bioavailability of Trazodone hydrochloride.

Keywords: Immediate release, therapy, administration, drug, compliance.


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