FORMULATION DEVELOPMENT AND EVALUATION OF AMISULPRIDE ONCE DAILY TABLET

Abstract

The objective of the present study was to develop once-daily tablet of Amisulpride, a second generation antipsychotic, a substituted Benzamide. The tablets were prepared by the wet granulation method. Microcrystalline Cellulose, Hydroxy Propyl methylcellulose (HPMC), Talc, Magnesium Stearate, Iso Propyl alcohol, Xanthan Gum, Kollidone, Cross Pobidone, Aerosil, Avesil 101, 112, 102, Sodium Bi-carbonate, Poly vinylpyrollidone K-30, Carbopol with varying excipients Six bilayer formulations AM₁-AM₆ were prepared by compressing both Instant Release (IR) and Sustained Release (SR) granules. The granules were evaluated for bulk density, tapped density, compressibility, Hausner ratio and moisture content. The tablets AM₁-AM₆ were evaluated. The granules showed satisfactory flow properties. All the tablets formulations showed acceptable Pharmacotechnical properties and complied within specifications for tested parameters. The results of dissolution studies indicated that the formulation AM₁, AM₂ and AM₃ the release retardant use in combination of SR part & IR part, AM₁(80:20), AM₂(80:20)in combination of HPMC and poloxmer 188 and AM₃ use is xanthane gum but process not fissile and dissolution was faster. Formulation AM₆ exhibited satisfactory drug release; amisulpride OD Bi-layer 400 mg tablets dissolved more than 90% in 24 hours.