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Research Journal of Pharmacy and Technology
Year : 2015, Volume : 8, Issue : 9
First page : ( 1294) Last page : ( 1306)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2015.00235.8

Formulation and Evaluation of Amisulpride Nanocrystal Tablets

Dr. Sathali Abdul Hasan A.*, Prakash Jeya Chandra S.K.

The Principal and HOD, Department of Pharmaceutics, College of Pharmacy, Madurai Medical College, Madurai-625 020, Tamil Nadu, India

*Corresponding Author E-mail: ahsathali@gmail.com

Online published on 28 October, 2015.

Abstract

Amisulpride is an antipsychotic drug which belongs to BCS type II classification. The present study aims to develop nanocrystals of amisulpride in order to enhance solubility and dissolution rate by decreasing particle size of drug. The amisulpride nanocrystals with small and uniform particle size were successfully prepared by emulsion solvent diffusion method is based on the high pressure homogenization technique using βcyclodextrin, sodium lauryl sulphate, hydroxy propyl methyl cellulose E15 and polyvinyl alcohol as stabilizers at different concentrations. The compatability studies was done by infrared spectroscopy and differential scanning calorimetry showed that no interaction between the drug and stabilizers. The amisulpride nanocrystals were evaluated for drug content, invitro dissolution study, SEM, X-ray powder diffraction, particle size distribution, zeta potential and solubility studies. The X-ray powder diffraction (XRPD) confirmed that there was no change in the crystalline state by this size reduction process. The presence of stabilizers made the nanocrystal formulations more stable. The solubility and in vitro dissolution studies suggested that the nanocrystal formulations can improve the bioavailability of the amisulpride by improving its solubility and dissolution rate when compared to pure drug. It was showed that BCD 1.8% concentration gives better drug release profile and enhances the solubility. The amisulpride nanocrystal tablets were successfully prepared from the best formulation by direct compression method. Precompression and post compression evaluation studies are also performed. Amisulpride nanocrystal tablet showed better drug release profile when compared to marketed and amisulpride tablet.

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Keywords

Nanocrystals, Amisulpride, Emulsion Solvent Diffusion, High Pressure Homogenization, Nanocrystal Tablets.

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