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Effect of Temperature and Stirring Rate on Flow and Compactability Properties of Simvastatin Spherical Crystals



Varshosaz J1 ; Tavakoli N1 ; Salamat FA1
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  1. 1. Department of Pharmaceutics, School of Pharmacy and Isfahan Pharmaceutical Sciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran

Source: International Journal of Pharmacy and Pharmaceutical Sciences Published:2011

Abstract

Simvastatin is a water insoluble drug used as a hypocholestrolemic agent. Its pharmacological effects are limited by its poor water solubility. After successful production of simvastatin spherical crystals by emulsion solvent diffusion method and improvement its dissolution rate, the aim of present study was to determine the effect of processing temperature and stirring rate on micromeretic properties of prepared crystals. Particle size analysis, dissolution rate profiles, pack ability, hydrophobicity, and flow properties of spherical crystals were studied. The particle size of spherical aggregates was about 37 μm and the dissolution efficiency of simvastatin up to 60 min increased to about 2 fold in phosphate buffer solution containing 0.5% sodium dodecyl sulfate (pH 7) using the rotating paddle method. At high temperature the high stirring rate and at low temperature the low stirring rate resulted in free flow crystals. Untreated powder had better flow ability and compressibility than crystals, but spherical crystals showed enhanced solubility due to their higher hydrophilicity compared to the untreated powder. Spherical crystallization is an effective technique to improve the dissolution rate of simvastatin but its flow should be facilitated by some free flow excipients.
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