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Inventi Rapid - Pharmaceutical Process Development

Articles

  • Inventi:ppd/27942/19
    APPLICATION OF RESPONSE SURFACE METHODOLOGY IN DEVELOPMENT AND CHARACTERIZATION OF PIOGLITAZONE HYDROCHLORIDE NANOPARTICLES USING HIGH PRESSURE HOMOGENIZER
    Satish K Mandlik, Yahya A Moolla*

    Pioglitazone, a class II BCS drug having poor water solubility and slow dissolution rate may have a negative impact on its bioavailability, sub-therapeutic plasma drug levels and thus may lead to therapeutic failure. In order to improve its solubility and thus dissolution rate, chitosan loaded nanoparticles were prepared and passed through high-pressure homogenizer with varying pressure and number of cycle. A response surface design namely Box-Behnken design was implemented to optimized the nanoparticles. Chitosan (X1), pressure (X2) and the number of cycles (X3) were selected as independent variables whereas particle size (Y1) and entrapment efficiency (Y2) were selected as dependent variables. FTIR and DSC study revealed no interaction between drug and excipients. Particle size and entrapment efficiency were found in the range of 39.1 nm to 250.3 nm and 70.78 to 93.71 % respectively. A design expert V8 software was used to determine the relationship between the dependent and independent variables were drawn out from the mathematical equations and response surface plots. Statistical analysis was performed using ANOVA which was found to be a significant and quadratic model was obtained by MLRA for particle size and for entrapment efficiency. TEM analysis shows that spherical shape of nanoparticles. In-vivo pharmacokinetic study of optimized batch shows high bioavailability as compared with the pure drug. From the above result, high-pressure homogenizer was found to be the best method of preparation for nanoparticles as well as it has wide industrial acceptance as it is reproducible and industrial scalability.

    How to Cite this Article
    Satish K Mandlik, Yahya A Moolla. Application of Response Surface Methodology in Development and Characterization of Pioglitazone Hydrochloride Nanoparticles Using High Pressure Homogenizer. Inventi Rapid: Pharmaceutical Process Development, 2019(2):1-7, 2019.
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