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Formulation, In-vitro Evaluation and Optimization of Nanoemulsion of Raloxifene Hydrochloride
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| Author:
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NARENDRA CHOTAI, BINAL R. PANDYA, RAJNIKANT M. SUTHAR, HARDIK K. PATEL
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| Abstract:
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The aim of the present work was to prepare nanoemulsion of raloxifene hydrochloride by high pressure homogenization method with a view to enhance its solubility and dissolution. The solubility of drug was determined in different oils, surfactants and co-surfactants. Pseudoternary phase diagrams were plotted on the basis of solubility data of drug in various components to evaluate the nanoemulsification region. The capmul MCM C8, tween 20 and propylene glycol were selected as the oil, surfactant and co-surfactant respectively for the formulation development. A box-behnken design was adopted for the preparation nanoemulsion possessing optimized characteristics. Concentration of oil (X1), concentration of Smix (X2), and homogenization pressure (X3) were selected as independent variables whereas globule size and cumulative % drug release after 24 hrs (Q24) were selected as dependent variables. Total fifteen batches (B1 to B15) were formulated and evaluated for different parameters such as globule size, polydispersibility index (PDI), drug content, % transmittance, refractive index (RI), pH, viscosity, in-vitro drug release study, zeta potential and transmission electron microscopy. Amongst all prepared batches B12 (oil-15%, Smix-50% and 35% water) showed satisfactory results of globule size and in-vitro drug release and it can be considered as optimized formulation. It was compared with marketed product and pure drug for their in-vitro release study and found to be promising formulation.
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| Keyword:
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Nanoemulsion, Phase diagram, Globule size, Zeta potential, Box-behnken design.
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| DOI:
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