Formulation Development and Optimization of Nitrendipine Nanosuspension with Improved Pharmacokinetic Characteristics
DOI:
https://doi.org/10.37285/ijpsn.2013.6.2.7Abstract
Poorly water-soluble drugs such as nitrendipine (~2.0 µg/ml at 37◦C in water) offer challenging problems in drug formulation as poor solubility is generally associated to poor dissolution characteristics and thus to poor oral bioavailability. To enhance these characteristics, we prepared and evaluated nitrendipine nanosuspension using the nanoprecipitation technique. The important process parameters, the concentration of nitrendipine in the organic phase, concentration of surfactant in the anti-solvent, and starring speed were evaluated using 33 full factorial designs. It was observed that the concentration of nitrendipine in the organic phase, concentration of surfactant in the anti-solvent, and starring speed significantly affect the particle size as well as dissolution velocity. Differential scanning calorimetry studies confirmed that the crystallinity of the drug was maintained after the nanoprecipitation suggesting that improved dissolution of nitrendipine nanosuspensions could be attributed to reduction in particle size. This formulation may offer a superior pharmacokinetic profile due to nanotechnological design.
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Keywords:
Nanosuspension, Dissolution Enhancement, Nanoprecipitation, Mean Particle Size
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