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Development of highly stable nifedipine solid-lipid nanoparticles.

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This study developed stabilized nifedipine solid-lipid nanoparticles (SLNs) using trehalose as a cryoprotectant. Trehalose-lyophilized SLNs demonstrated excellent redispersibility and stability, improving nifedipine solubility.

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Area of Science:

  • Pharmaceutical Nanotechnology
  • Drug Delivery Systems
  • Materials Science

Background:

  • Nifedipine exhibits poor aqueous solubility, limiting its therapeutic efficacy.
  • Solid-lipid nanoparticles (SLNs) offer a promising platform for enhancing the solubility and bioavailability of poorly soluble drugs.
  • Stabilization of SLNs during lyophilization is crucial for maintaining their physical and chemical integrity.

Purpose of the Study:

  • To prepare and characterize highly stabilized nifedipine-loaded solid-lipid nanoparticles (NI-SLNs).
  • To evaluate the efficacy of various sugar moieties as cryoprotectants during lyophilization of NI-SLNs.
  • To assess the impact of trehalose on the physicochemical properties, redispersibility, and stability of NI-SLNs.

Main Methods:

  • High-pressure homogenization was employed to formulate NI-SLNs using phospholipids.
  • Lyophilization of NI-SLNs was performed with different monosaccharides and disaccharides, focusing on trehalose.
  • Particle size, polydispersity index (PDI), zeta potential, drug loading, encapsulation efficiency, redispersibility, and stability were analyzed.
  • Solid-state characterization was conducted using DSC, XRD, FTIR, and SEM.

Main Results:

  • NI-SLNs exhibited favorable characteristics: 68.5 nm particle size, 0.3 PDI, -62.1 mV zeta potential, 2.7% drug loading, and 97.5% encapsulation efficiency.
  • NI-SLNs lyophilized with trehalose (NI-SLN-Tre) showed improved redispersibility and maintained structural integrity.
  • Trehalose at 2.5% w/v with a two-fold dilution proved optimal for lyophilization, preserving the amorphous state of nifedipine.
  • NI-SLN-Tre demonstrated excellent stability for up to 6 months under accelerated conditions.

Conclusions:

  • Trehalose is an effective cryoprotectant for stabilizing nifedipine-loaded solid-lipid nanoparticles during lyophilization.
  • The optimized lyophilization process using trehalose enhances the redispersibility and long-term stability of NI-SLNs.
  • This approach holds significant potential for improving the formulation and delivery of nifedipine.