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February 14, 2026Drug Development and Industrial Pharmacy1 citations

Quality by Design-Driven Approach to Develop a Nanocarrier-Based Sulfasalazine Topical System for Rheumatoid Arthritis Management

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ARAnkit RajPNPradip NirbhavaneHGHimanshu Gandhi

Key Points

  • The aim is to enhance the transdermal delivery of Sulfasalazine via nanocarrier technology.
  • Encapsulated Sulfasalazine into nanostructured lipid carriers using solvent diffusion evaporation.
  • Optimized formulation variables with Box-Behnken Design including lipid concentration and ultrasonication time.
  • Conducted particle size, PDI, entrapment efficiency analysis, and morphological assessment using SEM.
  • In vitro drug release and ex vivo skin permeation were evaluated along with anti-inflammatory activity.
  • The optimized nanocarrier had a mean particle size of 112.5 nm and PDI of 0.090.
  • The entrapment efficiency of the SSZ-NLC was 89%.
  • The SSZ-NLC-gel showed 65.17% drug release over 24 hours, significantly higher than the conventional gel's 25.73%.
  • Ex vivo permeation results indicated improved skin absorption compared to the conventional gel.
  • The anti-inflammatory evaluation revealed 77.2% inhibition of BSA denaturation at 5000 μg/mL concentration.

Abstract

ObjectiveThis study was conducted to improve the transdermal delivery of Sulfasalazine, by encapsulating it into the nanostructured lipid carrier (NLC)-based gel products.MethodsSulfasalazine (SSZ) was loaded into NLCs through solvent diffusion evaporation method. Box-Behnken Design (BBD) was used to optimize formulation variables such as lipid concentration, ethanol concentration, and ultrasonication time. The optimized NLCs were analysed for particle size, PDI, and entrapment efficiency, and then morphological analysis was performed using SEM. The NLC dispersion was added to a 1% gel base of Carbopol 934. The developed gel formulation was assessed for its in vitro release, ex vivo skin permeation and anti-inflammatory activity (BSA protein denaturation assay).ResultsOptimized SSZ-NLCs had a mean particle size of 112.5 nm, PDI of 0.090, and entrapment efficiency of 89%. SEM ensured spherical and uniform particle morphology. The SSZ-NLC- gel exhibited higher drug release (∼65.17% in 24 h) compared to the SSZ-conventional gel (∼25.73%). The ex vivo permeation exhibited higher skin permeation than conventional gel. The anti-inflammatory studies indicated concentration-dependent suppression of BSA denaturation with 77.2% inhibition at 5000 μg/mL.ConclusionThe developed gel formulation has shown desired characteristics to serve as a topical treatment of rheumatoid arthritis.

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Cite This Study

Raj et al. (2026) studied this question.

synapsesocial.com/papers/699010942ccff479cfe56ed1https://doi.org/10.1080/03639045.2026.2630260
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