Flufenamic Acid-Loaded Self-Nanoemulsifying Drug Delivery System for Oral Delivery: From Formulation Statistical Optimization to Preclinical Anti-Inflammatory Assessment

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  • Alshehri Sultan
    Department of Pharmaceutics, College of Pharmacy, King Saud University College of Pharmacy, Almaarefa University
  • Imam Syed Sarim
    Department of Pharmaceutics, College of Pharmacy, King Saud University
  • Hussain Afzal
    Department of Pharmaceutics, College of Pharmacy, King Saud University
  • Alyousef Abdul Malik
    Department of Pharmaceutics, College of Pharmacy, King Saud University
  • Altamimi Mohammad
    Department of Pharmaceutics, College of Pharmacy, King Saud University
  • Alsulays Bader
    Department of Pharmaceutics, College of Pharmacy, Prince Sattam bin Abdulaziz University
  • Shakeel Faiyaz
    Department of Pharmaceutics, College of Pharmacy, King Saud University

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<p>This research work aimed to prepare and optimize “self-nanoemulsifying drug delivery system (SNEDDS)” by applying full factorial design (FFD) to improve solubilization and subsequently antiinflammatory efficacy of flufenamic acid (FLF). Suitable excipients were screened out based on the maximum solubility of FLF. FFD was applied using lipid (X1) and surfactant (X2) as independent variables against droplet size (Y1, nm), zeta potential (Y2, mV) and polydispersity index (PDI, Y3). Desirability function identified the main factors influencing the responses and possible interactions. Moreover, the optimized formulation (OFS1) was characterized and compared with pure FLF suspension. The prepared formulations (FS1–FS9) showed the size, PDI and zeta potential of 14.2–110.7 nm, 0.29–0.62 and –15.1 to –28.6 mV, respectively. The dispersion and emulsification of all formulations meted out within 2 min suggesting immediate release and successful solubilization. The optimized formulation OFS1 demonstrated ~ 85% drug release within 1 h which was significantly higher (p ˂ 0.05) than FLF suspension. The hemolysis study negated the probable interaction with blood cells. Eventually, improved anti-inflammatory efficacy was envisaged which might be attributed to increased drug solubility and absorption. The present nanocarrier could be a promising approach and alternative to conventional dosage form.</p>

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