Abstract
Acute otitis media (AOM) is an infection that occurs in the middle ear and may cause complications and affect quality of life. The study focused on the preparation of niflumic acid (NA) loaded novasomes for the efficient treatment of AOM through trans-tympanic drug delivery. NA loaded novasomes were formulated using Span 60 with oleic acid or lauric acid as a free fatty acid (FFA). Novasomes were prepared via ethanol injection technique using D-optimal design to evaluate the influence of 3 independent variables on the novasomes’ characteristics which are: entrapment efficiency percent (EE%), particle size (PS), polydispersity index (PDI), and zeta potential (ZP), and identify the best formula for additional investigations. The best formula determined was (N6) which contains 50 mg Span 60 and 50 mg oleic acid used as FFA. N6 exhibited EE% = 92.96 ± 0.37 %, PS = 389.25 ± 1.77 nm, PDI = 0.34 ± 0.00, and ZP = −40.90 ± 0.28 mV. N6 had a spherical shape with high elasticity. Also, it showed a sustained in vitro release compared to NA suspension. Additionally, in vivo investigations against AOM in rats and a histopathological study ensured the therapeutic effectiveness and safety of N6 and its superiority over NA suspension. Mostly, the findings showed the great efficacy of novasomes for trans-tympanic delivery of NA for the treatment of middle ear inflammation.
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