Background: Flunarizine Dihydrochloride (FDC) is used as a Prophylaxis to a migraine. It
has solubility issues and it is practically insoluble in water and alcohol. FDC is widely prescribed for a
migraine which is available in the form of tablets, and capsules. It is advantageous to deliver FDC as a
nasal drug delivery system in the form of the nanoemulsion. Nanoemulsion increases the solubility of
the poorly soluble drug as well as increases the transport of drug delivery through nasal mucosa by
which it may offer quick onset of action. The high vasculation and permeability of nasal mucosal influence
the drug absorption by which it can be easily accessible to blood capillaries then the therapeutic
response may be faster which is desirable in migraine treatment.
Methods: In this research, FDC Nanoemulsions were prepared by using IPM, β cyclodextrin, tween 80,
polyethylene glycol, GMS and poloxamer 407. The prepared nanoemulsions were optimized by varying
the concentration of surfactant, Co surfactant, IPM and GMS ratios. The best formulation was characterized
by using XRD, Master Sizer, Zeta Sizer, and Zeta Potential. Further the prepared nanoemulsions
were studied for in vitro drug release profile by using Simulated Nasal Fluid (SNF). The release profile
was analyzed by suitable pharmacokinetic models.
Results: The mean particle size of FN2 was found to be 242.3±211.8 as compared to FN4 which is
larger 351.7±162.9. So it was demonstrated from the results that FN2 was found to be the best formulation
with the lowest mean particle size with the diameter of 155.7 nm whereas FN4 got 288.4 nm size
which is higher than FN2. The PDI was found to be less which is 0.317 for FN2 and 0.164 for FN4. The
drug release profile was consistent and reproducible in in vitro studies conducted in SNF (simulated nasal
Conclusion: The nanoemulsions shown the variation in particle size, % EE, in vitro dissolution profile.
The prepared nanoemulsions increased the solubility of Flunarizinedihydrochloride as it is poorly soluble
drug as well as the nanoemulsions can be delivered through the nose for better therapeutic action.
The emusions were stable during the short term stability studies.