NASALIDE® (flunisolide) nasal spray is intended for administration
as a spray to the nasal mucosa. Flunisolide, the active component of NASALIDE
nasal spray, is an anti-inflammatory steroid with the chemical name: 6a-fluoro-11b,16a,17,21-tetrahydroxypregna-1,4-diene-3,20-dione
cyclic 16,17-acetal with acetone (USAN).
Flunisolide is a white to creamy white crystalline powder with a molecular
weight of 434.49 and molecular formula of C24H31FO6.
It is soluble in acetone, sparingly soluble in chloroform, slightly soluble
in methanol, and practically insoluble in water. It has a melting point
of about 245 C.
Each 25 mL spray bottle contains flunisolide 6.25 mg (0.25 mg/mL) in
a solution of propylene glycol, polyethylene glycol 3350, citric acid,
sodium citrate, butylated hydroxyanisole, edetate disodium, benzalkonium
chloride and purified water, with NaOH and/or HCl added to adjust the
pH to a target of 5.3.
After initial priming (5 to 6 sprays), each spray of the unit delivers
a metered droplet spray of 100 mg formulation containing 25 mcg of flunisolide.
The size of the droplets produced by the unit is in excess of 8 microns
to facilitate deposition on the nasal mucosa. The contents of one nasal
spray bottle deliver 200 sprays.