Flunisolide Nasal Solution

DRUG DESCRIPTION

Flunisolide, the active component of flunisolide nasal solution (flunisolide nasal spray .025%) , is an anti-inflammatory glucocorticosteroid with the chemical name: 6?-fluoro-11?,16?,17,21 tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone, hemihydrate. It has the following chemical structure:

Flunisolide structural formula illustration

Flunisolide is a white to creamy white crystalline powder with a molecular weight of 443.51 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 245C. The octanol:water partition coefficient is 2.17 at neutral pH.

Flunisolide nasal solution (flunisolide nasal spray .025%) is a metered dose manual pump spray unit containing 0.025% w/w flunisolide in an aqueous medium containing benzalkonium chloride, butylated hydroxytoluene, citric acid, edetate disodium, polyethylene glycol 400, polysorbate 20, propylene glycol, sodium citrate, sorbitol and purified water. Sodium hydroxide and/or hydrochloric acid may be added to adjust the pH to 4.5 to 6.0. Each 25 mL spray bottle contains 6.25 mg of flunisolide.

After initial priming (5 to 6 sprays), each spray of the pump spray unit delivers a metered spray of 100 mg formulation containing 29 mcg of flunisolide. The size of 99.5% of the droplets produced by the unit is greater than 8 microns. The contents of one nasal spray bottle delivers 200 sprays in addition to the priming sprays.



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