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Nasalide Online, Description, Chemistry, Ingredients - Flunisolide (Nasal Spray)
DESCRIPTION
Flunisolide, the active component of NASAREL nasal spray, is an
anti-inflammatory glucocorticosteroid with the chemical name:
6(alpha)-fluoro-11(beta),16(alpha),17,21
tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone,
hemihydrate. It has the following chemical structure:

Flunisolide is a white to creamy white crystalline powder
with a molecular weight of 443.51 and molecular formula of C 24 H 31 FO 6
. 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. The octanol:water partition coefficient is 2.17 at
neutral pH.
NASAREL 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 dihydrate, sorbitol and purified water. Sodium hydroxide
and/or hydrochloric acid may be added to adjust the pH to a target of 5.2.
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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