Flunisolide hemihydrate, the active component of AEROSPAN™ (flunisolide HFA, 80 mcg) Inhalation Aerosol, is a corticosteroid having the chemical name 6α-Fluoro-11β, 16α, 17, 21 –tetrahydroxylpregna-1, 4-diene-3, 20-dione cyclic-16, 17-acetal with acetone, hemihydrate and the following chemical structure:
Flunisolide hemihydrate is a white to creamy white crystalline powder with
a molecular weight of 443.51 and an empirical formula of C24H31O6F
•½ H2O. It is soluble in acetone, ethyl alcohol and HFA-134a and
practically insoluble in water.
AEROSPAN Inhalation Aerosol is a pressurized, metered-dose inhaler unit intended for oral inhalation only. The inhaler unit consists of a metal canister, a purple actuator, and a gray spacer. Each unit contains a 0.24 % w/w solution of flunisolide hemihydrate in 10:90 w/w ethanol:1,1,1,2-tetrafluoroethane (HFA 134a). After priming, each actuation delivers 139 mcg of flunisolide hemihydrate in 58 mg of solution from the canister valve and 80 mcg of flunisolide hemihydrate (equivalent to 78 mcg flunisolide) from the spacer at a flow rate of 30 L/min for 4 seconds.
Using an in-vitro method at a fixed volume of 2 L, each actuation at
the beginning of canister content delivers from the spacer 76 mcg (95% of the
label claim) at a flow rate of 30 L/min, 61 mcg (76% of the label claim) at
a flow rate of 20 L/min, 85 mcg (106% of the label claim) at a flow rate of
40 L/min, and 96 mcg (120% of the label claim) at a flow rate of 60 L/min. The
actual amount of drug delivered to the lung may depend upon patient factors,
such as timing and coordination between the actuation and inspiration and the
strength and duration of the inspiration. Data show that both the one- and two-
actuation doses are depleted by 75% or more after waiting one second between
actuation and inhalation.
The 5.1-g net weight canister provides 60 metered actuations and the 8.9-g net weight canister provides 120 metered actuations.
AEROSPAN Inhalation Aerosol should be primed before using for the first time by releasing 2 test sprays into the air away from the face. In cases where the inhaler has not been used for more than 2 weeks, the inhaler should be primed again by releasing 2 test sprays into the air away from the face.
This product does not contain chlorofluorocarbon (CFC).
Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.