PIRIVA® HandiHaler® (tiotropium bromide inhalation powder) consists of a capsule dosage form containing a dry powder formulation of SPIRIVA intended for oral inhalation only with the HandiHaler inhalation device.
Each light green, hard gelatin capsule contains 18 mcg tiotropium (equivalent to 22.5 mcg tiotropium bromide monohydrate) blended with lactose monohydrate as the carrier.
The dry powder formulation within the capsule is intended for oral inhalation only.
The active component of SPIRIVA is tiotropium. The drug substance, tiotropium bromide monohydrate, is an anticholinergic with specificity for muscarinic receptors. It is chemically described as (1α, 2β, 4β, 5α, 7β-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide monohydrate. It is a synthetic, non-chiral, quaternary ammonium compound. Tiotropium bromide is a white or yellowish white powder. It is sparingly soluble in water and soluble in methanol. The structural formula is:
tiotropium bromide (Spiriva, Handihaler) Structural Formula Illustration
Tiotropium bromide (monohydrate) has a molecular mass of 490.4 and a molecular formula of C19H22NO4S2Br·H2O.
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