Spiriva Description

Spiriva: Light green hard capsules with the product code TI 01 and company logo printed on the capsule.
Each capsule contains 22.5 microgram tiotropium bromide monohydrate equivalent to 18 microgram tiotropium.
The delivered dose (the dose that leaves the mouthpiece of the HandiHaler device) is 10 microgram tiotropium.
Spiriva Respimat: SPIRIVA RESPIMAT cartridges contain a clear, colourless, solution for inhalation filled into a plastic container which is inside an aluminium cylinder (cartridge) for use with the RESPIMAT inhaler. SPIRIVA RESPIMAT is for oral inhalation only.
Each pack consists of one RESPIMAT inhaler and one cartridge, delivering 60 metered puffs. Each puff contains tiotropium 2.5 micrograms, equivalent to tiotropium bromide monohydrate 3.1 micrograms.
Active ingredient: tiotropium (as tiotropium bromide monohydrate).
Chemical name: 3-Oxa-9-azoniatricyclo[3.3.1.0^2,4]nonane, 7-[(hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-, bromide, monohydrate, (1α, 2β, 4β, 5α, 7β)-.
Molecular formula: C₁₉H₂₂NO₄S₂Br.H₂O.
Molecular weight: 490.4 (monohydrate).
CAS number: 139404-48-1.
Tiotropium bromide is a white to yellowish-white, odourless crystalline powder. It exists as a quaternary ammonium salt, and there are no ionisable functional groups on the molecule. The active substance is not optically active.
Tiotropium bromide is freely soluble in dimethyl sulphoxide, soluble in methanol, sparingly soluble in water and practically insoluble in methylene chloride. The solubility in aqueous solutions at room temperature is approx. 2.5%, independent of pH. At pH 7.4, the apparent partition coefficient (log P_app) is -2.25.
A monohydrate form of tiotropium bromide is produced by the synthetic process. The compound melts with decomposition between 225°C and 235°C, when determined by differential scanning calorimetry at a heating rate of 10 K per minute.
Excipients/Inactive Ingredients: Spiriva: Lactose monohydrate (which contains milk protein).
Spiriva Respimat: Benzalkonium chloride, disodium edetate, purified water, and hydrochloric acid for pH adjustment.