Ultibro Breezhaler Description

Each capsule contains 143 micrograms indacaterol maleate equivalent to 110 micrograms indacaterol and 63 micrograms glycopyrronium bromide equivalent to 50 micrograms glycopyrronium.
The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 85 micrograms indacaterol and 43 micrograms glycopyrronium.
Indacaterol maleate: Chemical name (IUPAC): (R)-5-[2-(5,6-Diethylindan-2-ylamino)-1-hydroxyethyl]-8-hydroxy-1H quinolin-2-one maleate.
INN/AAN: Indacaterol Maleate.
CAS name: Indacaterol Maleate: 5-[(1R)-2-[(5,6-diethyl-2,3-dihydro-1H-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxy-2(1H)-quinolinone,(2Z)-2-butenedioate (salt) (9CI).
CAS no.: Indacaterol maleate: 753498-25-8.
Molecular formula: Indacaterol maleate: Free base anhydrous: C₂₄H₂₈N₂O₃.
Maleate salt: C₂₄H₂₈N₂O₃ C₄H₄O₄.
Molecular weight: Indacaterol maleate: Free base: 392.49.
Maleate salt: 508.56 (maleate salt).
Stereochemistry: Indacaterol maleate: (R) enantiomer.
Aqueous Solubility: Indacaterol maleate: At 25°C mostly insoluble or very slightly soluble in aqueous media across the pH range from 1 to 10 (water solubility <0.11 mg/mL).
Partition coefficient: Indacaterol maleate: Distribution coefficient D in n-octanol/buffer pH 7.4 at 37.0 +/- 0.5°C: 212.6 (log D = 2.33).
pKa: The pKa of Indacaterol maleate in water at room temperature are 7.3 and 8.0.
Glycopyrronium bromide: Chemical name (IUPAC): 3-(2-Cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidinium bromide. Pyrrolidinium, 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl-, bromide-3-Hydroxy-1,1-dimethylpyrrolidinium bromide α-cyclopentylmandelate.
INN/AAN: Glycopyrronium bromide.
CAS name: Glycopyrronium bromide: Pyrrolidinium, 3-[(2-cyclopentyl-2-hydroxy-2-phenylacetyl)oxy]-1,1-dimethyl-, bromide (1:1).
CAS no.: Glycopyrronium bromide: 596-51-0.
Molecular formula: Glycopyrronium bromide: C₁₉H₂₈NO₃·Br.
Molecular weight: Glycopyrronium bromide: Salt form: 398.33.
Stereochemistry: Glycopyrronium bromide: 2 asymmetric carbon atoms and is an optically inactive racemic mixture of 2 stereoisomers (S,R) and (R,S).
Aqueous Solubility: Glycopyrronium bromide: At 25°C freely soluble in aqueous media across the pH range from 1 to 10 (water solubility >100 mg/mL).
Partition coefficient: Glycopyrronium bromide; Distribution coefficient D in Octanol/Water at 37.0 +/- 0.5°C: 0.098 (log D = -1.01).
pKa: Glycopyrronium bromide is a quaternary ammonium salt and permanently ionised between pH 1 and 14.
Ultibro Breezhaler hard capsules are for oral inhalation only. Ultibro Breezhaler is also supplied with a BREEZHALER inhalation device to permit oral inhalation of the contents of the capsule shell.
Excipients/Inactive Ingredients: Capsule fill: Lactose monohydrate/Lactose hydrate, magnesium stearate.
Capsule shell components: Hypromellose, purified water, carrageenan, potassium chloride, FD&C Yellow 5/Tartrazine.
Black Printing Ink: Shellac, ethyl alcohol, isopropyl alcohol, propylene glycol, n-butyl alcohol, ammonium hydroxide, potassium hydroxide, water purified, iron oxide black E172.
Blue Printing Ink: Shellac, ethyl alcohol, FD&C Blue 2, n-butyl alcohol, titanium dioxide, propylene glycol, isopropyl alcohol.