The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are albuterol sulfate and ipratropium bromide.

Albuterol sulfate, is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13H 21NO 3) 2*H 2SO 4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol.

Figure 3.1-1. Chemical structure of albuterol sulfate.

Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate ( endo,syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20H 30BrNO 3*H 2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons.

Figure 3.1-2. Chemical structure of ipratropium bromide.

Each 3 mL Sterile Unit-dose Vial contains 0.5 mg of ipratropium bromide (0.017%) and 3 mg 1 albuterol sulfate (0.083%) in an isotonic, sterile, aqueous solution containing sodium chloride and 1 N hydrochloric acid to adjust to pH 4.

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION).