Inhaler solutions

Draft Guidance for Industry—Nasal Spray and Inhalation Solution, Suspension and Spray Drug... 

ALBUTEROL SULFATE INHALATION SOLUTION 20ML BOTTLE WITH DROPPER 6505012579963 BT 10 41 ... 

Rx Albuterol sulfate and ipratropium bromide inhalation solution ... 

Inhalation solutions are designed to deliver a drug into the respiratory tree of a patient for a local or systemie effect. Examples of compounded inhalation solutions (Table 9) include individually and in combinations of albuterol, cromolyn, morphine sulfate, corticosteroids, ipratropium, metaproterenol, terbutaline, and others. 

Injectables, Inhalation solutions a. Sterility test, b. CCI, AET. c. Bacterial endotoxin test Test all batches on stability with the exception of the first three batches for AE a. b. c. 0 only 0, 12, 24, 36 months 0 and expiry only... 

Children 2 to 12 years of age (15 kg or more) 2.5 mg (1 UD vial) 3 to 4 times/day by nebulization. Children weighing less than 15 kg who require less than 2.5 mg/dose (ie, less than a full UD vial) should use the 0.5% inhalation solution. Deliver over approximately 5 to 15 minutes. 

Metered dose Inhaler-2 to 3 inhalations every 3 to 4 hours. Do not exceed 12 inhalations/day. Not recommended for children younger than 12 years of age. Inhalant solutions - Usually, treatment need not be repeated more often than every 4 hours to relieve acute bronchospasm attacks. In chronic bronchospastic pulmonary diseases, give 3 to 4 times/day. A single dose of nebulized metaproterenol in the treatment of an acute attack of asthma may not completely abort an attack. Not recommended for children younger than 12 years of age. 

Solution incompatibility Advise patients that ipratropium inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within 1 hour. 

Inhalation solution 0.5 mg ipratopium bromide and 3 mg albuterol sulfate (equiv. to 2.5 mg albuterol base) DuoNeb (Dey)... 

Bronchial asthma (inhalation solution, aerosol) As prophylactic management of bronchial asthma. Cromolyn is given on a regular, daily basis in patients with frequent symptomatology requiring a continuous medication regimen. 

Prevention of bronchospasm (inhalation solution, aerosol) To prevent acute bronchospasm induced by exercise, toluene diisocyanate, environmental pollutants, and known antigens. 

Children Safety and efficacy of inhalation solution have not been established. 

Tobramycin Inhalation solution For chronic pulmonary infection cystic fibrosis. 

Dosage form Pulmozyme Inhalation Solution is a sterile, preservative-free, highly purihed solution of recombinant human deoxyribonuclease I (dornase alfa). Each Pulmozyme single-use ampule will deliver 2.5 ml of the solution to the nebulizer bowl. The aqueous solution contains domase alfa l.Omg/ml. 

Aerosol 200 dose metered-dose inhaler Solution for nebulizer 0.02%... 

U.S. Food and Drug Administration (FDA) (2002, July), Nasal spray and inhalation solution, suspension, and spray drug products. Chemistry, manufacturing, and controls documentation, Guidance for industry. FDA, Washington, DC, 1—45. 

Inhalation drug products include inhalation aerosols (metered dose inhalers) inhalation solutions, suspensions, and sprays (administered via nebulizers) inhalation powders (dry powder inhalers) and nasal sprays. The CMC and preclinical considerations for inhalation drug products are unique in that these drug products are intended for respiratory tract-compromised patients. This is reflected in the level of concern given to the nature of the packaging components that may come in contact with the dosage form or the patient. 

Inhalation solution and suspension drug products are typically aqueous-based formulations that contain therapeutically active ingredients and can also contain additional excipients. Aqueous-based oral inhalation solutions and suspension must be sterile (21 CFR 200.51). Inhalation solutions and suspensions are intended for delivery to the lungs by oral inhalation for local or systemic effects and are used with a specified nebulizer. Unit-dose presentation is recommended for these drug products to prevent microbial contamination during use. The container closure system for these drug products consists of the container and closure and can include protective packaging such as foil overwrap. 

AccuNeb (albuterol sulfate) inhalation solution is supplied in two strengths in unit-dose vials. Each unit-dose vial contains either 0.75 mg of albuterol sulfate (equivalent to 0.63 mg of albuterol) or 1.50 mg of albuterol sulfate (equivalent to 1.25 mg of albuterol) with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution, and sulfuric acid is added to adjust the pH of the solution to 3.5. 

Atrovent inhalation solution is administered by oral inhalation with the aid of a nebulizer. It contains ipratropium bromide 0.02% (anhydrous basis) in a sterile, isotonic... 

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