Albuterol stability and expiration
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Albuterol Stability in Different Formulations and Storage Conditions
Stability of Albuterol Solutions for Nebulization and Intravenous Use
Albuterol solutions, including both preservative-free (PF) and those containing benzalkonium chloride (BAC), have been shown to remain chemically stable for up to 168 hours (7 days) at both room temperature and under refrigeration, with no significant loss of potency or changes in physical appearance. This stability was observed at both high and low concentrations commonly used in clinical settings, and no differences were found between the two formulations or storage conditions. Additionally, sterility was maintained for at least 10 days under these conditions, with no bacterial growth detected in either formulation .
For more concentrated albuterol (salbutamol) solutions prepared in polypropylene syringes for intensive care or obstetric use, stability was maintained for at least 30 days when stored at 5°C (±3°C) and protected from light. No changes in color, turbidity, precipitation, pH, or microscopic appearance were observed, and the drug concentration remained consistent throughout the storage period .
Similarly, albuterol solutions at concentrations used for continuous nebulization (200 micrograms/mL) were stable for at least 7 days in various container types, including polyvinyl chloride bags, polyolefin bags, polypropylene syringes, and borosilicate glass tubes, under both refrigerated and room temperature conditions .
Metered-Dose Inhaler (MDI) Formulations: Impact of Drug Form and Excipients
The chemical and physical stability of albuterol in metered-dose inhaler (MDI) formulations is highly dependent on the drug form (base vs. sulfate), the type of propellant, and the presence of cosolvents. Albuterol sulfate formulations demonstrated good chemical stability for up to 12 months at 30°C and 40°C/85% relative humidity, especially when a cosolvent was included. In contrast, albuterol base formulations were less stable, except in certain ethanol-free formulations. Physical stability was also better in sulfate formulations with cosolvents, while base formulations tended to show crystal growth and agglomeration, leading to poor suspension quality. Thus, selecting the appropriate drug form and excipients is crucial for ensuring long-term stability in MDI products .
Albuterol Expiration and Practical Considerations
Recommended Expiration Based on Stability Data
Based on available data, albuterol solutions for nebulization and intravenous use can be considered stable for at least 7 days at room temperature or under refrigeration, and up to 30 days for concentrated solutions stored in syringes at 5°C with light protection Gulley2019Lardinois2019Hunter1998. For MDI formulations, stability can extend up to 12 months depending on the formulation constituents and storage conditions .
Clinical Implications
The demonstrated stability of albuterol under various conditions allows for advance preparation and storage of solutions, which can be especially beneficial in emergency and intensive care settings. However, it is important to note that while chemical and physical stability are well established, these studies do not address the therapeutic efficacy of different formulations, which may require further investigation .
Conclusion
Albuterol is chemically and physically stable in a variety of formulations and storage conditions, with preservative-free and BAC-containing solutions maintaining sterility and potency for at least 7 days at room temperature or under refrigeration, and concentrated solutions remaining stable for up to 30 days when refrigerated and protected from light. For MDI products, the choice of drug form and excipients is critical for long-term stability. These findings support the safe advance preparation and storage of albuterol solutions in clinical practice.
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Effect of Albuterol on Expiratory Resistance in Mechanically Ventilated Patients
Albuterol significantly decreases expiratory resistance in mechanically ventilated COPD patients, but inspiratory resistance and the whole expiratory flow-volume curve cannot accurately evaluate bronchodilator response.
Sterility and Stability Testing of Preservative-free Albuterol.
Preservative-free albuterol is sterile and stable up to 168 hours when stored at room temperature or under refrigerated conditions, but its therapeutic efficacy in treating asthma exacerbations remains unclear.
Long-term Physiochemical Stability of Concentrated Solutions of Salbutamol (Albuterol) in Polypropylene Syringes for Use in the Intensive Care Unit and in Obstetrics.
Concentrated solutions of salbutamol (albuterol) in polypropylene syringes are physically and chemically stable for at least 30 days when stored at 5°C 3°C with protection from light.
Stability of albuterol in continuous nebulization.
Albuterol solutions for continuous nebulization remain stable for at least seven days in various containers under tested conditions, with more than 90% of initial concentration remaining.
Tolerability and Efficacy of Two Doses of Aerosolized Albuterol in Ventilated Infants with BPD
Aerosolized albuterol at 1.25mg and 2.5mg doses did not affect expiratory flow at 75% of exhalation in infants with severe bronchopulmonary dysplasia receiving invasive ventilation, but 2.5mg dose showed greater inspiratory pressure improvement.
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