A Comparison of Pharmaceutical Product Performance of Albuterol Inhalers Available in the United States and Those Obtained in a Mexican Border Town. (December 2015)

• Record Type: Journal Article
• Authors: Nocella, Meira; Kilber, Emily; Witmer, Brittney; Karlage, Kelly; Myrdal, Paul
• Is Part Of: Journal of pharmacy technology. Volume 31:Number 6(2015:Nov./Dec.)
• Page Start: 289
• Page End: 295
• Publication Date: 2015-12
• Subjects: asthma -- β-2-adrenergic agonists -- international medicine/issues -- medication safety -- pharmaceutics -- inhalers; Pharmacy -- Periodicals; Pharmaceutical technology -- Periodicals; Chemotherapy -- Periodicals; 615.105
• DOI: 10.1177/8755122515595052
• Languages: English
• ISSNs: 8755-1225

Abstract

Background: American residents travel to Mexico to purchase medications for a fraction of US cost and frequently without prescription requirements. A previous bioequivalence study found differences in lung function measures between 2 brands of Mexican-manufactured albuterol inhalers (both 100 µg/puff). An investigation of the pharmaceutical performance of different inhalers available may illuminate why different clinical results may be observed and offer insight to consumer and provider expectations of such products.Objective: The purpose of this study is to provide some reasonable expectations for a medical tourist who shops in Mexico for albuterol metered dose inhalers (MDIs) or for their health care providers by comparing pharmaceutical product performance of the consumer-available brands.Methods: Five different albuterol MDI products were purchased in Nogales, Mexico. The albuterol content was quantified through high-performance liquid chromatography. The inhalers were analyzed to determine the amount of the albuterol dose that can be considered respirable and compared with the findings from 2 US innovator products.Results: The mean respirable mass for each brand of albuterol MDI was compared with that of the other 4 brands and the 2 US innovator products using Student's t test. All evaluations showed significant differences ( P < .05) except for 3 comparisons (Sacrusyt vs Assal, P = .89; Xeneric-S vs non-US Ventolin, P = .98; Victory vs US Proventil HFA, P = .06).Conclusion: Since pharmaceutical variability was found among the albuterol MDIs evaluated in this study, consumers and clinicians should appreciate possible differences in product performance of albuterol MDIs obtained in Mexico.