Comparison of Caffeine Disposition Following Administration by Oral Solution (Energy Drink) and Inspired Powder (AeroShot) in Human Subjects

Summary

Aims

To determine the disposition and effects of caffeine after administration using a new dosage form (AeroShot) that delivers caffeine by inspiration of a fine powder into the oral cavity and compare it to an equivalent dose of an oral solution (energy drink) as the reference standard.

Methods

Healthy human subjects (n=17) inspired a 100 mg caffeine dose using the AeroShot device or energy drink on separate study days. Heart rate, blood pressure, and subject assessments of effects were measured over an eight-hour period. Plasma concentrations of caffeine and its major metabolites were determined by liquid chromatography-mass spectrometry. Pharmacokinetic, cardiovascular, and perceived stimulant effects were compared between AeroShot and energy drink phases using a paired t-test and standard bioequivalency analysis.

Results

Caffeine disposition was similar after caffeine administration by the AeroShot device and energy drink: Cmax 1790 and 1939 ng/ml, and AUC 15579 and 17569 ng/ml x h, respectively, but they were not bioequivalent: AeroShot AUC of 80.3% (CI 71.2-104.7%) and Cmax of 86.3% (CI 62.8-102.8%) compared to the energy drink. Female subjects did have a significantly larger AUC compared to males after consumption of the energy drink. The heart rate and blood pressure were not significantly affected by the 100 mg caffeine dose, and there were no consistently perceived stimulant effects by the subjects using visual analog scales.

Conclusion

Inspiration of caffeine as a fine powder using the AeroShot device produces a similar caffeine profile and effects compared to administration of an oral solution (energy drink).

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