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Stuart L. Nightingale, MD
Food and Drug Administration Rockville, Md

JAMA. 1993;270(17):2051.

	Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings.

In Reply.

—Since the time that AeroBid was approved in 1984, the requirements for its type of dose delivery system have been revised as our understanding of these medications has increased. Aerosolized steroid medications are currently required to demonstrate, among other properties, adequate puff-to-puff reproducibility over the claimed life of the canister.

A frequent complexity that arises is the problem of the number of doses vs the number of actuations. The canisters are labeled with the number of actuations. Because a certain number of these are normally expended in the priming of the valve by the patient at the time of dosing, the number of actuations that are available for dosing is lower. Thus, a patient who takes two puffs twice a day theoretically could expect 25 days of medication from a 100-spray canister. However, if the unit is primed once a day, the duration drops to 20 days, and . . . [Full Text PDF of this Article]

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