The Inhalation Ad Hoc Advisory Panel for the USP Performance Tests of Inhalation Dosage Forms

Abstract

* The Inhalation Ad Hoc Advisory Panel for the USP Performance Tests of Inhalation Dosage Forms ABSTRACT The US Pharmacopeia (USP) contains standards for tests, procedures, and acceptance criteria for inhalation dosage forms that are administered orally and intranasally. Product quality and performance tests are concerned primarily with the assessment of drug delivery and deposition in the respiratory tract. This Stimuli article evaluates the scientific rationale, if any, for in vitro dissolution tests for inhalation dosage forms. Studies that determine the profiles and kinetics of dissolution for inhaled therapeutics have been performed, but a literature review could not find compelling evidence suggesting that such dissolution testing is kinetically and/or clinically crucial for currently approved inhalation drug products. Even so, because of the possible development of novel inhalation products with modified or controlled dissolution and release, a USP standard for assessing dissolution of inhalation dosage forms may be considered in the future if scientifically warranted.