Abstract
OPINION article Front. Pharmacol., 03 June 2015Sec. Experimental Pharmacology and Drug Discovery https://doi.org/10.3389/fphar.2015.00117
Highlights
The inhalational drug market, especially the generic market, has a tremendous growth potential globally (GBI Research, 2011; Espicom, 2013; Transperancy: Market Research, 2013)
The United States Food and Drug Administration (FDA) has defined bioequivalence as (U.S FDA, 2014), “The absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.”
There is a considerable amount of ongoing debate regarding the universally acceptable methodology for conducting PK studies for inhaled drugs (Daley-Yates and Parkins, 2011)
Summary
Since the inhalational route delivers the drug at the site of action, the systemic concentration is very low, sometimes too low to be detected by the standard bioanalytical methods. This either requires increasing the dose of the drug or developing more sensitive methods of drug assay (Silvestro et al, 2012). Increasing the dose could endanger the safety of human volunteers, for example, increased incidence of tremors, palpitations and hypokalemia due to Salbutamol (Lipworth et al, 1989; Fowler and Lipworth, 2001), anticholinergic side effects due to Glycopyrronium and Tiotropium (Durham, 2004; Hansel et al, 2005; Loke and Singh, 2013), etc
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