Pharmacokinetics and Bioavailability of Hydromorphone Nasal Spray

Abstract

ABSTRACTAimTo evaluate the pharmacokinetics and bioavailability of two formulations of intranasal hydromorphone hydrochloride in adult postoperative patients.MethodIn an open‐label, randomised, crossover study a convenience sample of adult postoperative patients received intravenous hydromorphone 1 mg and intranasal hydromorphone 2 mg (with and without chitosan).ResultsPharmacokinetic data sets from 19 patients showed intranasal hydromorphone produced detectable serum levels within 2 minutes of administration, with mean bioavailability of 49.5% (without chitosan) and 67.5% (with chitosan). Mean peak serum concentrations were 0.92 ng/mL (without chitosan) and 1.16 ng/mL (with chitosan). Summed pain intensity differences suggest that intravenous hydromorphone produced a better clinical response.ConclusionThe bioavailability of intranasal hydromorphone is approximately 0.6 of intravenous hydromorphone. Adding chitosan to the intranasal solution did not significantly increase the bioavailability of hydromorphone.