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Pharmacokinetic Bridging Study for the Inhalation of Nicotine in Saline in Male Sprague-Dawley Rats

Principal Investigator: Qiangen Wu (CTP Contact: Prabha Kc)
Funding Mechanism: FDA Internal
ID Number: E07763.01
Award Date: 1/26/2021
Institution: National Center for Toxicological Research (NCTR)


Additional information on nicotine pharmacokinetics (PK) following inhalation will be useful in accurately predicting its PK across species (i.e., rodents, non-human primates, and humans). The CTP-NCTR InhaleCore Group has recently completed studies evaluating nicotine PK profiles in rats following a single dose administration by inhalation, oral gavage, and intravenous injection (E07607.01 and E07716.01). In these studies, the dose formulations for inhalation exposure consisted of nicotine in propylene glycol and water. Due to possible unknown inhalation toxicities of propylene glycol and its potential to impact the lungs, propylene glycol is probably not an appropriate vehicle for investigating nicotine inhalation toxicity in planned subacute and subchronic inhalation toxicology studies. In this study, the InhaleCore Group will assess the applicability of the previously collected PK data (nicotine in propylene glycol and water) to the PK profiles for new nicotine formulations (nicotine in saline) that will be used in the planned studies. Results from these studies will provide useful information for the development of physiologically-based pharmacokinetic (PBPK) modeling to characterize the PK of nicotine and its metabolites (cotinine and 3-hydroxycotinine) in rodents across different routes of exposure. 
 

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