Evidence map›Paper›PMID 33354734›Full record

ArticleClinical pharmacokinetics2021

Nicotine Population Pharmacokinetics in Healthy Smokers After Intravenous, Oral, Buccal and Transdermal Administration.

Per O Olsson Gisleskog, Juan José Perez Ruixo, Åke Westin, Anna C Hansson, Paul A Soons

Open access · hybridAbstract read
In one paragraph

Article in Clinical pharmacokinetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
0.3field-weighted citation impact, top 41% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 15 citations in OpenAlex.

  1. Proteomic profiling of metabolizing enzymes and transporters in 2 layers of Caucasian human skin.Drug metabolism and disposition: the biological fate of chemicals · 2026
    Article
  2. Review
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  4. Article
  5. Continuous Nicotine Monitors for Personal Nicotine Pharmacokinetics: A Receptor-Aware Research Agenda.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2025
    Review
  6. Article
  7. Mechanisms of altered hepatic drug disposition during pregnancy: small molecules.Expert opinion on drug metabolism & toxicology · 2025
    Review
  8. Article
  9. Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 2 countries.

Per O Olsson GisleskogSGS Exprimo NV, Life Science Services, London, UK.ORCID 0000-0002-0706-8783
Juan José Perez RuixoJanssen Research & Development, Quantitative Sciences, Beerse, Belgium.ORCID 0000-0001-9890-745X
Åke WestinMcNeil AB, Global Medical Affairs and Clinical Research, Helsingborg, Sweden.ORCID 0000-0001-6125-8919
Anna C HanssonMcNeil AB, Clinical Science, Helsingborg, Sweden.ORCID 0000-0003-2357-5029
Paul A SoonsJanssen Pharmaceutica NV, Alliance Management, Turnhoutseweg 30, 2340, Beerse, Belgium. psoons@its.jnj.com.ORCID 0000-0001-6333-4938
Helsingborgs lasarett · SEJanssen (Belgium) · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn 4 decades, numerous nicotine replacement therapy products have been developed. Population pharmacokinetic models can support exposure-response modeling and inform nicotine replacement therapy product development, but only limited model-based cross-study population pharmacokinetic analyses for nicotine replacement therapy products have been published.

objectivesThe aim of this retrospective analysis was to assess the population pharmacokinetics of nicotine across intravenous, oral, transdermal and oromucosal (mouth spray, chewing gum, lozenge and inhaler) routes and formulations in healthy smoking subjects.

methodsData on 930 unique subjects (46,016 observations) from 29 single- and repeated-dose studies with multiple formulations across intravenous, oral, transdermal and oromucosal routes of administration were included. Data from intravenous and extravascular routes of administration were modelled separately for run efficiency reasons. For developing extravascular models, clearance and disposition parameters and their inter-individual variabilities were fixed to the estimates for intravenously delivered nicotine. Detectable pre-dose nicotine concentrations were modelled as a hypothetical nicotine bolus into the central compartment at the start of wash-out. Modelling repeated-dose oral and buccal administrations required a time-dependent increase in clearance or decrease in bioavailability to describe the data adequately.

resultsDisposition of intravenous nicotine was best described by a three-compartment model with initial and terminal half-lives of 7 min and 4.5 h, respectively, and the absorption of single oral doses was best described with a first-order absorption rate constant of 1.55 h

conclusionsRobust population pharmacokinetic models were developed for five nicotine replacement therapy product types and for intravenous and oral nicotine. These population pharmacokinetic models are used in exposure-response analyses and simulation-based nicotine replacement therapy product design.

Indexed as

NicotineSmoking CessationAdministration, CutaneousAdministration, OralHumansRetrospective StudiesSmokersTobacco Use Cessation DevicesNicotine

Identifiers

PMID33354734
PMCPMC8016787
OpenAlexW3117748466

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.