Trial reportBritish journal of clinical pharmacology2002
Determination of the relative bioavailability of salbutamol to the lungs and systemic circulation following nebulization.
Trial report in British journal of clinical pharmacology, 2002. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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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.
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Who cites it
10 citing papers in PubMed, 27 citations in OpenAlex.
- Evaluation of Preliminary Bronchodilation Effect on Aerosol Delivery from a Dry Powder Inhaler for Patients with Chronic Obstructive Pulmonary Disease with Suboptimal Peak Inspiratory Flow Rate.Clinical pharmacokinetics · 2025Trial
- Trial
- Efficiency of Ipratropium Bromide and Albuterol Deposition in the Lung Delivered via a Soft Mist Inhaler or Chlorofluorocarbon Metered-Dose Inhaler.Clinical and translational science · 2016Trial
- Lung deposition of BDP/formoterol HFA pMDI in healthy volunteers, asthmatic, and COPD patients.Journal of aerosol medicine and pulmonary drug delivery · 2010Trial
- Systemic exposure and implications for lung deposition with an extra-fine hydrofluoroalkane beclometasone dipropionate/formoterol fixed combination.Clinical pharmacokinetics · 2009Trial
- The Advanced Integrated Respiratory (AIR) Model: Comparative Analysis of Salbutamol Sulphate Deposition from pMDI, DPI, and Nebuliser Versus the NGI.Pharmaceutical research · 2026Article
- Aerosol delivery via noninvasive ventilation: role of models and bioanalysis.Annals of translational medicine · 2021Review
- Clinical Pharmacology Considerations for Developing Small-Molecule Treatments for COVID-19.Journal of clinical pharmacology · 2020Review
- Relative bioavailability of terbutaline to the lung following inhalation, using urinary excretion.British journal of clinical pharmacology · 2011Article
- A radiometric study of factors affecting drug output of jet nebulizers.Indian journal of pharmaceutical sciences · 2010Article
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsClinical studies comparing nebulized drug delivery systems could be flawed because of the high doses used. We have compared lung and total systemic delivery of salbutamol from a nebuliser with that from a metered dose inhaler by measuring urinary recovery of drug and its sulphate metabolite.
methodsTwelve healthy volunteers provided urine samples at 0, 0.5, 1, 2, 4, 8, 12 and 24 h after the start of dosing. Formulations and doses were 5 x 100 microg oral solution (ORAL), 5 x 100 microg from a metered dose inhaler (MDI), 2.5 mg using a nebuliser (NEB) and NEB with 25 g oral charcoal (NEBC). Each study phase was separated by 7 days and the order of dosing was randomized.
resultsMean (s.d.) 30 min urinary salbutamol excretion after ORAL, MDI, NEB and NEBC was 0.4 (0.7), 12.1 (3.7), 15.0 (3.9) and 18.2 (5.7) microg, respectively (all P<0.001 compared with ORAL). When normalized for the dose available for inhalation from MDI, NEB and NEBC, the mean (s.d.) 30 min urinary excretion of salbutamol was 2.4 (0.7), 2.9 (0.6) and 2.7 (0.6)%, respectively, with a mean ratio (90% confidence interval) between NEB and NEBC, of 95.3 (91.1, 99.5)%. The mean (s.d.) excretion of salbutamol plus its metabolite over 24 h post ORAL, MDI, NEB and NEBC dosing was 297.9 (38.3), 290.3 (41.4), 266.5 (44.6) and 151.7 (40.9) microg, respectively. The mean ratio (90% confidence interval) between MDI and ORAL, and NEB and ORAL were 97.5 (94.1, 101.0) and 90.7 (81.2, 100.2)%, respectively. The NEBC data indicate that 6.07 (1.04)% of the nominal nebulized dose was delivered to the lungs.
conclusionsThe 30 min urinary recovery of salbutamol, an index of the relative systemic bioavailability of salbutamol following inhalation, can be used to compare the lung deposition of nebulized systems. Similarly, the urinary 24 h recovery of salbutamol plus its metabolite, an index of the relative systemic bioavailability of salbutamol following inhalation, can be used to compare the delivery of nebulized drug to the systemic circulation.
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