Evidence map›Paper›PMID 17510755›Full record

Trial reportPharmaceutical research2007

Determination of the relative bioavailability of salbutamol to the lungs following inhalation from dry powder inhaler formulations containing drug substance manufactured by supercritical fluids and micronization.

Catherine H Richardson, Marcel de Matas, Harold Hosker, Rahul Mukherjee, Ian Wong, Henry Chrystyn

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Pharmaceutical research, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.7field-weighted citation impact, top 25% 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

9 citing papers in PubMed, 29 citations in OpenAlex.

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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

6 authors at 3 institutions in 1 country.

Catherine H RichardsonInstitute of Pharmaceutical Innovation, University of Bradford, Bradford, BD7 1DP, UK.
Marcel de Matas
Harold Hosker
Rahul Mukherjee
Ian Wong
Henry Chrystyn
University of Bradford · GBAiredale General Hospital · GBUniversity of London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe relative lung bioavailability of salbutamol sulfate particles produced using supercritical fluids (SEDS) and delivered by dry powder inhaler (DPI) was compared with the performance of a conventional micronized drug DPI using the same device design (Clickhaler, Innovata Biomed). MATERIALS AND

methodsTwelve healthy volunteers and 11 mild asthmatic patients completed separate four-way randomised cross-over studies, assessing the relative bioavailability of salbutamol sulfate (urinary excretion method), formulated as SEDS particles (three batches) and micronized particles (Asmasal inhaler, UCB Pharma Ltd). Post-treatment improvements in patient lung function were assessed by measuring FEV(1). Physicochemical evaluation of the three SEDS batches revealed inter-batch differences in particle size and shape.

resultsThere was no significant difference in the relative lung bioavailability of salbutamol and its bronchodilator response between the best performing SEDS formulation and the Asmasal inhaler in volunteers and patients, respectively. SEDS salbutamol sulfate showing wafer like morphology gave greater fine particle dose, relative lung bioavailability and enhanced bronchodilation compared to other SEDS batches containing elongated particles.

conclusionsActive Pharmaceutical Ingredient (API) manufactured using supercritical fluids and delivered by DPI can provide similar lung bioavailability and clinical effect to the conventional micronized commercial product. Product performance is however notably influenced by inter-batch differences in particle characteristics.

Indexed as

Administration, InhalationAlbuterolAsthmaBiological AvailabilityChemistry, PharmaceuticalCross-Over StudiesFemaleForced Expiratory VolumeHumansLungMaleNebulizers and VaporizersParticle SizeAlbuterol

Identifiers

PMID17510755
OpenAlexW2018548889

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.