Evidence map›Paper›PMID 26438533›Full record

Trial reportEuropean journal of clinical pharmacology2016

Plasma pharmacokinetics and synovial concentrations of S-flurbiprofen plaster in humans.

Ikuko Yataba, Noboru Otsuka, Isao Matsushita, Miho Kamezawa, Ichimaro Yamada, Sigeru Sasaki, Kazuo Uebaba, Hideo Matsumoto, Yuichi Hoshino

Erratum issuedOpen access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in European journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
4.2field-weighted citation impact, top 7% 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

19 citing papers in PubMed, 28 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

Ikuko YatabaDevelopment Headquarters, Taisho Pharmaceutical Co. Ltd, 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan.
Noboru OtsukaDevelopment Headquarters, Taisho Pharmaceutical Co. Ltd, 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan. n-otsuka@so.taisho.co.jp.
Isao MatsushitaDevelopment Headquarters, Taisho Pharmaceutical Co. Ltd, 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan.
Miho KamezawaMitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Ichimaro YamadaMitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Sigeru SasakiSapporo Tsukisamu Chuo Orthopedics, Sapporo, Japan.
Kazuo UebabaFaculty of Health Science, Teikyo Heisei University, Ichihara, Japan.
Hideo MatsumotoInstitute for Integrated Sports Medicine, School of Medicine, Keio University, Tokyo, Japan.
Yuichi HoshinoOrthopedics Surgery, School of Medicine, Jichi Medical University, Shimotsuke, Japan.
Mitsubishi Tanabe Pharma CorporationTaisho Pharmaceutical (Japan) · JPJichi Medical University · JPKeio University · JPTeikyo Heisei University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe purpose of this study is to investigate the pharmacokinetics and deep tissue penetration capability of the newly developed S-flurbiprofen plaster (SFPP) in humans.

methodsStudy 1: SFPP tape-type patch (2-60 mg) was applied to the lower back for 24 h in healthy adult volunteers. S-flurbiprofen (SFP) plasma concentration was measured over time to examine SFP pharmacokinetics. Study 2: SFPP (20 mg) was applied for 12 h to the affected knee of osteoarthritis (OA) patients who were scheduled for total knee arthroplasty. Deep tissues (synovial tissue and synovial fluid) were collected during surgery to compare SFP concentrations after application of SFPP or a commercially available flurbiprofen (FP) gel-type patch.

resultsStudy 1: The plasma concentration of SFP was sustained during 24-h topical application of the SFPP, showing a high percutaneous absorption ratio of 51.4-72.2 %. Cmax and AUC0-∞ were dose-proportional. Study 2: After application of the SFPP for 12 h, SFP concentrations in the synovial tissue and synovial fluid were 14.8-fold (p = 0.002) and 32.7-fold (p < 0.001) higher, respectively, than those achieved by the FP patch.

conclusionsSustained plasma concentration of SFP and high percutaneous absorption ratio was observed after 24-h topical application of the SFPP. Compared to the FP patch, the SFPP showed superior percutaneous absorption and greater tissue penetration of SFP into the synovial tissue. Greater tissue penetration of the SFPP seemed to be primarily due to its formulation. Thus, SFPP is expected to show higher efficacy for the treatment of knee OA.

Indexed as

Administration, TopicalAdultAgedAged, 80 and overAnti-Inflammatory Agents, Non-SteroidalFemaleFlurbiprofenHealthy VolunteersHumansMaleMiddle AgedOsteoarthritis, KneeSingle-Blind MethodSynovial MembraneTransdermal PatchYoung AdultAnti-Inflammatory Agents, Non-SteroidalFlurbiprofenPharmacokineticsS-flurbiprofenSynovial tissueTissue concentrationTopical NSAIDs

Identifiers

PMID26438533
PMCPMC4701782
OpenAlexW1845638336

What OpenQuestion holds

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LicenceCC BY
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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.