Evidence mapPaperPMID 33653417Full record

ArticleBMC pharmacology & toxicology2021

Patient safety and public health concerns: poor dissolution rate of pioglitazone tablets obtained from China, Myanmar and internet sites.

Mohammad Sofiqur Rahman, Naoko Yoshida, Hirohito Tsuboi, Erina Maeda, Andrea Vanessa Velasco Ibarra, Theingi Zin, Yoshio Akimoto, Tsuyoshi Tanimoto, Kazuko Kimura

Open access · goldAbstract read
In one paragraph

Article in BMC pharmacology & toxicology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 27% 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

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Quality of dorzolamide hydrochloride and timolol maleate containing eye drops distributed online.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2023
    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

9 authors at 2 institutions in 2 countries.

Mohammad Sofiqur RahmanMedi-Quality Security Institute, Graduate School of Medical Sciences, Kanazawa University, 920-1192, Kanazawa, Japan. rahmansofique@staff.kanazawa-u.ac.jp.ORCID 0000-0002-3793-5526
Naoko YoshidaDepartment of Clinical Pharmacy and Healthcare Sciences, Kanazawa University, 920-1192, Kanazawa, Japan.
Hirohito TsuboiDepartment of Clinical Pharmacy and Healthcare Sciences, Kanazawa University, 920-1192, Kanazawa, Japan.
Erina MaedaDepartment of Clinical Pharmacy and Healthcare Sciences, Kanazawa University, 920-1192, Kanazawa, Japan.
Andrea Vanessa Velasco IbarraDepartment of Clinical Pharmacy and Healthcare Sciences, Kanazawa University, 920-1192, Kanazawa, Japan.
Theingi ZinDepartment of Food and Drug Administration (FDA), Ministry of Health and Sports, Naypyidaw, Myanmar.
Yoshio AkimotoMedi-Quality Security Institute, Graduate School of Medical Sciences, Kanazawa University, 920-1192, Kanazawa, Japan.
Tsuyoshi TanimotoPharmaceutical and Medical Device Regulatory Science Society of Japan, 150-0002, Osaka, Japan.
Kazuko KimuraMedi-Quality Security Institute, Graduate School of Medical Sciences, Kanazawa University, 920-1192, Kanazawa, Japan.
Kanazawa University · JPMinistry of Health and Sports · MM

Funding

Ministry of Health, Labour and Welfare N/APharmaceutical Manufacturers Association of Japan (JPMA) N/A
6 · The paper itself

Abstract

backgroundPoor quality medicines have serious implications for public health. The aim of this study was to explore the quality of the antidiabetic pioglitazone, using samples collected in China and Myanmar, and samples purchased online.

methodsIn this cross-sectional study, we examined samples (n = 163) collected from hospitals in Shanghai, China in 2012 (n = 44), products purchased via the internet and imported into Japan in 2013 (n = 59), and samples purchased in shops in Yangon, Myanmar in 2015 (n = 60). Collected samples were subjected to visual inspection, authenticity investigation and quality testing (potency, content uniformity and dissolution test) by high-performance liquid chromatography. Samples were rated as compliant or non-compliant based on the relevant pharmacopoeial acceptance criteria.

resultsVisual inspection of all samples revealed compliant products. However, responses from manufacturers during authenticity investigation were poor. Among the n = 44 samples from China, one was non-compliant in the potency test. Among the n = 59 samples personally imported into Japan, 38% of generic samples were found to be non-compliant. In Myanmar, 13.3% of samples were non-compliant. Non-compliant samples predominantly failed in the dissolution test. All non-compliant samples were generic.

conclusionsDespite the apparent satisfactory outcome on the samples from China, pioglitazone samples collected in Myanmar and purchased online for personal import into Japan included many substandard products, which failed quality assessment predominantly because of poor dissolution. Internet providers did not comply with Japanese regulations in various respects.

Indexed as

Drugs, GenericHypoglycemic AgentsPioglitazoneChinaCross-Sectional StudiesDrug LiberationHospitalsHumansInternetJapanMyanmarPatient SafetyQuality ControlTabletsDrugs, GenericHypoglycemic AgentsPioglitazoneTabletsAntidiabeticMedicinePharmacoepidemiologyPioglitazoneQualitySubstandard

Identifiers

PMID33653417
PMCPMC7923830
OpenAlexW3133714353

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.