Evidence map›Paper›PMID 29611498›Full record

ArticleThe American journal of tropical medicine and hygiene2018

Survey to Identify Substandard and Falsified Tablets in Several Asian Countries with Pharmacopeial Quality Control Tests and Principal Component Analysis of Handheld Raman Spectroscopy.

Tomoko Kakio, Hitomi Nagase, Takashi Takaoka, Naoko Yoshida, Junichi Hirakawa, Susan Macha, Takashi Hiroshima, Yukihiro Ikeda, Hirohito Tsuboi, Kazuko Kimura

Abstract read
In one paragraph

Article in The American journal of tropical medicine and hygiene, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
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

8 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Substandard and Falsified Medicines in Myanmar.Pharmacy (Basel, Switzerland) · 2020
    Article
  7. Emerging Trends in Clinical Tropical Medicine Research.The American journal of tropical medicine and hygiene · 2019
    Article
  8. Quality assessment of DiflucanMedicine access @ point of care
    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

10 authors.

Tomoko KakioAnalytical Development, Pharmaceutical Sciences, Takeda Pharmaceutical Company, Ltd., Osaka, Japan.
Hitomi NagaseDrug Management and Policy, Faculty of Pharmacy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan.
Takashi TakaokaDrug Management and Policy, Faculty of Pharmacy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan.
Naoko YoshidaDrug Management and Policy, Faculty of Pharmacy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan.
Junichi HirakawaChemical Analysis Business, Thermo Fisher Scientific K.K., Yokohama, Japan.
Susan MachaGlobal Product Protection, Takeda Pharmaceuticals U.S.A., Inc., Deerfield, Illinois.
Takashi HiroshimaAnalytical Development, Pharmaceutical Sciences, Takeda Pharmaceutical Company, Ltd., Osaka, Japan.
Yukihiro IkedaAnalytical Development, Pharmaceutical Sciences, Takeda Pharmaceutical Company, Ltd., Osaka, Japan.
Hirohito TsuboiDrug Management and Policy, Faculty of Pharmacy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan.
Kazuko KimuraDrug Management and Policy, Faculty of Pharmacy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The World Health Organization has warned that substandard and falsified medical products (SFs) can harm patients and fail to treat the diseases for which they were intended, and they affect every region of the world, leading to loss of confidence in medicines, health-care providers, and health systems. Therefore, development of analytical procedures to detect SFs is extremely important. In this study, we investigated the quality of pharmaceutical tablets containing the antihypertensive candesartan cilexetil, collected in China, Indonesia, Japan, and Myanmar, using the Japanese pharmacopeial analytical procedures for quality control, together with principal component analysis (PCA) of Raman spectrum obtained with handheld Raman spectrometer. Some samples showed delayed dissolution and failed to meet the pharmacopeial specification, whereas others failed the assay test. These products appeared to be substandard. Principal component analysis showed that all Raman spectra could be explained in terms of two components: the amount of the active pharmaceutical ingredient and the kinds of excipients. Principal component analysis score plot indicated one substandard, and the falsified tablets have similar principal components in Raman spectra, in contrast to authentic products. The locations of samples within the PCA score plot varied according to the source country, suggesting that manufacturers in different countries use different excipients. Our results indicate that the handheld Raman device will be useful for detection of SFs in the field. Principal component analysis of that Raman data clarify the difference in chemical properties between good quality products and SFs that circulate in the Asian market.

Indexed as

FraudAntihypertensive AgentsBenzimidazolesBiphenyl CompoundsChinaComputers, HandheldHumansIndonesiaJapanMyanmarPharmacopoeias as TopicPrincipal Component AnalysisQuality ControlSpectrum Analysis, RamanTabletsTetrazolesAntihypertensive AgentsBenzimidazolesBiphenyl Compoundscandesartan cilexetilTabletsTetrazoles

Identifiers

PMID29611498
PMCPMC6086158

What OpenQuestion holds

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Registered trials

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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.