ArticleObesity facts2010
Pharmaceutical quality of nine generic orlistat products compared with Xenical(r).
Article in Obesity facts, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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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.
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
5 citing papers in PubMed, 9 citations in OpenAlex.
- Comparative lipidomic profiling of African trypanosomes reveals metabolic distinctions impacting pan-species drug development.PLoS neglected tropical diseases · 2026Article
- Pharmacodynamic testing and new validated HPLC method to assess the interchangeability between multi-source orlistat capsules.Drug design, development and therapy · 2017Article
- Substandard drugs: a potential crisis for public health.British journal of clinical pharmacology · 2014Review
- Roles of chemical complexity and evolutionary theory in some hepatic and intestinal enzymatic systems in chemical reproducibility and clinical efficiency of herbal derivatives.TheScientificWorldJournal · 2014Review
- The assessment of side effects of health recommendations given to youth in general and children and adolescents with obesity.Obesity facts · 2010Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo compare the pharmaceutical quality of Xenical (chemically produced orlistat) with nine generic products, each produced by fermentation processes.
methodsXenical 120 mg capsules (Roche, Basel, Switzerland) were used as reference material. Generic products were from India, Malaysia, Argentina, Philippines, Uruguay, and Taiwan. Colour, melting temperature, crystalline form, particle size, capsule fill mass, active pharmaceutical ingredient content, amount of impurities, and dissolution were compared. Standard physical and chemical laboratory tests were those developed by Roche for Xenical.
resultsAll nine generic products failed the Xenical specifications in four or more tests, and two generic products failed in seven tests. A failure common to all generic products was the amount of impurities present, mostly due to different by-products, including side-chain homologues not present in Xenical. Some impurities were unidentified. Two generic products tested failed the dissolution test, one product formed a capsule-shaped agglomerate on storage and resulted in poor (</=15%) dissolution. Six generic products were powder formulations.
conclusionsAll tested generic orlistat products were pharmaceutically inferior to Xenical. The high levels of impurities in generic orlistat products are a major safety and tolerability concern.
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Registered trials
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.