ArticleBMC pharmacology & toxicology2017
Erroneous formulation of delayed-release omeprazole capsules: alert for importing countries.
Article in BMC pharmacology & toxicology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- Acid-Neutralizing Omeprazole Formulation for Rapid Release and Absorption.Pharmaceutics · 2025Article
- Enteric-coating film effect on the delayed drug release of pantoprazole gastro-resistant generic tablets.F1000Research · 2023Article
- A comprehensive analysis of selected medicines collected from private drug outlets of Dhaka city, Bangladesh in a simple random survey.Scientific reports · 2022Article
- Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis.Scientific reports · 2021Article
- Patient safety and public health concerns: poor dissolution rate of pioglitazone tablets obtained from China, Myanmar and internet sites.BMC pharmacology & toxicology · 2021Article
- A prospective, randomized, masked, placebo-controlled crossover study for the effect of 10 mg omeprazole capsules on gastric pH in healthy dogs.Journal of veterinary internal medicine · 2021Article
- Clarification of the internal structure and factors of poor dissolution of substandard roxithromycin tablets by near-infrared chemical imaging.International journal of pharmaceutics · 2021Article
- Substandard and Falsified Medicines in Myanmar.Pharmacy (Basel, Switzerland) · 2020Article
- A Cross-Sectional Investigation of the Quality of Selected Medicines for Noncommunicable Diseases in Private Community Drug Outlets in Cambodia during 2011-2013.The American journal of tropical medicine and hygiene · 2019Article
- Quality of medicines in resource-limited settings: need for ethical guidance.Global bioethics = Problemi di bioetica · 2018Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPoor drug quality is a matter of serious concern, especially in countries where drug regulation and law enforcement are constrained by limited resources. This study was carried out to investigate the cause of quality failure of omeprazole in Cambodia in 2010 and Myanmar in 2014.
methodsWe conducted pharmacopoeial quantity, content uniformity and dissolution tests of 156 samples of omeprazole capsules collected in Cambodia in 2010 and Myanmar in 2014. High failure rates were found, especially in dissolution testing, and detailed investigation of several unacceptable samples was carried out by means of in-vitro dissolution profiling, scanning electron microscopy (SEM) and X-ray computed tomography (X-ray CT) to identify the cause of failure.
resultsDissolution profiling with and without the acid stage showed that acid caused premature omeprazole release, indicating that the enteric coating of the omeprazole granules was ineffective. SEM examination of two failed samples revealed cracked and broken granules mixed with apparently intact omeprazole granules in the capsule. X-ray CT examination indicated that some granules of failed samples completely lacked enteric coating, and others had incomplete and non-uniform enteric coating or malformation.
conclusionsOmeprazole capsules collected in Myanmar and Cambodia showed high failure rates in pharmacopoeial tests, especially dissolution tests. Some samples were found to have ineffective or absent enteric coating of the granules, resulting in premature dissolution and degradation in acidic conditions. This is a potentially serious public health issue that needs to be addressed by regulatory authorities in Cambodia and Myanmar, possibly through a collaborative initiative with manufacturers.
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