| Title |
Erroneous formulation of delayed-release omeprazole capsules: alert for importing countries
|
|---|---|
| Published in |
BMC Pharmacology and Toxicology, May 2017
|
| DOI | 10.1186/s40360-017-0138-5 |
| Pubmed ID | |
| Authors |
Mohammad Sofiqur Rahman, Naoko Yoshida, Hirohito Tsuboi, Tep Keila, Tey Sovannarith, Heng Bun Kiet, Eav Dararth, Theingi Zin, Tsuyoshi Tanimoto, Kazuko Kimura |
| Abstract |
Poor 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. We 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. Dissolution 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. Omeprazole 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. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 23 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 23 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Other | 3 | 13% |
| Researcher | 3 | 13% |
| Student > Ph. D. Student | 3 | 13% |
| Lecturer > Senior Lecturer | 1 | 4% |
| Lecturer | 1 | 4% |
| Other | 3 | 13% |
| Unknown | 9 | 39% |
| Readers by discipline | Count | As % |
|---|---|---|
| Pharmacology, Toxicology and Pharmaceutical Science | 7 | 30% |
| Chemistry | 2 | 9% |
| Social Sciences | 2 | 9% |
| Nursing and Health Professions | 1 | 4% |
| Agricultural and Biological Sciences | 1 | 4% |
| Other | 0 | 0% |
| Unknown | 10 | 43% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 05 May 2017.
All research outputs
#16,700,406
of 24,561,012 outputs
Outputs from BMC Pharmacology and Toxicology
#260
of 465 outputs
Outputs of similar age
#200,403
of 315,355 outputs
Outputs of similar age from BMC Pharmacology and Toxicology
#11
of 19 outputs
Altmetric has tracked 24,561,012 research outputs across all sources so far. This one is in the 21st percentile – i.e., 21% of other outputs scored the same or lower than it.
So far Altmetric has tracked 465 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 5.3. This one is in the 34th percentile – i.e., 34% of its peers scored the same or lower than it.
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We're also able to compare this research output to 19 others from the same source and published within six weeks on either side of this one. This one is in the 31st percentile – i.e., 31% of its contemporaries scored the same or lower than it.