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Erroneous formulation of delayed-release omeprazole capsules: alert for importing countries
Mohammad Sofiqur Rahman1, Naoko Yoshida2, Hirohito Tsuboi2
1Drug Management and Policy, Kanazawa University, Kanazawa, Japan. rahmansofique@gmail.com.
BMC Pharmacology & Toxicology
|May 5, 2017
Summary
Poor quality omeprazole capsules in Cambodia and Myanmar failed dissolution tests due to ineffective enteric coating. This indicates a serious public health risk requiring regulatory attention.
Area of Science:
- Pharmaceutical Sciences
- Drug Quality Control
- Medicinal Chemistry
Background:
- Poor drug quality is a significant global issue, particularly in regions with limited regulatory resources.
- Investigated the root causes of omeprazole capsule quality failures in Cambodia (2010) and Myanmar (2014).
Purpose of the Study:
- To determine the reasons behind the high failure rates of omeprazole capsules in Cambodia and Myanmar.
- To identify specific quality defects in omeprazole formulations that led to pharmacopoeial test failures.
Main Methods:
- Conducted pharmacopoeial tests (quantity, content uniformity, dissolution) on 156 omeprazole capsule samples.
- Performed in-vitro dissolution profiling, scanning electron microscopy (SEM), and X-ray computed tomography (X-ray CT) on failed samples.
Main Results:
- High failure rates observed, especially in dissolution testing.
- Ineffective enteric coating identified as the primary cause, leading to premature drug release in acidic conditions.
- SEM and X-ray CT revealed cracked, broken, and uncoated granules, along with incomplete or non-uniform enteric coating.
Conclusions:
- Omeprazole capsules in Cambodia and Myanmar exhibited significant quality issues, primarily related to inadequate enteric coating.
- The ineffective coating results in premature degradation, posing a public health concern.
- Urgent regulatory action and potential manufacturer collaboration are recommended to address these quality failures.
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