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.
Despite increasing attention to the quality of medicines for communicable diseases, focus on medicines for non-communicable diseases remains inadequate. In 2010, quality test results of omeprazole in Cambodia indicated that more inspection and monitoring of medicines for non-communicable diseases is necessary [6]. The availability of falsified and substandard medicines in Myanmar was reported by WHO in 1999 [15], but since then there has been no systematic survey in the country, and the current situation is unclear, except for sporadic reports of falsified medicines. Based on our experience in Cambodia during 2006-2013 [6], where we encountered various poor quality (mostly substandard) medicines, omeprazole was chosen as one of the target medicines for investigation in Myanmar, in consultation with the Department of Food and Drug Administration (FDA), Myanmar. Among 156 samples of omeprazole capsules collected in Cambodia in 2010 and Myanmar in 2014, we found high failure rates in pharmacopoeial tests, especially dissolution tests. This is broadly consistent with other reports of substandard drugs in Cambodia [26, 27].
British Pharmacopoeia 2010 Download Pdf
The investigational samples consisted of 154 samples of hard gelatin capsules containing 20 mg of omeprazole in enteric-coated pellets and 2 tablet samples purchased from different drug stores in Cambodia in 2010 and Myanmar in 2014. In Cambodia, samples were collected from pharmacies, depots, wholesaler and outlets of Phnom Penh, Svay Rieng and Kandal provinces. In Myanmar, collected samples were from pharmacy, hospital, and wholesalers of Yangon region. These samples of different serial and batch number were imported to Cambodia and Myanmar from 53 different manufacturers in seven countries. Samples were stored below 25 C after collecting and all the quality analysis of the samples was finished before the expiration date of the samples. After quality-testing as required by the indicated pharmacopoeia, we selected five samples for further investigation based on the gravity of their failure in the dissolution test.
Samples of omeprazole capsules collected in Cambodia in 2010 and Myanmar in 2014 showed high failure rates in pharmacopoeial testing, especially in the dissolution test. In-vitro dissolution profiling, scanning electron microscopy and X-ray computed tomography showed that failed samples contained granules with ineffective (cracked or incomplete) or absent enteric coating. This would result in premature dissolution in acidic conditions after oral administration, and could result in treatment failure. This situation is a potentially serious public health issue that needs to be addressed by regulatory authorities in Cambodia and Myanmar, possibly through legal measures and collaborative initiatives with manufacturers.
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