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Assessment of the pharmaceutical quality of omeprazole capsule brands marketed in Egypt
Open accessAbstract
The pharmaceutical quality of 7 local omeprazole capsule brands in Egypt was assessed relative to the proprietary product (Losec). Drug content, content uniformity, drug release (using USP test for enteric coated articles and a modified release test) were determined. Products were subjected to a 3-month stability study. Of the 7 brands, 6 had satisfactory drug content and content uniformity. All brands passed the USP drug release test. The modified release test proved to be more discriminative. After 3 months storage, drug content of 3 brands remained > 90% and 2 of these brands maintained drug release above 75%. Changes in pellet appearance during storage were indicative of omeprazole chemical degradation.
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“However different reported studies over the last years revealed that marketed products with the same amount of active ingredient exhibit marked differences in their therapeutic responses.”
From Evaluation and comparison of in-vitro dissolution profiles for different brands of amoxicillin capsules (2013) · cites this paper as [8]
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“The presences of generic products that are not interchangeable with that of the innovator and/or with each others have been reported 4, 6, 8-10 .”
From Evaluation and comparison of in-vitro dissolution profiles for different brands of amoxicillin capsules (2013) · cites this paper as [8]
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Kassaye, L., & Genete, G. (2013) · African Health Sciences · doi:10.4314/ahs.v13i2.25 · Cited by 80
Ameri, M. N. A., Nayuni, N. K., Kumar, K. G. A., Perrett, D. I., Tucker, A. T., & Johnston, A. E. (2011) · Results in Pharma Sciences · doi:10.1016/j.rinphs.2011.12.001 · Cited by 61
Labeling of omeprazole with technetium-99m for diagnosis of stomach
Sanad, M. H. (2013) · Radiochemistry · doi:10.1134/s1066362213060076 · Cited by 51
Bendas, E. R., & Abdelbary, A. A. (2014) · International Journal of Pharmaceutics · doi:10.1016/j.ijpharm.2014.04.030 · Cited by 40
El‐Kimary, E. I., & Ragab, M. A. A. (2020) · Critical Reviews in Analytical Chemistry · doi:10.1080/10408347.2020.1791042 · Cited by 19
Metadata
- Authors
- El Sayed, A., Boraie, N. A., Ismail, F. A., El Khordagui, L. K., & Khalil, S. A.
- Venue
- Eastern Mediterranean Health Journal
- Published
- 2007-11-01
- Volume
- 13
- Issue
- 6
- Pages
- 1427-1437
- ISSN
- 1020-3397 (ISSN-L)
- 1687-1634
- OpenAlex
- W1580798268
- Cited by
- 20
- References
- 0
- Citations by year
- 2026: 2 · 2024: 2 · 2023: 1 · 2022: 1 · 2021: 2 · 2020: 2 · 2019: 1 · 2017: 1 · 2015: 1 · 2014: 1 · 2013: 5
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Eastern Mediterranean Health Journal (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pharmaceutical Quality and Counterfeiting
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Keywords
- omeprazole, generic drug brands, drug content, content uniformity, drug release, enteric coating, stability studies, chemical degradation, pharmaceutical quality control, Egypt
- MeSH terms
- Analysis of Variance, Anti-Ulcer Agents, Biological Availability, Capsules, Chemistry, Pharmaceutical, Drug and Narcotic Control, Drug Packaging, Drug Stability, Drug Storage, Egypt, Humans, Humidity, Hydrogen-Ion Concentration, Omeprazole, Product Surveillance, Postmarketing, Solubility, Tablets, Enteric-Coated, Time Factors, Drug Costs
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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
