Are antibiotics substandard in Lebanon? Quantification of active pharmaceutical ingredients between brand and generics of selected antibiotics
Abstract Background In developing countries, brand-generic substitution is not based on validated scientific evidence that confirm the therapeutic equivalence of the generic to the originator. Rather, decisions are made based on the availability of generic medications. Substitution by inappropriate...
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| Format: | Article |
| Language: | English |
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BMC
2020-02-01
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| Series: | BMC Pharmacology and Toxicology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s40360-020-0390-y |
| _version_ | 1819022718631149568 |
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| author | Eva Hobeika Joanna Farhat Joseph Saab Walid Hleihel Samar Azzi-Achkouty Georges Sili Souheil Hallit Pascale Salameh |
| author_facet | Eva Hobeika Joanna Farhat Joseph Saab Walid Hleihel Samar Azzi-Achkouty Georges Sili Souheil Hallit Pascale Salameh |
| author_sort | Eva Hobeika |
| collection | DOAJ |
| description | Abstract Background In developing countries, brand-generic substitution is not based on validated scientific evidence that confirm the therapeutic equivalence of the generic to the originator. Rather, decisions are made based on the availability of generic medications. Substitution by inappropriate preparations applies to antibiotics, which may increase the risk of resistance in case of underdosing. This analytical study aims to dose and assess for the accuracy of labeling three oral antibiotic preparations, namely ciprofloxacin hydrochloride, amoxicillin trihydrate and amoxicillin trihydrate-clavulanate potassium, the active pharmaceutical ingredients (APIs) found in brand and generic tablets available on the Lebanese market. Methods One brand and 4 generics of ciprofloxacin tablets, 3 generic amoxicillin tablets, and 1 brand and 4 generics of amoxicillin-clavulanic acid medications, were quantified, taking 2 batches of each. According to the United States Pharmacopeia (USP) guidelines, ultra-high pressure liquid chromatography was used to measure the APIs content within tablets. The USP required assay limit of the API was taken as the main comparison criteria. Results Out of the 5 ciprofloxacin medications tested, all 5 were out of the 2% required range, thus being substandard. For amoxicillin, all 3 medications were within the 20% range. As for amoxicillin-clavulanic acid medications, 4 out of 5 medications met the 30% required range of clavulanic acid and one exceeded the claimed amount of clavulanic acid, while all 5 met the assay limit for amoxicillin. Conclusion These findings raise safety and efficacy concerns, providing solid grounds for potential correlations of antibiotic resistance/substandard antibiotics. |
| first_indexed | 2024-12-21T04:27:27Z |
| format | Article |
| id | doaj.art-58704c4ae55448d5a166fce5e07f0450 |
| institution | Directory Open Access Journal |
| issn | 2050-6511 |
| language | English |
| last_indexed | 2024-12-21T04:27:27Z |
| publishDate | 2020-02-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pharmacology and Toxicology |
| spelling | doaj.art-58704c4ae55448d5a166fce5e07f04502022-12-21T19:16:01ZengBMCBMC Pharmacology and Toxicology2050-65112020-02-0121111210.1186/s40360-020-0390-yAre antibiotics substandard in Lebanon? Quantification of active pharmaceutical ingredients between brand and generics of selected antibioticsEva Hobeika0Joanna Farhat1Joseph Saab2Walid Hleihel3Samar Azzi-Achkouty4Georges Sili5Souheil Hallit6Pascale Salameh7Faculty of Arts and Sciences, Holy Spirit University of Kaslik (USEK)Faculty of Arts and Sciences, Holy Spirit University of Kaslik (USEK)Faculty of Arts and Sciences, Holy Spirit University of Kaslik (USEK)Faculty of Arts and Sciences, Holy Spirit University of Kaslik (USEK)School of Engineering, Holy Spirit University of Kaslik (USEK)Drug Information Center, Order of Pharmacists of LebanonFaculty of Medicine and Medical Sciences, Holy Spirit University of Kaslik (USEK)INSPECT-LB: Institut National de Sante Publique, Epidemiologie Clinique et ToxicologieAbstract Background In developing countries, brand-generic substitution is not based on validated scientific evidence that confirm the therapeutic equivalence of the generic to the originator. Rather, decisions are made based on the availability of generic medications. Substitution by inappropriate preparations applies to antibiotics, which may increase the risk of resistance in case of underdosing. This analytical study aims to dose and assess for the accuracy of labeling three oral antibiotic preparations, namely ciprofloxacin hydrochloride, amoxicillin trihydrate and amoxicillin trihydrate-clavulanate potassium, the active pharmaceutical ingredients (APIs) found in brand and generic tablets available on the Lebanese market. Methods One brand and 4 generics of ciprofloxacin tablets, 3 generic amoxicillin tablets, and 1 brand and 4 generics of amoxicillin-clavulanic acid medications, were quantified, taking 2 batches of each. According to the United States Pharmacopeia (USP) guidelines, ultra-high pressure liquid chromatography was used to measure the APIs content within tablets. The USP required assay limit of the API was taken as the main comparison criteria. Results Out of the 5 ciprofloxacin medications tested, all 5 were out of the 2% required range, thus being substandard. For amoxicillin, all 3 medications were within the 20% range. As for amoxicillin-clavulanic acid medications, 4 out of 5 medications met the 30% required range of clavulanic acid and one exceeded the claimed amount of clavulanic acid, while all 5 met the assay limit for amoxicillin. Conclusion These findings raise safety and efficacy concerns, providing solid grounds for potential correlations of antibiotic resistance/substandard antibiotics.http://link.springer.com/article/10.1186/s40360-020-0390-yGenericBrandBrand-generic substitutionSubstandardCiprofloxacin hydrochlorideAmoxicillin trihydrate |
| spellingShingle | Eva Hobeika Joanna Farhat Joseph Saab Walid Hleihel Samar Azzi-Achkouty Georges Sili Souheil Hallit Pascale Salameh Are antibiotics substandard in Lebanon? Quantification of active pharmaceutical ingredients between brand and generics of selected antibiotics BMC Pharmacology and Toxicology Generic Brand Brand-generic substitution Substandard Ciprofloxacin hydrochloride Amoxicillin trihydrate |
| title | Are antibiotics substandard in Lebanon? Quantification of active pharmaceutical ingredients between brand and generics of selected antibiotics |
| title_full | Are antibiotics substandard in Lebanon? Quantification of active pharmaceutical ingredients between brand and generics of selected antibiotics |
| title_fullStr | Are antibiotics substandard in Lebanon? Quantification of active pharmaceutical ingredients between brand and generics of selected antibiotics |
| title_full_unstemmed | Are antibiotics substandard in Lebanon? Quantification of active pharmaceutical ingredients between brand and generics of selected antibiotics |
| title_short | Are antibiotics substandard in Lebanon? Quantification of active pharmaceutical ingredients between brand and generics of selected antibiotics |
| title_sort | are antibiotics substandard in lebanon quantification of active pharmaceutical ingredients between brand and generics of selected antibiotics |
| topic | Generic Brand Brand-generic substitution Substandard Ciprofloxacin hydrochloride Amoxicillin trihydrate |
| url | http://link.springer.com/article/10.1186/s40360-020-0390-y |
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