Differences in In Vitro Disintegration Time among Canadian Brand and Generic Bisphosphonates
The objective of this study was to compare the disintegration times among Canadian-marketed brand (alendronate 70 mg, alendronate 70 mg plus vitamin D 5600 IU, and risedronate 35 mg) and generic (Novo-alendronate 70 mg and Apo-alendronate 70 mg) once-weekly dosed bisphosphonates. All disintegration...
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| Format: | Article |
| Language: | English |
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Wiley
2014-01-01
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| Series: | Journal of Osteoporosis |
| Online Access: | http://dx.doi.org/10.1155/2014/420451 |
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| author | Wojciech P. Olszynski Jonathan D. Adachi K. Shawn Davison |
| author_facet | Wojciech P. Olszynski Jonathan D. Adachi K. Shawn Davison |
| author_sort | Wojciech P. Olszynski |
| collection | DOAJ |
| description | The objective of this study was to compare the disintegration times among Canadian-marketed brand (alendronate 70 mg, alendronate 70 mg plus vitamin D 5600 IU, and risedronate 35 mg) and generic (Novo-alendronate 70 mg and Apo-alendronate 70 mg) once-weekly dosed bisphosphonates. All disintegration tests were performed with a Vanderkamp Disintegration Tester. Disintegration was deemed to have occurred when no residue of the tablet, except fragments of insoluble coating or capsule shell, was visible. Eighteen to 20 samples were tested for each bisphosphonate group. The mean (±standard deviation) disintegration times were significantly P<0.05 faster for Apo-alendronate (26±5.6 seconds) and Novo-alendronate (13±1.1 seconds) as compared to brand alendronate (147±50.5 seconds), brand alendronate plus vitamin D (378±60.5 seconds), or brand risedronate (101±20.6 seconds). The significantly faster disintegration of the generic tablets as compared to the brand bisphosphonates may have concerning safety and effectiveness implications for patients administering these therapies. |
| format | Article |
| id | doaj-art-e2b37a61966d4cdab60208aa5df54103 |
| institution | Kabale University |
| issn | 2090-8059 2042-0064 |
| language | English |
| publishDate | 2014-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Osteoporosis |
| spelling | doaj-art-e2b37a61966d4cdab60208aa5df541032025-02-03T01:33:01ZengWileyJournal of Osteoporosis2090-80592042-00642014-01-01201410.1155/2014/420451420451Differences in In Vitro Disintegration Time among Canadian Brand and Generic BisphosphonatesWojciech P. Olszynski0Jonathan D. Adachi1K. Shawn Davison2Saskatoon Osteoporosis Centre and Department of Medicine, University of Saskatchewan, Suite 103, 39-23rd Street East, Saskatoon, SK, S7K 0H6, CanadaDepartment of Medicine, St. Joseph’s Hospital, McMaster University, 501-25 Charlton Avenue E., Hamilton, ON, L8N 1Y2, CanadaUniversity of Victoria, P.O. Box 1700 STN CSC, Victoria, BC, V8W 2Y2, CanadaThe objective of this study was to compare the disintegration times among Canadian-marketed brand (alendronate 70 mg, alendronate 70 mg plus vitamin D 5600 IU, and risedronate 35 mg) and generic (Novo-alendronate 70 mg and Apo-alendronate 70 mg) once-weekly dosed bisphosphonates. All disintegration tests were performed with a Vanderkamp Disintegration Tester. Disintegration was deemed to have occurred when no residue of the tablet, except fragments of insoluble coating or capsule shell, was visible. Eighteen to 20 samples were tested for each bisphosphonate group. The mean (±standard deviation) disintegration times were significantly P<0.05 faster for Apo-alendronate (26±5.6 seconds) and Novo-alendronate (13±1.1 seconds) as compared to brand alendronate (147±50.5 seconds), brand alendronate plus vitamin D (378±60.5 seconds), or brand risedronate (101±20.6 seconds). The significantly faster disintegration of the generic tablets as compared to the brand bisphosphonates may have concerning safety and effectiveness implications for patients administering these therapies.http://dx.doi.org/10.1155/2014/420451 |
| spellingShingle | Wojciech P. Olszynski Jonathan D. Adachi K. Shawn Davison Differences in In Vitro Disintegration Time among Canadian Brand and Generic Bisphosphonates Journal of Osteoporosis |
| title | Differences in In Vitro Disintegration Time among Canadian Brand and Generic Bisphosphonates |
| title_full | Differences in In Vitro Disintegration Time among Canadian Brand and Generic Bisphosphonates |
| title_fullStr | Differences in In Vitro Disintegration Time among Canadian Brand and Generic Bisphosphonates |
| title_full_unstemmed | Differences in In Vitro Disintegration Time among Canadian Brand and Generic Bisphosphonates |
| title_short | Differences in In Vitro Disintegration Time among Canadian Brand and Generic Bisphosphonates |
| title_sort | differences in in vitro disintegration time among canadian brand and generic bisphosphonates |
| url | http://dx.doi.org/10.1155/2014/420451 |
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