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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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Detalles Bibliográficos
Autores principales: Olszynski, Wojciech P., Adachi, Jonathan D., Davison, K. Shawn
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi Publishing Corporation 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4202245/
https://www.ncbi.nlm.nih.gov/pubmed/25349772
http://dx.doi.org/10.1155/2014/420451
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author Olszynski, Wojciech P.
Adachi, Jonathan D.
Davison, K. Shawn
author_facet Olszynski, Wojciech P.
Adachi, Jonathan D.
Davison, K. Shawn
author_sort Olszynski, Wojciech P.
collection PubMed
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.
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spelling pubmed-42022452014-10-27 Differences in In Vitro Disintegration Time among Canadian Brand and Generic Bisphosphonates Olszynski, Wojciech P. Adachi, Jonathan D. Davison, K. Shawn J Osteoporos Research Article 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. Hindawi Publishing Corporation 2014 2014-10-02 /pmc/articles/PMC4202245/ /pubmed/25349772 http://dx.doi.org/10.1155/2014/420451 Text en Copyright © 2014 Wojciech P. Olszynski et al. https://creativecommons.org/licenses/by/3.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Olszynski, Wojciech P.
Adachi, Jonathan D.
Davison, K. Shawn
Differences in In Vitro Disintegration Time among Canadian Brand and Generic Bisphosphonates
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
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4202245/
https://www.ncbi.nlm.nih.gov/pubmed/25349772
http://dx.doi.org/10.1155/2014/420451
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