dc.contributor.author |
Schurad, Bjoern |
dc.contributor.author |
Koch, Cornelius |
dc.contributor.author |
Schug, Barbara |
dc.contributor.author |
Morte, Adelaida |
dc.contributor.author |
Vaqué, Anna |
dc.contributor.author |
Torre Fornell, Rafael de la |
dc.contributor.author |
Iniesta, Marc |
dc.date.accessioned |
2023-03-22T07:14:36Z |
dc.date.available |
2023-03-22T07:14:36Z |
dc.date.issued |
2022 |
dc.identifier.citation |
Schurad B, Koch C, Schug B, Morte A, Vaqué A, De la Torre R, Iniesta M. Comparative bioavailability study of a novel multi-day patch formulation of rivastigmine (twice weekly) with Exelon® transdermal patch (daily)- a randomized clinical trial. Curr Alzheimer Res. 2022;19(7):541-53. DOI: 10.2174/1567205019666220823105059 |
dc.identifier.issn |
1567-2050 |
dc.identifier.uri |
http://hdl.handle.net/10230/56316 |
dc.description.abstract |
Background: Rivastigmine, a reversible AChEI for symptomatic treatment of mild to moderately severe Alzheimer's dementia, is administered once daily transdermal patches, enabling an easier and continuous drug delivery. A novel multi-day (twice week) patch formulation was developed with greater convenience for patients' therapeutic management. Objective: To assess the bioequivalence under SS conditions of the multiple-day rivastigmine transdermal patch (Test Product, RID-TDS) in comparison to the once-daily Exelon® transdermal patch (Reference Product), both at a release rate of 9.5 mg/24 h. Design: Single-center, open-label, randomized, multiple-dose study in healthy male adults in a 2- period, 2-sequence-crossover design with multiple applications. Methods: Patches were applied on 11 consecutive days for Exelon® and a 4-3-4-day regimen for the multiday test patch (RID-TDS), separated by a 14-day wash-out period. The safety, local tolerability and inhibitory effect of rivastigmine on plasma BuChE activity were also evaluated. Results: 57 subjects completed the study according to the protocol. Calculated point estimates and 90% CI for all primary parameters (AUC96-264, Cmax96-264 and Cmin96-264) were within the predefined acceptance interval of 80.00-125.00%. They were 113.64% (107.33-120.33), 105.14% (98.38- 112.38) and 107.82% (97.78-118.89) respectively. Satisfactory adhesion (CI of mean adhesion above 90%) was demonstrated for RID-TDS but not for Exelon®. Conclusion: Bioequivalence was demonstrated between RID-TDS mg twice a week and Exelon® once daily in SS. Patch adhesion favored RID-TDS despite the longer dosing interval. Both products were well tolerated. |
dc.format.mimetype |
application/pdf |
dc.language.iso |
eng |
dc.publisher |
Bentham Science Publishers |
dc.relation.ispartof |
Curr Alzheimer Res. 2022;19(7):541-53 |
dc.rights |
This is an Open Access article published under CC BY 4.0 https://creativecommons.org/licenses/by/4.0/legalcode |
dc.rights.uri |
https://creativecommons.org/licenses/by/4.0/legalcode |
dc.title |
Comparative bioavailability study of a novel multi-day patch formulation of rivastigmine (twice weekly) with Exelon® transdermal patch (daily)- a randomized clinical trial |
dc.type |
info:eu-repo/semantics/article |
dc.identifier.doi |
http://dx.doi.org/10.2174/1567205019666220823105059 |
dc.subject.keyword |
Alzheimer's disease |
dc.subject.keyword |
Bioavailability |
dc.subject.keyword |
Bioequivalence |
dc.subject.keyword |
Butyrylcholinesterase |
dc.subject.keyword |
Healthy subjects |
dc.subject.keyword |
Pharmacokinetics |
dc.subject.keyword |
Rivastigmine |
dc.subject.keyword |
Transdermal patch |
dc.rights.accessRights |
info:eu-repo/semantics/openAccess |
dc.type.version |
info:eu-repo/semantics/publishedVersion |