Comparative bioavailability study of a novel multi-day patch formulation of rivastigmine (twice weekly) with Exelon® transdermal patch (daily)- a randomized clinical trial
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- 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.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.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.doi http://dx.doi.org/10.2174/1567205019666220823105059
- dc.identifier.issn 1567-2050
- dc.identifier.uri http://hdl.handle.net/10230/56316
- 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.accessRights info:eu-repo/semantics/openAccess
- dc.rights.uri https://creativecommons.org/licenses/by/4.0/legalcode
- 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.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.type.version info:eu-repo/semantics/publishedVersion