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Pharmacological evaluation and safety of a donepezil patch

Authors
Shin, Chang YellKim, Hae-SunCha, Kwang-HoKim, Hyun JungChoi, Won SeokJang, Sun WooSohn, Uy Dong
Issue Date
Dec-2020
Publisher
AVOXA-MEDIENGRUPPE DEUTSCHER APOTHEKER GMBH
Citation
PHARMAZIE, v.75, no.12, pp 656 - 661
Pages
6
Journal Title
PHARMAZIE
Volume
75
Number
12
Start Page
656
End Page
661
URI
https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/53947
DOI
10.1691/ph.2020.0588
ISSN
0031-7144
Abstract
Our aim was to assess the feasibility of transdermal delivery of donepezil and evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of donepezil patch in vitro and in vivo. Donepezil patches were applied to the skin of rabbits and humans for 7 days, then, the PK profiles were observed in a dose-dependent manner. Donepezil was continuously released from the patch for 7 days as compared to oral administration in hairless rats and rabbits. In hairless rats, peak acetylcholinesterase (AChE) inhibition of 34.7 +/- 2.0% was observed within 8 h after oral administration of 4 mg/head donepezil, and lasted for less than 24 h, consistent with changes in the plasma donepezil concentration. Peak AChE inhibition by the donepezil patch was equivalent to that in the orally administered group. Donepezil was released continuously from the patch for 7 days with a linear PK in both rats and rabbits. AChE activity inhibition was dependent on donepezil plasma concentration. The data exhibited excellent PK/PD correlation. There was no dermal irritation (erythema/edema) in placebo or donepezil patch group during the study period in minipigs. Thus, Dong-As donepezil patch appeared to be generally safe and was well tolerated.
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