Development and In Vitro-Ex Vivo Evaluation of Novel Polymeric Nasal Donepezil Films for Potential Use in Alzheimer's Disease Using Experimental Design

Development and In Vitro-Ex Vivo Evaluation of Novel Polymeric Nasal Donepezil Films for Potential Use in Alzheimer's Disease Using Experimental Design

The objective and novelty of the present study is the development and optimization of innovative nasal film of Donepezil hydrochloride (DH) for potential use in Alzheimer’s disease. Hydroxypropyl-methyl-cellulose E50 (factor A) nasal films, with Polyethylene glycol 400 as plasticizer (factor B), and...

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Bibliographic Details
Published in:Pharmaceutics 2022-08, Vol.14 (8), p.1742
Main Authors: Papakyriakopoulou, Paraskevi, Rekkas, Dimitrios M, Colombo, Gaia, Valsami, Georgia
Format: Article
Language:eng
Subjects:
Alzheimer's disease
Cellulose
Design of experiments
Diagnosis
donepezil hydrochloride
Drug delivery systems
Drug dosages
Drug therapy
Drugs
Evaluation
Hormone replacement therapy
Hydration
Materials
Metabolism
Methyl-β-Cyclodextrin
nasal delivery
nasal films
permeation profile
Pharmaceuticals
Polymer films
Polymers
Vehicles
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Summary:The objective and novelty of the present study is the development and optimization of innovative nasal film of Donepezil hydrochloride (DH) for potential use in Alzheimer’s disease. Hydroxypropyl-methyl-cellulose E50 (factor A) nasal films, with Polyethylene glycol 400 as plasticizer (factor B), and Methyl-β-Cyclodextrin, as permeation enhancer (factor C), were prepared and characterized in vitro and ex vivo. An experimental design was used to determine the effects of the selected factors on permeation profile of DH through rabbit nasal mucosa (response 1), and on film flexibility/foldability (response 2). A face centered central composite design with three levels was applied and 17 experiments were performed in triplicate. The prepared films exhibited good uniformity of DH content (90.0 ± 1.6%−99.8 ± 4.9%) and thickness (19.6 ± 1.9−170.8 ± 11.5 μm), storage stability characteristics, and % residual humidity (
ISSN:1999-4923
1999-4923