Academic Journal
Development and In Vitro-Ex Vivo Evaluation of Novel Polymeric Nasal Donepezil Films for Potential Use in Alzheimer's Disease Using Experimental Design
| العنوان: | Development and In Vitro-Ex Vivo Evaluation of Novel Polymeric Nasal Donepezil Films for Potential Use in Alzheimer's Disease Using Experimental Design |
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| المؤلفون: | Papakyriakopoulou, Paraskevi, Rekkas, Dimitrios M, Colombo, Gaia, Valsami, Georgia |
| المساهمون: | Papakyriakopoulou, Paraskevi, Rekkas, Dimitrios M, Colombo, Gaia, Valsami, Georgia |
| سنة النشر: | 2022 |
| المجموعة: | Università degli Studi di Ferrara: CINECA IRIS |
| مصطلحات موضوعية: | Alzheimer’s disease, design of experiment, donepezil hydrochloride, hydroxypropyl-methyl-cellulose, Methyl-β-Cyclodextrin, nasal delivery, nasal film, permeation profile, polyethylene glycol |
| الوصف: | 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-beta-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 mu m), storage stability characteristics, and % residual humidity (<3%), as well as favourable swelling and mucoadhesive properties. Response surface methodology determined the optimum composition for flexible nasal film with maximized DH permeation. All selected factors interacted with each other and the effect of these interactions on responses is strongly related to the factor's concentration ratios. Based on these encouraging results, in vivo serum and brain pharmacokinetic study of the optimized nasal film, in comparison to DH oral administration, is ongoing in an animal model. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | STAMPA |
| اللغة: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/pmid/36015368; info:eu-repo/semantics/altIdentifier/wos/WOS:000845785200001; volume:14; issue:8; firstpage:1742-1; lastpage:1742-21; numberofpages:21; journal:PHARMACEUTICS; https://hdl.handle.net/11392/2501232; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85137380820; https://www.mdpi.com/1999-4923/14/8/1742 |
| DOI: | 10.3390/pharmaceutics14081742 |
| الاتاحة: | https://hdl.handle.net/11392/2501232 https://doi.org/10.3390/pharmaceutics14081742 https://www.mdpi.com/1999-4923/14/8/1742 |
| Rights: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.93DB0578 |
| قاعدة البيانات: | BASE |
| DOI: | 10.3390/pharmaceutics14081742 |
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