Novel nasal niosomes loaded with lacosamide and coated with chitosan: A possible pathway to target the brain to control partial-onset seizures

This work aimed to develop and produce lacosamide-loaded niosomes coated with chitosan (LCA-CTS-NSM) using a thin-film hydration method and the Box-Behnken design. The effect of three independent factors (Span 60 amount, chitosan concentration, and cholesterol amount) on vesicle size, entrapment eff...

Full description

Bibliographic Details
Main Authors: Alaa S. Tulbah, Mohammed H. Elkomy, Randa Mohammed Zaki, Hussein M. Eid, Essam M. Eissa, Adel A. Ali, Heba A. Yassin, Basmah Nasser Aldosari, Ibrahim A. Naguib, Amira H. Hassan
Format: Article
Language:English
Published: Elsevier 2023-12-01
Series:International Journal of Pharmaceutics: X
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2590156723000506
_version_ 1797741443458007040
author Alaa S. Tulbah
Mohammed H. Elkomy
Randa Mohammed Zaki
Hussein M. Eid
Essam M. Eissa
Adel A. Ali
Heba A. Yassin
Basmah Nasser Aldosari
Ibrahim A. Naguib
Amira H. Hassan
author_facet Alaa S. Tulbah
Mohammed H. Elkomy
Randa Mohammed Zaki
Hussein M. Eid
Essam M. Eissa
Adel A. Ali
Heba A. Yassin
Basmah Nasser Aldosari
Ibrahim A. Naguib
Amira H. Hassan
author_sort Alaa S. Tulbah
collection DOAJ
description This work aimed to develop and produce lacosamide-loaded niosomes coated with chitosan (LCA-CTS-NSM) using a thin-film hydration method and the Box-Behnken design. The effect of three independent factors (Span 60 amount, chitosan concentration, and cholesterol amount) on vesicle size, entrapment efficiency, zeta potential, and cumulative release (8 h) was studied. The optimal formulation of LCA-CTS-NSM was chosen from the design space and assessed for morphology, in vitro release, nasal diffusion, stability, tolerability, and in vivo biodistribution for brain targeting after intranasal delivery. The vesicle size, entrapment, surface charge, and in vitro release of the optimal formula were found to be 194.3 nm, 58.3%, +35.6 mV, and 81.3%, respectively. Besides, it exhibits sustained release behavior, enhanced nasal diffusion, and improved physical stability. Histopathological testing revealed no evidence of toxicity or structural damage to the nasal mucosa. It demonstrated significantly more brain distribution than the drug solution. Overall, the data is encouraging since it points to the potential for non-invasive intranasal administration of LCA as an alternative to oral or parenteral routes.
first_indexed 2024-03-12T14:26:47Z
format Article
id doaj.art-e4b4a6b37e664cf598d4737476fde337
institution Directory Open Access Journal
issn 2590-1567
language English
last_indexed 2024-03-12T14:26:47Z
publishDate 2023-12-01
publisher Elsevier
record_format Article
series International Journal of Pharmaceutics: X
spelling doaj.art-e4b4a6b37e664cf598d4737476fde3372023-08-18T04:31:31ZengElsevierInternational Journal of Pharmaceutics: X2590-15672023-12-016100206Novel nasal niosomes loaded with lacosamide and coated with chitosan: A possible pathway to target the brain to control partial-onset seizuresAlaa S. Tulbah0Mohammed H. Elkomy1Randa Mohammed Zaki2Hussein M. Eid3Essam M. Eissa4Adel A. Ali5Heba A. Yassin6Basmah Nasser Aldosari7Ibrahim A. Naguib8Amira H. Hassan9Department of Pharmaceutics, College of Pharmacy, Umm Al-Qura University, Makkah 21955, Saudi ArabiaDepartment of Pharmaceutics, College of Pharmacy, Jouf University, Sakaka 72341, Saudi Arabia; Corresponding authors.Department of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, P.O. Box 173, Al-Kharj 11942, Saudi Arabia; Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef 62511, EgyptDepartment of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef 62511, Egypt; Corresponding authors.Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef 62511, EgyptDepartment of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef 62511, EgyptDepartment of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Sinai University (Arish campus), Arish, EgyptDepartment of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi ArabiaDepartment of Pharmaceutical Chemistry, College of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi ArabiaDepartment of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef 62511, EgyptThis work aimed to develop and produce lacosamide-loaded niosomes coated with chitosan (LCA-CTS-NSM) using a thin-film hydration method and the Box-Behnken design. The effect of three independent factors (Span 60 amount, chitosan concentration, and cholesterol amount) on vesicle size, entrapment efficiency, zeta potential, and cumulative release (8 h) was studied. The optimal formulation of LCA-CTS-NSM was chosen from the design space and assessed for morphology, in vitro release, nasal diffusion, stability, tolerability, and in vivo biodistribution for brain targeting after intranasal delivery. The vesicle size, entrapment, surface charge, and in vitro release of the optimal formula were found to be 194.3 nm, 58.3%, +35.6 mV, and 81.3%, respectively. Besides, it exhibits sustained release behavior, enhanced nasal diffusion, and improved physical stability. Histopathological testing revealed no evidence of toxicity or structural damage to the nasal mucosa. It demonstrated significantly more brain distribution than the drug solution. Overall, the data is encouraging since it points to the potential for non-invasive intranasal administration of LCA as an alternative to oral or parenteral routes.http://www.sciencedirect.com/science/article/pii/S2590156723000506IntranasalPharmacokineticsNose-to-brain deliveryFocal seizuresAntiepilepticChitosomes
spellingShingle Alaa S. Tulbah
Mohammed H. Elkomy
Randa Mohammed Zaki
Hussein M. Eid
Essam M. Eissa
Adel A. Ali
Heba A. Yassin
Basmah Nasser Aldosari
Ibrahim A. Naguib
Amira H. Hassan
Novel nasal niosomes loaded with lacosamide and coated with chitosan: A possible pathway to target the brain to control partial-onset seizures
International Journal of Pharmaceutics: X
Intranasal
Pharmacokinetics
Nose-to-brain delivery
Focal seizures
Antiepileptic
Chitosomes
title Novel nasal niosomes loaded with lacosamide and coated with chitosan: A possible pathway to target the brain to control partial-onset seizures
title_full Novel nasal niosomes loaded with lacosamide and coated with chitosan: A possible pathway to target the brain to control partial-onset seizures
title_fullStr Novel nasal niosomes loaded with lacosamide and coated with chitosan: A possible pathway to target the brain to control partial-onset seizures
title_full_unstemmed Novel nasal niosomes loaded with lacosamide and coated with chitosan: A possible pathway to target the brain to control partial-onset seizures
title_short Novel nasal niosomes loaded with lacosamide and coated with chitosan: A possible pathway to target the brain to control partial-onset seizures
title_sort novel nasal niosomes loaded with lacosamide and coated with chitosan a possible pathway to target the brain to control partial onset seizures
topic Intranasal
Pharmacokinetics
Nose-to-brain delivery
Focal seizures
Antiepileptic
Chitosomes
url http://www.sciencedirect.com/science/article/pii/S2590156723000506
work_keys_str_mv AT alaastulbah novelnasalniosomesloadedwithlacosamideandcoatedwithchitosanapossiblepathwaytotargetthebraintocontrolpartialonsetseizures
AT mohammedhelkomy novelnasalniosomesloadedwithlacosamideandcoatedwithchitosanapossiblepathwaytotargetthebraintocontrolpartialonsetseizures
AT randamohammedzaki novelnasalniosomesloadedwithlacosamideandcoatedwithchitosanapossiblepathwaytotargetthebraintocontrolpartialonsetseizures
AT husseinmeid novelnasalniosomesloadedwithlacosamideandcoatedwithchitosanapossiblepathwaytotargetthebraintocontrolpartialonsetseizures
AT essammeissa novelnasalniosomesloadedwithlacosamideandcoatedwithchitosanapossiblepathwaytotargetthebraintocontrolpartialonsetseizures
AT adelaali novelnasalniosomesloadedwithlacosamideandcoatedwithchitosanapossiblepathwaytotargetthebraintocontrolpartialonsetseizures
AT hebaayassin novelnasalniosomesloadedwithlacosamideandcoatedwithchitosanapossiblepathwaytotargetthebraintocontrolpartialonsetseizures
AT basmahnasseraldosari novelnasalniosomesloadedwithlacosamideandcoatedwithchitosanapossiblepathwaytotargetthebraintocontrolpartialonsetseizures
AT ibrahimanaguib novelnasalniosomesloadedwithlacosamideandcoatedwithchitosanapossiblepathwaytotargetthebraintocontrolpartialonsetseizures
AT amirahhassan novelnasalniosomesloadedwithlacosamideandcoatedwithchitosanapossiblepathwaytotargetthebraintocontrolpartialonsetseizures