Alectinib-Loaded Chitosan–Alginate Nanoparticles: A Novel Synthesis Method with In Vitro and In Vivo Evaluations

<b>Background/Objectives</b>: Non-small cell lung cancer (NSCLC) constitutes over 84% of all lung cancer cases and is a leading cause of cancer-related mortality globally. Alectinib, a second-generation anaplastic lymphoma kinase (ALK) inhibitor, is effective in ALK-positive NSCLC; howev...

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Main Authors: Tha’er Ata, Israa Al-Ani, Nida Karameh, Mahmood R. Atta, Wael Abu Dayyih
Format: Article
Language:English
Published: MDPI AG 2025-04-01
Series:Pharmaceutics
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Online Access:https://www.mdpi.com/1999-4923/17/4/492
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author Tha’er Ata
Israa Al-Ani
Nida Karameh
Mahmood R. Atta
Wael Abu Dayyih
author_facet Tha’er Ata
Israa Al-Ani
Nida Karameh
Mahmood R. Atta
Wael Abu Dayyih
author_sort Tha’er Ata
collection DOAJ
description <b>Background/Objectives</b>: Non-small cell lung cancer (NSCLC) constitutes over 84% of all lung cancer cases and is a leading cause of cancer-related mortality globally. Alectinib, a second-generation anaplastic lymphoma kinase (ALK) inhibitor, is effective in ALK-positive NSCLC; however, its clinical potential is hampered by poor aqueous solubility and limited oral bioavailability. This study aimed to develop Alectinib-loaded chitosan–alginate nanoparticles (ACANPs) to enhance its solubility, oral bioavailability, and therapeutic efficacy. <b>Methods</b>: ACANPs were synthesized using a novel combined solid/oil/water (s/o/w) emulsification technique with ionotropic gelation. Characterization was performed using Fourier-transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), dynamic light scattering (DLS), and zeta potential measurements. A validated high-performance liquid chromatography (HPLC) method quantified the Alectinib. In vitro drug release studies compared free Alectinib with ACANPs. Cytotoxicity against NSCLC cell lines (A549 and H460) was assessed using MTT assays. Pharmacokinetic parameters were evaluated in rats using LC–MS/MS. <b>Results</b>: ACANPs showed a high encapsulation efficiency (~97%), an average particle size of 161 nm, and a positive zeta potential of +21 mV. In vitro release studies revealed a threefold increase in drug release from ACANPs over 48 h compared to free Alectinib. Cytotoxicity assays demonstrated significantly reduced IC<sub>50</sub> values for ACANPs. Pharmacokinetic analyses showed an enhanced maximum plasma concentration (C<sub>max</sub>) and area under the curve (AUC), indicating a 78% increase in oral bioavailability. <b>Conclusions</b>: ACANPs substantially improved the solubility, cytotoxic efficacy, and oral bioavailability of Alectinib, suggesting their potential as a promising nanocarrier system for enhancing NSCLC treatment outcomes.
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spelling doaj-art-f1dfa636d0694e8d862e1403e934ffc42025-08-20T03:13:45ZengMDPI AGPharmaceutics1999-49232025-04-0117449210.3390/pharmaceutics17040492Alectinib-Loaded Chitosan–Alginate Nanoparticles: A Novel Synthesis Method with In Vitro and In Vivo EvaluationsTha’er Ata0Israa Al-Ani1Nida Karameh2Mahmood R. Atta3Wael Abu Dayyih4Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Pharmacological and Diagnostic Research Center (PDRC), Al-Ahliyya Amman University, Amman 19328, JordanDepartment of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Pharmacological and Diagnostic Research Center (PDRC), Al-Ahliyya Amman University, Amman 19328, JordanDepartment of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Middle East University, Amman 11831, JordanDepartment of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Pharmacological and Diagnostic Research Center (PDRC), Al-Ahliyya Amman University, Amman 19328, JordanDepartment of Pharmaceutical Chemistry, Faculty of Pharmacy, Mutah University, Al Karak 61710, Jordan<b>Background/Objectives</b>: Non-small cell lung cancer (NSCLC) constitutes over 84% of all lung cancer cases and is a leading cause of cancer-related mortality globally. Alectinib, a second-generation anaplastic lymphoma kinase (ALK) inhibitor, is effective in ALK-positive NSCLC; however, its clinical potential is hampered by poor aqueous solubility and limited oral bioavailability. This study aimed to develop Alectinib-loaded chitosan–alginate nanoparticles (ACANPs) to enhance its solubility, oral bioavailability, and therapeutic efficacy. <b>Methods</b>: ACANPs were synthesized using a novel combined solid/oil/water (s/o/w) emulsification technique with ionotropic gelation. Characterization was performed using Fourier-transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), dynamic light scattering (DLS), and zeta potential measurements. A validated high-performance liquid chromatography (HPLC) method quantified the Alectinib. In vitro drug release studies compared free Alectinib with ACANPs. Cytotoxicity against NSCLC cell lines (A549 and H460) was assessed using MTT assays. Pharmacokinetic parameters were evaluated in rats using LC–MS/MS. <b>Results</b>: ACANPs showed a high encapsulation efficiency (~97%), an average particle size of 161 nm, and a positive zeta potential of +21 mV. In vitro release studies revealed a threefold increase in drug release from ACANPs over 48 h compared to free Alectinib. Cytotoxicity assays demonstrated significantly reduced IC<sub>50</sub> values for ACANPs. Pharmacokinetic analyses showed an enhanced maximum plasma concentration (C<sub>max</sub>) and area under the curve (AUC), indicating a 78% increase in oral bioavailability. <b>Conclusions</b>: ACANPs substantially improved the solubility, cytotoxic efficacy, and oral bioavailability of Alectinib, suggesting their potential as a promising nanocarrier system for enhancing NSCLC treatment outcomes.https://www.mdpi.com/1999-4923/17/4/492Alectinibchitosanalginatenanoparticlesion gelationbioavailability
spellingShingle Tha’er Ata
Israa Al-Ani
Nida Karameh
Mahmood R. Atta
Wael Abu Dayyih
Alectinib-Loaded Chitosan–Alginate Nanoparticles: A Novel Synthesis Method with In Vitro and In Vivo Evaluations
Pharmaceutics
Alectinib
chitosan
alginate
nanoparticles
ion gelation
bioavailability
title Alectinib-Loaded Chitosan–Alginate Nanoparticles: A Novel Synthesis Method with In Vitro and In Vivo Evaluations
title_full Alectinib-Loaded Chitosan–Alginate Nanoparticles: A Novel Synthesis Method with In Vitro and In Vivo Evaluations
title_fullStr Alectinib-Loaded Chitosan–Alginate Nanoparticles: A Novel Synthesis Method with In Vitro and In Vivo Evaluations
title_full_unstemmed Alectinib-Loaded Chitosan–Alginate Nanoparticles: A Novel Synthesis Method with In Vitro and In Vivo Evaluations
title_short Alectinib-Loaded Chitosan–Alginate Nanoparticles: A Novel Synthesis Method with In Vitro and In Vivo Evaluations
title_sort alectinib loaded chitosan alginate nanoparticles a novel synthesis method with in vitro and in vivo evaluations
topic Alectinib
chitosan
alginate
nanoparticles
ion gelation
bioavailability
url https://www.mdpi.com/1999-4923/17/4/492
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