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image of Ibrutinib Loaded Nanostructured Lipid Carriers for the Management of Chronic Lymphocytic Leukemia: Synchronizing In Silico, In Vitro, and In Vivo Studies

Abstract

Introduction

Ibrutinib is a selective tyrosine kinase inhibitor used to treat chronic lymphocytic leukemia (CLL). However, it has low oral bioavailability (2.9%), which is attributed to low solubility (0.002 mg/mL) and a first-pass effect. Ibrutinib-loaded nanostructured lipid carriers (IBR-NLCs) were prepared and investigated in this study to overcome the solubility and presystemic metabolism issues. The goal of the current study was to formulate IBR-NLCs for enhanced bioavailability. IBR-NLCs were optimized using a 32 factorial design and evaluated using various and parameters.

Methods

IBR interaction with solid lipid (Glyceryl monostearate) and liquid lipid (oleic acid) was studied using molecular docking. The hot-melt ultrasonication method was used to formulate IBR-NLCs, and a 32 factorial design was used for optimization. Particle size, PDI, zeta potential, entrapment efficiency, DSC, XRD, FTIR, SEM, and study were used to evaluate the NLCs. HepG2 cell lines were used to study the cytotoxicity of IBR-NLCs and IBR suspension. IBR-NLCs were administered to male Wistar rats in the presence and absence of cycloheximide (CXI) to compare pharmacokinetic parameters.

Results and Discussion

Molecular docking confirmed good interaction between IBR-GMS and IBR-oleic acid. The optimized IBR-NLCs exhibited particle sizes, PDI, zeta potentials, and %EE of 154.5 ± 0.7 nm, 0.2 ± 0.0, -25.8 ± 1.1 mV, and 84.0 ± 1.2%, respectively. Differential Scanning Calorimetry (DSC) reveals the development of molecular dispersion of IBR in the melted lipid matrix, and X-Ray Diffraction (XRD) studies show a decline in the crystalline drug peaks in the formulation's diffractogram. SEM images showed uniformity distributed spherical-shaped particles. According to an investigation, IBR-NLCs exhibited a sustained release pattern of 98.0 ± 0.5% with a Korsmeyer-Peppas model mechanism (R2 = 0.9615). The IC values of IBR suspension and IBR-NLCs were 4.155 µg/mL and 3.03 µg/mL. The AUC of IBR-NLCs administered in the absence of CXI was 1.60 times higher than the AUC values in the presence of CXI, indicating lymphatic transport.

Conclusion

IBR-NLCs appear to be promising as a novel innovative nanocarrier for the management of CLL.

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2025-08-26
2025-10-18

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Ibrutinib Loaded Nanostructured Lipid Carriers for the Management of Chronic Lymphocytic Leukemia: Synchronizing In Silico, In Vitro, and In Vivo Studies
Bentham Science Publishers ; https://doi.org/10.2174/0113816128378420250804145740
/content/journals/cpd/10.2174/0113816128378420250804145740
/content/journals/cpd/10.2174/0113816128378420250804145740
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  • Article Type:     Research Article
Keywords: Keynote: Chronic lymphocytic leukemia ; design of experiments ; ibrutinib ; lymphatic targeting ; oral route ; nanostructured lipid carriers

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