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Volume 26, Issue 4
  • ISSN: 1389-2010
  • E-ISSN: 1873-4316

Abstract

Introduction

The objective of the reported work was to develop Montelukast sodium (MS) solid lipid nanoparticles (MS-SLNs) to ameliorate its oral bio-absorption. Herein, the high-pressure homogenization (HPH) principle was utilized for the fabrication of MS-SLNs.

Methods

The study encompasses a 23 full factorial statistical design approach where mean particle size (Y) and percent entrapment efficiency (Y) were screened as dependent variables while, the concentration of lipid (X), surfactant (X), and co-surfactant (X) were screened as independent variables. The investigation of MS-SLNs by DSC and XRD studies unveiled the molecular dispersion of MS into the SLNs while TEM study showed the smooth surface of developed MS-SLNs. The optimized MS-SLNs exhibited mean particle size (MPS) = 115.5 ± 1.27 nm, polydispersity index (PDI) = 0.256 ± 0.04, zeta potential = -21.9 ± 0.32 mV and entrapment efficiency (EE) = 90.97 ± 1.12%. The pharmacokinetic study performed in Albino Wistar rats revealed 2.87-fold increments in oral bioavailability.

Results

The accelerated stability studies of optimized formulation showed good physical and chemical stability. The shelf life estimated for the developed MS-SLN was found to be 22.38 months.

Conclusion

At the outset, the developed MS-SLNs formulation showed a significant increment in oral bioavailability and also exhibited excellent stability in exaggerated storage conditions.

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2025-03-29

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Design of Optimized Solid Lipid Nanoparticles of Montelukast Sodium and Assessment of Oral Bioavailability in Experimental Model
Current Pharmaceutical Biotechnology 26, 576 (2025); https://doi.org/10.2174/0113892010300965240612054349
/content/journals/cpb/10.2174/0113892010300965240612054349
/content/journals/cpb/10.2174/0113892010300965240612054349
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  • Article Type:     Research Article
Keyword(s): factorial design; high-pressure homogenization; Montelukast sodium; oral bioavailability; shelf life; solid lipid nanoparticles; stability

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