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Preparation and Evaluation of Gefitinib Containing Nanoliposomal Formulation for Lung Cancer Therapy

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Abstract

The present study was aimed to develop and optimize nanoliposomes of gefitinib for effective tumor targeting. Central composite design was used to study the effect of formulation variables: sonication time, Tween 80/soya lecithin ratio, and cholesterol/soya lecithin ratio on particle size and entrapment efficiency. Gefitinib-loaded nanoliposomes were prepared using modified emulsification and ultrasonic method. The nanoliposomes of optimized batch (GF16) were found ellipsoidal or quasi-spherical in shape, with an average size of 99.88 nm and highest entrapment efficiency (88.91 ± 0.6758%). In comparison to the marketed formulation, the optimized batch released gefitinib in a sustained manner (80.16 ± 0.4849%) in 24 h following the Korsemeyer-Peppas’ model, in a mechanism combining Fickian diffusion and liposome relaxation. Furthermore, the cytotoxicity assay revealed gefitinib-loaded nanoliposomes had reduced cytotoxicity as compared to free drug in A549 and H1299 cells with an IC50 value 9.32 ± 1.25 and 8.54 ± 1.08 µM, respectively. The significant cytotoxic response of the developed nanoliposomes may be attributed due to its low particle size, high entrapment efficiency, and prolonged drug release profile. Nanoliposomes had favorable physical stability when stored at a temperature of 4 °C. Overall, the developed nanoliposomes may be considered as a promising anticancer formulation, which needs further clinical investigations and may provide a new direction to the cancer clinics.

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Abbreviations

NSCLC:

Non-small cell lung cancer

EGFR:

Epidermal growth factor receptor

PI3K:

Phosphoinositide 3-kinase

mTOR:

Mammalian target of rapamycin

MAPK:

Mitogen-activated protein kinase

TKIs:

Tyrosine kinase inhibitors

Mg-ATP:

Magnesium-adenosine triphosphate

EGFR-TK:

Epidermal growth factor receptor tyrosine kinase

CCD:

Central composite design

ICH:

International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use

HPLC:

High performance liquid chromatography

PDI:

Polydispersity index

DSC:

Differential scanning calorimeter

FT-IR:

Fourier transform infrared

KBr:

Potassium bromide

TEM:

Transmission electron microscope

USP:

United States Pharmacopeia

DMEM:

Dulbecco’s Modified Eagle’s Medium

FBS:

Fetal bovine serum

IC:

Inhibitory concentration

ANOVA:

Analysis of variance

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Funding

This work was supported by the grant-in-aid to Department of Pharmaceutical Sciences, Maharishi Dayanand University, Rohtak, under the plan of Major Research Project (F.No.-43–485/2014 (SR)) by University Grants Commission, India.

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Authors and Affiliations

  1. Department of Pharmacy, Panipat Institute of Engineering and Technology (PIET), Smalkha, Panipat, Haryana, 132102, India

    Seema Rohilla

  2. Amity Institute of Pharmacy, Amity University Uttar Pradesh, Noida, 201313, India

    Rajendra Awasthi

  3. Discipline of Pharmacy, Graduate School of Health, University of Technology Sydney, Ultimo, NSW, 2007, Australia

    Meenu Mehta & Kamal Dua

  4. Department of Life Sciences, School of Pharmacy, International Medical University, Bukit Jalil, 57000, Kuala Lumpur, Malaysia

    Dinesh Kumar Chellappan

  5. School of Pharmacy, Suresh Gyan Vihar University, Jagatpura, Jaipur, 302017, India

    Gaurav Gupta

  6. School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, 144411, Punjab, India

    Monica Gulati & Sachin Kumar Singh

  7. Department of Chemical Pathology, School of Pathology, Faculty of Health Sciences and National Health Laboratory Service, University of the Free State, Bloemfontein, South Africa

    Krishnan Anand

  8. School of Life Sciences, University of Technology Sydney, Ultimo, NSW, 2007, Australia

    Brian G. Oliver

  9. Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia

    Brian G. Oliver

  10. Faculty of Health, Australian Research Centre in Complementary and Integrative Medicine, University of Technology Sydney, Ultimo, Australia

    Kamal Dua

  11. Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, 124001, Haryana, India

    Harish Dureja

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  1. Seema Rohilla
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Correspondence to Kamal Dua or Harish Dureja.

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Rohilla, S., Awasthi, R., Mehta, M. et al. Preparation and Evaluation of Gefitinib Containing Nanoliposomal Formulation for Lung Cancer Therapy. BioNanoSci. 12, 241–255 (2022). https://doi.org/10.1007/s12668-022-00938-6

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