Design, development, and characterisation of clofazimine-loaded mannosylated nanostructured lipid carriers: 3³-Box-Behnken design approach

ABSTRACT

The Mycobacterium Tuberculosis infection can be treated via clofazimine (CLF)-loaded nanostructured lipid carriers (NLCs). Precipitation-hot microemulsification-probe sonication method was employed for formulation of CLF-NLCs and optimised by using 3³ Box–Behnken design. The surface of CLF-NLCs was modified with mannose ligands. The mannose modified and bare CLF-NLC formulations show highest encapsulation efficiencies greater than 70%. The preliminary evaluations were performed by using analytical techniques like Fourier transform infrared spectroscopy, differential scanning colorimetry, and powder X-ray diffraction studies. In-vitro drug release studies showed pH-dependent, sustained drug release profiles and best fitted for first order and Higuchi kinetics. The spherical morphologies of NLCs were confirmed by field-emission scanning electron microscopy. The formulations showed high storage stability at ambient and refrigerated conditions. Thus, present research successfully demonstrated the application of QbD principles in developing CLF-NLCs and improved the performance of CLF.

KEYWORDS:

• Quality by Design (QbD)
• clofazimine
• Nanostructured Lipid Carriers (NLCs)
• characterisation

Acknowledgments

Authors are grateful to Chancellor, NMIMS (Deemed-to-be University) and management of SVKM’s NMIMS, School of Pharmacy and Technology Management, Shirpur.

Disclosure statement

The authors report no conflict of interest.

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Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.