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Optimization of dexamethasone mixed nanomicellar formulation.

Kishore Cholkar1, Sudharshan Hariharan, Sriram Gunda

  • 1Division of Pharmaceutical Sciences, School of Pharmacy, University of Missouri-Kansas City, 5258 Health Science Building, 2464 Charlotte Street, Kansas City, Missouri, 64108-2718, USA.

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Summary

A novel mixed nanomicellar formulation (MNF) using D-α-tocopherol polyethylene glycol-1000 succinate (Vit E TPGS) and octoxynol-40 (Oc-40) enhances dexamethasone solubility and stability. This safe and effective MNF is suitable for human topical ocular drops.

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Ophthalmology

Background:

  • Dexamethasone is a potent corticosteroid with limited aqueous solubility, hindering topical ocular delivery.
  • Developing stable and effective drug delivery systems is crucial for improving therapeutic outcomes in ophthalmology.

Purpose of the Study:

  • To develop a clear aqueous mixed nanomicellar formulation (MNF) of dexamethasone.
  • To utilize D-α-tocopherol polyethylene glycol-1000 succinate (Vit E TPGS) and octoxynol-40 (Oc-40) for enhanced dexamethasone delivery.
  • To optimize the MNF for improved solubility, stability, and safety for ocular applications.

Main Methods:

  • A three-level full-factorial design was employed to optimize the formulation.
  • Solvent evaporation method was used for formulation preparation.
  • Formulations were characterized by entrapment efficiency, size, polydispersity index (PDI), and critical micellar concentration (CMC).
  • (1)H NMR and cytotoxicity studies were conducted for drug integrity and safety assessment.

Main Results:

  • A specific blend ratio (Vit E TPGS:Oc-40 at 4.5:2.0 wt%) yielded optimal entrapment, small nanomicellar size, and narrow PDI.
  • Dexamethasone solubility in the MNF increased approximately 6.3-fold compared to its normal aqueous solubility.
  • The CMC of the polymer blend was significantly lower than individual polymers, indicating enhanced micelle formation.
  • (1)H NMR confirmed the absence of free dexamethasone, and cytotoxicity studies showed no adverse effects on corneal cells.

Conclusions:

  • The developed mixed nanomicellar formulation (MNF) of dexamethasone is stable, safe, and significantly enhances drug solubility.
  • The optimized MNF demonstrates potential as a suitable vehicle for human topical ocular drops.
  • Further in vivo evaluations are recommended to confirm the therapeutic efficacy and safety for ocular administration.