Design and optimization of prednisolone nanoparticle loaded oral fast dissolving film for mouth ulcers

Year 2025, Volume: 29 Issue: 6, 2542 - 2564, 02.11.2025

Ujwala S. Desai Praveen D. Chaudhari Dipak P. Gonde Sohan N. Bharambe

https://doi.org/10.12991/jrespharm.1798210

Abstract

An oral ulcer occurs due to the erosion or loss of the upper mucosal layer, representing one of the most
commonly encountered pathological conditions within the oral cavity. Typically, these lesions are painful and are
predominantly located on the inner surfaces of the lips and cheeks. Despite their distinct characteristics, all forms of
Recurrent aphthous stomatitis have a significant impact on quality of life and interfere with activities of daily living.
Prednisolone Sodium Phosphate [PSP] is a corticosteroid drug used for allergies, inflammatory, autoimmune diseases
and in malignancies. PSP belongs to the Biopharmaceutics Classification System [BCS] class II and exhibits minimal
solubility in water. Therefore, nanotechnology is used for the preparation of formulation which has greater absorption
and bioavailability. The objective of the present research work is to formulate nanoparticles to improve solubility of
Prednisolone Sodium Phosphate [PSP] by using Emulsion- Solvent Evaporation method, and incorporate these
nanoparticles into fast dissolving mouth films for mouth ulcers. Further, we optimized PSP nanoparticles using design
of experiments and evaluated optimized prednisolone nanoparticles for Particle Size, Zeta Potential, Polydispersity
Index, Scanning Electron Microscopy and X-Ray Diffraction. The oral fast dissolving films were evaluated on the basis
of physical appearance, thickness, pH, weight disintegration time, folding endurance, and stability study. In-vitro
dissolution studies demonstrated that more than 80% drug was released from fast- dissolving films. Incorporation of
PSP into nanoparticles resulted in increased solubility of PSP and oral fast dissolving films were utilized as a medium
to transport these nanoparticles for drug delivery applications which have better therapeutic efficiency and
bioavailability with significantly higher drug release profile.

Keywords

Nanoparticle , prednisolone sodium phosphate , solubility , oral films

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