Ujwala S. DESAI, Praveen D. CHAUDHARI, Dipak P. GONDE, Sohan N. BHARAMBE
Journal of Research in Pharmacy - 2025;29(6):2542-2564
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.
