Design, development, and optimization of mucoadhesive buccal films of ganaxolone for enhanced bioavailability

Onkar  Pawar; Rahul  Godge; Ganesh  Shinde; Kailas  Barde; Akshay  Vikhe

doi:10.69857/joapr.v13i2.943

Authors

Onkar Pawar Department of Pharmaceutical Quality Assurance, Pravara Rural College of Pharmacy, Pravaranagar
Rahul Godge Department of Pharmaceutical Quality Assurance, Pravara Rural College of Pharmacy, Pravaranagar
Ganesh Shinde Department of Pharmaceutics, Institute of Pharmacy, Loni KD
Kailas Barde Department of Pharmaceutical Quality Assurance, Pravara Rural College of Pharmacy, Pravaranagar
Akshay Vikhe Department of Pharmaceutical Quality Assurance, Pravara Rural College of Pharmacy, Pravaranagar

DOI:

https://doi.org/10.69857/joapr.v13i2.943

Keywords:

Ganaxolone, CDKL5 deficiency disorder, Mucoadhesive buccal films,, HPMC K4M, Moringa gum, Factorial design, Drug delivery

Abstract

Background: CDD disorder affects children mainly during their first three months of life. The buccal route offers advantages over oral administration for ganaxolone by avoiding first-pass metabolism and providing direct systemic absorption. This study aimed to formulate and characterise mucoadhesive buccal films of ganaxolone to increase its bioavailability. Methods: Mucoadhesive buccal films were prepared using a solvent casting technique employing HPMC K4M and Moringa gum as polymers. The formulation was optimized using a 3²-factorial design, where polymer concentrations were varied systematically to achieve optimal film properties. Nine batches (OF1-OF9) were formulated and evaluated for various physicochemical parameters, mucoadhesive strength, percentage drug content, goat buccal mucosa permeation study, and stability analysis. Results: Based on the findings, the OF8 batch containing optimal polymer ratio (250mg HPMC K4M and 60mg Moringa gum) emerged as the superior formulation with 94.45±0.34% drug content, 15.37±0.58 N/mm² tensile strength, and 7.8±0.57 N mucoadhesive strength. Permeation studies consequently confirmed 96.37% of the drug at 8 hours with a 13.63 µg /cm² /h permeation rate. There was no evidence of drug-excipient interaction in FTIR and DSC analysis. The formulation was set to be stable for 6 months at accelerated conditions (40±2°C, 75±5% RH) with an average tensile strength above 15 N/mm² and an average ex-vivo drug permeation of 93%. Conclusion: This optimized buccal film formulation demonstrates promising potential for clinical application in CDD treatment by offering enhanced bioavailability, controlled release, and patient-friendly administration, which is particularly beneficial for pediatric patients.

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