Extraction, development, and ex-vivo evaluation of thermoresponsive mucoadhesive in-situ nasal gel incorporating Lablab purpureus mucilage and Pluronic F127 for enhanced intranasal delivery of Diclofenac Sodium.

OBJECTIVE

This study aimed to develop and evaluate a thermoresponsive, mucoadhesive in-situ nasal gel using Lablab purpureus mucilage and Pluronic F127 for intranasal delivery of Diclofenac Sodium to enhance bioavailability by bypassing first-pass metabolism, improving mucosal retention, and minimizing irritation.

SIGNIFICANCE: Incorporating L. purpureus mucilage with Pluronic F127 yields a stable, mucoadhesive gel enhancing Diclofenac nasal delivery.

METHODS

Twelve formulations containing varying ratios of L. purpureus mucilage, HPMC K-100, Carbopol 940, Pluronic F68, and Pluronic F127 were evaluated for pH, viscosity, gelling behavior, mucoadhesion, and drug content. In-vitro release, permeation, kinetic modeling, 6-month stability, and histopathological safety on goat nasal mucosa were also assessed.

RESULTS

Formulations showed pH 5.82 ± 0.02-6.52 ± 0.02, viscosity 97.63 ± 0.63 cP (25 °C) to 220.67 ± 1.21 cP (37 °C), and gelling temperatures 29.8 ± 0.21 -41.9 ± 0.52 °C. Mucoadhesive strength ranged from 3011.89 ± 1.21 to 6679.89 ± 0.45 dyne/cm2, with drug content 87.8 ± 0.3-97.7 ± 0.8%. FA6 exhibited 95.8% release and 96.8% permeation following first-order kinetics, while FB6 followed the Korsmeyer-Peppas model.

CONCLUSIONS

FA6 demonstrated optimal mucoadhesion, permeation, and stability, confirming strong potential as an effective thermoresponsive nasal delivery system for Diclofenac Sodium.