Design and Statistical Optimization of Fast-Dissolving Buccal Films of Doxylamine Succinate for Allergy Treatment

Aim and Objectives

The present work aimed to prepare a FDBF with a fixed dose of Doxylamine succinate. This film provides fast relief from sudden allergic reactions.

Materials and Methods

FDBF were produced employing a technique known as solvent casting. Eight different formulations were tested in an experiment where we varied three factors: X1-PVA concentration, X2-PVP concentration and X3-PG concentration. The two responses were: Y1-disintegration time (sec) and Y2-cumulative drug release (%). Each formulation was subjected to a range of evaluations, including weight variation, folding endurance, thickness, drug content and in vitro studies. Statistical analysis of the responses was performed using Design Expert software version 13.0 trial edition.

Results

All the formulations of the films were transparent, non-sticky and could be easily peeled off. They satisfactory exhibited all the evaluation parameters. The concentration of the PVA, PVP and PG was observed to significantly influence on both the disintegration time and drug release. The optimized formulation OF1, dissolved in 68 sec and drug released at 71.5%. Ex vivo testing on goat buccal mucosa showed a drug release rate of 73.3%. The results of the short-term stability test of optimized formulation OF1 according to the International Council for Harmonization guidelines confirmed that the product stays stable for one month at temperature of 30°C±2°C and relative humidity of 65%±5%.

Conclusion

Based on these results, it can be concluded that FDBF present a promising drug delivery approach for DOXS bypassing first-pass metabolism. This facilitates rapid drug permeation, improving absorption and bioavailability.