Development, in vitro Evaluation, and in vivo Study of Adhesive Buccal Films for the Treatment of Diabetic Pediatrics via Trans Mucosal Delivery of Gliclazide.

OBJECTIVE

Development and evaluation of bucco-adhesive films of Gliclazide for pediatric use.

METHODS

Sixteen films were formulated using a different combination of Gelatin, Hydroxy propyl methyl cellulose (HPMC), polyvinyl alcohol, Hydroxy propyl cellulose (HPC), chitosan, polyethylene glycol, sodium alginate, and carbopol. Compatibility study for drug and polymers was conducted using differential scanning calorimetry method and Fourier transform infrared spectroscopy. All films were examined for drug content, weight variation, thickness, swelling index, muco-adhesion and folding endurance. In vitro drug release has been completed for two hours. Stability studies were conducted at 4°C, 25°C, and 40°C for selected films. The optimized formulation based on in vitro data was selected for a bioavailability study in rabbits.

RESULTS

The selected film formula (carbopol 2%, HPMC 2%) did not demonstrate interactions between the drug and polymers, while it showed accepted content, muco-adhesion, and mechanical properties. The in vitro release study showed rapid and complete release of drug from films. Stability studies confirmed accepted stability of the selected film at 4°C and 25°C, but the film get hard with few particles at 40°C. The bioavailability studies conducted showed that there was 2.1 fold increase in the AUC of selected film compared with oral tablets.

CONCLUSION

Bucco adhesive films of Gliclazide is a promising dosage form for the treatment of diabetes in children.