Formulation and evaluation of buccal films loaded with insulin encapsulated in glucose responsive amphiphilic dendrimer micelles.

The objective was to prepare a mucoadhesive buccal film containing amphiphilic dendrimer micelles nanoparticles (APD micelles NPs) loaded with insulin. The APD micelles NPs were synthesized by a series of chemical reactions followed by self-assembly. Insulin loading was done by mixing insulin with APD micelles solution. A mucoadhesive buccal film was prepared using solvent casting method. Stability of the buccal film after 3 months of storage in a refrigerator was investigated in terms of viscosity, drug loading, FTIR, in vitro drug release and morphology. The APD micelles NPs had good encapsulation efficiency and good loading capacity. FTIR results showed no interaction with the drug. In vitro release of insulin was glucose sensitive, increasing with time and with glucose levels and sustained for 8-10 h. The Loaded buccal film showed good physical appearance, excellent folding endurance, good mucoadhesive and tensile strength, neutral surface pH, acceptable thickness and weight. Insulin release from buccal film was not affected by the extra barrier. The stability study indicated that the film did not show any changes. In conclusion, APD micelles NPs were able to control insulin release according to glucose levels. The buccal film is expected to enhance the bioavailability of insulin compared to oral administration.