Applications of β-limit dextrin as a matrix forming excipient for fast disintegrating buccal dosage formats.

Purpose: To compare the properties of buccal delivery matrices (wafers) made with dextrin, β-limit dextrin and pre-gelatinised starch.

Methods: The constituent α-glucans were tested for their mucoadhesive properties in solution plus their content of crystalline material (differential scanning calorimetry, DSC). Wafers were made by lyophilisation of aqueous solutions/dispersions of the α-glucans. Physical properties of the wafers were evaluated using texture analysis, dissolution coupled to photography and scanning electron microscopy (SEM).

Results: The results highlighted how the β-limit dextrins chemical and physical properties were ideally suited for the production of buccal delivery wafers. Dissolution testing confirmed the excellent hydration profile of the β-limit dextrin (within wafers) with time. Using SEM it was evident that the homogeneous "bee-hive" like structure of the β-limit dextrin wafers, unlike the other α-glucans, provided a rapidly hydratable strong porous matrix.

Conclusions: The β-limit dextrin α-glucan makes a superb (lyophilised) mucoadhesive delivery structure for the delivery of active agents to the buccal mucosa.