Manufacturing and characterisation of a novel composite dosage form for buccal drug administration.

The potential of alternative routes of application compared to the traditional oral route is constantly growing. Especially in transmucosal applications for the oral cavity, easy accessibility is an attractive feature with many new opportunities. The combination of a minitablet and a buccal mucoadhesive carrier film has been shown to enable safe and accurate drug administration compared to semi-solid formulations currently available on the market. In order to investigate these so-called composite dosage forms in more detail, two different manufacturing methods were compared within this study to investigate the resulting properties. The formulation development of the minitablets containing lidocaine, complying with the compendial requirements, resulted in immediate release using both manufacturing methods (more than 80% lidocaine release after 3-4 min using direct incorporation, 7-8 min by the gluing method). Differences in morphology and drug migration behaviour could be observed. The directly incorporated minitablets revealed a twofold higher drug migration (1.5 mm) into the mucoadhesive shielding film within two weeks compared to the glued minitablets (0.8 mm). These findings enable a further optimization of the formulation depending on the duration of the application and the feasibility for the addressed patient population.