Ultra–fast disintegrating ODTs comprising viable probiotic bacteria and HPMC as a mucoadhesive

Abstract

Orodispersible tablets (ODTs) are a convenient dosage form and a recent trend in formulation development. The fast disintegration is accompanied by rapid removal of the active principle and the excipients from the mouth due to saliva flow and swallowing. Probiotic bacteria are a promising strategy to fight disease with bacterial aetiology in the mouth, but a certain residence time in the oral cavity is inevitable to exert their positive effects. The addition of a mucoadhesive polymer, like hydroxypropyl methylcellulose (HPMC), is an auspicious strategy to prolong this residence time. Nevertheless, the disintegration time of the tablets should still meet the acceptance level from the FDA (<30 s). To reach intimate contact of bacteria and mucoadhesive polymer on the one hand and to support fast disintegration on the other hand, granulation of probiotic bacteria and mucoadhesive HPMC with a methacrylic acid copolymer was performed first. Moreover, high mucoadhesion could be obtained because bacteria and mucoadhesive polymer could interact more strongly with the mucosa after the ODT disintegrated and the methacrylic acid copolymer dissolved in the pH neutral saliva.