Formulation and study of nebivolol containing orodispersable tablets

Abstract In case of chronic diseases patient compliance to long-term treatment is of utmost importance. Patient compliance is generally higher for pharmaceutical forms dispersing in the oral cavity. One classic example for long-term therapy is hypertension. The aim of this study is to obtain nebivolol hydrochloride containing orally disintegrating tablets. As manufacturing technology, direct compression was chosen and rapid disintegration was aimed to be achieved using superdisintegrants. Various formulae have been developed, containing Kollidon and Polyplasdone in different concentrations, and the obtained dry powder mixtures were studied for their rheological properties. Afterwards these mixtures were compressed to obtain tablets. Active ingredient was embedded in the formulations with the shortest disintegration times (15 and 18 seconds) and the obtained tablets were studied for disintegration time, mechanical resistance, drug content and dissolution. Our results show that the pharmaceutical formulations containing Kollidon CL 5% or Polyplasdone XL 3% fulfill the requirements of orally disintegrating tablets, having a disintegration time under 3 minutes, proper mechanical resistance (greater than 80N) and the dissolution of the active ingredient is greater than 80% in 30 minutes.