Formulation of orodispersible tablets containing paracetamol and their in vitro characterization – a QBD approach

Abstract

Quality by Design (QbD) concept in drug formulation and development was introduced in order to achieve and ensure a proper product quality through a good process understanding. By identifying the variability sources that influence the product characteristics, the product quality can be built from the development phase. By applying this concept, in the present experimental work was intended to develop and evaluate orodispersible tablets (ODTs) with paracetamol. In order to reach a good balance between their properties: quick disintegration, convenient hardness and a fast drug release, a statistical method was used. 36 formulations were prepared according to a D-optimal experimental design. The formulation factors used in the design were: the type of the diluent agent, the type of disintegrate agent, and the percentages of the disintegrant, sweetener and flavour. The obtained tablets were analysed in vitro for their friability, disintegration time, wetting time and dissolution profile. During this experiment it was observed that the mechanical properties were mainly influenced by the type of diluent agent used, the disintegrant agent and it’s ratio in each formulation. The percentage of sweetener and flavour also influenced the dissolution profile, beside the other formulation variables. QbD approach was successfully applied within this study and the ODTs with paracetamol that have desired pharmaceutical characteristics may be successfully prepared.