QUALITY BY DESIGN APPROACH FOR DEVELOPMENT OF AZITHROMYCIN ORAL RECONSTITUTABLE SUSPENSION AND ITS COMPARISON WITH MARKETED PRODUCT

Devika Sonawane*, Dr. Pravin Chaudhari, Vikas Thorat and Shrikant Dhavale

ABSTRACT

The aim of this work was to develop stable suspension containing Azithromycin was suitable for large scale manufacturing. The product developed by QbD was found comparable with marketed product. The present investigation concerns with the evaluation of the effect of formulation variables on viscosity and phase separation volume in developing stable reconstitution suspension containing azithromycin by applying Quality by Design. The quality by design (QbD) approach was applied for optimizing the formulation of Azithromycin dry powder for oral suspension using Design-Expert Software (version 10.0 state ease, USA).A Central Composite Design (CCD) was employed in formulating the suspension containing Xanthan Gum (XG) and Hydroxy Propyl Cellulose (HPC). To optimize this formulation a Quality Target Product Profile (QTTP) was established in which Critical Quality Attributes (CQAs) such as viscosity and phase separation volume quantified. As Critical Process Parameters (CPP) that was evaluated for their effect on the CQAs the percentage of XG and the percentage of HPC were chosen.CCD was used to evaluate the effects of the CPPs on the CQAs of the final product. The main effect and interaction terms were evaluated by quadratic model to predict formulation with the desired viscosity and phase separation volume. The concentration of suspending agent and its quadratic term were found to be significantly effective for all the response variables.

Keywords: Azithromycin, Reconstitution suspension, Quality by Design, Design of Experiment.