Preparation and Optimization of Directly Compressible Excipient Using Design of Experiment Approach

Abstract

Introduction: Excipients are a vital part of any pharmaceutical formulation which also effects its efficiency. To improve the formulation aspects an excipient with desired characteristics is required. There is always a need for better excipients to improve the formulation parameters which makes excipient improvement research inevitable. As it is very difficult to develop new excipient, co-processed excipients can fill the gap.

Objective: In the present study the aim is to develop an optimized novel co-processed excipient of mannitol and microcrystalline cellulose using spray drying technique.

Methods: In the present study microcrystalline cellulose and mannitol are chosen as excipients to be co-processed by spray drying process. 32 factorial design was applied to develop an optimized co-processed excipient which is then compressed in tablets by incorporation of drug zaltoprofen.  The tablets are then subjected to various evaluation parameters.

Results: It has been found that the particle size of co-processed excipient of microcrystalline cellulose and mannitol was found to be 212 ± 2.2 µm and the dilution potential was found up to 80%. Disintegration time of prepared tablets was less than 8 minutes and in vitro drug release of optimized batch was 95% in 25 minutes.

Conclusions: The optimized co-processed excipient using factorial design approach was successfully prepared and found to be superior in all the properties as compared to physical mixture. The zaltoprofen tablets have shown a release of 95% within 25 minutes.