Background:
Developing a new excipient and obtaining its market approval is an expensive,
time-consuming and complex process. Compared to that, the co-processing of already approved excipients
has emerged as a more attractive option for bringing better characteristic excipients to the market.
The application of the Design of Experiments (DoE) approach for developing co-processed excipient
can make the entire process cost-effective and rapid.
Objective:
The aim of the present investigation was to demonstrate the applicability of the DoE approach,
especially 32 full factorial design, to develop a multi-functional co-processed excipient for the
direct compression of model drug - cefixime trihydrate using spray drying technique.
Methods:
The preliminary studies proved the significant effect of atomization pressure (X1) and polymer
ratio (microcrystalline cellulose: mannitol - X2) on critical product characteristics, so they were
selected as independent variables. The angle of repose, Carr’s index, Hausner’s ratio, tensile strength
and Kuno’s constant were selected as response variables.
Result:
The statistical analysis proved a significant effect of both independent variables on all response
variables with a significant p-value < 0.05. The desirability function available in Design Expert 11®
software was used to prepare and select the optimized batch. The prepared co-processed excipient had
better compressibility than individual excipients and their physical mixture and was able to accommodate
more than 40 percent drug without compromising the flow property and compressibility.
Conclusion:
The present investigation successfully proved the applicability of 32 full factorial design as
an effective tool for optimizing the spray drying process to prepare a multi-functional co-processed
excipient.
