Preparation and Optimization of Multi-Functional Directly Compressible Excipient: An Integrated Approach Of Principal Component Analysis And Design Of Experiments.

Preparation and Optimization of Multi-Functional Directly Compressible Excipient: An Integrated Approach Of Principal Component Analysis And Design Of Experiments. Drug Dev Ind Pharm. 2020 Oct 23;:1-44 Authors: Mori D, Rathod P, Parmar R, Dudhat K, Chavda J Abstract Developing a new excipient and obtaining its market approval is an expensive, time-consuming, and complex process. The application of multivariate analytical approach - principal component analysis (PCA) in combination with DoE approach can make the process of developing co-processed excipient cost-effective and rapid. The present investigation was aimed to demonstrate the applicability of the DoE approach and PCA in developing a co-processed excipient by using spray drying technique. The preliminary studies suggested a significant effect of inlet air temperature (X1) and polymer ratio (Chitosan chlorhydrate (CC): mannitol - X2) on critical product characteristics so they were selected as independent variables in 32 full factorial design. The result of regression analysis suggested a significant effect of both independent variables on all response variables. The PCA of practically obtained value suggested a strong effect of all the selected response variables on the model. The prepared co-processed excipient had better tableting properties compared to the physical mixture of excipients and was able to accommodate more than 80 percent drug without compromising the flow pro...
Source: Drug Development and Industrial Pharmacy - Category: Drugs & Pharmacology Tags: Drug Dev Ind Pharm Source Type: research