Abstract
Experimental results pertaining to natural pharmaceutical complex products (NPCPs) often exhibit large variabilities in their associated response variables. To improve the quality of an NPCP, systemic studies (i.e., statistical analysis and mathematical optimization), including variability analysis and robust optimization, are often required. To this end, a systemic approach for an NPCP development process is proposed by integrating robust design and optimization methodologies. A quality function deployment method can be used to systematically define a standardized manufacturing process and relevant process variables for Chong Kun Dang (CKD)-497. Based on those variables, an experiment is designed using response surface methodology to mathematically estimate the output response functions associated with input variables. In addition, a design space (DS), which can guarantee the quality of an NPCP, is demonstrated by utilizing the overlaid contour plots of the estimated response functions. Finally, a CKD-497 case study is conducted for verification and validation.
Highlights
We propose a robust optimization approach based on design of experiments (DoE), which may be widely used in many industries and in medicine to achieve the target quality of Chong Kun Dang (CKD)-497
We have proposed input variables (IVs) conditions to optimize the output response variables (ORVs) based on a DoE approach to achieve the target quality of CKD-497 and have verified the optimization results through Reproducibility experiments (RE)
By comparing and analyzing the results of previous experiments and RE from different aspects, it was confirmed that the inherent variability occurring in natural substances could be reduced through process optimization techniques
Summary
Product quality in the pharmaceutical industry is increasingly being recognized as important by researchers and companies. Stringent regulations, such as good manufacturing practice (GMP) and quality by design (QbD), were proposed and applied in the pharmaceutical industry to improve drug quality. To comply with GMP and QbD regulations, many pharmaceutical industries have undertaken several methods, such as quality factors and process improvement activities [1]. The manufacture of natural pharmaceutical complex products (NPCPs) requires much effort as natural substances, which are the main constituents of NPCP, generally exhibit considerable variability in their properties that cannot be controlled . This study targets Chong Kun Dang (CKD)-497 as NPCP under development in CKD Pharm
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