Published Paper Details:

All pharmaceutical products are formulated to specific dosage forms for drugs to be effectively delivered to patients. The major advantages of using design of experiments (DOE) are to develop and optimize manufacturing processes and control, increase the accuracy of performance and reduce the number of required tests. DOE takes into account all input variables simultaneously, systematically, and efficiently. Each single input variable and multi-variables interaction can be evaluated and their effect(s) on each response variables can be identified. The aim of this research is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The scientific approach may be used with identification of the desired dosage form a performance attributes through the target product profile. From this target product profile, an initial list of critical quality attributes was developed. A risk assessment was undertaken to identify the variables and unit operations which are most likely to impact the critical quality attributes. Once the significant parameters identification, they can be further studied (using design of experiments model) to achieve a higher level of process understanding. This was then used to focus development activities on potential high risk areas.