Use of risk assessment and Plackett-Burman design for developing resveratrol spray-dried emulsions: A quality-by-design approach

Abstract

In this study, the resveratrol spray-dried emulsions were developed using a quality-by-design approach. Further, the product and process factors that affected the quality of the spray-dried emulsions were analyzed and illustrated using an Ishikawa diagram. The product and process risks were prioritized using a risk-ranking system. The low methoxyl pectin (LMP) amount, caprylic/capric glyceride (CCG) amount, homogenization time, homogenization speed, inlet temperature, pump speed, drying airspeed, and de-blocking speed were observed to be the eight highest risk factors. Further, the criticality of these eight factors on the responses was determined using the Plackett–Burman design. Increasing the LMP amount increased the particle size, whereas increasing the CCG amount enhanced the drug-loading capacity and drug dissolution at 5-min intervals (Q5) and decreased the moisture content. Q5 was positively affected by the homogenization speed and pump speed; however, it was negatively affected by the LMP amount. The spraying efficiency was affected by the pump speed and the LMP amount. Further, the risk level of the homogenization time, inlet temperature, drying airspeed, and de-blocking speed were reduced. However, the LMP amount, CCG amount, homogenization speed, and pump speed were observed to remain at high risk and require further investigation. The risk assessment and Plackett–Burman design mitigated the risks and identified the critical factors that affected the quality of the resveratrol spray-dried emulsions and the spray-drying process.