Development and evaluation of herbal supplement: A quality by design approach

Abstract

The present study aims to develop Herbal Antioxidant Supplement by using Quality by Design approach. Quality target product profile for Herbal Antioxidant Supplement was defined and critical quality attributes were identified. Initial Risk assessments of critical materials were done by employing Risk Priority Number. The effects of critical parameters (concentration of starch and croscarmellose sodium) were investigated by executing design of experimentation using Central Composite Design. The optimized formulation was evaluated for Antioxidant activity by in-vitro model like free radical scavenging by 2, 2-Diphenyl-1- picrylhydrazyl method. It was observed that formulation variables X1: Starch and X2: Croscarmellose sodium showed significant effect on the response Y1: Disintegration time (min) and response Y2: Friability (%). The Formulation comprising starch-30 mg/tab and Croscarmellose sodium-30mg/tab fulfils the criteria of quality target product profile and Certified Quality Auditor for Herbal Antioxidant Supplement. In-vitro antioxidant screening revealed that the developed Herbal Antioxidant Supplement has proved to show pronounced antioxidant activity. This study confirmed that quality by design is an effective approach for understanding the quality parameters for optimizing Herbal Supplement.